cyrilzakka/clinical-trials huggingface dataset:
Entecavir Prophylaxis for Hepatitis B Reactivation for CD20 Positive B-cell Lymphoma Patients With Resolved Hepatitis B (Negative Hepatitis B Surface Antigen, Positive Hepatitis B Core Antibody)

This phase 2 trial aims to evaluate the efficacy of entecavir prophylacxis for hepatitis B virus (HBV) reactivation that continues until 6 months after completing CD20 monoclonal antibody therapy in patients with CD20-positive B-cell lymphomas and resolved hepatitis B (negative hepatitis B surface antigen, positive hepatitis B core antibody).


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed CD20 positive B-cell lymphoma;
* Plan to receive first-line anti-lymphoma therapy containing CD20 monoclonal antibodies;
* Negative HBsAg, HBV-DNA lower than the detection limit and positive anti-HBC at baseline;
* Total bilirubin less than 1.5X the upper limit of normal (ULN), AST and ALT less than 2.5X ULN;
* ECOG PS: 0\~2;
* Estimated survival time \>3 months.

Exclusion Criteria:

* Positive HBsAg or HBV-DNA higher than the detection limit at baseline;
* Previous chemotherapy or radiotherapy for lymphoma;
* Other primary liver diseases, such as chronic hepatitis C, hepatitis D, autoimmune hepatitis, Wilson' s disease or primary biliary cirrhosis;
* Pregnant or lactating women;
* History of immunodeficiency, including positive HIV, or other acquired congenital immunodeficiency disease, or history of organ transplantation.
Protein Requirements In Active Populations

Protein requirements in active individuals have been suggested to be greater than the current recommended dietary allowance (RDA).

Nutritional requirements for dietary amino acids in adults have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity.

Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than the RDA based on nitrogen balance data.

The purpose of this study is to measure the protein requirement in active, young adult males using the IAAO technique in the presence of a variable intensity exercise stimulus.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, active, young adult males who regularly participate in moderate-vigorous activity 5x per week, for a minimum of 1 hour
* A minimum score of 10 on the Beep Test (a measure of aerobic fitness)

Exclusion Criteria:

* Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+)
* Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
* Regular tobacco use
* Illicit drug use
Treatment of Resistant Hypertension by Renal Sympathetic Denervation in Patients Undergoing Dialysis Therapy

The study is designed to investigate the efficacy of renal nerve denervation in treating drug-resistant hypertension in patients with end stage renal disease.

Drug resistant hypertension is very common in end stage renal disease treated by dialysis. The prevalence of hypertension has been evaluated to be over 50% and up 80%. In this patient group mortality figures are high because of cardiovascular diseases which are complications of hypertension. Renal nerve denervation is a new intervention to treat hypertension. By applying radiofrequency pulses to the renal arteries, the nerves in the vascular wall (adventitia layer) can be denervated. This causes reduction of renal sympathetic afferent and efferent activity and blood pressure can be decreased. The technique and its efficacy in end stage renal disease has not been systematically studied. There are case reports which have showed promising responses to denervation. In the present study 30 patients over 18 years are planned undergo renal denervation if the medical treatment (three different drugs including diuretics) has failed to decrease blood pressure sufficiently(160/100mmHg). The failure of medical treatment will be documented by ambulatory blood pressure measurements. After renal nerve denervation a two year follow-up of patients with ambulatory blood pressure measurements will be organized. The blood pressures before and after denervation are compared and the quality of life of the patients is evaluated by questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* patients with end stage renal disease and drug-resistant blood pressure.

Exclusion Criteria:

* pregnancy
* secondary hypertension
* unstable coronary artery disease
Pelvic Floor Displacement in Women With SUI and Healthy Women: An Ultrasound Study (Stress Urinary Incontinence)

Pelvic floor main role is to maintain continence. pelvic floor malfunction could lead to urinary incontinence (UI). The known prevalence of UI among women is 25%-72%, in about 25%-50% it is Stress Urinary Incontinence (SUI), SUI prevalence changes with age and obstetric history. SUI is the complaint of involuntary leakage on activities which involves inter abdominal pressure rase, such as effort or exertion, or sneezing or coughing. pelvic floor movement is coordinated with the diaphragm, it moves caudally while inhaling and cranially while exhaling. it was shown that cranial sagittal displacement of the pelvic floor is correlated to pelvic floor normal and efficient function. in order to maintain continence while internal abdominal pressure rises the pelvic floor as to work in a precise trajectory, timing and force. observing the Urinary bladder by trans abdominal ultra sound (TAUS) was found as a valid and reliable way to estimate pelvic floor sagittal displacement and function.

50 women between the age 25-50 with a history of one vaginal delivery will be recruited for the study. 25 women who complain about stress urinary incontinence (research group) and 25 healthy women (control group). all research participants will sign first a participant consent form. all participants will be interviewed about their own delivery, measured for weight and height and follow a trans abdominal ultra sound (TAUS) examination. the research group participants will be asked to fill a quality of life questionaire concerning their SUI complaint.

at the TAUS examination the participant will be asked to perform:

1. 3 times quiet breathing.
2. 3 times forced exhalation.
3. 3 times cough. while doing so an ultra sound image of the urinary bladder will be saved for displacement measurements.

Eligibility Criteria:
Inclusion Criteria:

* women after one vaginal delivery on term.
* women aged 25-50
* members of 'macabi medical services'

Exclusion Criteria:

* pregnancy
* nulliparous women
* women who had C section delivery
* known neurologic disease
* previous history of pelvic or back surgery
* previous history of pelvic fracture
* known pulmonary disease
* active urinary tract infection
A Safety, Tolerability and Preliminary Pharmacokinetics of BILR 355 BS Single-rising Dose Study in Healthy Male Volunteers

Assessment of safety, tolerability and preliminary pharmacokinetics in healthy male volunteers after oral administration of BILR 355 BS


Eligibility Criteria:
Inclusion Criteria:

All participants in the study should be healthy males, ranging from 21 to 50 years of age and their body mass index (BMI) be within 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters).

In accordance with Good clinical practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
* Any laboratory value outside the clinically accepted reference range
* Excessive physical activities within the last week before the trial or during the trial

Following exclusion criteria are of special interest for this study:

- Erythema, exanthema and comparable skin alterations
Disease Burden of RSV

Respiratory diseases are one of the leading causes of morbidity and mortality among young children, and respiratory syncytial virus (RSV) is the most common pathogen causing these respiratory diseases in this age group. RSV can present in the form of a variety of clinical syndromes, including upper respiratory tract infections, bronchiolitis, pneumonia, exacerbations of asthma and viral-induced wheeze. RSV is highly seasonal and occurs mostly during winter seasons in temperate climates. Sixty to seventy percent of all children experience an RSV infection before the age of one, and nearly all do so before the age of two.(

'Burden of disease' is a general term without a universally accepted definition and refers to the human and economic costs that result from poor health. RSV 'burden of disease' studies in young children (aged 0-4 years), have mostly been focused on the morbidity and mortality rates of RSV infections. The socio-economic burden of RSV infections in young children has been studied, however, a meta-analysis showed that of the 365,828 RSV disease episodes included in cost-analysis studies, only 27,286 (7.4%) focused on outpatient and emergency cases. To our knowledge, only two outpatient studies have prospectively investigated the clinical and socio-economic burden of laboratory confirmed RSV infections in young children; and both studies collected data in the early 2000s. More recently, one study has investigated the health care use, duration of illness and complications associated with RSV in a cohort of newborn infants. There is therefore a lack of knowledge on the clinical and socio-economic disease burden of RSV infections in young children in primary care.

Current treatment options for RSV infections are limited to supportive care. The only available antiviral monoclonal antibody (mAb) 'Palivizumab' is considered cost-effective for certain high-risk group infants and requires monthly injections during winter. New candidate RSV vaccines and mAbs (with longer half-life times) are in late-stage clinical trials. Therefore, accurate estimates of the burden of RSV infections, including in primary care, are crucial to better assess the overall impact RSV infections may have on the society.


Eligibility Criteria:
Inclusion Criteria:

1. Age \<5 years
2. Consulting a primary care practitioner with symptoms of an acute respiratory infection (ARI)
3. Participation agreement of at least one of the two parents/legal guardians before intervention

Follow-up criterion

1) Sampled children with a lab-confirmed diagnosis of RSV.

Exclusion Criteria:

1. Signs of severity (moderate to severe respiratory distress, oxygen saturation SpO2 \< 92%, dehydration, Glasgow \< 13) for children \< 3 month-old in emergency department
2. No consultation with a doctor in the previous 24 hours
3. Insufficient knowledge about the national language by the parents/legal guardians
4. Intellectual disabilities of the parents/legal guardians
5. Special personal circumstances in the family (based on the judgement of the primary care physician e.g. a recent death in the family)
Ceftriaxone in the Management of Bipolar Depression

We aim to study the efficacy of intravenous ceftriaxone in a four-week, inpatient, placebo-controlled, double-blind study, as an augmentation therapy in patients with bipolar disorder, currently depressed, who have failed to respond to conventional treatments.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of bipolar disorder
* Presence of a current major depressive episode on the SCID
* Score of 17 or greater on the HDRS
* Failure to respond to two previous medication trials
* Capable of giving voluntary written consent

Exclusion Criteria:

* Hypersensitivity to penicillin or cephalosporin, resulting in anaphylaxis
* Significant current substance dependence/abuse within 3 months preceding the trial
* Significant history of intravenous drug abuse
* Active suicidal ideation
* Pregnant/lactating mothers
* Significant medical history
* Patients on anticoagulation treatment
* Patients who test positive for HIV or Hep B or C
Risk of Positive Doping Tests Following Ingestion of Supplements Contaminated With Trace Quantities of Nandrolone Metabolites

There is compelling evidence that some dietary supplements consumed by the general population are manufactured and stored under conditions that lead to contamination of the end product with small amounts of extraneous materials. In most cases, this is harmless, but for athletes liable to drug testing as a consequence of their participation in sport, the potential consequences of even trivial amounts of a prohibited substance may be catastrophic. Quality control procedures for pharmaceutical products normally specify the absence of contaminants at a level of more than 0.1%, ie 1mg/g. However, in the case of an anabolic steroid such as nandrolone, the amount that will cause a positive test has been estimated to be about 1-3µg (Geyer et al, 2004). In the case of a supplement that is taken in high doses (20-30 g/d), such as for example creatine, this means that a contamination level of something closer to 0.00001% (ie 1µg/g) may cause a positive test. This work have been supported by recent findings from our laboratory (Judkins et al, 2006). These data demonstrate that as little as 10μg of 19-noradrostenedione (19-NorAD) added to a creatine supplement resulted in a positive doping test in all volunteers testing. This is one thousand times less that the purity level specified for pharmaceutical agents and at this level, these contaminants are without any pharmacological action.

Proposals are under development to regulate the sale of dietary supplements for use by athletes to avoid accidental doping positives as a result of ingestion of contaminated supplements. This requires a knowledge of the amounts of contaminant that is likely to cause problems. The aim of the present study was to examine the urinary excretion pattern of nandrolone metabolites following 1µg, 2.5µg and 5µg doses of 19-norandrostendione in both male and female subjects. The quantity of 19-norandrostenedione administered in this study is representative of the amount previously reported as an undeclared contaminant in some dietary supplements. Given the speculation surrounding positive doping cases being attributed to ingestion of sports supplements contaminated with pro-hormones, this presents an important consideration for both athletes and doping agencies, as well as supplement manufacturers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers aged between 18 - 35 years of age

Exclusion Criteria:

* Any potential participant competing in sport at a level where there is even a remote possibility of being called for a drugs test was excluded
Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)

The primary objective of this study was to assess the proportion of participants in the infliximab plus naproxen arm versus the placebo plus naproxen arm, in a population of participants with moderate-to-severe active axial spondyloarthritis and disease duration of ≤3 years, who achieve the Assessment in Ankylosing Spondylitis (ASAS) partial remission criteria.

In the 28-week treatment phase, participants were randomized to receive either infliximab plus naproxen or placebo plus naproxen.

After 28-weeks of treatment, participants that achieved partial remission in the treatment phase were randomized to continued treatment with naproxen or to receive no treatment and were followed for an additional 24 weeks (follow-up phase).

Eligibility Criteria:
Inclusion Criteria:

Participant must:

* be 18 to 48 years of age
* have diagnosis of active axial spondyloarthritis, with disease duration of less than or equal to 3 years.
* have active disease during trial enrollment
* have limited treatment history for axial spondyloarthritis (must meet certain criteria)
* agree to an acceptable method of contraception (for women of childbearing potential and all men)
* must meet certain tuberculosis screening requirements
* must meet certain laboratory screening safety requirements
* have an x-ray of the sacroiliac joints available from within the previous 12 months (or have one performed during the Screening visit if site is outside of Germany).

Exclusion Criteria:

Participant will be excluded:

* for certain medical conditions and/or recent history of certain medical disorders
* for current or recent treatment with certain other medications and certain vaccinations.
* for being a woman who is breastfeeding, pregnant, or intending to become pregnant.
* if known to have had a substance abuse problem within the previous 3 years prior to screening.
* if currently participating in any other clinical study.
* for other administrative reasons.
Cumulative Irritation Test

The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.

Healthy, adult volunteers of either sex will be patched daily on his/her back with multiple strengths of AN2718 in 2 different topical dosage forms and an active comparator over the course of 21 consecutive days. Twenty-four hours after each application, the patches will be removed and the site evaluated using a five-point scale for irritation.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following criteria for inclusion in the study.

1. Healthy volunteers of either sex, at least 18 years of age or older.
2. Females must be of non-childbearing potential (i.e., post-menopausal or surgically sterile \[bilateral oophorectomy and/or total hysterectomy\]). All females must submit to a urine pregnancy test and have a negative result at Day 1 and at the final study visit.
3. Subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with making readings of skin reactions.
4. Willingness to follow the study procedures and complete the study.
5. Written informed consent obtained.

Exclusion Criteria:

1. Any skin disease that would in any way confound interpretation of the study results. Atopic dermatitis/eczema, psoriasis will be excluded.
2. Chronic asthma will be excluded.
3. Pregnant or nursing mothers.
4. A history of sensitivity to any component of any of the formulations.
5. Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study.
Discomfort Score Identifies Painfulness During Unsedated Colonoscopy

Some patients felt no pain or only mild discomfort with the unsedated colonoscopy. However, unsedated colonoscopy was thought to be an option for some but not for all. If we could able to identify which patients at high risk for painful colonoscopy in preoperational stage, targeted administration of sedatives or special techniques to these patients would be an attractive option.

Here we prospectively collected the data during colonoscopy and investigated the possible risk factors associated with painful colonoscopy by using a step-wise multivariate regression model. Furthermore we developed a novel point score to predict whether the patients at high risk for painful colonoscopy and targeted offer an appropriate method of colonoscopy or with the aid of special techniques to help the completion of procedure.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent unsedated colonoscopy

Exclusion Criteria:

* (1) no bowel preparation or colon cleansing by enema only; (2) no need to reach cecum; (3) prior finding of severe colon stenosis or obstructing tumor; (4) history of colectomy; (5) unstable hemodynamics; (6) pregnant; (7) unable to give informed consent.
Burger Allen Exercises in Knee OA With Type II Diabetes

There is a potential link between diabetes mellitus (DM) and severity of osteoarthritis .Type 2 diabetes is a part of the metabolic syndrome (Mets) accompanied by ageing and mechanical stress are also a risk factor to osteoarthritis. Every anatomical component of the joint demonstrated faster joint deterioration and elevated inflammation at microcellular environment of individuals with DM. Normal chondrocytes capacity to adapt to the local glucose level is impaired by OA and there is a significant risk of glucose toxicity and increased glucose absorption. The most dependable and effective treatment for mild to early joint osteoarthritis is exercise. Active free exercises i.e. Buerger Allen exercises are used as a conservative perfusion therapy because they rely on how gravity affects the smooth muscles in the valves. Synovial fluid supports the joint's ability to recover while also reducing inflammation and enhancing overall joint function. The aim of the study is to determine the effect of Buerger Allen exercise and low intensity high repetition exercises on pain, range of motion and disability in knee osteoarthritis with type 2 diabetes. The study would be randomized controlled trial. Total thirty-six subjects will be assigned randomly by using lottery randomization into two groups. Group A will receive conventional therapy and an additional Buerger Allen exercise while Group B will be a control group receiving only baseline treatment. Numeric pain rating scale (NPRS), Ankle Brachial Index, KOOS and Goniometer will be used as outcome measure tools for pain, range of motion and disability. Measure will be taken at baseline and at the end of treatment session. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25.0.If data will be normally distributed then parametric if not normally distributed than non-parametric

One of the most common joint conditions, osteoarthritis (OA), causes diarthrodial articular cartilage to deteriorate, which in turn causes disability in adults. Osteoarthritis (OA) and Type 2 diabetes mellitus (T2DM) are common illnesses whose prevalence is projected to increase. The association between diabetes mellitus and OA was originally identified in 1961.After adjusting for body mass index, type 2 diabetes was recently discovered to be an independent risk factor of severe OA, with a Hazard Ratio (HR) of 2.1. One of the most popular forms of exercise for diabetic patients is the Buerger Allen exercise, which improves lower extremity perfusion and alleviates symptoms in those with lower limbs arterial insufficiency by using postural changes, stimulation of peripheral circulation, and application of muscle contraction. It has been found that nurses can prevent foot ulcers and lower limb amputations by educating the public, screening high-risk individuals, and giving medical care.

Eligibility Criteria:
Inclusion Criteria:

* Both Genders from Age:45-65 year

Exclusion Criteria:

* Joint Instability