cyrilzakka/clinical-trials huggingface dataset:
Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

This is an open label, multicenter, exploratory, single arm, two-stage study aiming to explore efficacy and safety of lenalidomide and dexamethasone combination (LD) as first line therapy in previously untreated patients with primary Plasma Cell leukemia (PPCL).

The primary endpoint was response rate according to International Uniform Criteria; secondary endpoints were: i) time to progression (TTP), progression free survival (PFS, and overall survival (OS); ii) percentage of eligible PPCL patients able to mobilize and collect peripheral blood stem cells after LD treatment; iii) percentage of eligible PPCL patients able to undergo autologous or allogeneic stem cells transplantation after LD treatment; iv) serious/severe adverse event (SAEs) rate.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients fulfilling the IMWG diagnostic criteria of PPCL
* Age \> 18 years
* ECOG performance status of 0,1 or 2
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* Myocardial infarction within 6 months prior to enrollment or uncontrolled angina
* Severe uncontrolled ventricular arrhythmias
* ECG evidence of acute ischemia or active conduction system abnormalities
* Female subjects either pregnant or breast-feeding
* Serious medical or psychiatric illness
* Total bilirubin greater than 2.0 mg/dL and/or SGOT or SGPT greater than two and a half times normal (unless due to primary malignancy)
* History of severe hepatic dysfunction
* Active infections or HIV positivity
* Uncontrolled insulin-dependent diabetes mellitus
* Uncompensated major thyroid or adrenal dysfunction
* Hemodialysis or peritoneal dialysis
* Renal dysfunction (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator)
* ECOG performance status of 3 (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator)
Effectiveness of Chlorhexidine Wipe for Prevention of Multidrug-resistant Organisms in Intensive Care Unit Patients

The purpose of this study is to determine 2% chlorhexidine wipes are effective in preventing of colonization of multi-drug resistant bacteria in intensive care unit patients.

The purpose of this study is to evaluate the usefulness of bathing with chlorhexidine wipe to reduce the risks of multidrug resistant bacteria acquisition and hospital-acquired bloodstream infection among ICU patients

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Admission in critical care unit eg. ICU, respiratory care unit, Cardiac care unit with in 24 hours
* Expected duration of critical care unit admission \> 48 hours

Exclusion Criteria:

* History of chlorhexidine allergy
Reliability and Validity of the Elderly Mobility Scale, French Version

This study evaluates the reliability of the French version of the "elderly mobility scale" and its correlation with the "frailty elderly scale "

The research question:

How to effectively measure the physical independence of the elderly at home and how, from this measure, the investigators can determine the fragility threshold of the elderly.

The elderly mobility scale measures the critical points of the patient's physical autonomy. This scale was developed in Great Britain. The purpose of this study is to establish the reliability of this French version scale and to study the correlation with the elderly scale fragility.

People are recruited by a Medical consultant. After consent, their frailty is measured and a prescription is done to see a Physical therapist. The physical therapist will evaluate the physical points measured/ mentioned in the Elderly Mobility Scale, twice in a week, with two different assessors.

Eligibility Criteria:
Inclusion Criteria:

* living at home, more than 70 years old

Exclusion Criteria:

* current recovery for orthopaedic problems
* Cognition impairment
* all acute problems with an impairment of mobility
Cognitive Stimulation in Adolescents

The purpose of this study is to see if computer tasks that challenge the brain (cognitively stimulating tasks) can improve memory and other types of thinking in adolescents and young adults who are being treated for substance use problems. The study will compare the effects of different versions of the computer tasks.


Eligibility Criteria:
Inclusion Criteria:

* age 14-21
* Diagnosis of substance use disorder (SUD) by DSM-IV criteria with marijuana as primary substance of abuse
* eligible for intensive outpatient treatment

Exclusion Criteria:

* Untreated psychiatric disorder that might make participation hazardous
* Any condition associated with severe cognitive impairment
Open Label Study of TRx0014 in Alzheimer's Disease

This is an open label, dose-ranging study of two doses of TRx0014 in patients with mild or moderate Alzheimer's Disease. The trial is made available to any patient ongoing on treatment in the clinical trial designated TRx-014-001 at termination of that study. Treatment for each individual patient will continue for as long as the treating physician feels there is benefit to the patient. This current protocol covers each patient for 12 months in the first instance.


Eligibility Criteria:
Inclusion Criteria:

* The patient may be of either sex and must be supervised by a carer who is competent to ensure compliance with the medication and who is willing to participate in completing the various assessments. The carer must provide written consent to his or her own participation in the study.
* Patients with capacity must give written informed consent to participate in this study. Patients who lack capacity to consent must be in agreement with entering into the study and have a personal legal representative giving written informed consent to their participation.
* The patient must have been ongoing in TRx-014-001 at time of study termination.

Exclusion Criteria:

* There are no exclusion criteria. All patients taking medication at the termination of study TRx-014-001 and who wish to participate are eligible for recruitment.
Evaluation of Immunological Disorders of T Lymphocytes and Endocrinological Disorders as Pathogen Factors in Patients With Metaplasia of Urinary Bladder

Background: Squamous metaplasia refers to the pathological transformation of the urothelium leading to non-keratinised stratified squamous metaplasia (N-KSM).

Objective: To present the investigators experiences in the diagnosis and treatment of N-KSM of the urinary bladder in children.

Design, setting, and participants: In this study, the investigators present their experiences in the diagnosis and treatment of N-KSM of the urinary bladder in children aged from 5 to 17 years. From 2005 to 2013, metaplasia was diagnosed in 119 patients - 116 girls and 3 boys. The reasons behind visiting the hospital were non-specific intense pain in the abdomen, recurrent urinary tract infections, and urination disorders. The most common symptoms of urinary bladder dysfunction were pollakiuria and difficulties in initiating micturition and retention of urine (reduced detrusor muscle activity).

Outcome measurements and statistical analysis: In 20 patients (16.8%), metaplasia was incidentally diagnosed during cystoscopy performed for other causes. Only the children whose bladders showed metaplastic changes on cystoscopy were subjected to a bladder biopsy for collecting specimens for further histopathological examination.

Eligibility Criteria:
Inclusion Criteria:

* The follow-up duration was 1-8 years.
* The main reasons behind visiting the hospital were:

  1. recurrent urinary tract infection,
  2. urinary urgencies,
  3. pollakiuria,
  4. difficulty in initiating micturition,
  5. pain in hypogastrium,
  6. night wetting and day wetting,
  7. menstruation's disorders,
  8. urolithiasis,
  9. defects of urinary system and hematuria.

Exclusion Criteria:

* No confirmation of squamous metaplasia of the urinary bladder in diagnostic cystoscopy
Profile of Soluble and Cellular Biomarkers and of Functional Imaging During Antiangiogenic Therapies in Cancer Patients

Tumour angiogenesis has been identified to play a critical role in tumour growth and this knowledge has led to the identification of new targets for cancer therapy. Multiple angiogenic factors are involved in the regulation of angiogenesis, among them VEGF (vascular endothelial growth factor) and its receptor are of crucial relevance. The inhibition of VEGF signaling by monoclonal antibodies or small molecules (kinase inhibitors) has already been successfully established for the treatment of different cancer entities and multiple new drugs are being tested in clinical trials. The ever-expanding list of antiangiogenic agents being available in the near future will raise the questions when to use which agent and in which sequence. As a consequence biomarkers are going to be indispensible tools for choosing the most effective drugs and to predict dosing and resistance.

The present project is based on an academic clinical trial in which patients suffering from different cancer types (colorectal cancer, non-small cell lung cancer, renal cell cancer and hepatocellular cancer) treated routinely with antiangiogenic agents will be included. Consecutive serum and blood probes will be taken and will be examined and correlated with functional imaging and the clinical course. The following parameters have been selected: soluble markers in the plasma (VEGF, bFGF, ICAM, sVGFR-2 IL-8, SDF1 and Dickkopf 3) and cellular parameters like circulating endothelial cells (CEC) and circulating endothelial progenitor cells (CEPs).

In conclusion, the present project is screening for potential biomarkers and biomarker combinations relevant for antiangiogenic drugs in different tumour types. The predictive value of such profiles should then be evaluated in larger cohorts. In the future such profiles could possibly help clinicians to use these agents more effectively and therefore also more economically.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Patients with HCC, NSCLC, RCC or CRC treated with an approved antiangiogenic drug (bevacizumab, sorafenib, sunitinib)\*
* Patients with at least one measurable lesion. Lesions must be measurable by CT-scan or MRI (Magnetic resonance imaging) according to Response Evaluation Criteria in Solid Tumours (RECIST)

Exclusion Criteria:

* Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate birth control measures during the course of the trial. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
* Known or suspected allergy to the investigational agent or any agent given in association with this trial -_\> allergy
* MRI contraindications: implants (pacemaker)
Pulmonary Rehabilitation in Patients With Chronic Fibrotic Hypersensitivity Pneumonitis

The aim is to evaluate exercise capacity, respiratory functions, respiratory and peripheral muscle strength, inspiratory muscle endurance, physical activity level, quality of life, fatigue, dyspnea, anxiety, depression and investigate the impact of 24-session pulmonary rehabilitation training on these parameters in patients with chronic fibrotic hypersensitivity pneumonitis.

Hypersensitivity pneumonitis is a syndrome that results in the excessive immune response to inhalation of various antigenic particles in the environment. Patients often experience irreversible physiological disorders and severe dyspnea in the future. Common disorders in these patients are lung function abnormalities, decreased exercise capacity, muscle weakness, oxygen diffusion limitation, impaired quality of life, physical inactivity and fatigue. The aim of this study is to evaluate the effects of pulmonary rehabilitation training on exercise capacity, dyspnea, respiratory functions, respiratory and peripheral muscle strength, inspiratory muscle endurance, physical activity level, quality of life, fatigue, dyspnea, anxiety, depression in patients with chronic fibrotic hypersensitivity pneumonitis. The study was planned as a prospective, double-blind, case-control study. At least 30 patients with hypersensitivity pneumonitis will be included in the study. The cardiopulmonary rehabilitation program will be included inspiratory muscle training, upper extremity aerobic exercise and progressive resistance training will be performed in the exercise training group during 24 sessions. Alternative upper extremity exercises combined with breathing exercises will be performed in the control group. Functional exercise capacity, respiratory functions, respiratory and peripheral muscle strength, inspiratory muscle endurance, physical activity levels, quality of life, fatigue, dyspnea, anxiety and depressions will be evaluated before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable
* Under standard medication
* 18-80 years of age
* Patients diagnosed with chronic fibrotic hypersensitivity pneumonitis

Exclusion Criteria:

* Having another diagnosed respiratory or cardiac problem
* Orthopedic, or neurological psychiatric diseases with a potential to affect functional capacity,
* Having a skeletal-muscular disease that may affect evaluation results
* Uncontrolled asthma, MI (myocardial infarction) in the last 4 weeks, unstable AP (angina pectoris), 2-3. degree block, rapid ventricular or atrial arrhythmias, ventricular aneurysm, acute systemic disorders (ARF (acute renal failure), thyrotoxicosis, infection), cooperation problem, severe aortic stenosis, dissecting aneurysm, uncontrolled CHF (chronic heart failure), uncontrolled hypertension ventricular aneurysm, severe pulmonary hypertension, thrombophlebitis / intracardiac thrombus, recent systemic/pulmonary embolism, acute pericarditis, endocarditis, myocarditis
* Cognitive disorders
* Patients who have contraindications for exercise testing.
A Study of Safety of Weekly Subcutaneous Pegzilarginase in Subjects With Arginase 1 Deficiency

This is an open-label, multicenter study to evaluate the safety of weekly SC administration of pegzilarginase over 12 months in subjects with ARG1-D. The study consists of a screening period of up to 4 weeks, a subsequent 12-month treatment period, and a Safety Follow-Up Visit 2 weeks after the last treatment.

Open-label, multicenter study to evaluate the safety of weekly SC administration of pegzilarginase over 12 months in subjects with ARG1-D. The study consists of a screening period of up to 4 weeks, a subsequent 12-month treatment period, and a Safety Follow-Up Visit 2 weeks after the last treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Prior enrollment in pegzilarginase clinical studies, with completion of treatment or continued dosing as of the study termination date
2. Written informed consent by subject/parent/legal guardian, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
3. Negative pregnancy test within 7 days prior to dosing in childbearing subjects if they are sexually active
4. If the subject (male or female) is engaging in sexual activity that could lead to pregnancy, must be surgically sterile, post-menopausal (female), or must agree to use a highly effective method of birth control during the study and for a minimum of 30 days after the last study drug administration. Highly effective methods of contraception include combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation, progesterone-only hormonal contraception associated with inhibition of ovulation, intrauterine device, or intrauterine hormone-releasing system

Exclusion Criteria:

1. Subjects with acute or ongoing hyperammonemia within 6 weeks of the first dose
2. Subjects with medical conditions or underlying issues that, in the opinion of the Investigator, would preclude participation in the study
Effects of Photobiomodulation in a Population Suffering From Fibromyalgia

The development of an integral and global treatment to improve the quality of life in those with fibromyalgia syndrome (FMS) is challenging, thus a whole body Photobiomodulation (PBM) therapy program is proposed as an effective option.

This study is a randomized, placebo-controlled clinical trial. Participants will be recruited in a private care practice and randomized to receive either a whole body Photobiomodulation (PBM) therapy program or placebo. Primary outcomes will be pain (Numeric Pain Rating Scale; Widespread Pain Index; Symptom Severity Score), functionality (Fibromyalgia Impact Questionnaire; The Leisure Time Physical Activity Instrument), quality of soft tissue (elastography) and central sensitisation (pain pressure threshold and the Autonomic Symptom Profile). Secondary outcomes will be psychological factors (Pain Catastrophising scale, Tampa Scale, Self-Efficacy questionnaire). Assessments will be at baseline, after treatment 6, immediately following the last treatment (4 weeks), and then 2 weeks and at 3 monthly follow up intervals to 6 months after completion of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed from FM presenting generalized pain in at least four or five regions.
* Present symptoms for at least 3 months at similar levels.

Exclusion Criteria:

- Inflammatory, neurological, or orthopedic disease which can alter balance, hearing, and vision, and cognitive impairment in terms of the ability to answer questions.
Remote Neurocognitive and Psychological Assessment in PKU

PKU is a rare autosomal recessive condition associated with disruption in dopamine synthesis. Although early diagnosis and treatment prevent the severe impairments associated with untreated PKU, individuals with early-treated PKU (ETPKU) nonetheless experience significant sequelae, including impaired working memory and increased risk for anxiety problems. Past research with other clinical populations (e.g., generalized anxiety disorder) suggests that the two phenomena may be linked, with increased anxiety contributing to poorer WM performance. Currently we propose to initiate an exciting new line of research examining the potential relationship between anxiety and WM in ETPKU. The proposed study will also apply remote neuropsychological performance-based assessment to the study of ETPKU and thus overcoming the geographical limitations/challenges associated with recruitment of participants with this rare disease.


Eligibility Criteria:
Inclusion Criteria:

* Participants with PKU will be included if they were diagnosed as newborns and immediately started on treatment.

Exclusion Criteria:

* Individuals with a history of neurologic compromise or major medical disorder unrelated to PKU (e.g., closed head injury, diabetes, multiple sclerosis) will be excluded. In addition, individuals with PKU will be excluded if they are on a medication called Peg-Valiant/ PEG-PAL/ Pegvaliase/Palynziq.
A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain

The purpose of this study is to evaluate the efficacy and safety of Lyrica in Indian patients with nerve pain


Eligibility Criteria:
Inclusion criteria:

* Peripheral neuropathic pain
* Score of at least 40 mm on the VAS of the SF-MPQ at screening and baseline
* Completion of at least 4 daily pain diary entries with an average daily pain score of at least 4 over the 7 days prior to baseline

Exclusion criteria:

(none)
Feasibility and Safety of High-intensity Exercise Training in Patients Surviving COVID-19

This current protocol encompasses an investigator-blinded randomized exercise intervention in 10 COVID-19 survivors that have been discharged from hospital. The subjects will be randomized to perform three different exercise training protocols in a random order.

The aim is to clarify the feasibility and safety of three training protocols in COVID-19 survivors. The hypothesis is that patients surviving COVID-19 will be able to comply to all training protocols.

The study is a randomized crossover trial testing the feasibility and safety of three different training protocols in 10 COVID-19 survivors that have been discharged from hospital. The subjects will be randomized to perform three different exercise training protocols in a random order.

The aim is to clarify the feasibility and safety of three training protocols in COVID-19 survivors. The hypothesis is that patients surviving COVID-19 will be able to comply to all training protocols.

The study consists of 4 visits with 1 baseline session (a medical screening and fitness test) and 3 different training sessions. Each training is separated by 1-week washout, to account for potential confounding by leisure activity performed just before the training, patients will be wearing activity watches (Polar).

Feasibility and safety evaluation will be based on 1) how tolerable and enjoyable the training was based on a subjective questionnaire (Likert Scale) 2) compliance to the prescribed exercise protocol with regard to duration and intensity and 3) experienced side effects.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 40 years
* A laboratory-confirmed initial positive test followed by one negative tests of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ≤ 6 months after hospital discharge
* ≤10 L oxygen requirement during hospitalization

Exclusion Criteria:

* Present atrial fibrillation
* Diagnosed with acute myocarditis
* Health conditions that prevent participating in the exercise intervention
* Patients who cannot undergo MR scans (e.g. kidney disease or metallic implants)
* Treatment with IL-6 receptor antagonists (tocilizumab, kevzara) within the last month due to drug interference with the cardiopulmonary exercise adaptations.