cyrilzakka/clinical-trials huggingface dataset:
An Open Label Study to Evaluate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Maintenance Renal Transplant Recipients

To evaluate whether maintenance renal transplant patients on micophenolate mofetil (MMF) can be safely converted to EC-MPS, based on adverse events and acute rejection within 6 months after switching from MMF to a EC-MPS regimen.


Eligibility Criteria:
Inclusion criteria

1. Males and females aged between 18 and 80 years.
2. Recipients of first or secondary cadaveric, living related or unrelated donor kidney transplant at least 6 months after transplantation.
3. Patients currently receiving CsA-ME with MMF , with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months prior to Screening.
4. Patients receiving MMF at reduced dose prior to study entry
5. Patients in a stable condition in terms of graft function (serum creatinine not above 2.3 mg/dL (=204 µmol/L) at screening and at baseline, or not increased by more than 20% at baseline compared to values obtained at screening), no change of immunosuppressive regimen due to graft malfunction, and any known clinically significant physical and/or laboratory changes for at least 2 months prior to enrollment.
6. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to or at screening. Effective contraception must be used during the trial, and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
7. Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

Exclusion Criteria

1. Multi-organ patients (e.g., kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed)
2. Evidence of graft rejection or treatment of acute rejection within two months prior to Screening.
3. Patients with any known hypersensitivity to EC-MPS or other components of the formulation (e.g., lactose)
4. Patients with thrombocytopenia (\<75,000/mm3), with an absolute neutrophil count of \<1,500/mm3 and/or leukocytopenia (\<2,500/mm3), and/or hemoglobin \<6.0 g/dL prior to enrollment.
5. Patients who have received an investigational drug within two weeks prior to Screening (i.e., before Day -14 of run-in period).
6. Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
7. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
8. Presence of clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that would interfere with the appropriate conduct of the study.
9. Known positive HIV and/or Hepatitis B surface antigen positive.
10. Evidence of drug and/or alcohol abuse.
Efficiency of Shock-wave Therapy in Symptomatic Hip Osteoarthritis

The objectives of treatment in hip osteoarthritis are pain relief, improve joint range of motion and muscle force, gait rehabilitation, patient education and socio-professional reintegration.The non-pharmacological and non-surgical methods include certain types of physical therapy: massage, heat, ultrasound, laser, shockwave therapy. Few studies have been conducted so far for outcome measurement in symptomatic hip osteoarthritis.

The objectives of treatment in hip osteoarthritis are pain relief, improve joint range of motion and muscle force, gait rehabilitation, patient education and socio-professional reintegration.The non-pharmacological and non-surgical methods include certain types of physical therapy: massage, heat, ultrasound, laser, shockwave therapy. Among them, shockwave therapy is not a new treatment method, and seems to be effective in rotator cuff pathology, tennis elbow, and also on knee osteoarthritis, but few studies have been conducted so far for outcome measurement in symptomatic hip osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* unilateral or bilateral hip osteoarthritis

Exclusion Criteria:

* other disorders that are contraindications for shockwave or ultrasound application
Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.


Eligibility Criteria:
Inclusion Criteria:

* Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
* Prior use of Herceptin (trastuzumab), and a taxane
* Adequate cardiac and renal function

Exclusion Criteria:

* More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) \[Tyverb\]
* Bone as the only site of disease
* Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)
* Significant gastrointestinal disorder with diarrhea as major symptom
A Study to Learn About the Effects of Multiple Doses of Sisunatovir on People With Respiratory Syncytial Virus (RSV) Infection

The purpose of the study is to learn about the safety, pharmacokinetics and antiviral activity of the study medicine (called sisunatovir/RV521) for the potential treatment of respiratory syncytial virus (RSV). Sisunatovir will be given as multiple doses during the treatment period. RSV is a highly contagious virus that can lead to serious lung infections in patients with reduced ability to fight infection. Most vulnerable populations include babies, the elderly and patients that have received a bone marrow transplant.

This study is seeking healthy participants who are:

1. Aged 18 to 45 years old and will agree to the use of highly effective methods of contraception.
2. with a body mass index (BMI) of 18.0 to 30.0 Kg/m2 This study will consist of 2 cohorts of 33 participants each. In both cohorts participants will be exposed to the challenge virus on study day 0. Cohort 1 will receive either 200 mg of sisunatovir or placebo (looks the same as sisunatovir but contains no active medicine) 2 times a day for 5 days. Cohort 2 will receive either 350 mg of sisunatovir or placebo 2 times a day for 5 days. Participants will start taking the study medicine upon confirmation of RSV infection (or evening of Day 5 if not positive to RSV). The study medicine will be administered 12 hours apart (or twice daily). Each participant will remain in the quarantine unit until discharge on Day 12.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 45 years, inclusive
* In good health with no history of major medical conditions
* A total body weight ≥ 50 kg and a body mass index (BMI) of \>/=18kg/m2 and \</=30kg/m2

Exclusion Criteria:

* Evidence of any clinically significant or currently active major medical condition
* Positive for Human Immunodeficiency Virus, active Hepatitis A, B or C test
* Significant nose or nasopharynx abnormalities
* Abnormal lung function
* History or currently active symptoms suggestive of upper or lower respiratory tract infection
The Use of Angiotensin Converting Enzyme Inhibitors and Incident Respiratory Infections, Are They Harmful or Protective?

The study use UK based linked electronic health records from the Clinical Research Datalink (CALIBER) of 5.6 million individuals to conduct a matched case-control study to investigate the incidence of influenza in individuals prescribed ACEI compared to those not prescribed ACEI.


Eligibility Criteria:
Inclusion Criteria:

* We identify individuals aged 18 years or older and registered in the current primary care practice for at least one year.

Exclusion Criteria:

* We exclude individuals with a prior history of influenza and viral pneumonia before study entry.
A Study in Healthy Japanese Men to Test How Well Different Doses of BI 765845 Are Tolerated

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 765845 in healthy male Japanese subjects following intravenous administration of single rising doses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests at screening visit
* Japanese ethnicity, according to the following criteria, born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who are Japanese
* Age of 18 to 45 years (inclusive) at screening visit
* BMI of 18.5 to 24.9 kg/m2 (inclusive) at screening visit
* Signed and dated written informed consent in accordance with ICH-Good Clinical Practice (GCP) and local legislation prior to admission to the trial
* Subjects who agree to minimise the risk of making their partner pregnant by fulfilling any of the following criteria starting from the start of infusion of trial medication until 90 days after end of infusion of trial medication:

  * Use of adequate contraception, any of the following methods plus condom: intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration
  * Vasectomized (vasectomy at least 1 year prior to enrolment)
  * Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner
  * Female partner is postmenopausal, defined as no menses for 1 year without an alternative medical cause

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator at screening visit
* Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range of 50 to 90 bpm at screening visit
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders (including any history of cardiovascular diseases such as atherosclerosis, previous myocardial infarction or angina pectoris)
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or history of stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
A Prospective Observational Study on Discontinuation of Medication of Shinbaro Capsule

This study investigates how gastrointestinal toxicity affects discontinuation of medication given to patients with osteoarthritis in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Minimum 20- year-old patients diagnosed with osteoarthritis
* Within 2 weeks prior to participation, not taken anti-inflammatory analgesic drug such as the Shinbaro Capsule, Celecoxib Capsule and NSAIDs(non-steroidal anti-inflammatory drugs)
* Written consent form voluntarity

Exclusion Criteria:

* Diagnosed with disease that may affect measurement of efficacy clinically
* Diagnosed with clinically significant phycological disorder, and taking medication
* Participated in a clinical trial within 4 weeks
* Pregnant or lactating woman
* History of malignant disease within the previous 5 years
* Patients who seem not to participate in the study at investigator's discretion
Effects of PNF Technique in Children With Post Fracture Elbow Stiffness

Daily living activities are an essential part of a child's development, providing endless opportunities for play, learning, and imaginative expression. The desired result as the child get bored after a while so we use it for benefits. Proprioceptive Neuromuscular Facilitation is a stretching technique utilized to improve muscle elasticity and has been shown to have a positive effect on active and passive range of motions. In clinical settings, PNF is already utilized by therapists to restore functional range of motion (ROM) and increase strength in patients who have sustained soft tissue damage or received invasive surgeries.

This Randomized clinical trial study will be conducted in THQ hospital Arifwala/DHQ pakpattan with calculated sample size 26. Study will be approved by ethical committee. After that informed consent will be taken and patients will be randomly assigned to (Group A) control group these individuals will receive Maitland's mobilization with everyday object activities (Group B) experimental group (these individuals will receive baseline treatment and PNF technique ) frequency will be 5 session per week of 30 min and duration is of 4 weeks. Ranges will be assessed by Goniometry DASH outcome measure scale will use to assess functional activity. Data will be analyzed by SPSS latest version.

Eligibility Criteria:
Inclusion Criteria:

* Children Age 3-7 years
* Either gender
* Contracture 4-8 weeks post traumatic injuries.
* Post-operative

Exclusion Criteria:

* Burn contracture
* Contracture due to neurological conditions
* Dupytren's contracture, Volkmann's contracture etc.
* Contracture more than 8 week
Micronutrient and Malnourished Elderly

The purpose of this study is to evaluate the micronutrient status of malnourished elderly after oral nutritional supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Age : above or equal to 70 years

AND :

* Weight loss above or equal to 5% in one month
* OR weight loss above or equal to 10% in 6 months
* OR BMI between 18 and 21
* OR albuminaemia between 30 and 35 g/L
* OR MNA-SF less or equal to 7

Exclusion Criteria:

* Severe malnutrition
* Contraindication to oral nutrition
* Severe pathologies
* Inflammatory syndrome (CRP \> 30 mg/L)
* Severe dementia (Mini Mental Score \< 10)
EMI and CIED: Is High Power Charging of Battery Electric Car Safe?

It is not known if the use of high power charging systems for electric vehicles may interfere with the functionality of implanted pacemakers and cardioverter-defibrillators.

The use of electric cars for public and private transport is increasing all over the world. Moreover the charging technique is improving and enables very fast charging with the use of high power. It is not known if the use of high volume charging systems interfere with cardiac implantable electronic devices. The study evaluates different types of high volume charging systems connected to different full electric vehicles with regard to electromagnetic interference with implanted pacemakers or cardioverter-defibrillators.

Eligibility Criteria:
Inclusion Criteria:

* implanted cardiac implantable electronic device with regular function

Exclusion Criteria:

* implanted cardiac implantable electronic device with irregular function
Discovering the Antecedents of Rheumatoid Arthritis Flare

Longitudinal study of patients with rheumatoid arthritis comparing measures of disease activity with blood samples.

80% of patients living with rheumatoid arthritis can expect fluctuations in their symptoms over time. Dramatic increases in disease activity are considered flare. This study will follow patients with increased risk for flare prospectively for one year. Serial questionnaires and disease activity scores will be compared to blood samples to better understand the molecular phenotype of rheumatoid arthritis flares.

Eligibility Criteria:
Inclusion Criteria:

* 2010 criteria for Rheumatoid Arthritis
* Swelling of at least one joint and or elevated acute phase reactants
* Greater than or equal to 40 years old or less than or equal to 65 year old female sex
* cyclic citrullinated peptide antibody + in the past 12 months

Exclusion Criteria:

* hemoglobin \< 9
* white blood cell count \< 3.5
* Diagnosis of any active malignancy within the last 3 years besides non-melanomatous skin cancer
* Diagnosis of diabetes and requires insulin
* HIV+, Hep B S Ag+, Hep C polymerase chain reaction +
* Untreated latent tuberculosis
* Diagnosis of any additional systemic autoimmune connective tissue disease
* Inability to reliably complete study requirements
* History, physical, social or laboratory findings suggestive of any other medical or psychological condition that would, in the opinion of the principal investigator, make the candidate ineligible for the study
Reference Nurse Program for Pressure Ulcers in Primary Care

Introduction: Pressure ulcers (PU) are the most common chronic wounds in all levels of care in health centers. The chronic wound care by skilled personnel is key to healing and management of these injuries. An inter-clinical telematic program for PU in Primary Care (PC) can improve the effectiveness of interventions and cost savings.

Objective: To evaluate the effectiveness and costs reduction after the implementation in PC setting of a chronic wounds reference nurse and a teleconsultation program aimed to nurses for the management of PU in patients in home care setting.

Methodology: A prospective pilot clinical trial in which 46 primary care nurses in Osakidetza will be randomly assigned to two parallel groups: experimental group and control group. Each nurse will recruit at least 1 new patient in home care with PU in stage II-III. The intervention will consist of a telematic advice from the reference nurse regarding chronic wound management in relation to a specific PU. Patients will be monitored for 8 weeks with a minimum of 4 repeated measurements of the Resvech Index 2.0. To evaluate the effectiveness of the intervention, multilevel models or linear mixed models to take into account the auto-correlation at the individual level and nurse, will be used


Eligibility Criteria:
Inclusion Criteria:

* New cases of PU in Stage II-III, treated by the same nurse over time at patient's home. (Stage II: Partial loss of skin thickness that affects the epidermis, dermis, or both. Ulcer surface that looks like abrasion, blister, or shallow crater; Stage III: Full thickness loss of skin involving damage or necrosis of subcutaneous tissue that may extend down to but not through the underlying fascia)

Exclusion Criteria:

* Patients with chronic wounds that are not PU
* PU in patients with plastic surgery
* Patients who move periodically
* Patients requiring hospitalization during follow-up
* Patients in which nurse is expected to be changed during follow-up
* Terminal patients
Nutritional Safety and Metabolic Benefits of Oncometabolic Surgery for Obese Gastric Cancer Patients

The metabolic effect of oncometabolic surgery (long limb Roux-en Y reconstruction) for early gastric cancer patients has been revealed in a few pilot studies. However, the nutritional safety has not been dealt with in previous literatures. This is a prospective pilot study for evaluating the nutritional safety and metabolic benefits of oncometabolic surgery for obese early gastric cancer patients.

We performed long limb uncut Roux-en Y gastrojejunostomy (uRYGJ) in 20 patients with clinical T1N0 stage and preoperative body mass index (BMI) ≥ 32.5 kg/m2 or ≥ 27.5 kg/m2 with co-morbidities between September 2015 and July 2016.

The primary endpoint was the incidence of micronutrients' deficiency (iron, folate, vitamin B12) at postoperative 1 year and secondary endpoints were anemia incidence, BMI change and remission rates of co-morbidities.

Eligibility Criteria:
Inclusion Criteria:

* Lesion located on distal or mid stomach Lesion confined to submucosa (cT1b) : Early gastric cancer No evidence of metastatic enlarged lymph nodes Preoperative body mass index (BMI) ≥ 32.5 kg/m2 or ≥ 27.5 kg/m2 with co-morbidities

Exclusion Criteria:

* Being unable to understand the risks, benefits and compliance requirements of this trial Non- Korean speaker American society of anesthesiology (ASA) class IV or higher Other malignancy within 5 years.
A Randomised Comparison of Left and Right Sided Approaches to Ablation of the Atrioventricular Junction

This study will compare right sided atrioventricular node ablation to left sided atrioventricular node ablation

Right-sided atrioventricular node ablation has been the initial conventional approach however up to 18.5% of patients require switching to a left sided approach or have a challenging procedure. Previous studies have found that left sided ablation is more efficacious than right-sided ablation requiring less than 5 applications of radiofrequency energy to induce atrioventricular block.

This study will compare right sided atrioventricular node ablation to left sided atrioventricular node ablation

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Referred for atrioventricular node ablation for any such indication

Exclusion Criteria:

* Stroke or transient ischaemic attack (TIA) within 6 months
* Myocardial infarction within 6 months
* Medical conditions limiting expected survival to \<1 year
* Moderate to severe aortic stenosis
* History of aortic or mitral valve replacement
* Pregnancy or breast feeding women
Musical Biofeedback for Sensorimotor Control Capacity of Hands

In the proposed study, the investigators assumed that music support treatment, a multisensory-based framework for ameliorating brain plasticity, combined with low-amplitude vibration stimulation can prime motor system and change in motor performance for the patient with a peripheral injury or the loss of a limb. The specific aim of this study is to develop a Multisensory Biofeedback with Musical Interface system, with the aim of improving the sensorimotor impairment of patients' hands.The expected outcomes of this research are to clarify the effects of application Multisensory Biofeedback with Musical Interface on motor and hand function for patients with hand injuries.


Eligibility Criteria:
Inclusion Criteria:

* tendon and bone injury in hand, wrist, and forearm; peripheral nerve injury in upper extremity; replantation; a combination of nerve and tendon or vascular injury; the protective sensation of the hand is absent or impaired

Exclusion Criteria:

* patients with deficits in cognition, perception or language comprehension, as well as severe pain and swelling in the upper limbs