cyrilzakka/clinical-trials huggingface dataset:
Effect of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastasis

It is the aim of this clinical study to evaluate the skeletal-related event rate and tolerability of zoledronic acid in patients with prostate cancer patients and bone metastases.


Eligibility Criteria:
Inclusion criteria:

* Signed informed consent
* A histologically confirmed diagnosis of carcinoma of the prostate
* Therapy with hormonal treatments (medical or surgical castration)
* Patients must have objective evidence of metastatic disease to bone.
* Adequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value
* ECOG performance status of 0, 1 or 2

Exclusion criteria:

* Bone pain which requires strong narcotic therapy with centrally acting analgesic agents.
* More than 3 bisphosphonate applications in patients history.
* Previous Radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) within 3 months prior to Visit 2.
* Abnormal renal function as evidenced by

A calculated creatinine clearance \< 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula:

CrCl= \[140-age (years)\] x weight (kg) {x 0.85 for female patients} \[72 x serum creatinine (mg/dL)\]

* Corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L)
* Life expectancy \< 6 months
* Patients with evidence in the six months prior to randomization of severe cardiovascular disease (defined as uncontrolled congestive heart failure), hypertension refractory to treatment, or symptomatic coronary artery disease uncontrolled by treatment
* Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of randomization
* Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
* Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)

Other protocol-defined inclusion and exclusion criteria may apply.
Prehabilitation for Gastrectomy

Prehabilitation has been demonstrated to be an effective strategy to improve outcomes in patients undergoing some of the abdominal operations. It may increase the physical capacity of the patient, improve postoperative quality of life and even decrease the postoperative morbidity. Currently, the most effective strategy seems to be a trimodal prehabilitation which includes: 1) Nutritional support 2) Psychological support and 3) Physical training.

This study will investigate personalized trimodal prehabilitation for patients undergoing gastrectomy for gastric cancer.

Prehabilitation group:

Patients will undergo 6 Minutes Walking Test (6-MWT), spiroergometry (VO2 max; AT), a grip strength test, a timed Up \& Go (TUG) test, 10 m sprint test and sit to stand test before and after prehabilitation. The trimodal intervention will involve:

1. Nutritional intervention: The dietetic physician will perform physical examination and evaluation of the nutritional status to provide individualized care to each patient. Patients will receive personalized recommendations for the prevention or correction of malnutrition.
2. Psychological intervention: Patients will undergo consultation by specialized onco-psychologist. The anxiety and depression level will be evaluated by HAD score and patients will be trained to perform techniques, such as relaxation to reduce and manage anxiety on at home basis.

   The psychologist also will enhance patients' motivation to comply with the exercise and nutritional aspects of the intervention.
3. Exercise intervention: Patients will be consulted by PM\&R physicians and physiotherapists and personalized exercise plans will be developed according to the results of 6MWT, AT and VO2peak. Exercises will focus on skeletal muscles and cardiopulmonary function training and the exercises feasible at home basis will be selected. All patients will undergo three supervised training sessions to learn the correct exercise techniques.

All patients will be routinely contacted to ensure compliance with prehabilitation program.

Patients scheduled for surgery first by multidisciplinary tumor board will undergo 4 weeks prehabilitation program, while patients scheduled for perioperative chemotherapy will undergo prehabilitation while neoadjuvant treatment will be administered.

Control group:

Patients will also undergo 6 Minutes Walking Test (6-MWT), spiroergometry (VO2 max; AT), a grip strength test, a timed Up \& Go (TUG) test, 10 m sprint test and sit to stand test before surgery or before and after neoadjuvant chemotherapy. Patients will not undergo prehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* Patient agrees to participate in a clinical study
* Patient requires surgical treatment for gastric cancer

Exclusion Criteria:

* Patient requiring surgical treatment for recurrent gastric cancer
* Patient condition not allowing to postpone surgery for at least 4 weeks
* Patients physical or mental condition which will not allow the patient to participate in prehabilitation program
Implementation of Harmonized Depression Outcome Measures in a Primary Care Registry and a Mental Health Registry

The purpose of this pilot project is to demonstrate feasibility and value of collecting harmonized outcomes measures for major depressive disorder (MDD) in two registries and combining the data to support patient-centered outcomes research.

The study is a longitudinal, multi-center observational feasibility study that will include data on eligible patients with a diagnosis of major depressive disorder (MDD). Retrospective data on previous disease status and patient characteristics will be collected and combined with longitudinal data from these data sources on outcomes during the study timeframe. All data will be collected from institution electronic medical records (EMRs), PRO portals, and other existing data sources, as needed.

Two registries (PsychPRO and the PRIME Registry) will participate in this feasibility study. A total of 20 sites participating in the registries (10 from each registry) will be recruited to participate in this study. To participate, sites must see adult patients with major depression or dysthymia and be willing to collect the PHQ-9 on a regular basis. Sites will have the option of using the Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scale to capture information on adverse events, but use of the FIBSER is not required.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years
* Diagnosis of major depression or dysthymia as documented in the patient's EMR

Exclusion Criteria:

* There are no exclusion criteria for this study.
Randomized Study of the Effects of Glucose on Cognition in Healthy Young and Elderly People and Parkinson's Disease Patients

This study will determine whether glucose facilitates memory in healthy elderly people and those with Parkinson's disease.

Subjects fast for 8 hours before receiving a test to determine their blood glucose levels. Following this test, subjects are randomized to receive either a glucose or saccharin sweetened drink. A series of memory tests and an additional 3 blood glucose level tests are administered approximately 15 minutes later. A minimum of 1 week afterward, the subjects return and receive the alternate sweetener followed by additional memory tests.

Eligibility Criteria:
Inclusion Criteria:

* Three groups of subjects are eligible for this study: Healthy young adults between ages 18 and 30; Healthy elderly adults between ages 60 and 90; AND Anyone diagnosed with Parkinson's disease

Exclusion Criteria:

* Prior surgery to remove part of the stomach
* Diabetes, Addison's, or Cushing's diseases
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-D4010 in Healthy Subjects

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-D4010 in healthy male subjects following single or multiple ascending doses.

This is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of SUVN-D4010 administered orally once a day to healthy male subjects. The study will be conducted under double blind conditions.

The primary objective is to evaluate the safety and tolerability of SUVN-D4010 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of SUVN-D4010,if possible.

The secondary objectives are to evaluate the single and repeat dose plasma pharmacokinetics following oral administration of single and multiple ascending doses of SUVN-D4010 in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male aged 18 to 45 years with a BMI between 18 and 30 kg/m2, (inclusive).

Exclusion Criteria:

* Standard exclusion criterion for Phase 1 clinical trial in healthy subjects.
* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
* History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
Effects of Home-based High-intensity Inspiratory Muscle Training for Stress Urinary Incontinence

Strengthening the diaphragm muscle, the roof of the pelvic floor muscles (PFM), may be an alternative intervention in patients suffering from stress urinary incontinence (SUI). This study aims to investigate the effects of home-based telerehabilitation-assisted high-intensity inspiratory muscle training (IMT) on PFM function and urinary symptoms in women with SUI.

The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-minute rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The IMT was performed twice a day, 7 days/week, for 8 weeks. The study group performed IMT at 60% of their baseline MIP and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session, while the control group performed a sham-IMT without applied resistance. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with stress urinary incontinence by a specialized Urologist
* Being female aged between 25 and 50 years
* To have the ability to access and use technological devices required by the study
* Being able to read and write
* Volunteering to research

Exclusion Criteria:

* Inability of the participant to understand or perform the procedures proposed during the evaluations or training program.
* Active urinary tract infection,
* pelvic organ prolapse stage 2 and more according to the pelvic organ prolapse staging system (Pelvic Organ Prolapse Quantification System (POP-Q))
* Fecal incontinence,
* Any neurogenic dysfunction of the lower urinary tract
* Conservative or surgical treatment of urinary incontinence in the last 12 months
* Previous pelvic floor training
* Less than three months after pregnancy or postpartum
* Having undergone any pelvic floor surgery (hysterectomy, etc.)
* Radiotherapy treatment in the last 12 months
* Severe low back pain or pelvic pain
* Lower extremity orthopaedic problems that may affect the pelvic structure (such as lower extremity inequality, total hip arthroplasty)
* Having any chronic respiratory disease
* Having any neurological disease
* Being in menopause
* Latex allergy
A Patient-Centered Intervention to Improve Opioid Safety

This is a randomized controlled trial of a multifaceted intervention designed to improve the safety of opioid prescribing. The specific aims of this study are to: (a) evaluate whether a multifaceted intervention (Improving the Safety of Opioid Prescribing; ISOP) enhances opioid safety, (b) assess whether participation in ISOP impacts the clinician-patient relationship, and (c) explore to what extent ISOP is associated with changes in pain and pain-related function.

The investigators will randomize primary care providers (PCPs) at the VA Portland Health Care System to either ISOP or the control condition; patients will be nested by clinician status. All PCPs who enroll will participate in either a two-hour educational workshop or the two-hour educational workshop + nurse care manager (NCM). The NCM will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to PCPs for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse. The investigators will recruit patients who are already prescribed chronic opioid therapy for chronic non-cancer pain. Participants will be enrolled for one year. Outcomes will be measured at baseline, and 6 and 12 months after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in primary care at the VA Portland Health Care System
* Receiving long-term opioid therapy (for at least 3 months) for chronic pain unrelated to a life-limiting disease
* Able to read and write in English

Exclusion Criteria:

* Age younger than 18 years old
* On opioid therapy for palliative or end-of-life care
* Current enrollment in an opioid substitution program
* Lack of access to a telephone
Posterior Tibial Artery Catheterization

Arterial catheterization in small children is challenging, even for experienced anesthesiologists. For successful arterial catheterization, the arterial diameter, cross-sectional area, and depth from the skin surface are important considerations, especially in pediatric patients. THe investigators examined the posterior tibial artery (PTA) and dorsalis pedis artery (DPA) using ultrasound (US) to find a reasonable alternative arterial cannulation site to the radial artery (RA) in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing general anesthesia needing invasive arterial monitoring

Exclusion Criteria:

* Surgery involving the both hands or foots
Heated Humidified Oxygen Compared to Dry Oxygen Therapy in Children With Bronchiolitis

The purpose of this study is to compare heat and humidified oxygen with cold and dry oxygen in children with bronchiolitis.

The hypotheses are that heating and humidifying inspired low flow supplemental oxygen will optimize mucociliary function thereby, 1) improve oxygenation, 2) decrease work of breathing, and 3) decrease length of hospital stay.

Bronchiolitis is the leading cause of acute respiratory illness and hospitalization in infants and young children. The mainstay of treatment is supportive care, which includes frequent nasal suctioning, intravenous fluid hydration, and supplemental oxygen for hypoxemia.

The airways normally heat and humidify inspired ambient air to core temperature amd 100% relative humidity at the carina. This environment, at core temperature, allows for optimal mucociliary clearance. Supplemental oxygen delivered via wall source is cold and dry, and does not reach core temperature and 100% humidity until some point distal to the carina, past the main bronchi. This presses on the lower respiratory tract to assist in heat and moisture exchange and thus decrease ciliary function. This, in combination with bronchiolitis, can impair mucociliary clearance.

Specific aim 1: Determine the effect of heated and humidified oxygen therapy on clinical improvement in children with bronchiolitis, based on Respiratory Distress Assessment Instrument (RDAI) and respiratory rate (RR).

Specific aim 2: Determine the effect of heated and humidified oxygen therapy on length of hospital stay and duration of supplemental oxygen requirement in children with bronchiolitis.

Eligibility Criteria:
Inclusion Criteria:

* Ages ≤24 months of age
* Physician diagnosed bronchiolitis
* Admitted to pediatric floor
* Supplemental oxygen requirement, \<4 L/min, for hypoxemia, oxygen saturation \<92% in room air

Exclusion Criteria:

* Prematurity, born \<37 weeks gestational age
* Admitted to pediatric intensive care unit for medical indication
* Requirement of heated, humidified high flow system
* Chronic lung disease (such as bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia, tracheostomy status, baseline oxygen requirement)
* Neuromuscular disorders
* Chromosomal defects
* Metabolic disorders
* Immunodeficiency
* Unrepaired cardiac abnormalities
A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)

The purpose of this research study is to evaluate the safety and effectiveness of Ridinilazole (SMT19969) in treating C. difficile Infection (CDI).


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Clinical diagnosis of CDI plus laboratory diagnostic test
* No more than 30 hours antimicrobial treatment for current CDI episode
* Female subjects of childbearing potential must use adequate contraception

Exclusion Criteria:

* Life-threatening or fulminant CDI
* Subjects with 2 or more episodes of CDI in the previous year
* Females who are pregnant or breastfeeding
* History of inflammatory bowel disease
* Co-administration of potent P-glycoprotein inhibitors
* Participation in other Clinical research studies within one month of screening
* Subjects that the Investigator feels are inappropriate for the study
A Qualitative Study Into How Patients Deal With Chemotherapy-related Side Effects at Home

This qualitative study explores how patients deal with the side effects from chemotherapy at their home, what factors and ideas influence their symptom self-management and how professional caregivers contribute to the management of their symptoms at home. Data are collected through semi-structured interviews with adult patients treated with chemotherapy and analysed using a Grounded Theory approach.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years) patients with (any type and any stage of) cancer who were undergoing chemotherapy treatment in an ambulatory setting or during short hospital stays
* Dutch speaking
* Able to provide informed consent and to participate in an interview

Exclusion Criteria:

* Patients who were in the first 2 cycles of treatment
* Patients for whom an interview was considered physically, mentally and/or emotionally too burdensome.
* Patients who had reported not to experience any side effect from treatment at all
Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years

The purpose of this study is to evaluate a) whether the seroconversion rates in children are equivalent after two and/or three partial vaccinations with TICOVAC 0.25 mL and TICOVAC 0.5 mL, and b) whether there is a difference in terms of safety between the two products.


Eligibility Criteria:
Inclusion Criteria:

* Male and female children aged between 6 and 47 months
* No history of any previous TBE vaccination
* Clinically healthy
* Informed consent provided by the parents

Exclusion Criteria:

* History of allergic reactions, in particular allergic reactions to one of the components of the vaccine
* Suffering from a disease that cannot be effectively treated or stabilised
* Suffering from a disease or undergoing a form of treatment which can be expected to influence immunological functions
* Suffering from a chronic, degenerative and/or inflammatory disease of the central nervous system
* HIV-positivity (no special HIV test required for the purpose of the study)
* Suffering from a febrile disease
* History of vaccination against yellow fever and/or Japanese encephalitis
* Participation in another clinical trial
Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)

This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study

The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.
2. Evidence of an informed consent document, signed and dated by the subject, indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures.
3. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
4. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at enrollment visit before first administration of Investigational Product (IP) in this study.
5. WOCBP who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of IP.
6. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of IP.

Exclusion Criteria:

1. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or seralutinib administration, unless associated with an ongoing AE and discussed with the Sponsor's medical monitor (MM) (or designee).
2. Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.
Efficacy of Stretching on Pain Sensitivity

The primary objective of this study is to determine the immediate efficiency of a six weeks regular stretching protocol on regional and distant pain sensitivity. It is hypothesised that regional and distant pain sensitivity will significantly decrease following six weeks of regular stretching.

The secondary objective of the study is to determine the effect after four-week cessation of the stretching protocol on regional and distant pain sensitivity. If regional and distant pain sensitivity decrease following regular stretching, it is hypothesised that the analgesic effect will abate following four-week cessation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women aged 18-65 years are recruited. As part of the screening, volunteers will also be asked to indicate known medical issues or diseases. Participants are included if they have no known medical conditions such as
* cognitive impairments,
* neurological,
* orthopaedic,
* or neuromuscular problems that might affect the somatosensory system or preclude stretching exercises or range of motion testing at the knee.

Exclusion Criteria:

* Individuals who regularly engage in flexibility training (e.g., stretching, tai chi, pilates or yoga)
* or use any medication that might affect the somatosensory system, such as pain medication, are excluded.