cyrilzakka/clinical-trials huggingface dataset:
Sexual Disability in Low Back Pain and Physiotherapy

A treatment centered on the person uses an approach capable of considering all the components of disability, from a physical, psychological and social point of views. Some studies have shown that sexual function is disturbed in subjects with low back pain (LBP) and sexual disability can contribute to a deterioration in quality of life. It has also been shown that, in sexually active patients complaining of LBP, sexuality is a significant mediator of the relationship between pain intensity and depressive symptoms.

The Oswestry Disability Index (ODI) includes a specific item to investigate sexual function (item #8). A previous study of ours confirmed the relationship between sexual disability detected by the ODI and the presence of depression, avoidance of activities and rumination (Ferrari et al. 2019 - Digital Object Identifier: 10.1589/jpts.31.360).

The discussion on sexual disability among patients and healthcare professionals is very limited, although patients require more involvement from clinicians, especially physiotherapists, as evidenced by our previous qualitative study (Ferrari et al. 2020 - Digital Object Identifier: 10.1080/09638288.2020 .1817161).

Although studies on this topic have highlighted the importance of this disability in the life of subjects complaining of LBP, little has been investigated on clinical behaviors of the physiotherapists in this area.

The goal of this observational study is to learn about the clinical behaviors of Italian physiotherapists in the management of LBP-related sexual disability. The main questions it aims to answer are:

* the knowledge of this topic;
* the ways in which sexual disability is detected in patients complaining of LBP (Oswestry Disability Index, specific open or closed questions, patient' reporting, etc.);
* the difficulties and obstacles in the management of sexual disability;
* the suggestions provided to the patient;
* the therapeutic strategies (procedures for pain modulation, exercises addressed to lumbar mobility, strength, endurance, etc.);
* the possible involvement of the patient' partner;
* the outcome measures.

The hypothesis of this survey is to highlight the degree of attention and competence of Italian physiotherapists with respect to this topic, the critical issues and therapeutic strategies for the management of LBP-related sexual disability.

Participants will answer to a online questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Being a physiotherapist registered with AIFI
* Carrying out physiotherapy treatments on subjects with low back pain
* Agreement to voluntarily sign informed consent to participate in the study
* Agreement to voluntarily sign consent to data processing

Exclusion Criteria:

* Inability to understand written Italian
* Being a retired physiotherapist
PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy

The purpose of this study is to determine the treatment effect of panitumumab in combination with FOLFOX compared to FOLFOX alone as first line therapy for metastatic colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

* Man or woman at least 18 years old
* Diagnosis of metastatic colorectal cancer
* At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyse Exclusion Criteria:
* History or known presence of central nervous system (CNS) metastases
* History of another primary cancer, except: Curatively treated in situ cervical cancer, or Curatively resected non-melanoma skin cancer, or Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 5 years before randomization
* Prior chemotherapy or systemic therapy for the treatment of metastatic colorectal carcinoma except: adjuvant fluoropyrimidine-based chemotherapy or prior fluoropyrimidine therapy administered solely for the purpose of radiosensitization
* Prior oxaliplatin therapy
* Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, cetuximab) or treatment with small molecule EGFr inhibitors (eg, erlotinib)
* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year prior to randomization History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan
* Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as \> Common terminology criteria (CTC) grade 2 \[CTCAE version 3.0\])
* Peripheral sensory neuropathy with functional impairment
Indacaterol in Heart Failure Patients: Any Role on Lung Fluid Regulation

The purposes of this study are:

1. To confirm safety of Indacaterol in stable Heart Failure.
2. To determine whether beta 2 alveolar receptor stimulation by Indacaterol is able to ameliorate lung diffusion in heart Failure patients treated with beta blockers.
3. To compare the effects of Indacaterol in patients treated with a non-selective beta blocker (Carvedilol) and a beta 1-selective beta blocker (Bisoprolol).


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults aged ≥ 18 years who have signed an Informed Consent Form.
* Patients with light chronic obstructive pulmonary disease never treated with bronchodilator drugs
* Co-operative patients
* Patients with a clinical diagnosis of chronic heart failure (HF)
* chronic myeloproliferative disorder with ejection fraction \< 40% with B Blockers therapy since at least 2 months. Optimized and individually tailored drug treatment including B blocker (Carvedilol or bisoprolol)
* Capability of performing Cardiopulmonary Exercise Test and lung diffusion test

Exclusion Criteria:

History or clinical documentation of:

* pulmonary embolism
* primary valvular heart disease
* pericardial disease
* severe obstructive lung disease
* significant peripheral vascular disease
* exercise-induced angina, st changes, or severe arrhythmias.
* Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range or HbA1c \> 8.0 % of total hemoglobin measured.
* Use of bronchodilators.
* Patients with a history (or family history) of long QT syndrome or whose corrected QT interval interval (Fridericia) measured at Visit 2 is prolonged: \>450 ms (males) or \>470 ms (females) as assessed by the central electrocardiogram (ECG) interpretation.
Study Evaluating Safety and Efficacy of Bazedoxifene/Conjugated Estrogens Combinations in Postmenopausal Women

The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, postmenopausal women aged 40 - 75 years inclusive
* Intact uterus
* Last natural menstrual cycle (without exogenous hormone therapy) completed at least 12 consecutive months before screening

Exclusion Criteria:

* A history or active presence of thrombophlebitis, thrombosis or thromboembolic disorders
* A history or active presence of cerebrovascular accident, stroke, or transient ischemic attack
* A history or active presence of malignancy, or treatment for malignancy, within the previous 10 years

Additional criteria applies.
The Impact of Dancing in Parkinson's Disease

This clinical study intends to confirm the results of previous studies showing the positive effect of dance on patients with Parkinson's disease on both mental and physical health via a randomized controlled trial. Patients will be randomized into the intervention group (dance courses in addition to standard care) or in the control group (standard care).

This is a clinical study on the benefits of dance in Parkinson's disease. In recent years, dance has become an interesting strategy to promote motor and non-motor functions in Parkinson's disease. More than a rehabilitation strategy, dance appears to be an optimal approach to promote functional outcomes as it combines physical, rhythmic, cognitive, emotional and social elements that could have a positive impact on multiple impairments in Parkinson's disease. The investigators believe that the notion of pleasure is crucial for rehabilitation, especially in people suffering from depression, and that it is often not taken into account in conventional rehabilitation strategies.

The goal of the present study is to confirm these preliminary results. This clinical study will run over two years, from January 2022 to January 2024, but an experimental session will last 4 months. The aim of this protocol is to better characterize the impact of dance on well-being, disease progression and possible neuronal reorganization in patients with Parkinson's disease. A better quality of life, a higher level of satisfaction and an improvement in functional status are expected in the experimental group.

During this study, three examinations will be carried out over 4 months. One at the start of the study, one at mid-term (after 8 weeks) and one at the end of the study. These evaluations will take place at the place of the dance lessons for the experimental group and within the university hospital for the control group.

Assessment will be done through different scales and questionnaires to assess well-being, satisfaction, feelings of happiness, functional status, cognitive functions and the correlation between functional and cognitive progress and neuronal activity.

This study is a "controlled and randomized" study that is to say that in a random manner, half of the participants will participate in weekly dance sessions lasting 60 minutes in addition to their conventional physiotherapy sessions while the control group will only receive conventional physiotherapy sessions during the first 4 months but will still benefit from dance sessions after the 4 months of evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Parkinson's disease
* Hoehn \& Yahr Stadium \<3
* Signature of the written consent form

Exclusion Criteria:

* No cardiac or respiratory or neurological or rheumatological disease incompatible with the practice of a physical activity
* Has not had any surgery interfering with motor function in the past 6 months
* Has no cognitive impairment - MoCA \<26
* Does not present hearing problems that do not all
The Efficacy of the Nanit-Insights App in Improving Infant Sleep

The proposed study aims to examine the effectiveness of Nanit-Insights, an app-based intervention for parents who wish to improve their infant's sleep.

The proposed study aims to examine the effectiveness of Nanit-Insights, an app-based intervention for parents who wish to improve their infant's sleep. The intervention provides parents with daily sleep metrics as well as personalized sleep recommendations, based on their infant's developmental stage and weekly sleep data.

Participants will be parents of 5-7 month-old infants, randomized into one of two groups: (1) the intervention group, which will include users who have purchased the baby monitor without subscribing to Nanit Insights and are then offered a six month subscription to Nanit-Insights when their baby is 5-7 months of age; and (2) the control group, which will include users of the baby monitor, who have not subscribed to Nanit-Insights.

Each group will include approximately 150 families.

Sleep will be assessed at baseline and 3- and 6-months following the beginning of the intervention. Computer vision technology will be used to assess infant sleep, as well as parental adherence to the intervention, allowing us to determine whether adherence mediates sleep benefits.

The results of this study are expected to evaluate the effectiveness of a low-cost, app-based intervention for infant sleep problems. Furthermore, the results may broaden the understanding of the mediating role of parent adherence in such interventions.

Eligibility Criteria:
Inclusion Criteria:

* Infant aged 5-7 months
* Presence of a moderate to severe sleep problem at baseline
* Sleeping arrangement in which the infant sleeps in a crib at night

Exclusion Criteria:

-
Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome

The overarching goal of this project is to improve the clinical quality of patients with Benzodiazepine-resistant alcohol withdrawal syndrome.


Eligibility Criteria:
Inclusion Criteria:

either

1. a requirement of either 200 mg of diazepam (or diazepam equivalents) in 4 hrs;
2. \> 40mg of diazepam (or diazepam equivalents) in 1 hr; or
3. an individual dose of 40 mg or greater of intravenous diazepam for control of agitation

Exclusion Criteria:

* if \< 18 years of age or had evidence of use of other illicit substances as determined by urine toxicology screen
A Study to Evaluate Immunogenicity of Various Schedules of Inactivated Polio Vaccine

The study will evaluate the humoral immunogenicity in various schedule combinations of full dose inactivated polio vaccines (IPV) via intramuscular administration (IM) and of the fractional dose of inactivated poliovaccine (f-IPV) via intradermal administration (ID).

The study will be conducted in a setting where only IPV is being used for polio prevention in infant immunization schedules.

The study population will include infants from Uruguay, a pioneer country in immunization programs in Latin America, where tOPV(trivalent oral polio vaccine) was used until 2012, after which the program changed to an all-IPV schedule without transition.

The primary IPV immunization schedule in the country is as stand-alone vaccine at 2, 4 and 6 months of age, with a booster dose at 15 months. This setting allows the evaluation of IPV immunogenicity in a scenario where the circulation of any poliovirus is highly unlikely.

Infants will receive two or three doses of full dose IPV IM or fractional dose f-IPV ID, in various schedule combinations (6 and 14 weeks; 10 and 14 weeks; 14 and 36 weeks; 6, 14 and 36 weeks; 10, 14 and 36 weeks). Immunological and safety assessments will be made after one dose, two doses and three doses.

The study will be conducted in Montevideo, Uruguay and a total of 1493 infants will be randomized into 6 groups. Other vaccines comprise DTPw-HB-Hib (pentavalent combined diphtheria-tetanus-whole cell pertussis-hepatitis B-Hib vaccine), Pneumococcal conjugate vaccine, Rotavirus and will be administered concomitantly.

Optimum immunogenicity expected from the dose/s of IPV in the post-eradication era will have to be balanced with the cost and supply constraints of IPV. This study will be critical to determine how many doses of IPV and which schedule will be recommended for the post-eradication era after the cessation of OPV (oral polio vaccine) usage globally.

Eligibility Criteria:
Inclusion Criteria:

* Infants of 6 weeks of age (-7 to + 7 days) on date of first vaccination
* Healthy, as assessed from medical history and physical examination by a study physician
* Written informed consent obtained from parents or legal representatives that they have been properly informed about the study and are able to comply with planned study procedures

Exclusion Criteria:

* Vaccinated with any poliovirus vaccine prior to inclusion
* A household contact with OPV vaccination history in the past 4 weeks
* HIV infection or pharmacologic immunosuppression.
* Known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde)
* Uncontrolled coagulopathy or blood disorder contraindicating intramuscular and intradermal injections.
* Acute severe febrile illness on day of vaccination deemed by the Investigator to be a contraindication for vaccination.
* Not suitable for inclusion or is unlikely to comply with the protocol in the opinion of the investigator.
Improving the Quality of Radiotherapy by Multi-Institution Knowledge-Based Planning Optimization Models (Acronym: MIKAPOCo, Multi-Institutional Knowledge-based Approach in Plan Optimization for the Community)

Investigators central hypothesis is that it is possible to create libraries of "consistent" Knowledge-Based plan-models derived from large Institutional experiences. These libraries can be used to guide automated RT planning and serve as tools to assist centers for plan quality assurance (QA) and plan prediction.

Quantifying Inter-institute variability of RT planning and building libraries of interchangeable and validated multi-Institutional KB plan prediction models is expected to impact on the quality of planning at the national level. The project has the potential of facilitating the introduction of AI approaches in plan optimization, thus reducing intra and inter-Institute planning variability. Improving plan quality is expected to translate into better outcome after RT in terms of local control and, even more, of side effects and Quality of life. Positive impact is also expected in patient selection for advanced techniques, in plan audit and plan optimization in clinical trials, in technology comparison and cost-benefit analyses as well as in the RT educational field.

Major aims

1. To create libraries of consistently generated KB models for patients treated with RT for breast and prostate cancer and for selected stereotactic-body RT (SBRT) applications based on the experience of many Italian Institutions; to quantify planning inter-institute variability in homogeneous classes of patients.
2. To group models based on their characteristics and interchangeability. To assess groups of highly interchangeable models to be considered for multi-institutional dose-volume histogram (DVH) prediction purposes.

Eligibility Criteria:
Inclusion Criteria:

* real life consecutive (or randomly chosen) plan data of patients treated for prostate cancer during the last 10 years;
* real life consecutive (or randomly chosen) plan data of patients treated for breast cancer during the last 10 years;
* real life consecutive (or randomly chosen) plan data of patients treated for selected SBRT situations (spine and prostate, according to RTOG 0631 and 0938 schemes respectively) during the last 10 years.

Exclusion Criteria:

-
NIVATS Versus IGAVATS: a Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases

The main objective of this study is to compare two independent groups of patients requiring lung biopsy for undetermined interstitial lung disease (ILD) in terms of diagnostic confidence as determined by histologists.

The primary objective of this study is to compare two independent groups of patients requiring lung biopsy for undetermined interstitial lung disease (ILD) in terms of diagnostic confidence as determined by histologists. The experimental arm will be operated under a neoteric non-intubated video assisted thoracic surgery (NIVATS) technique and the comparator arm under a usual intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) technique.

Secondarily, the two groups will also be compared in terms of: (i) further variables associated with histology, biopsy quality and size; (ii) surgical performance, (iii) patient trajectories and lung function; (iv) quality of life, and (v) harms.

Eligibility Criteria:
Inclusion Criteria:

* Patient with purported interstitial lung disease
* Patient requiring a surgical lung biopsy to reinforce diagnosis according to current recommendations and validated by a multidisciplinary assessment
* Minimum age: 18 years

Exclusion Criteria:

* Contra-indication for surgery
* Uncontrolled oesophageal gastric reflux despite optimal treatment
* Thoracic deformation (For example, pectus excavatum/carinatum or major scoliosis)
* Risk of pleural adhesion (For example, patient who has already undergone thoracic surgery)
* History of abnormal bleeding
* Predictable risk of difficult intubation
* Body mass index (BMI) \> 30
* Severe cardiovascular comorbidity (For example, instable ischemic cardiomyopathy)
* Unable to comply with all trial procedures/visits (For example, language barriers, upcoming move of household to another region, unwillingness to schedule the required followup visits.)
* Protected populations according to the French Public Health Code Articles L1121-5,6,8 (For example, pregnant, parturient or lactating women, prisoners, adults under guardianship or otherwise unable to consent.)
* Potential interference from another study (The patient is participating in another interventional study, or has done so in the past month, or is affected by an exclusion period stipulated by a previous study.)
* Non-beneficiary of the French single-payer national medical insurance system
* Lack of signed informed consent
Upgraded Smart Cloth Home Care System for Persons With Dementia

The purposes of this study are to develop an upgraded version of the smart-clothes home care model that include an interactive family caregiver App, and to examine its effect on a randomized controlled trial.

The purposes of this study are to develop an upgraded version of the smart-clothes home care model that include an interactive family caregiver App, and to examine its effect on a randomized controlled trial. This 3-year study will spend the first 6 months to developed the upgraded smart-clothes home care model, and the later 2 and a half years on the clinical trial and follow-ups. In addition to the original function of abnormal activity level, going out alone, abnormal number of getting-up at night, fall risks, this upgraded version will include monitoring for medication, abnormal life pattern, quality of hired help. The warning signals, along with weekly summary and related information will be sent to the family caregiver interactive App after the assessment of the home care nurses to provide guidance for family care.

During the first 6 months, the upgraded smart-clothes home care model will be developed according to qualitative and quantitative data of the prior study and expert reviews. For the clinical trial in later 2 1/2 years, a total of 60 participant families will be randomly assigned to experimental (N=30) and control (N=30) group, with experimental group receiving the upgraded smart-clothes home care for 6 months and control group received routine care with 6 month follow-ups. Outcomes including caregiver preparedness, balance between competing needs, health related quality of life and depressive symptoms, and fall, time up \& go, activities of daily living (ADLs), instrumental ADLs, cognitive function and quality of life of the patient will be followed every 2 month for 6 months. Intention-to-treat and hierarchical linear models will be used to analyze the results.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as having dementia
* can walk independently or with help
* able to communicate
* living in Northern Taiwan.
* Family caregiver age 20 or older
* taking primary responsibility in providing family care.

Exclusion Criteria:

* with terminal illness
* with severe diseases that can not be controlled.