cyrilzakka/clinical-trials huggingface dataset:
OSCAR - An Internet-based Supportive Coaching for Informal Caregivers of Adult Individuals With an Acquired Brain Injury

This is an intervention study for informal caregivers of adult patients with an acquired brain injury (stroke, traumatic brain injury or cerebral haemorrhage). It will determine whether an internet-based supportive coaching offers benefits to the caregivers in their own process of coping in the aftermath of a brain injury of a close relative. We expect the internet-based supportive coaching to be more effective in the treatment of emotional distress reactions and caregiver burden than the treatment as usual.

Background

A brain injury (e.g. stroke, traumatic brain injury) occurs all of a sudden and is often followed by complex neurological and psychological consequences. These consequences do not only affect the patients with the brain injury as Muriel Lezak already stated in 1988: "Brain damage is a family affair". Symptoms of depression and anxiety as well as an increased caregiver burden are common, but there is still a lack in randomized controlled trials that investigate the efficacy of multicomponent interventions for informal caregivers. The main aim of the current study is to close this scientific gap with an innovative method for this special population. OSCAR (the Internet-based supportive coaching) uses the Internet as a communication- and information brokering medium and is designed as a "guided-self-help tool" where a qualified therapist individually supports every participant. The key objective is to investigate the feasibility, acceptance and efficacy of an Internet-based supportive coaching (OSCAR) for informal caregivers of adult individuals with an acquired brain injury. It is expected that the Internet-based supportive coaching (OSCAR) leads to a better coping of emotional distress reactions and caregiver burden.

Objective

A key objective is to investigate the feasibility, acceptance and efficacy of an Internet-based supportive coaching (OSCAR) for informal caregivers of adult individuals with an acquired brain injury.

Methods

To one part, OSCAR is part of a randomized controlled intervention study where a standard neuropsychological therapy is compared with an integrative neuro-psychotherapy. The Internet-based supportive coaching (OSCAR) for the caregivers is part of the integrative neuro-psychotherapy arm.

Additionally a randomized controlled intervention study with a waiting list-control-group design is realised.

Assessments will be made at baseline, after 4 months (progress), after ending with the training (termination) and at 6 months post treatment (follow-up).

Eligibility Criteria:
Inclusion Criteria:

* Family caregiver of an adult with a stroke, cerebral haemorrhage or traumatic brain injury
* sufficient German language skills
* at least 3 months after the brain injury
* access to a computer with internet access
* minimum age of 18 years
* informed consent to participate voluntarily in the study

Exclusion Criteria

* acute suicidal tendency
Backward Walking Observation Training in People With Stroke and Gait Quality in Stroke

Walking impairment is one of the most common and concerning issues for individuals with stroke. Previous studies have often used improvements in walking speed and distance as reference indicators for gait performance progress in individuals with stroke. However, for people with chronic stroke, it may be more appropriate to prioritize improving gait symmetry and gait variability to enhance gait quality as a primary intervention goal. Additionally, stroke can lead to an imbalance in interhemispheric brain activity, which evolves as motor function recovers. According to the literature review, backward walking may extend the support time of the lower limbs, thereby enhancing the weight-bearing capacity of the affected limb. This, in turn, could promote gait symmetry and reduce gait variability. Changes in brain activity might also accompany such improvements in gait quality. Therefore, this study aims to investigate the immediate, short-term and post carryover intervention effects of backward walking observation training on gait quality in individuals with chronic stroke as well as to explore its effects on interhemispheric activity balance in individuals with chronic stroke.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 6 months after the diagnosis of stroke
* Independent walking over at least 7m with or without a walking aid
* Mini-mental state examination score ≥ 24

Exclusion Criteria:

* Had difficulty in backward walking
* Any neuromuscular disorders history
* With visual or auditory disorders
* Unstable cardiac status or uncontrolled hypertension
* Any musculoskeletal disorders that would affect walking ability
Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer

The anticancer agent paclitaxel (Taxol for Injection Concentrate, Bristol-Meyers Squibb) has a broad spectrum of activity against several human cancers including carcinomas of ovary, breast, lung, esophagus and head and neck cancer. Taxol has shown remarkable activity against metastatic breast cancer, yielding response rates in the range of 40% to 60% in chemotherapy-naive patients and 25%-30% in patients refractory to anthracycline-containing regimens (Taxol package insert). The major limitation of Taxol is its poor water soluability requiring Cremophor (containing castor oil and ethanol) as a solvent. Taxol in this vehicle must be administered over 3-24 hours, and hypersensitivity reactions to Cremophor require a premedication routine of a corticosteroid, an antihistamine, and an H2 antagonist.

ABI-007, a unique protein formulation of paclitaxel, has been developed to reduce the toxicities associated with Taxol and Cremophor EL/ethanol vehicle while maintaining or improving the chemotherapeutic effect of the drug.

The activity of ABI-007 in other malignancies is not yet well established. This open-label Phase I/II study is being conducted to define the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of ABI-007, and evaluate the safety and antitumor activity of ABI-007 in patients with advanced Stage IV non-small cell lung cancer (NSCLC).

Eligibility Criteria:
Patients must be:

* Histologically or cytologically confirmed advanced stage IV NSCLC with evidence of inoperable local recurrence or metastasis
* If female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
* Eighteen years of age or older
* No other current active malignancy
* Measurable disease (defined by RECIST criteria) documented radiographically
* Patient must have received no prior chemotherapies for the treatment of metastatic disease. Radiation therapy to a major bone marrow-containing area must have been completed 3 or more weeks prior to study entry. Prior treatment with EGF-targeted therapies is permitted.
* If, at baseline, patient has ANC greater than or equal to 1.5 x 109 cells/L; platelets greater than or equal to 100 x 109 cells/L and Hgb greater than or equal to 9 g/dL
* If, at baseline, patient has AST and ALT of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin NORMAL; creatinine levels less than or equal to 1.5 mg/dL and alkaline phosphatase levels less than or equal to 2.5 x the upper limit of normal range (unless alkaline phosphatase elevation is felt to be related to bone metastases and there is no radiologic evidence of hepatic metastasis)
* Expected survival of greater than 12 weeks
* ECOG performance status 0-1 (Karnofsky \> 70)
* Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.
Improving Hypertension Detection and Control Through a Hypertension Certification Program Based Upon the Hypertension Canada Guidelines

This study will assess the impact of a hypertension management certification program for community pharmacists on the blood pressure control of patients managed by the pharmacists enrolled. The investigators will compare the systolic blood pressure of patients identified to have hypertension in the community that are followed by pharmacists who have undergone the certification course, and compare their blood pressure outcomes to subjects managed by pharmacists who have not yet received the training.

Hypertension Canada proposes the first "Hypertension Canada Professional Certification Program"(HC-PCP), specifically designed for Alberta pharmacists, to provide care and support to those at risk for or living with hypertension. Through this program, the investigators hope to help with prevention of the costly and chronic conditions to which hypertension often leads, like kidney failure, stroke, and heart disease.

The HC-PCP aims to provide training to pharmacists in the screening, prevention, and management of hypertension. It has been identified that the development and implementation of this certification program provides a unique opportunity to evaluate the impact of such a program on blood pressure reduction.

The investigators are aiming to assess the impact of pharmacist management on blood pressure control in patients with hypertension.

The development of the HC-PCP and the evaluation of its impact will occur in 2 phases. Phase 1 involves the development and implementation of the educational portion of the certification program. Phase 2 involves conducting a 1 year long study to assess the impact of the HC-PCP on blood pressure in patients with poorly controlled hypertension. This will be launched in pharmacies in Alberta.

Eligibility Criteria:
Inclusion Criteria:

* Patients with poorly controlled blood pressure (\>140/90mmHg or \>130/80mmHg if they have diabetes).

Exclusion Criteria:

* Unwilling to sign the consent form.
* Unwilling to participate in follow up visits.
* Current hypertension urgency or emergency (SBP \> 180mmHg or DBP \> 120mmHg).
Omega-3 Fatty Acids That Affect the Immune System in Kidney Transplant Patients

The purpose of this study is to evaluate the effectiveness of nutritional supplements in increasing the amount of omega-3 fatty acids (and arginine) in the red blood cell membranes and plasma of kidney transplant patients, and, secondarily, to compare patient compliance. The long-term goal of this study is to develop low risk therapies that will allow improved and lasting survival of donor tissue with minimal suppression of the immune system.

Short-term survival rates of donor tissue after kidney transplantation have improved significantly in recent years because of improved immunosuppression. Rates of long-term tissue loss have changed less because of a high incidence of chronic rejection, infectious complications, and cardiovascular disease. Data suggest that both early and late complications might be reduced in transplant recipients by dietary intervention to raise levels of omega-3 fatty acids and arginine.

Prior to transplantation, participants are randomized to one of three groups. Group 1 participants serve as controls and receive no dietary supplements. Participants in Group 2 receive daily nutritional supplements of arginine and canola oil according to body weight. Group 3 participants receive daily nutritional supplements of arginine and a fish oil emulsion according to body weight. All participants receive a standard, low-fat dietary consultation. The status of participants is evaluated peri-transplant and at 1, 3, 6, and 9 months.

Eligibility Criteria:
Inclusion Criteria:

* End-stage renal disease.
* Candidate to receive a living-related donor, living unrelated donor, or first cadaver kidney with at least 1 HLA mismatch.
* Negative crossmatch with the intended donor.
* Adults must have moderate to severe hypertension and/or take at least 1 medication for hypertension daily.
* Willingness to comply with the dietary supplements, including canola oil, a flavored drink mix, or an orange flavored pudding.

Exclusion Criteria:

* Pregnancy or breast-feeding.
* Women of childbearing age who are not willing or able to practice acceptable methods of contraception.
* HIV-positive.
* Positive test for HBV E-AG/DNA and HCV.
* Received an organ transplant or plan to receive a multiple organ transplant.
* Phenylketonuria.
* Participation in other investigational studies within 30 days of the renal transplant.
* Allergy or anaphylactic reactions to eggs or L-arginine.
* ABO blood incompatibility.
* Children who have previously received more than 5 blood transfusions.
* History of stroke.
A Novel Probiotic Mixture in Adults With IBS

Irritable bowel syndrome (IBS) is faced by gastroenterologists on a daily basis and probiotics are a potential therapeutic tool, however, there is no strain recommendations. This multicenter re-al-world, single-arm, open-label study aims to assess the effectiveness, safety, and patient satis-faction of a novel probiotic mixture in patients with IBS. Methods: This study is conducted by Italian gastroenterologists who enroll patients with IBS. Throughout the 8-week treatment (T1) period with a probiotic mixture (Lactobacillus paracasei 101/37 LMG P-17504, Lac-tobacillus plantarum 14D CECT 4528, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve BL10 LMG P-17500, and Bifidobacterium animalis ssp. lactis Bi1 LMG P-17502), participants complete a questionnaire to evaluate IBS symptoms at baseline, at the end of treatment, and after one-month follow-up (T2).

Irritable bowel syndrome (IBS) is faced by gastroenterologists on a daily basis and probiotics are a potential therapeutic tool, however, there is no strain recommendations. This multicenter re-al-world, single-arm, open-label study aims to assess the effectiveness, safety, and patient satis-faction of a novel probiotic mixture in patients with IBS. Methods: This study is conducted by Italian gastroenterologists who enroll patients with IBS. Throughout the 8-week treatment (T1) period with a probiotic mixture (Lactobacillus paracasei 101/37 LMG P-17504, Lac-tobacillus plantarum 14D CECT 4528, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve BL10 LMG P-17500, and Bifidobacterium animalis ssp. lactis Bi1 LMG P-17502), participants complete a questionnaire to evaluate IBS symptoms at baseline, at the end of treatment, and after one-month follow-up (T2).

Eligibility Criteria:
Inclusion Criteria:

* recurrent abdominal pain at least once per week during the past three months associated with two or more of the following criteria:
* related to defecation,
* Associated with a change in the frequency of stool,
* Associated with a change in the appearance of stool.

Exclusion Criteria:

* none
ED90 of Norepinephrine and Phenylephrine Boluses Under Intensive Treatment in Preeclamptic Patients

The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine boluses for treating postspinal anesthesia hypotension under intensive treatment in preeclamptic patients during cesarean section

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine boluses for treating postspinal anesthesia hypotension under intensive treatment in preeclamptic patients during cesarean section

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* Primipara or multipara
* Singleton pregnancy ≥32 weeks
* American Society of Anesthesiologists physical status classification I to III
* Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Baseline blood pressure ≥160 mmHg
* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly
Effects of BCG on Influenza Induced Immune Response

In the present study, the investigators want to investigate whether prior BCG-vaccination improves the efficacy of influenza ("the flu") vaccination in young and/or old healthy volunteers and consequently could protect against influenza virus infection.

Influenza virus infection leads to millions of cases of severe illnesses worldwide and up to an estimated 500.000 deaths annually. The potential for the sudden emergence of pandemic influenza strains represents an incessant threat on even a larger scale. seasonal influenza vaccination is the backbone of influenza management. However, antibodies generated by vaccination, most often do not effectively neutralize emergent strains due to the high mutation rate of the influenza viral genome. In addition, although vaccination is effective in up to 85% of healthy adults, only 40-60% of the elderly are able to mount an protective antibody response due to an agerelated decline in immune function (so-called immunoscenescence). As a result, the protective effects of influenza vaccination are limited, and strategies to improve host immune defenses against influenza virus infection per se, and following influenza vaccination, are highly warranted.

It is suggested that prior vaccination with Bacille Calmette-Guérin (BCG) could enhance resistance to other infectious diseases in addition to protection to tuberculosis (TBC) and, in mice, protection of prior BCGvaccination against influenza infection was demonstrated long ago. However, only recently substantial evidence for these nonspecific beneficial effects of BCG-vaccination in humans has been provided by several randomized clinical trials. Considering these potentiating effects of BCG-vaccination, it could be a viable strategy to improve efficacy of influenza vaccination, and/or enhance immune defenses against influenza virus infection per se. If so, this would have an enormous impact on clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤35 yrs
* Male
* Healthy

Exclusion Criteria:

* History of influenza vaccination within the year prior to study entry
* History of BCG vaccination within 5 years prior to study entry
* History of Mantoux testing within the year prior to study entry
* Vaccination other than BCG or influenza, within 3 months prior to study or within study period
* Medical history of any disease associated with immune deficiency
* Clinically significant acute illness, including infections, within 4 weeks before vaccination
* Participation in a drug trial or donation of blood 3 months prior to study entry
* Use of recreational drugs within 21 days prior to experiment day
* Recent hospital admission or surgery with general anaesthesia (\<3 months)
* Known chronic kidney or liver disease
* Latent or active tuberculosis infection
The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage

The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population.

Study Design:

Retrospective

Eligibility Criteria:
Inclusion criteria:

* Patients must be continuously enrolled in a health plan during the pre-index period;
* Patients must have at least one inpatient, or one physician office visit, emergency room visit with a diagnosis of AF (ICD-9-CM diagnosis code: 427.31in any position) on the index date or during the pre-index period;
* Patients must have a prescription for dabigatran or warfarin (this first prescription will be the index date);
* Patients must be treatment naive from all OAC use prior to first dabigatran or warfarin prescription;
* Aged 18-89 on the index date;

Exclusion criteria:

* Patients with valvular procedures related to the baseline AF diagnosis will be excluded;
* Patients with transient causes of AF such as hyperthyroidism, any cardiac surgery, pericarditis, mycoarditis, pulmonary embolism within 3 months prior to their first diagnosis of AF;
Retrospective Data Review of ReCap Total Hip Resurfacing

Retrospective Data Review on clinical outcomes and survivorship of ReCap Total Hip Resurfacing


Eligibility Criteria:
Inclusion:

* Patients received ReCap total hip resurfacing
Safety and Efficacy of IBI322 in Chinese Subjects With Advanced Malignant Tumors

This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.

Phase 1a/Ib study will be conducted to evaluate the tolerability, safety, PK, PD, immunogenicity and preliminary antitumor activity of IBI322 in China. Phase 1a is dose escalation and plans to enroll approximately 38-60 subjects with advanced malignant solid tumors who failed the standard treatment. Phase Ib is dose expansion, and plans to enroll approximately 180 subjects with advanced malignant tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors.
2. At least one evaluable lesion.
3. Male or female subject above 18 years old, no more than 75 years old.
4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
5. Must have adequate organ function

Exclusion Criteria:

1. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
2. Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) /anti-programmed death ligand 2 (PD-L2) antibodies
3. Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
4. Patients who are on anticoagulants and /or require concomitant aspirin or other nonsteroids anti-inflammatory medications. Patients with a history of a bleeding diathesis (von Willebrand disease, end stage liver disease, hemophilia, etc.)
5. Subjects who have a history of blood transfusion within 2 weeks prior to the study.