cyrilzakka/clinical-trials huggingface dataset:
Management of Frailty in Older Adults With Turmeric and Tulsi Supplements

The aim of this study is to determine the efficacy of turmeric and tulsi polyherbal formulation in the management of frailty in the elderly population.

Frailty is a wasting syndrome of old age that leaves a person vulnerable to falls, functional decline, morbidity and mortality. Reducing the severity of frailty will provide large benefits for individuals, their families and for the society. It is assumed that early intervention with frail people will improve quality of life and reduce the costs of care. This trial is testing the frailty intervention with herbal medicine. If this frailty intervention is shown to be effective, there are major potential benefits to the frail older population generally in terms of decreased disability. The interventions being examined are readily transferable to routine clinical practice and can potentially be applied routinely in aged care services.

Eligibility Criteria:
Inclusion Criteria:

* Subjects above the age of 65 years, providing written informed consent.
* Meeting three or more Cardiovascular health study frailty criteria
* Mild or no cognitive impairment (defined as a Mini-Mental State Examination score \>23),
* Able to walk without personal assistance and no other physical limitations that can limit participation and adherence, particularly to exercise intervention program

Exclusion Criteria:

People will be ineligible to participate in the trial if they:

* Live in a residential aged care facility
* Severe audio-visual impairment
* Progressive, degenerative neurologic disease like Parkinsonism, fits/ epilepsy, etc.
* Rapidly progressive or terminal illness under palliative care with life expectancy less than 12 months
* History of alcohol abuse or any other substance abuse
* Severely affect muscle/joint dysfunction resulting in disability
* Hospital admission in the past 3 months
* Regular physical training or physiotherapy or current participation in a vigorous exercise or weight-training program more than once per week
* Undergoing therapeutic diet incompatible with nutritional supplementation
* In the opinion of research clinician, the intervention is deemed to be potentially hazardous for the subject, such as serious cardiac and pulmonary disease.
Right Versus Left Infraclavicular Approach for Subclavian Vein Cannulation

Central venous cannulation is an essential procedure in the anaesthetic and critical care practice. Ultrasound has revolutionized the practice favoring the internal jugular cannulation to the other sites .Subcalvian vein cannulation has fallen out of favor mainly due to the difficult visualization with the ultrasound, especially in obese patients and the inevitable position of the clavicle acting as a bony obstacle , in addition to the anatomical position in vicinity to the pleura which might raise the risk of pneumothorax . Indeed the subclavian vein cannulation is more comfortable and tolerated by the patient especially those requiring long term intravenous therapy, with less rates of infection and thrombosis. This mandated the development of a safer and efficient technique for the cannulation empowered by the ultrasound technology.

The infracalvicular approach or the proximal axillary vein cannulation has been described but is not popular. It provides a potentially safer and successful technique with less complication both in "experienced" and "less experienced"operators . All the patients will receive general anaesthesia with laryngeal mask insertion . Careful sterilization of the surgical site and strict aseptic techniques for the handling of the ultrasound probe will be pursued

All patients will be in supine position, with the arm abducted to 45 degrees , the angle of the arm will be adjusted to acquire best image. The probe will be placed in he parasagittal plane in the deltopectoral groove medial to the coracoid process . The image will be optimized regarding the depth , focus and the gain accordingly for the best image of the axillary artery and vein similar to that acquired when performing an infraclavicular approach for brachial plexus block . The probe will be rotated to obtain a longitudinal image of the axillary vein . The needle will be introduced in real time imaging , in an in-plane technique and blood will be aspirated , the guidewire will be introduced in real time imaging .The internal jugular vein will be scanned bilaterally via ultrasonography to exclude malposition of the guidewire and will be reported in case of such. The catheter will be introduced through the sheath and will be tunneled the skin, Infraclavicular incision will be performed for the port site , the port will be secured in a dissected pocket right above the pectoralis major muscle .Flush back will be confirmed from the port .The incision will be closed in layers .The final position of the catheter tip will be confirmed using fluoroscopic guidance. In case of difficult visualization or failure of cannulation of one side , the subclavian vein of the contralateral side will be scanned and cannulated . The internal jugular vein will be the cannulated instead if any further difficulties were encountered .

Eligibility Criteria:
Inclusion Criteria:

.Patients requiring porta Cath insertion.

Exclusion Criteria:

.Abnormalities in the platelet count or coagulation .

.Thrombosis of the target vein, .Soft tissue infection of the overlying area.
A Study in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

The purpose of this study is to determine the overall response rate, time to progression, and 1 yr survival with cetuximab in patients with ovarian or primary peritoneal carcinoma.

To determine the overall response rate of cetuximab alone in subjects with ovarian or primary peritoneal carcinoma who have persistent or recurrent disease following 1-2 previous regimens of chemotherapy. Potential relationship between response, dose, and the occurence of rash in the treatment of subjects who have stable disease after the initial 6 weeks of treatment, time to progression, and 1 yr survival.

Eligibility Criteria:
Inclusion Criteria:

* subjects must have recurrent or persistent epithelial ovarian or primary peritoneal carcinoma. Histologic confirmation of the original primary tumor is required.
* EGFR expression must be positive as determined by an outside reference lab
* Subjects must have had a treatment-free interval following platinum of \<12 mos
* All subjects must have measurable disease at baseline
* Subjects must have at least one recurrent lesion to be used to assess response
* Recovery from effect of recent surgery, radiotherapy or chemotherapy

Exclusion Criteria:

* Subjects with other invasive malignancies (including peritoneal mesotheliomas)
* Subjects with unstable cardiac disease or MI within 6 mos
* Subjects with Acute hepatitis
* Subjects with active or uncontrolled infection
* A history of prior cetuximab or other therapy which targets the EGFR pathway or prior history of prior chimerized or murine monoclonal antibody therapy
The Effectiveness of Nivolumab Monotherapy as First-Line Therapy in Adults With Advanced Melanoma in Germany

A retrospective, observational study based on chart reviews for patients with advanced melanoma treated with nivolumab monotherapy prescribed as first-line therapy between June 2015 and June 2016, conducted in a representative sample of sites in Germany.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a primary diagnosis of advanced melanoma (histologically confirmed stage III \[unresectable\] or stage IV skin, ocular, or mucosal melanoma)
* Newly initiated with nivolumab monotherapy as their first-line therapy for previously untreated advanced melanoma between June 2015 and June 2016
* At least 18 years of age at time of treatment decision

Exclusion Criteria:

* Patients with a current primary diagnosis of a cancer other than advanced melanoma ie, a cancer other than melanoma that requires systemic or other treatment
* Patients currently included in an interventional clinical trial for his/her locally advanced or metastatic melanoma. Patients who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for overall survival can be enrolled. In case of a blinded study, the treatment arm (ie, type of administered treatment) needs to be known.
* Patients \< 18 years of age at time of treatment initiation

Other protocol defined inclusion/exclusion criteria could apply
Effects of Physical Activity During Pregnancy on the Newborn's Cognitive Function

Background: It is now generally accepted that an active lifestyle is beneficial for cognition, but can these benefits be transmitted for the active pregnant woman to her unborn child? This has been demonstrated in rats where the pups born of mothers who exercised during pregnancy had increased hippocampal neurogenesis and better memory and learning capabilities. Human studies tend to confirm this by looking at behavioral results, ie. better orientation and state regulation skills in newborns. The aim of the present study is to verify this on the electrophysiological level and to determine the effects of an active lifestyle during pregnancy on the newborn's brain development.

Methods: 60 pregnant women will be included in a randomized controlled trial. The exercise group will be asked to exercise a minimum of 20 minutes, 3 times per week, at a minimal intensity of 55% of their maximal aerobic capacity. The control group will not be given exercise counselling. Newborns' brain activity will be recorded using electroencephalography (EEG) 10 days post partum. The primary outcome measure will be the amplitude and latency of the mismatch negativity (MMN), a component of the auditory event-related potential (ERP) that can be used to investigate the auditory sensory memory.


Eligibility Criteria:
Inclusion Criteria:

* First trimester of pregnancy
* 20 to 35 years of age
* Pre-pregnancy BMI between 18 and 25
* Primipara
* Without any known health issues
* Use of folic acid

Exclusion Criteria:

* Use of alcohol, cigarettes or illegal drugs
* Pregnancy complications
* Unable or unwilling to breastfeed
* Excessive or insufficient weight gain
Turkish Version of F-2-MS

The aims of this study were to perform cultural adaptation of the F-2-MS and provide information regarding the factor structure, reliability and validity of the instrument in Turkish speaking patients with Multiple Sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 20-65 years, with an EDSS score of 0-5, who have not had an attack in the last 2 months, who have no cognitive problems (a score of 6 or more according to the Hodkinson Mental Test), who do not have additional neurological diseases other than MS, and who volunteer to participate in the study will be included.

Exclusion Criteria:

* Individuals with an EDSS score greater than 5, who are in the attack period, who have vestibulosupressant or drug or alcohol use habits that cause neuropathy, and who have communication problems will be excluded from the study.
Self Selection Trial of Naproxen Sodium

A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their own use based on expected duration of pain greater than 12 hours.


Eligibility Criteria:
Inclusion Criteria:

* At least 12 years of age
* Report taking at least one dose of Over-the-counter (OTC) analgesic for pain in the past month
* Able to read and understand English
* Provide written informed consent (subjects 12-17 years of age provide written assent and/or parent or legal guardian provide written consent)
* Provide contact information

Exclusion Criteria:

* Have participated in a trial involving OTC analgesics in the last 6 months
* They or someone else in the household work for a market research company, an advertising agency, a public relations firm, a pharmaceutical company, as a healthcare professional, or as part of a health care practice (eliminated for reasons of confidentiality or increased awareness of drugs and their labels)
* Have a history of known allergies to Nonsteroidal Antiinflammatory Drugs (NSAIDs) (i.e., naproxen, ibuprofen, acetaminophen, aspirin, etc.)
* Have a history of heart surgery in the last 60 days or plans for heart surgery in the next 60 days
* Female subjects who have a positive urine pregnancy test or who are breastfeeding.
A Novel Appendicitis TriMOdal Prediction Score (ATMOS) for Acute Appendicitis in Pregnancy: a Retrospective Observational Study

Acute appendicitis (AA) is a disease of younger age, but it occurs in 1 out of 500-2000 pregnancies. The current treatment of choice for AA in pregnancy is surgical. Even with standard clinical examination, serum inflammatory markers, and transabdominal ultrasound, the decision on surgical treatment of acute appendicitis (AA) and the rate of negative appendectomy in pregnancy are still unsatisfactory. There are several scoring systems (Alvarado, Tzanakis) that help making decision on operating more easier, however their specificity is either high with low sensitivity, or the other way around. In addition, all scores are based on adult non-pregnant population. We are making an observational study to develop a scoring system that would include ultrasonic imaging with clinical-biochemical parameters while not compromising sensitivity and specificity.

The study includes extraction of medical data for pregnant women, age 18 years or older, admitted to the University Hospital Centre Zagreb, Zagreb, Croatia, with the suspicion of AA, from January 2010 to December 2020. The aim of this study is to develop a scoring system that would include ultrasonic imaging with clinical-biochemical parameters while not compromising sensitivity and specificity.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women, age 18 years or older, admitted to the University Hospital Centre Zagreb, Zagreb, Croatia, with the suspicion of acute appendicitis, from January 2010 to December 2020.

Exclusion Criteria:

* non-pregnant patients
* pregnant patients younger than 18 years
* diagnosis made with CT or MRI
* pregnant patients with the acute abdomen (intraoperative diffuse peritonitis) from acute appendicitis
The Effects of Muscles Strength on Physical Performance in Patients With Multiple Sclerosis

Muscle weakness, which is one of the most common symptoms in patients with MS, limits the activities of daily life activities of patients by causing balance and gait disturbance. Lower extremity muscle strengths of MS patients are reported to be weaker than healthy individuals. Broekmans et al. showed that the weakness of the knee flexor and extensor muscles in patients with MS caused a decrease in walking distance and they are important determinants of walking capacity.

The effects of the endurance and strength of core muscles, as well as the extremity muscles, are important on physical performance. The weakness of the extremities and core muscles in MS patients also affects the sit-to-stand performance negatively as well as a decrease in walking speed and capacity.

In this study, it was aimed to investigate the effects of extremity and core muscle strength on walking and sitting-up performance of MS patients.

Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The strength of the extremity and core muscles, walking capacity, and sit-to-stand performance will be evaluated once.

Investigators will use descriptive statistics and t-tests to compare variables between groups. Investigators will examine the correlations between variables using Pearson bivariate correlations. The significance level is set at p\<0,05

Eligibility Criteria:
Inclusion Criteria:

* Participants who 18-65 years of age
* MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month.

Exclusion Criteria:

* Participants who have orthopedic, vision, hearing, or perception problems
Retinal Nerve Fiber Layer Thickness Changes in Migraine: A Meta-Analysis of Case-control Studies

Optical coherence tomography (OCT) is a non-invasive retinal imaging technology that can provide high-resolution cross-sectional images of the peripapillary retinal nerve fiber layer (RNFL) and measure its thickness. A reduction of the RNFL thickness has been detected in several neurodegenerative diseases, such as multiple sclerosis, CADASIL and Alzheimer's disease. Different studies have reported RNFL changes also in migraine, is a common hereditary chronic neurovascular disorder, characterized by dysfunction of the autonomic nervous system. The pathophysiology of migraine has not been fully clarified, but there is increasing evidence that episodes of migraine with aura are initiated by a focal reduction in cerebral blood flow, which occurs most commonly in the posterior region of one hemisphere. Although vasoconstriction of cerebral and retinal blood vessels is a transient phenomenon, the chronic nature of the migraine might cause permanent structural abnormalities of the brain and also of the retina, which may correlate with RNFL thinning. Previous studies on this subject, however, reported contradicting results. Some investigations reported reductions of the RNFL thickness while others did not. In the present study, in order to determine whether RNFL thickness is reduced in migraine patients, the investigators performed a meta-analysis and systematically evaluated RNFL thickness measurements with OCT in a series of migraine patients and in the healthy control groups.


Eligibility Criteria:
Inclusion Criteria:

1. case-control studies;
2. patients with Migraine were compared with healthy controls;
3. all subjects underwent RNFL thickness measurement by OCT;
4. studies should provide the data of peripapillary RNFL thickness;
5. sample size ≥10 in each group.

Exclusion Criteria:

1. authors did not make RNFL measurements;
2. study without healthy control group;
3. the outcome values can not be used for meta-analysis;
4. duplicated articles.
Validity of Neurocognitive Assessment Methods in Childhood ADHD

The aim of the study is to examine the prospective validity of neurocognitive functions and emotional factors in schoolchildren with ADHD and a control group of typically developing schoolchildren at baseline and after three years.

In spite of extensive research on children with ADHD, there is still insufficient understanding of the discriminative validity of neurocognitive tests and how test results of neurocognitive functions and ratings of emotional factors and ADHD symptoms change over time and interacts during development. The project is studying the validity of clinical assessment methods within the Swedish child and adolescent psychiatry service (CAP) related to the identification of ADHD, additional impairments, and comorbidity. The prospective validity of neurocognitive functions and emotional factors in schoolchildren with ADHD and a control group of typically developing schoolchildren at baseline and after three years will be investigated.

Specific aims: Aim I: Study how attentiveness and impulsivity in ADHD change over three years by comparing the results of psychological tests and rating scales at baseline and after three years Aim II: Study intellectual development in ADHD by comparing the results of intelligence tests at baseline and after three years- Aim III: Study how emotional factors change over three years by comparing the results of rating scales at baseline and after three years

Eligibility Criteria:
Inclusion Criteria: The ADHD-group:

• The individuals were assessed and diagnosed with ADHD at the Neuropsychiatric Unit of the CAP Clinic in Lund in 2011-2012

Non-clinical group:

* School children from Lund.

Exclusion Criteria:

* If the individual had a diagnosed intellectual disability
* If the individual required an interpreter to participate in the study
Caring for Providers to Improve Patient Experience Study Phase 2 in Migori County

The activities described in this proposal are aimed at addressing health care provider stress and unconscious bias to improve quality of maternal health care, particularly related to the person-centered dimensions of care-i.e. care that is respectful and responsive to women's needs, preferences, and values. The investigators focus on health provider stress and unconscious bias because they are key drivers of poor-quality care that are often not addressed in interventions designed to improve quality of maternal health care. The investigators plan to (1) design an intervention that enables providers to identify and manage their stress and unconscious bias; (2) pilot the intervention to assess its feasibility and acceptability; and (3) assess preliminary effect of the intervention on: (a) provider knowledge, attitudes, and behaviors related to stress and unconscious bias; and (b) provider stress levels.

Poor person-centered maternal health care (PCMHC) contributes to high maternal and neonatal mortality in sub-Saharan Africa (SSA), and disparities in PCMHC are driving disparities in use of maternal health services., However, little research exists on how to improve PCMHC and reduce disparities. The investigators seek to fill this gap with this project. They propose targeting health provider stress and unconscious bias as fundamental factors driving both poor PCMHC and disparities in PCMHC. Health care provider stress and unconscious bias are important to consider because: (1) providers in low-resource settings often work under very stressful conditions; (2) unconscious bias is prevalent in every society including SSA; and (3) these factors are mutually reinforcing drivers of poor quality care and disparities in person-centered care. In the first phase of the project (CPIPE1), they conducted research to examine (1) the factors associated with PCMHC and identified provider stress and unconscious bias as key contributing factors. They also examined the levels of provider stress and unconscious bias and the types of stressors and biases in Migori County, Kenya. The results of that research will be used to inform this phase (CPIPE2), the aims of which are to: (1) design a multicomponent theory and evidence-based intervention that enables providers to identify and manage their stress and unconscious bias; (2) pilot the intervention to assess its feasibility and acceptability; and (3) assess preliminary effect of the intervention on: (a) provider knowledge, attitudes, and behaviors related to stress and unconscious bias; and (b) provider stress levels using a pretest-posttest control group design. They will use the results of the pilot to refine the intervention and develop an R01 proposal for a multi-site evaluation with a larger sample and longer follow up to assess impact on PCMHC. This study will yield valuable information to inform quality improvement efforts for PCMHC.

Eligibility Criteria:
Inclusion Criteria:

* Providers working in maternity units of the intervention facilities are all eligible.

Exclusion Criteria:

* Inability to attend scheduled training.