cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of the STANDING Algorithm for the Differential Diagnosis of Vertigo

Differential diagnosis of vertigo is complex especially in emergency department, nevertheless it is crucial. The aim of this study is to assess the accuracy of STANDING algorithm for discriminate central from peripheral type of vertigo, identifying more easily the presence of ischemic stroke.

Vertigo represents a common medical problem which afflicts about 20-30% of the population and it is a frequent cause of abstention from work and disability. In most cases it is provoked by a benign disease of inner ear, however it can be the main symptom of a more dangerous illness like ischemic or hemorragic stroke, cerebral neoplasm or demyelinating disease. Indeed, vertigo is the prevailing clinical problem in patients with misdiagnosed ischemic stroke, leading to an increase of mortality in the acute phase of disease. In the current state, two diagnostic algorithm have been proposed for the evaluation of acute vertigo, named with the acronyms HINTS and STANDING. The former is characterized by high sensibility and specificity when utilized by a specialist physician, but it is cumbersome to used in emergency department. Conversely, the latter has been validated exactly in this setting and comprises the evaluation of benign paroxysmal positional vertigo and of upright position. The aim of this study is to estimate the accuracy of STANDING algorithm in differentiating peripheral vertigo from central from, in particular ischemic stroke, and its potential usefulness in decreasing the use of neuroimaging and specialist consultant.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years of age.
* patients affected by vertigo, dizziness or balance disorder.

Exclusion Criteria:

* age under 18.
* patients unable to cooperate (with severe dementia or incapable to provide consensus).
* patients affected by disease of cervical spine or any trauma of this part of body that contraindicate the manipulation of neck.
* impractical follow-up.
* dying patient (less three estimated months to live).
* patients with neurologic deficit identified during triage examination (Cincinnati Prehospital stroke scale, CPSS\>0) of suffering from another disease that can be the cause of dizziness/balance disorder (e.g. anemia, arrhythmia, hypoglycemia, alcoholic intoxication).
* patients without symptoms at the time of examination.
* patients who deny the participation in the study.
Phenylketonuria and Hyperphenylalaninemia Nutrition Study

The mainstay of PKU treatment is a low-phenylalanine diet (i.e restriction of natural protein), and supplementation with a protein substitute (a mixture of amino acids free from phenylalanine, also containing micronutrients and vitamins) and special low-protein foods, to meet the patient's energy requirements. When diet and treatment is relaxed after childhood, adult and adolescent patients with phenylketonuria are at risk for malnutrition, depending on the compliance with treatment and the intake of amino acid supplements.

In this study, nutrition status of patients with PKU and hyperphenylalaninemia is systematically assessed under ongoing current treatment, in relation to Phe-tolerance, compliance with treatment, and psychosocial issues.

Study participants do not undergo any specific therapeutic or diagnostic intervention.


Eligibility Criteria:
Inclusion criteria:

* PKU (Phenylketonuria) or hyperphenylalaninemia
* male or female, minimum age 16y
* signed informed consent

Exclusion criteria:

- patient who can not comply with the study protocol (e.g. unable to fill in questionnaires by themselves or a representative)
Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis)

We will investigate the process of vitiligo induction and the influence of different commonly used cream treatments on this process. Studies comparing different treatments for vitiligo in the induction stage of the disease are still missing. The study hypothesis = cream treatment can stop actively spreading vitiligo lesions during the early induction stage of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Male and female,
* Age 18-70 years,
* Extensive vitiligo (\> 50% body surface area),
* Patients asking for depigmenting therapy,
* Not pregnant.

Exclusion Criteria:

* Children,
* Non extensive vitiligo (\< 50% boy surface area),
* Patients not asking for depigmenting therapies,
* Pregnant.
The Effect of Midwifery Care Given to Couples Experiencing Pregnancy Loss on Grief and General Well-Being

This study was designed as a randomised controlled, 2-group, pre-test-post-test comparative, experimental study to increase the general well-being of women experiencing pregnancy loss and to decrease the level of perinatal grief.

Objective: The aim of this study was to examine the effect of midwifery care and counselling based on Swanson Care Theory for couples experiencing pregnancy loss on womens perinatal grief and general well-being levels.

Method: The study had an experimental two-group pretest-posttest design. Midwifery care and counselling based on Swanson Care Theory is a grief support program consisting of eight interviews, including four face-to-face interviews after the woman\&#39;s admission to the clinic and four telephone interviews until the 30th day after discharge. The study was conducted with 76 couples admitted to the obstetrics and gynecology department of a training and research hospital in Istanbul between August 2023 and May 2024 with a diagnosis of pregnancy loss. The intervention group (n=38) received midwifery care and counselling based on Swanson Care Theory in addition to routine midwifery care in accordance with clinical procedures, whereas the control group (n=38) received only routine midwifery care in accordance with clinical procedures. This study used the Women Experiencing Pregnancy Loss Introductory Information Form, Men Experiencing Pregnancy Loss Introductory Information Form, Perinatal Bereavement Scale, and General Well-Being Scale.

Eligibility Criteria:
Inclusion Criteria

* To agree to participate in the research with a partner.
* Speak and understand Turkish.
* To be 18 years of age or older.
* To be at least primary school graduate.
* Having experienced loss after spontaneous pregnancy.
* Not being diagnosed with a psychiatric illness.

Exclusion Criteria:

* Pregnancy loss due to medical termination
* Being pregnant with assisted reproductive techniques and experiencing pregnancy loss
RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.

This is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based therapy in US community oncology network settings.


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  1. Diagnosed with locoregional recurrent or metastatic female breast cancer.
  2. Pathologically confirmed HR-positive/HER2-negative diagnosis.
  3. Received treatment with palbociclib in combination with letrozole as initial endocrine-based therapy for advanced/metastatic breast cancer:

     1. Initiated treatment with palbociclib at least 3 months following the provider's first use of palbociclib following its FDA approval.
     2. At least 1 month of follow-up (at least one visit with the provider) after initiation of palbociclib.
  4. Postmenopausal (or receiving surgical or medical treatment to induce menopause) at the time of initiation of palbociclib.
  5. ≥18 year old at initiation of palbociclib.

     Exclusion Criteria:
* No exclusion criteria will be imposed for the selection of patients.
Web-administered STAIR for Patients on Behavioral Health Waitlists

Posttraumatic stress disorder (PTSD) is a significant public health challenge with population prevalence rates in the US between 6.1 to 9.2%. There are large racial and socioeconomic inequities in access to PTSD treatment, as up to half (30-50%) of patients in safety net clinical settings meet criteria for PTSD, yet only 13% receive any behavioral health treatment. Workforce shortages are one major barrier to accessing care. Additional barriers to care can include heightened mental health stigma and mistrust of health services.

Digital mental health interventions (DMHIs) may be suitable within the continuum of care for PTSD in hospital settings, given their potential for rapid-access, scalability, and the high acceptability of DMHI among individuals with high stigma and social needs. Among the available DMHIs for PTSD, the investigators have selected web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), based on emerging scientific evidence and a close collaboration with Boston Medical Center (BMC) users (patients and providers) in a previous pilot study in primary care.

The aim of this randomized study is to implement webSTAIR at BMC in the Recovery from Stress and Trauma through Outpatient Care, Research, and Education (RESTORE) Center's subspecialty clinic.


Eligibility Criteria:
Inclusion Criteria:

* Client on the RESTORE Center waitlist at Boston Medical Center
* Over 18 years of age
* Able to receive therapy in English or Spanish (per participant report)
* Exposure to trauma (as indicated by the Life Events Checklist for the DSM-5 \[LEC-5\])
* Probable PTSD (as indicated by the PTSD Checklist for the DSM-5 \[PCL-5\] based on PCL score of 33+).
* Reasonable to access to technology (e.g., phone, computer, internet access).

Exclusion Criteria:

* Patient declines to be in the study.
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of PAT-1251 in Healthy Adult Subjects

A single-center, randomized, placebo-controlled study consisting of both a single ascending dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability, pharmacokinetics and effect of food using PAT-1251 orally administered to healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive
* body weight of 50 to 100 kg, inclusive
* subjects must be in good health

Exclusion Criteria:

* male subjects who do not agree, or whose partners of childbearing potential do not agree, to use appropriate contraception
* female subjects of childbearing potential who do not agree to use 2 acceptable methods of contraception
* history of, any clinically significant major disorder
* clinically significant allergic condition
* significant history of alcoholism or drug/chemical abuse
* use of any tobacco or nicotine-containing products
* clinically significant abnormality in heart rate, blood pressure, temperature, respiration rate, electrocardiogram or clinical laboratory findings
* positive urine drugs of abuse screen or alcohol breath test
Understanding Neonatal Jaundice in Rwanda

This study exploits the distribution of low-cost high-quality phototherapy devices (Brilliance by D-Rev) to public hospitals in Rwanda to assess whether the provision of improved technology improves health care for infant jaundice. Specifically, the investigators are interested in measuring whether the provision of an additional high-quality phototherapy device, a known effective treatment for jaundice, successfully translates into improved care of neonatal jaundice in Rwanda where the burden of jaundice is particularly high.

The Ministry of Health (MIH) in Rwanda has planned to provide Brilliance devices (phototherapy) to 46 public hospitals in Rwanda. The investigators have worked with MIH to have the delivery of these machines be staggered over three phases through random selection. The methodology relies on the staggered distribution of Brilliance devices and survey data collected prior and during delivery dates to evaluate the provision of low-cost high quality phototherapy machines, following the basic design of a staggered randomized controlled trial. Specifically, the investigators will survey all hospitals prior to the receipt of any Brilliance devices to provide a baseline description of the care received in these facilities. These surveys will collect information on the facility itself, including average infant jaundice caseloads and descriptions of recent cases. The investigators will then randomly select 15 hospitals to receive the Brilliance units. Three months after installation of Brilliance has occurred at these facilities (Group 1), another randomly selected subset of 16 facilities (Group 2) will receive their Brilliance machines. Three months after these installations have been completed, the remaining facilities (Group 3) will receive their Brilliance machines. During this period, there will be ongoing data collection from the hospitals, creating a panel dataset on the jaundice-related caseloads at these facilities. The data collected will be akin to collecting hospital records of patients diagnosed with jaundice, but no identifiable patient information will be collected.

Eligibility Criteria:
Inclusion Criteria:

* For patient level record (de-identified), diagnosed by the facility for having infant jaundice
* The facilities are included based on selection by the Ministry of Health for receiving additional phototherapy machines.

Exclusion Criteria:

-
Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis

The goal of this study is to compare which treatment - BlephEx or MiBoFlo - will be a better option for patients suffering from dry eye secondary to Meibomian Gland dysfunction.

The investigators have previously studied the effect of the BlephEx instrument (debridement of lid debris) in relieving signs and symptoms of blepharitis (Connor CG et al, ARVO 2014). This previous study demonstrated positive results from the BlephEx treatment. Warming the eyelids (e.g., using warm wash cloths) still remains a viable treatment option for this disease. However, patients are often non-compliant with warm compress therapy due to the requirement of performing it at least twice per day. The MiBoflo delivers uniform and consistent amounts of heat to the eyelid. It is suggested that two treatments over 30 days is adequate to relieve signs and symptoms of Meibomian gland dysfunction. This equipment is currently used in optometric practices in this country.

There are no clinical studies comparing BlephEx and MiBoflo as treatment options for blepharitis. Hence, the current study will provide new and useful information on which treatment option may be better for treating blepharitis and Meibomian gland dysfunction. Part of this study will also investigate if a combination of BlephEx and MiBoflo treatments is more beneficial to the patient. The data generated will directly benefit clinical practice and impact several millions of patients who suffer from this Blepharitis and / or Meibomian gland dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Must have dry eye secondary to Meibomian gland dysfunction (posterior blepharitis)

Exclusion Criteria:

* Must not have active ocular surface infections. Must not be currently using steroids or immunosuppression eye drops.
Simulation Based Training In Medical Students

Transferring classroom learning to real-life situations is a challenge. Tabletop simulation exercises offer a low-cost and context-specific approach for educating students on appropriate responses during health emergencies.

This randomized controlled trial will evaluate the effectiveness of simulation-based training versus traditional lecture methods in enhancing outbreak investigation skills among medical students.

This randomized controlled trial will assess the efficacy of simulation-based training compared to conventional lecture methods in improving medical students' outbreak investigation skills. it will be Conducted at CMH Lahore Medical College over nine months, the trial will include 4th year MBBS students with no prior outbreak investigation training. Participants will be randomized into two groups: an intervention group undergoing simulation-based exercises and a control group receiving traditional lectures.

Eligibility Criteria:
Inclusion Criteria:

* 4th year MBBS students at CMH Lahore Medical College without prior outbreak investigation training,
* willing to participate and providing informed consent.

Exclusion Criteria:

* students with supplementary exams
* unwillingness to participate, or
* scheduling constraints.
Epidemiology of Chronic Hepatitis C and Disease Modelling

Hepatitis C (HCV) is a major health problem amongst people who inject drugs (PWID) and have limited contact with health care services. Halfway houses (HH) serve to reintegrate former drug users into society. Strategies to eliminate HCV must focus on screening for HCV amongst HH. Linkage to care for PWID population is an issue globally.

The aim is to determine the sero-prevalence, demographics, disease distribution and factors associated with the risk of HCV transmission amongst former drug users at Halfway Houses. The secondary aim would be to determine the best models of care that can be used to link these individuals to existing healthcare services in a pragmatic, randomised fashion

Halfway Houses are invited to participate in a program of HCV education, point-of-care screening using Oraquick test and staging with Fibroscan® by a small mobile team of healthcare workers. A detailed survey regarding illicit drug injecting practices is performed. Those who are tested positive are referred to medical care.

It is anticipated that the prevalence of Hepatitis C within the drug injecting population along with the stages of liver disease such that models for disease burden can be determined.

This is a pragmatic observational study of point of care HCV screening in the halfway house resident /PWID population.

In the secondary aim the HCV positive subjects are randomised to traditional referral pathway (HCV positive cases attend primary care facilities to get referral to specialist clinic in hospital) and 'direct' open access where the HCV positive cases has direct open access to specialist clinic as above (by passing primary care physicians). We observe the no. of subjects being linkage to specialist care, and HCV treatment

Eligibility Criteria:
Inclusion Criteria:

* Former Drug Users residing in Halfway Houses

Exclusion Criteria:

* Age below 21 years
* Residents of Halfway Houses who have never used drugs
Special Drug Use Investigation of Glucobay OD

The objective of this study is to assess the efficacy and safety under practical use of Glucobay OD. A total of 5,000 patients are to be enrolled to the study and assessed during 1 year observation period.


Eligibility Criteria:
Inclusion Criteria:

* Glucobay OD naive diabetics. patients with at least one of the following conditions: Uncontrollable with dietary therapy,exercise cure, diabetes medication, insulin therapy.

Exclusion Criteria:

* Patients who are contraindicated based on the product label
A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema

The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing hereditary angioedema attacks when it is administered under the skin of subjects with hereditary angioedema. The safety of C1-esterase inhibitor will also be assessed. Each subject will enter a run-in period of up to 8-weeks. Subjects who complete the run-in period and who are eligible will then enter the treatment phase which comprises two sequential treatment periods. In the treatment phase, subjects will be randomized to one of four arms consisting of treatment with low- or higher-volume C1-esterase inhibitor in one treatment period and treatment with low- or higher-volume placebo in the other treatment period. The study will measure the number of hereditary angioedema attacks that subjects experience while receiving each treatment.


Eligibility Criteria:
Inclusion Criteria:

Run-In Period Inclusion Criteria:

* Males or females aged 12 years or older.
* A clinical diagnosis of hereditary angioedema type I or II.
* Hereditary angioedema attacks over a consecutive 2-month period that required acute treatment, medical attention, or caused significant functional impairment.
* For subjects who have used oral therapy for prophylaxis against HAE attacks within 3 months of Screening: use of a stable regimen within 3 months of Screening, with no plans to change.

Eligibility Criteria for Entering Treatment Period 1:

* Laboratory confirmation of type I or type II hereditary angioedema, including C1-esterase inhibitor functional activity less than 50% AND C4 antigen level below the laboratory reference range.
* No clinically significant abnormalities as assessed using laboratory parameters.
* During participation in the run-in period, subjects must have experienced hereditary angioedema attacks that required acute treatment, required medical attention, or caused significant functional impairment.

Exclusion Criteria:

Run-In Period Exclusion Criteria:

* History of clinical significant arterial or venous thrombosis, or current history of a clinically significant prothrombotic risk.
* Incurable malignancies at screening.
* Any clinical condition that will interfere with the evaluation of C1-esterase inhibitor therapy.
* Clinically significant history of poor response to C1-esterase therapy for the management of hereditary angioedema.
* Receiving therapy prohibited by the protocol, including medications for hereditary angioedema prophylaxis.
* Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progesterone-containing products) within 3 months prior to the screening visit.
Help Arthritis With Exercise in West Virginia

The purpose of this project is to determine if an evidence-based, community-delivered physical activity program, EnhanceFitness, yields benefits for participants with arthritis. The 3-year project will: 1) conduct a meta-analysis of community-based exercise programs for adults, 2) implement and evaluate the EnhanceFitness program in West Virginia using a randomized, controlled (wait list) design, and 3) disseminate the results to community and public health partners. It is anticipated that participation in the EnhanceFitness program will result in reduced pain, improved physical function and physical activity levels for adults with arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Any type of self-reported, doctor-diagnosed arthritis

Exclusion Criteria:

* Any co-existing conditions where exercise is a contraindicated
* Impaired cognitive status
* Non-ambulatory