cyrilzakka/clinical-trials huggingface dataset:
Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type II

This study evaluates the safety and efficacy of PHA-022121 administered orally for prophylaxis against angioedema attacks in patients with hereditary angioedema (HAE). The study consists of 2 parts, with patients completing participation in Part 1 prior to initiation of treatment in Part 2. Part 1 of the study has 3 parallel arms and approximately 30 patients will be equally randomized to one of two dose regimens of PHA-022121 or matching placebo. Patients will continue to the single open-label arm in Part 2 of the study after completion of Part 1. The screening period is up to 8 weeks and the treatment periods are 12 weeks (Part 1) and 30 months (Part 2) in duration.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form
* Diagnosis of HAE type I or II
* Documented history of at least 3 HAE attacks within the last 3 consecutive months prior to screening, or a minimum of 2 HAE attacks during the screening period
* Reliable access and experience to use standard of care acute attack medications

Exclusion Criteria:

* Pregnancy or breast-feeding
* Clinically significant abnormal electrocardiogram
* Any other systemic disease or significant disease or disorder that would interfere with the patient's safety or ability to participate in the study
* Use of C1-esterase inhibitor, oral kallikrein inhibitors, attenuated androgens, anti-fibrinolytics, or monoclonal HAE therapy within a defined period prior to enrolment
* Abnormal hepatic function
* Abnormal renal function
* History of alcohol or drug abuse within defined period, or current evidence of substance dependence or abuse
* Participation in any other investigational drug study within defined period
Comparison of Efficacy, Safety and Anti-Inflammatory Effect Between Topical 0.05%Cyclosporine A Emulsion and REFRESH® in Patients With Moderate to Severe Dry Eyes

To compare the efficacy, safety and tolerability of 0.05% topical cyclosporin eye drop to Refresh in moderate to severe dry eye patients. Null hypothesis is: there is no difference between these two groups.

Inclusion criteria:

1. Participants are moderate to severe dry eye patients aged more than 18 years of age
2. Oxford staining scores of more than five.
3. OSDI scores of more than 0.1

Outcome measurements:

Main parameter is staining score (corneal + conjunctival) Other parameter is OSDI score, symptom of ocular surface discomfort score, number of daily artificial tear needed, TBUT, Schirmer I score, cytokines level \& markers Safety parameters: VA, IOP, cyclosporin level

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe dry eye

Exclusion Criteria:

* lid anomaly, previous CsA use
The Effect of Education on Drug Compliance and Quality of Life in Hepatitis B Patients

The aim of this study is to determine the effect of the education given to patients with CHB who use oral antiviral drugs on oral antiviral drug use on drug compliance and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with CHB for at least 6 months,

  * To be over 18 years old,
  * Using oral antiviral treatment for at least three months,
  * To be a literate person,
  * No malignancy other than hepatocellular carcinoma,
  * Not having vision and hearing problems,
  * Not having cognitive or psychiatric problems,
  * Patients/patient relatives who can use smartphones (In order to invite the patients to the 3rd and 6th month controls and to inform and remind the experimental group about the training time, they / their relatives should have and can use a mobile phone)
  * Volunteer to participate in the study.

Exclusion Criteria:

* •Continuing to use alcohol after the first evaluation,

  * Not willing to participate in the study,
  * Patients with a psychiatric diagnosis,
  * Patients who do not meet the sample inclusion criteria.
Clinic to Community Connections - Broader Distribution

This study addresses education needs in gestational diabetes care and followup at the staff and patient levels.

In the initial phase, nurses and community health workers will complete specific training modules on gestational diabetes developed for this study. The effectiveness of the education modules will be evaluated through pre/post surveys of participants assessing diabetes knowledge, attitudes, and self-efficacy.


Eligibility Criteria:
Inclusion Criteria:

Clinic staff: nurses (RN, LPN, BSN), community health workers, and others involved in maternal child health care

Exclusion Criteria:

Clinic staff: individuals not involved in maternal child health care or who do not consent to participate in study
Tumor and Treatments Impact on Neurocognitive Functions and Quality of Life of Patients With OMS Grade II Glioma

This is a multicenter prospective study:2 independant cohorts of patients with OMS grade II glioma will be followed during 5 years.

* cohort A: patients in first-line treatment (surgery, radiotherapy or chemotherapy)
* cohort B: patients with disease simple monitoring.

The primary endpoint is to evaluate the impact of tumor and treatments on neurocognitive functions and quality of life, using validate and standard tests.


Eligibility Criteria:
Inclusion Criteria:

* OMS grade II glioma
* signed informed consent
* age \>=18
* IK \>=80%
* ability to read, write and undertand French

Exclusion Criteria:

* glioma localized to brainstem
* other neurologic or psychiatric disease
* history of other malignancies, other than curatively treated in-situ carcinoma of the cervix or basal cell carcinoma of the skin, or any other curatively treated cancer with no sign of recurrence within 5 years prior to randomization
* neuroleptic concomitant treatment
* pregnant or lactating women
The Effect of Eye Movement Desensitization and Reprocessing Intervention in Hypertension Patient.

Eye Movement Desensitization and Reprocessing intervention may improve anxiety, depression, systolic blood pressure and heart rate variability in patients with hypertension.


Eligibility Criteria:
Inclusion Criteria:

1. age of 20-80 years,
2. diagnosed with primary hypertension as in SBP ≥130 mmHg or DBP ≥80 mmHg,
3. and able to read and understand Chinese or Taiwanese and willing to participate in this study,

Exclusion Criteria:

1. . Secondary hypertension
2. . Hypertension Crisis.
Examining the Effectiveness of Multidisciplinary Care Teams in Improving Outcomes for Breast Cancer Patients

To compare clinical outcomes, patient-reported measures (PROMs), and healthcare utilization between standard care with or without an MDCT in a cohort of women treated for breast cancer.

This single-center, prospective interventional trial evaluates the effectiveness of Multidisciplinary Care Teams (MDCTs) in improving outcomes for newly diagnosed breast cancer patients at Hayatabad Medical Complex, Peshawar. The study enrolled 73 participants from May 2021 to April 2024, with follow-up sessions every six months for up to two years.

Participants were randomly assigned to two groups:

Group A (n=37): Received care through MDCTs, which included radiologists, oncologists, and surgeons collaborating to create personalized treatment plans and monitor patient progress.

Group B (n=36): Received standard therapy according to existing institutional protocols.

The study assesses multiple outcomes, including \*\*disease-free survival (DFS), overall survival (OS), recurrence rates, complication rates, patient-reported outcomes (PROs), quality of life (measured via SF-36), and healthcare utilization.

Statistical analyses include Kaplan-Meier survival curves, log-rank tests, Cox proportional hazards regression models, repeated-measures ANOVA, and linear regression models to identify predictors of survival and quality of life.

The study protocol was approved by the Institutional Review Board (IRB) and complies with the Declaration of Helsinki. All participants provided informed consent prior to enrollment.

Eligibility Criteria:
Inclusion Criteria:

All female patients, diagnosed with breast cancer

Exclusion Criteria:

Previous treatment for breast cancer, concurrent enrollment in another clinical research, and serious medical conditions that could affect study outcomes
The Effects of Early Life PUFA and R-TFA on AD: A Systematic Review and Meta-analysis

The purpose of this study is to evaluate whether early life natural exposure to fatty acid affects the AD risk.

The prevalence of Allergic Diseases (AD) is rising dramatically worldwide especially in more industrialized countries during the past two decades, representing a substantial disease burden of individuals and health service cost. Early life nutritional exposures could modify the gene expression and susceptibility of allergic diseases (AD), yet the effects of early life polyunsaturated fatty acids (PUFA) and ruminant trans fatty acids (R-TFA) on AD remain unclear.Therefore,the investigators performed the meta-analysis and systematic review to evaluate whether early life natural exposure to PUFA and R-TFA affects the AD risk.

Eligibility Criteria:
Inclusion Criteria:

* Studies needed to provide endpoints of AD, and risk estimates \[odds risk (OR), relative risk (RR) or hazard ratio (HR)\] for PUFA or R-TFA as the exposure. We included English language articles only, while scanned titles /abstracts of non-English language articles to evaluate agreement with the results published in English.

Exclusion Criteria:

* Studies were excluded if they didn't report the profile of PUFA or R-TFA, or if they targeted participants with medical condition.
A Clinical Trial to Evaluate Clifutinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia(AML)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of Clifutinib Besylate in Relapsed/refractory AML patients with FLT3-ITD mutation.

It is a multi-center , open-label, single arm study conducted in 2 parts. Dose-escalation part: Subjects will receive oral Clifutinib Besylate once on C0D1.After 3 days,they will receive Clifutinib Besylate once daily repeatedly until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days.

Expansion part:Expansion cohort might be set to further investigate the safety and efficacy of Clifutinib Besylate at or lower MTD dose recommended by dose-escalation part.

Eligibility Criteria:
Inclusion Criteria:

* Documented acute myeloid leukemia according to World Health Organization（WHO） criteria(excluding acute promyelocytic leukemia), with FLT3-ITD gene mutation,refractory after common or enhanced chemotherapy or relapse.
* ECOG performance status of 0-1.
* Subjects must have adequate organ function and meeting all of the following laboratory review before enrollment：

  * Lood routine examination: WBC≤2000/mm3;
  * Liver function: Alanine aminotransferase (ALT) and Aspartate transaminase (AST) ≤2.5×upper limit of normal(ULN); serum bilirubin ≤ 1.5 × ULN;
  * Renal function: Serum creatinine ≤ 1.5×ULN, or the creatinine clearance (CrCl)≥ 60 mL / min calculated by the Cockcroft-Gault formula;
  * Electrolyte: serum potassium≥3.0mmol/L; serum calcium≥2.0 mmol/L;serum magnesium≥0.5 mmol/L;
  * Coagulation function:fibrinogen≥1.0g/L; activated partial thromboplastin time( APTT)≦ULN+10s; prothrombin time(PT)≤ULN+3s.

Exclusion Criteria:

* Received FLT3 inhibitors within 4 weeks prior to the administration;
* Received hematopoietic stem cell transplantation within2 months prior to the administration or received immunosuppressor beceause of GVHD;
* Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks prior to administration;
* Nitrosourea and mitomycin chemotherapy within 6 weeks prior to the administration;
* Have taken live vaccines within 4 weeks prior to /or concurrent with the administration;
* Have received a trial investigational product, or participated in other clinical trials within 4 weeks prior to administration;
* Documented promyelocytic leukemia (t (15; 17) (q22; q11) and / or promyelocytic leukemia(PML)/retinoic acid receptor alpha (RARa) positivity found in the chromosome, variant acute promyelocytic leukemia;
* With myeloid sarcoma or invasion of central nervous system;
* NCI CTCAE 4.03 ≥ 2 grade of arrhythmia, or corrected QT interval(QTc )\> 450 ms ; patients with a history of torsion or congenital QT prolonged syndrome; active infectious disease judged by the investigator.
Outcomes of Patients Who Fail to Respond to Fluconazole Treatment of Severe Candida Albicans Infections

The primary aims of this study are to identify and characterize the immediate consequences of patients who fail fluconazole treatment during the treatment of severe infection, and to determine if fluconazole failures are more frequently associated with fluconazole-resistant or fluconazole-susceptible strains of C. albicans.

The primary aims of this study are to identify and characterize the immediate consequences of patients who fail fluconazole treatment during the treatment of severe infection, and to determine if fluconazole failures are more frequently associated with fluconazole-resistant or fluconazole-susceptible strains of C. albicans (i.e. does in vitro resistance matter?). Perhaps the breakpoints are not correct and need to be changed, as has recently happened with vancomycin.

A third objective is to calculate fluconazole PK/PD parameters such as AUIC, and compare the calculated AUIC values of patients who fail with fluconazole-susceptible vs fluconazole-resistant isolates. Specifically for fluconazole, the question here is whether dose matters, and can aggressive dosing offset higher MICs. Thus in all cases, we will also determine the AUIC of fluconazole in order to fully characterize the impact of dose chosen on the outcomes of treated patients who fail to respond to fluconazole. The clinical, microbiological, and pharmacoeconomic outcomes of patients who fail fluconazole therapy and are subsequently hospitalized with severe infections caused by C. albicans will be documented and described.

Eligibility Criteria:
Inclusion Criteria:

1. Medical history, clinical signs and symptoms, and radiological findings consistent with severe C. albicans infection. For example, the criteria for pneumonia are as follows:

   1. A core body temperature \>38C \[100.4F\] or \<36.1 C \[97oF\] or leukocytosis (blood leukocyte count \>10,000 cells/mm3) or bandemia (\>10% bands).
   2. Chest radiographic examination that shows a new or progressive infiltrate, consolidation, cavitation, or pleural effusion.
   3. Rales, dullness to percussion, or decreased breath sounds on physical examination of the chest, new onset of purulent sputum, or change in character of sputum.
2. A positive culture must demonstrate the presence of C. albicans, isolated from a properly obtained respiratory or blood sample, collected within 72 hours of admission to a hospital. All patients with respiratory cultures must produce sputum with Gram stain analysis indicating the relative absence of contaminating oropharyngeal squamous cells and the presence of a significant number of WBCs and morphologically distinct bacteria. Fluconazole sensitivity testing results must be available for the initial C. albicans isolate.
3. Must have received, and failed to respond to, at least 4 days of treatment with fluconazole.

4. Admitted to a hospital or ICU for treatment of a severe infection.

Exclusion Criteria:

1. Pregnant or lactating women
2. Cystic fibrosis
3. Life expectancy \<3 months from underlying disease
4. Underlying lung carcinoma
Preventing Adolescents From Entering the Juvenile Justice System

This randomized controlled study tests an innovative juvenile diversion model that integrates evidence-based family therapy.Immediate and longer term effects of the family intervention will be compared to Services As Usual with 120 adolescents participating in Miami-Dade's Civil Citation Program.

This study proposes to rigorously test the innovative Civil Citation Program (CCP)with an integrated evidence-based family intervention, Multidimensional Family Therapy\[MDFT\](Liddle, 2002).

The study sample includes youth referred to the CCP throughout Miami-Dade county and who according to CCP screening are rated as high risk for re-offending. Youth are 12-17 years old with a first or second misdemeanor charge (excluding any gang, violence, or sex crimes charge). Nearly all (97%) of these youth are ethnic minorities (Hispanic and African American). They are at risk for school failure, substance use, and chronic delinquency due to drug availability in their communities, poor family functioning, peer drug use/delinquency, and school failure / disengagement.

120 youth who enter the Civil Citation Program and are eligible for the study will be assigned to one of the two interventions: CCP+SAU or the experimental intervention, CCP+MDFT.

The study asks a classical services research question(Compton et al, 2005) - does the addition of a family therapy intervention, multidimensional family therapy, into an existing diversion program significantly enhance the program outcomes in key outcome domains: recidivism, substance use, delinquency, school and family functioning.

Eligibility Criteria:
Inclusion Criteria:

* Youth 12 to 17 years old
* Parent or guardian willing to participate in assessments/treatment
* Demonstrate risk for mental health, substance abuse, or anger/adjustment problems on the Juvenile Services Department screening warranting intervention but not requiring residential treatment

Exclusion Criteria:

* Youth under the age of 12 or over the age of 18
* Parent/guardian not willing to participate in assessments and treatment
* Youth not demonstrating mental health, substance abuse or anger/adjustment problems
* Youth requiring residential treatment
* Youth with severe mental illness or retardation
Vending Labeling Sales and Intercepts Study

The aim of this study is to compare the impact of 4 different types of front of package (FOP) food and beverage messages: 1) green labels on healthy foods, 2) red/yellow/green labels on less healthy/moderately healthy/healthy foods, 3) physical activity calorie equivalent labels, and 4) posters reminding consumers of the sweetened beverage tax on consumers' beverage and snack selections.

This project involves a randomized field experiment. The investigators worked with the vending contractor for the City of Philadelphia to randomize vending machine locations (covering \~260 beverage and snack machines) to one of the four different message conditions: 1) single green traffic light labels (on healthy foods); 2) multiple traffic light labels (red traffic light labels applied to less healthy foods, yellow applied to moderately healthy foods, and green on healthy foods); 3) physical activity labels (calorie content displayed in terms of physical activity equivalents); 4) posters reminding consumers of the Philadelphia sweetened beverage tax and encouraging healthier choices. The City's vending machine contractors provided monthly aggregated sales data from each machine for analysis. Customer intercepts were also collected at the point of sale, after customers completed their purchase, to evaluate factors that moderate message influence. They were asked to answer questions about their perceptions of the different labels.

Eligibility Criteria:
Sales data include all purchases at the machine regardless of customer demographics.

Customer purchase assessment data were collected from:

Inclusion Criteria:

* Any person aged 18 or older making a purchase from the vending machines included in this intervention will be asked to participate in this study.

Exclusion Criteria:

* People who indicate they have already taken the survey are not eligible to take the survey again.
Ultrasound Probe Pressure on the Intratendon Doppler Signal in Patellar Tendinopathy

In the sports field, patellar tendinopathy is, as a pathology, one of the main concerns for athletes, both because of its incidence and because of the difficulty involved in their recovery. At the ultrasound level, tendinopathies can be divided, depending on the presence or absence of an intratendon Doppler signal, into hypervascular or hypovascular tendinopathy. Its classification is, today and clinically speaking, merely qualitative through the observation of the explorer. The ultrasound evaluation is carried out through a probe that is placed on the patient's skin, the procedure to be followed to obtain a vascular image is merely operator-dependent, that is, the position of the probe, the pressure exerted on the skin or even ultrasound optimization parameters can drastically modify the results.

Due to high pressure on the probe, the intratendon Doppler signal may be diminished in the quantitative variables of area, number of signals, pixel intensity, perimeter, solidity, perfusion index, circularity, major and minor diameter.

From a certain pressure on the probe, the intratendon Doppler signal can be drastically altered.

This study will try to evaluate the influence of the pressure exerted by the examiner with the probe on the quantitative variables of the intratendon Doppler signal in patellar tendinopathy.

To carry out the study, a single group with patellar tendinopathy will be established. Ultrasound evaluations with Doppler mode will be performed on the tendon using different probe pressures, monitoring the applied force and recording the images obtained for later analysis.


Eligibility Criteria:
Inclusion Criteria:

* Acceptance of participation in the study.
* Diagnosis of patellar tendinopathy with the presence of an intratendon Doppler signal.
* Subjects between the ages of 18 and 65.

Exclusion Criteria:

* Present some type of surgical intervention in the region to be explored that could alter in some way the ultrasound evaluation.
* Refer vascular pathology or the intake of medication that may alter blood flow or density.
* Having been treated with sclerosing techniques that can alter the perfusion or vascular resistance of the tendon tissue.
The Effect of Physical Therapy Intervention in Patients With Left Ventricular Assistive Device on Physical Function

To retrospectively investigate the effect of physical therapy intervention on improving physical function of patients post left ventricular assist device (LVAD) through electronic medical record survey

Method: Using portable electronic medical record system in National Taiwan University Hospital (NTUH), retrospectively survey medical record of patients who underwent left ventricular assist device (LVAD) operation in NTUH, compare improvement among those who had received physical therapy intervention and those who hadn't.

Inclusion criteria: aged older than 20 years old; diagnosed with heart failure and need LVAD implantation

Progress: Note down patients' clinical signs and symptoms, drug usage, imaging findings, physical therapy intervention details, and recovery of functional status. Physical therapy intervention details include: onset symptoms, history, treatment frequency, treatment type, any signs and symptoms during treatment progress and recovery of functional status post physical therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with heart failure, need left ventricular assist device intervention
* Over 20 years old
* Received physical therapy intervention

Exclusion Criteria:

* N/A