cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Female Community Health Volunteers Training on Hypertension Knowledge and Blood Pressure Measurement Skills in Nepal

The investigators aimed to investigate the effectiveness of training FCHVs in hypertension knowledge and blood pressure measuring skills and explore their perceptions of challenges and opportunities to deliver hypertension counseling and monitor Blood pressure in the community. The investigators conducted a quasi-experimental study design among 131 FCHVs from Namobuddha and Mandandeupur municipalities. The investigators quantitatively measured the baseline and end-line hypertension knowledge and BP measurement skills after providing a one-day training on hypertension knowledge and BP measurement. Furthermore, the investigators conducted three focus group discussions with FCHVs to explore the challenges and opportunities of FCHVs in community-based hypertension management.

Female Community Health Volunteers (FCHVs) in Nepal could play a role in preventing and managing hypertension. Limited studies have been conducted on Nepal's FCHV knowledge and capacity to deliver hypertension-related counseling and services. The investigators investigate the effectiveness of training FCHVs in hypertension knowledge and blood pressure measuring skills and explore their perceptions of challenges and opportunities to deliver hypertension counseling and monitor Blood pressure in the community. The investigators conducted a quasi-experimental study design among 131 FCHVs from Namobuddha and Mandandeupur municipalities. The investigators quantitatively measured the baseline and end-line hypertension knowledge and BP measurement skills after providing a one-day training on hypertension knowledge and BP measurement. The investigators used the Hypertension Knowledge Level Scale (HK-LS) to assess the knowledge through face-to-face interviews and observed BP measurement skills using an observation checklist. The investigators used paired t-tests to see the mean difference before and after the training. The investigators performed linear regression to assess the hypertension knowledge and BP measurement skills scores with socio-demographic and FCHV's general performance. Furthermore, the investigators conducted three focus group discussions with FCHVs to explore the challenges and opportunities of FCHVs in community-based hypertension management. The investigators transcribed the recorded discussion verbatim and analyzed it using the framework analysis method

Eligibility Criteria:
Inclusion Criteria:

* Appointed as FCHV
* Age 18 years and older

Exclusion Criteria:

* Not able to respond during the data collection period
* Out of municipality during the data collection period
A Study of 141W94 in Combination With Other Anti-HIV Drugs

To determine the steady-state pharmacokinetics of 141W94 in combination with saquinavir, indinavir and nelfinavir after multiple oral dosing. To determine the steady-state pharmacokinetics of saquinavir, indinavir, and nelfinavir in combination with 141W94 after multiple oral dosing. To assess the safety and tolerability of multiple doses of 141W94 when combined with saquinavir, indinavir and nelfinavir.

Patients will be randomized to receive open label 141W94 in combination with saquinavir, indinavir and nelfinavir. The randomized phase will be preceded by a single dose pharmacokinetic interaction study of 141W94 and indinavir in 12 patients. Data from this single dose investigation will be used to determine the dose of indinavir to be used in the randomized phase.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed provided used with caution:

Medications that may interact at CYP3A4 (either a substrate, inhibitor or inducer of the enzyme) should be used with caution.

Patients must have:

* Documented HIV infection.
* CD4+ cell count \>= 200 cells/mm3.

  1. Anticipated need for treatment with cytotoxic chemotherapeutic agents within the study time period.
* Treatment with immunomodulating agents.
* Medications that should not be administered with 141W94:

Terfenadine. Astemizole. Cisapride. Triazolam. Midazolam. Ergotamine/Dihydroergotamine-containing regimens. Antiretroviral drugs. Vitamin E supplements. Other experimental agents.

Anticipated need for radiation therapy within the study time period.

1. Prior protease inhibitors.

* Antiretroviral therapy within 2 weeks prior to entry.
* Treatment with cytotoxic chemotherapeutic agents within 4 weeks prior to entry.

Radiation therapy within 4 weeks prior to entry. Current alcohol or illicit drug use that, in the opinion of the investigator, may interfere with the patient's ability to comply with the dosing and protocol evaluations.
Prevalence of Fetal Congenital Anomalies Among Pregnant Women Attending University Hospital

Congenital anomalies occur in 2-3% of births. They account for 20-30% of perinatal deaths. The aim is to assess the prevalence of fetal malformations in pregnant women attending University hospital

This prospective cohort study of 20225 pregnant women attended Obstetrics Department of Beni-Suef University Hospital during period (January 2016 to January 2019). A full history taking was obtained according European surveillance of congenital anomalies EURO-CAT core data. All women underwent abdominal and transvaginal US (Toshiba Xario 200 unit): ▪ Females presented early in first trimester were scheduled for routine first trimester scan in accordance with international society of ultrasound in obstetrics and gynecology guidelines. ▪ Females presented early in second trimester were scheduled for a routine second trimester scan. ▪ Females presented afterwards, had a routine ultrasound scan for fetal malformations.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy

Exclusion Criteria:

* Medical conditions, chronic drug intake.
Deep Learning Model and Risk Factors for Tacrolimus-related Acute Kidney Injury

In this study, the investigators aim to develop a risk prediction model for acute kidney injury (AKI) in hospitalized patients using the calcineurin inhibitor tacrolimus. This will be achieved by mining electronic medical record data and employing explainable deep learning methods. The model will provide clinical decision support for timely intervention and treatment. Compared to traditional machine learning models, deep neural networks can extract more nuanced features from complex medical data and perform more precise pattern recognition, thereby enhancing prediction accuracy and reliability. By constructing a predictive tool based on explainable deep learning models, the investigators will better assess the association between the use of calcineurin inhibitors and AKI, explore targeted prevention strategies, and offer more precise predictions and intervention guidance to clinicians. Additionally, this research has significant socio-economic benefits and application potential. By reducing the incidence of AKI, the investigators can lower patient hospitalization duration and re-treatment costs, conserve medical resources, and improve patient quality of life. Preventive healthcare not only alleviates the physical and psychological burden on patients but also reduces the strain on the healthcare system, enhances healthcare efficiency, and promotes the rational allocation of medical resources.


Eligibility Criteria:
Inclusion Criteria:

* Use of tacrolimus during hospitalization, with standardized therapeutic drug monitoring
* Age of 18 years or older at the time of admission
* Length of hospital stay ≥ hours
* At least two serum creatinine level tests conducted during the hospital stay

Exclusion Criteria:

* Stage 5 chronic kidney disease prior to admission
* Incomplete clinical data
* Serum creatinine levels consistently below 40 mmol/L during hospitalization
Small Airways Disease in Asymptomatic and Symptomatic Subjects With Airway Hyperresponsiveness (AHR)

The purpose of this study is to study differences in small airways (\<2mm) parameters in asthma patients, subjects with asymptomatic airway hyperresponsiveness and healthy controls.


Eligibility Criteria:
Inclusion criteria for asymptomatic subjects with airway hyperresponsiveness (AHR) :

* Age between 18 and 65 years.
* Forced expiratory volume in one second (FEV1) \> 80% predicted post bronchodilator.
* Provocative concentration causing a 205 fall in FEV1 (PC20) methacholine \<8 mg/ml.
* No history of asthma or previous use of asthma medication.

Inclusion criteria for asymptomatic subjects without AHR :

* Age between 18 and 65 years.
* FEV1 \> 80% predicted post bronchodilator.
* PC20 methacholine \>8 mg/ml.
* No history of asthma or previous use of asthma medication.

Inclusion criteria for patients with asthma:

* Age between 18 and 65 years.
* FEV1 \> 80% predicted.
* PC20 methacholine ≤8 mg/ml.
* Doctor's diagnosis of asthma.
* No history of Chronic obstructive pulmonary disease (COPD).

Exclusion Criteria:

* Use of inhaled or oral steroids, antihistamines, nedocromil, theophylline, leukotrien antagonists or long-acting beta-agonists for at least three weeks before the start of the study.
* Any disease that may affect the outcome of the study as judged by the Investigator.
* FEV1 \<1.2 liter.
Effects of Ketamine on Eye Movements, Perception and Brain Function

In this study, the investigators examine the effects of low-dose ketamine on different oculomotor, perceptual and cognitive functions. They also examine effects on concurrent brain activity using blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI). A sample of N=25 healthy, male participants is required to complete the study. The design is within-subjects, placebo-controlled, double-blind and cross-over. A targeted ketamine level in plasma of 100ng/ml is applied. It is hypothesised that ketamine, compared to placebo, will lead to changes in task performance and brain activity similar to those observed in patients with schizophrenia.

The uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist ketamine has been proposed as a model system of the symptoms of schizophrenia. To complement this model system and to allow neurobiological as well as translational studies, biomarkers are often applied to people under the influence of ketamine. Here, we apply oculomotor, perceptual and cognitive biomarkers to healthy human volunteers whilst they undergo BOLD fMRI at 3 Tesla field strength. We use a counter-balanced, placebo-controlled, double-blind, within-subjects design. A sample of 25 healthy participants is required. Participants will receive intravenous (IV) racemic ketamine (with a 100ng/ml target plasma concentration) on one of two assessment days and they will receive placebo (intravenous saline) on the other assessment day. BOLD fMRI will be carried out on a Siemens Trio scanner at the Life\&Brain Centre, Bonn. In addition to brain functional and cognitive, perceptual and oculomotor responses, we will also measure self-ratings of psychosis-like experiences. These will be obtained using the Psychotomimetic States Inventory (PSI; Mason et al 2008).

Eligibility Criteria:
Inclusion Criteria:

* MRI-suitability
* suitability for video-based combined pupil and corneal reflection (VCPCR) eye-tracking
* good command of German language
* willingness to take part

Exclusion Criteria:

* any current or history of axis I disorder diagnosis as assessed by the Mini-International Neuropsychiatric Interview (M.I.N.I.)
* any neurological conditions and heart conditions
* use of any prescription or non-prescription medication up to one week before participation
* personal history of head-injuries, loss of consciousness, eye surgery or impairment of vision (other than corrective lenses)
* any other relevant medical conditions such as high blood pressure
* positive urine drug test (Drug-Screen Multi "5T", nal von minden GmbH)
* history of drug use or current drug use
* under- or overweight (below 18.5 and above 24.9 body mass index (BMI) values)
* any diagnosis of psychotic disorders among first-degree relatives
Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit

This prospective, randomized, controlled trial will compare the incidence of nosocomial infections (composite of primary bloodstream infections, catheter-associated urinary tract infections, ventilator-associated pneumonia, and surgical site infections) that occur in intensive care unit (ICU) patients bathed with 2% chlorhexidine solution versus patients who receive standard bathing (soap and water or non-medicated cloths).

Upon study enrollment, patients will be randomized to one of two study arms. Patients in study arm one will receive standard bathing (soap and water or non-medicated cloth) daily. Patients in study arm two will receive a 2% chlorhexidine bath on study day 1 and every 48 hours and a standard bath (soap and water or non-medicated cloths) on study day 2 and every 48 hours. Patients will be followed until ICU day 28 or discharged from the surgical ICU.

Hypothesis: Compared to standard daily bathing, chlorhexidine-based bathing on ICU admission and every 48 hours will decrease the incidence of nosocomial infections.

Eligibility Criteria:
Inclusion Criteria:

* Admission to the surgical intensive care unit at The Methodist Hospital (Houston, TX)
* Anticipated surgical intensive care unit length of stay of 48 hours or more

Exclusion Criteria:

* Pregnancy
* Age less than 18 years old
* Braden score of less than 9 upon admission to the surgical intensive care unit
* Known allergy to chlorhexidine gluconate
* Active skin irritation upon admission to the surgical intensive care unit
Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy

The primary objective of this study is to evaluate the effects of filgotinib in combination with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).


Eligibility Criteria:
Key Inclusion Criteria:

* Have a diagnosis of RA (2010 American College of Rheumatology \[ACR\]/European League Against Rheumatism \[EULAR\] criteria) and are ACR functional class I-III.
* Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and ≥ 6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both screening and Day 1.
* Limited or no prior treatment with MTX

Key Exclusion Criteria:

* Previous treatment with any janus kinase (JAK) inhibitor
* Previous therapy for longer than 3 months with conventional synthetic disease modifying antirheumatic drugs (csDMARDs) other than MTX or hydroxychloroquine
* Use of any licensed or investigational biologic disease-modifying antirheumatic drugs (DMARDs)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis

The purpose of this study is to determine whether AN2728 topical ointment is a safe and effective treatment for mild-to-moderate plaque-type psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stable mild-to-moderate plaque-type psoriasis involving 2-35% of total body surface area (BSA) excluding face, scalp, and genitals
* Willingness and ability to apply study medication as directed, comply with study instructions, and commit to attending all study visits
* Women of childbearing potential must agree to use contraception for the entire study period

Exclusion Criteria:

* Any dermatological conditions that could interfere with clinical evaluations
* Concurrent or recent use of certain topical or systemic medications without a sufficient washout period
* Significant confounding conditions as assessed by study doctor
* Participated in any other trial of an investigational drug within 30 days or participation in a research study concurrent with this study
* Use of lithium- or hydroxychloroquine-containing products (e.g., Plaquenil)
* Use of a beta-blocking medication (e.g., propranolol) if the dose has not been stabilized for at least 3 months
* Pregnancy or lactation
Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer

* To determine if docetaxel and cisplatin can be administered in a dose intense manner in the adjuvant setting in resected non-small cell lung cancer
* To evaluate the time to progression and overall survival
* To evaluate toxicities of this chemotherapy combination in the adjuvant setting
* To correlate XPD and ERCC1 polymorphisms with time to progression and toxicities in patients treated with this regimen


Eligibility Criteria:
Inclusion Criteria:

* Stage IB to IIIA non-small cell lung cancer completely resected within 4 to 8 weeks of initiating treatment on study
* Performance Status ECOG 0 or 1
* Peripheral neuropathy: \< grade 1
* Adequate blood cell counts
* Adequate liver and hepatic function
* Women of childbearing potential must have a negative pregnancy test.
* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter

Exclusion Criteria:

* Patients with a history of severe hypersensitivity reaction to Docetaxel® or other drugs formulated with polysorbate 80.
* Women who are breast-feeding.
* Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively)
* Uncontrolled cardiac disease or uncontrolled hypertension
Evaluation of Health Related Quality of Life and Patient Adherence in Case of Hungarian Patients Affected by Osteoarthritis

Translation and Cross-cultural adaptation process of the Osteoarthritis Knee and Hip Quality of Life questionnaire. According to granted guidelines, shared by the developer of the questionnaire, the study was conducted among Hungarian patients affected by osteoarthrosis.

This prospective study was performed among patients diagnosed - by the doctors acting as the expert panel of this study - with OA of the lower limb. The recruitment period was: June 2017 and November 2017, in six hospitals situated in six different geographical regions of Hungary. The participating hospitals were selected in a way to represent different geographic and cultural areas of the country; the patients were selected randomly by the doctors of the given sites. The process was conducted with the contribution of: (1) Translation committee (4 members), (2) Our research team, as moderator (4 members), (3) Expert panel (6 doctors professors of the study sites: orthopaedists, rheumatologists, musculoskeletal rehabilitation doctors). The used instruments were for the validation process: Short version of World Health Organization Quality of life questionnaire (WHOQoL-BREF), EuroQuality of Life - 5-dimension questionnaire as generic quality of life measurement tools (EQ-5D - VAS). In addiction 99 patients filled the questionnaires in an appropriate way. The results were evaluated by 23.0 version of SPSS program.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* clinically/doctor diagnosed knee and/or hip osteoarthritis
* native Hungarian language
* ability of self-filling and completely filled patient data sheet.

Exclusion Criteria:

* age under 18 years
* other type of OA osteoarthritis
* psychiatric disorders
* surgeries within 1 month
* incapable of filling out the forms/tools
Effects of Cerebellum or Supplementary Motor Area Functional Inactivation on Gait and Balance Control

In human, the physiology of gait and balance is not clearly established. By using functional imaging and electrophysiological techniques, various brain regions from the cortex to the midbrain area, including the cerebellum, have been identified as involved in such control. The specific role of these structures in both the capacity to go forward (locomotion) and stand upright (balance), but also in the different phases of the gait initiation process, are not known, however. In this study,the investigators aimed to assess the specific role of both the supplementary motor area (SMA) and the cerebellum in postural control during the initiation of gait. For this purpose, the investigators plan to study the gait initiation in 20 healthy subjects before and after functional inactivation (using inhibitory repetitive transcranial magnetic stimulation, rTMS) of the cerebellum or SMA. Biomechanical, kinematic and electromyographic parameters of the gait initiation will be recorded using a force platform, reflective markers with infrared cameras (VICON system) and lower limbs surface EMG electrodes.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years
* agree to participate to the study with signature of the informed consent
* heathy insurance
* normal clinical exam

Exclusion Criteria:

* previous medical history of neurological, rheumatological, orthopedic or psychiatric disorders
* contra-indication to MRI or TMS
* drug treatment that modifies the nervous central system excitability (antidepressant, antiepileptic, neuroleptic)
* chronic alcoholism
The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer

The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of patients were treated for six months on different doses. The patients had blood samples taken and measured for Testosterone in order to determine the most efficient dose to provide fast and sustained castration. The patients came to the clinic for 16 visits and dependent on the blood sample results they were invited to return for additional blood samples on a two weekly basis.

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent before any trial related activity
* Proven prostate cancer with a need for endocrine treatment
* Testosterone level within the normal range for the age

Exclusion Criteria:

* Previous or current hormonal treatment of prostate cancer
* Candidate for prostatectomy or radiotherapy
* History of severe asthma, anaphylactic reactions or Quincke's Oedema
* Hypersensitivity towards any component of FE200486
* Cancer disease within the last ten years except for prostate cancer and some skin cancers
* Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
* Mental incapacity or language barrier
* Having received an investigational product within the last 12 weeks preceding the trial
* Previous participation in this trial