cyrilzakka/clinical-trials huggingface dataset:
The Validation of Rockall Scoring System in Predicting Outcomes From Variceal Bleeding

Objective This study aims to evaluate the validation of the Rockall scoring system in predicting the outcomes of variceal bleeding among Sudanese patients.

Design/Method A cross-sectional hospital-based study involved 150 adult Sudanese patients presenting with upper gastrointestinal bleeding (UGIB) of variceal origin. Patients with UGIB resulting from causes other than varices and those who declined participation were excluded. Data were collected through a structured questionnaire complemented by upper gastrointestinal tract endoscopy findings, and patients were followed up until discharge.

Results The study encompassed 150 patients, predominantly male (117, 78%), aged between 18 and 60 years (n=119, 79%), residing mainly in central regions (134, 89%). The leading presenting complaints included hematemesis (70, 46.7%) and melena (22, 14.6%). Notably, peri-portal fibrosis (101, 67.3%) and cirrhosis (24, 16%) were the primary etiological factors, with a significant prevalence of alcohol consumption (87, 58%). Concerning the grade of esophageal varices, grades III and IV were most prevalent (67, 44.7% and 47, 31.3%, respectively), and fundal varices were identified in 13 patients (8.7%). The mean Rockall score was 3.83 ± 1.99, indicating moderate severity. Additionally, the Rockall score showed significant associations with the number of sessions, complications, bleeding recurrence, duration of hospital stay, and mortality (p \< 0.05).

Conclusion Understanding the significance of the Rockall scoring system and its applicability to Sudanese patients with variceal bleeding has the potential to guide more effective strategies in the management of upper gastrointestinal tract bleeding, ultimately improving patient outcomes and reducing morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years and older
* primary complaints of upper GI bleeding

Exclusion Criteria:

* Patients with upper GI bleeding resulting from causes other than varices
* who declined to participate in the study
Clinical Comparison of Toric Contact Lenses Fit Characteristics

The purpose of this study is to compare the fit characteristics between four Alcon commercially available toric contact lenses.

Subjects will be expected to attend 3 visits including the screening visit. The total duration of a subject's participation in the study will be approximately 19 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Able to be fit with contact lenses within the available range of sphere, cylinder power, and axes (based on lens availability).
* Best Corrected Visual Acuity (BCVA) better than or equal to 0.10 (logMAR) in each eye.
* Willing to stop wearing habitual contact lenses during in-office visits.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Current spherical, monovision or multifocal lens wearer.
* Protocol-specified biomicroscopy findings at screening.
* Current or history of herpetic keratitis in either eye.
* Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
* Other protocol-defined exclusion criteria may apply.
Lactate Compared to Creatine Kinase as Diagnostic Marker in Generalized Epileptic Seizure

The investigators compared the feasibility of serum creatine kinase and serum lactate concentration as diagnostic markers to distinguish between generalized tonic-clonic seizures (GTCS) and syncopes in clinical settings that require fast-action treatment, such as in the emergency departments.

The patients of this prospective study were selected from a sample of patients who were admitted to the emergency room of the University Hospital RWTH Aachen with an unclear impairment of consciousness. Only patients who later on were diagnosed as having experienced a GTCS or a syncope and whose serum lactate concentrations had been measured within 2 hours after the event were enrolled in the study. The investigators compared the specificity and sensitivity of the serum lactate concentrations at admission with the CK concentration at admission and the CK follow-up taken 10 to 48 hours after the event.

The values at admission were compared between patients from whom a blood sample was collected within 60 minutes after the event, and those from whom a blood sample was collected within 61-120 minutes after the event.

The comparison of initial lactate concentrations at admission with CK levels 10 - 48 hours later could only be performed on part of the patient collective because the other patients were already discharged at this time-point and could therefore not be included.

The initial blood samples were taken at patient arrival in the emergency room. The follow up was performed during the inpatient stay.

Serum lactate and CK concentrations between patient groups were statistically compared with a Mann-Whitney-U test. We defined cut-off values and their sensitivity and specificity by Receiver Operating Characteristic (ROC) analysis.

Eligibility Criteria:
Inclusion Criteria:

Patients with generalized tonic-clonic seizures and syncopes and whose blood samples were taken within 2 hours after the event

18 years or older

Observed seizure

Time of the event before admission was known

Diagnosis of an epileptic seizure or syncope had been entered in the final discharge report

Exclusion Criteria:

Prisoner

Age \< 18 years old

Competing explanations for serum lactate or CK elevation e.g. shock or trauma

Lack of capacity for consent
Evaluation of Safety and Efficacy of Avacopan in Subjects With Moderate to Severe Hidradenitis Suppurativa (AURORA)

Phase 2 study of Avacopan in Subjects with Moderate to Severe Hidradenitis Suppurativa

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 study in subjects with moderate to severe Hidradenitis Suppurativa.

The study is multicenter and will consist of three subject groups. Subjects will be randomized 1:1:1 to a treatment of 10mg avacopan twice daily, 30 mg avacopan twice daily or placebo twice daily for 12 weeks.

Following the 12 weeks double-blind treatment period, subjects on placebo will be re-randomized 1:1 to receive 10 mg or 30 mg avacopan twice daily for additional 24 weeks. Subjects treated with avacopan will continue to receive the same dose (either 10 mg or 30 mg twice daily) for additional 24 weeks.

Subjects will be on study treatment for 36 weeks and will be followed for 44 weeks for assessment of safety and efficacy.

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Primary efficacy analysis will be at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Clinical diagnosis of HS (Hurley Stage II or III), confirmed by a dermatologist, for at least 6 months prior to Screening
* HS lesions are present in at least 2 distinct anatomic areas
* Inadequate or loss of response to a systemic course of antibiotics typically of at least 90 days
* Must have at least 5 inflammatory nodules or abscesses at screening
* Use adequate birth control for subject and partners of child bearing potential
* Willing and able to give written Informed Consent

Exclusion Criteria:

* Pregnant or breast-feeding
* Any other skin disease that may interfere with the assessment of HS
* Rapidly progressive, expanding HS within 30 days prior to screening
* More than 20 draining fistulae at screening
* Any anti-TNF-α treatment for HS or for other conditions prior to Day 1 visit will be prohibited. Exception: Subjects who were previously treated with an anti-TNF-α drug and discontinued treatment \>12 weeks prior to Day 1 visit are allowed for enrollment
* Systemic antibiotics are generally excluded
* Topical antibiotics use within 14 days prior to Day 1 is excluded
* Have started a topical prescription medicine for HS within 14 days prior to screening
* A systemic medicine for HS, including biologics and other systemic therapies
* Have received within 14 days prior to Day 1 visit or is expected to require oral or transdermal opioid analgesics (except for tramadol) for any reason
Safety of Vitamin D Supplementation in Older Persons

This study will evaluate the safety over 6 months of two different doses of vitamin D (cholecalciferol) in men and women age 65 and older. It will also evaluate if supplementation with vitamin D improves physical performance.

120 ambulatory men and women ages 65 to 95 will be enrolled in this study. Each subject will participate in the clinical trial for 6 months.

Parathyroid hormone, vitamin D, and serum and urinary calcium will be measured periodically. Physical performance will be tested at baseline and throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* ambulatory

Exclusion Criteria:

* hypercalcemia
* hypercalciuria \> 4 mg/kg body weight/day
* primary, secondary, or tertiary hyperparathyroidism
* renal insufficiency (serum creatinine \> 2 mg/dL )
* history of nephrolithiasis
* treatment with vitamin D (ergocalciferol, cholecalciferol, calcitriol)
* treatment with anticonvulsants
* Paget's disease
* severe cardiac, pulmonary, hepatic, renal, or neurological disease
* life expectancy \< 1 year
* participation in another trial
Morphological, Structural and Functional Neural Substrates of Quality of Life in Schizophrenia

The aim of the investigators analysis is to identify the neural correlates of quality of life scores in schizophrenia. For this, the investigators will constitute group of patients according to their quality of life scores and the investigators will analyze their differences in patterns of brain structures and activations.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria (American Psychiatric Association(APA), 1994),
* age over 18 years,
* informed consent to participate in the studies
* French as native language

Exclusion Criteria:

* diagnosis other than schizophrenia on Axis I of DSM-IV,
* decompensated organic disease and mental retardation
Skin Biophysical Measures for Assessing Head and Neck Cancer-Related External Lymphedema

Selected measurements in healthy persons of skin tissue dielectric constant as reference values for subsequent use to evaluate patients with head and neck lymphedema.

Skin tissue dielectric constant (TDC) measurements will non-invasively be made bilaterally at two neck sites, bilaterally on two forearm sites and one site at the chin sub-mental area.

Measurements are made with subjects fully clothed and seated. Measurements are made in triplicate and averaged at each site. Full measurements take about 5-7 minutest to complete. Data will be analyzed to determine the neck-to-arm ratios and chin-to-arm ratios to establish normal ranges of these parameters for subsequent use as comparisons to evaluate and track changes in patients with head and neck lymphedema.

Eligibility Criteria:
Inclusion Criteria:

* Healthy with no current or past skin conditions affecting neck or arms

Exclusion Criteria:

1. Known to have diabetes of any type.
2. Having facial or neck hair that prohibits accurate measurements
Prevention of Sleep Apnea After General Anaesthesia With a MAD

Sleep apneic episodes increase after general anaesthesia up to the third postoperative night. A mandibular advancement device, called MAD, is a small device that is inserted in the patient's mouth during the night and allows the advancement of the mandible, preventing sleep apneic episodes. The objective of this randomized controlled trial is to determine whether a MAD reduces the impact of general anaesthesia on the increase of the sleep apneic episodes in the postoperative period. All patients will have their sleep-related respiratory data measured using a portable respiratory polygraphy recorder (ResMed Embletta® system). This portable recorder allows a non-invasive recording of nasal airflow through a nasal cannula, oxygen saturation (SpO2) via finger pulse oximetry, respiratory efforts through thoracic and abdominal belts, and body position.


Eligibility Criteria:
Inclusion Criteria:

- adult patient undergoing any lower limb surgery

Exclusion Criteria:

* continuous positive airway pressure (CPAP) treatment for obstructive sleep apnoea,
* presence of severe respiratory or cardiovascular disease
* preoperative consumption of benzodiazepine,
* chronic use of opioids \> 30 mg/day morphine equivalent
* no tooth
* patient known for malignant hyperthermia
Effects of Progressive Muscle Relaxation Exercises During Pregnancy.

Lumbopelvic pain (LPP) during pregnancy is defined as pregnancy-related low back, or pelvic girdle pain. Pregnancy is a significant time for sleep disruptions as well.PMR involves systematically tensing and relaxing different muscle groups in the body, starting from the feet or hands and progressing through the body. This study aims to evaluate the impact of progressive muscle relaxation (PMR) exercises on the alleviation of low back pain and sleeplessness in pregnant women in their pregnancy.

Literature suggests that Pregnancy involves hormonal and biomechanics adjustments, leading to changes in body systems for a secure fetus development. Painful symptoms and sleep disorders are common complaints, often present in the same individual.The exact cause of low back pain during pregnancy is not fully understood, but it is often linked to biomechanical, vascular, and hormonal changes.In the third trimester, 98% of women experience sleep difficulties, primarily caused by backache, urinary frequency, fetal movements, GERD, and leg discomfort.

The PMR technique involves deep breathing and progressive relaxation (tense-release) of major muscle groups. The technique promotes systematic relaxation of the major muscle groups of the body with the goal of physical and mental relaxation, reducing the response to stress, reducing skeletal muscle contractions, and decreasing pain sensations.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant females with Age 20-40 years.During second and third trimester with
* Uncomplicated pregnancies.Pregnancy related LBP \>3 on NPRS \& Insomnia severity index (ISI) \>10 score.Posterior lumbopelvic pain

Exclusion Criteria:

* Patients with Anterior Lumbopelvic Pain.
* Hemodynamically significant heart disease,
* Restrictive lung disease,
* Incompetent cervix/cerclage,
* Multiple gestation at risk for premature labor \& Persistent bleeding.
Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania

This is an individually randomized controlled trial to assess the effect of multiple micronutrient supplements (MMS) containing 60 and 45 mg iron as compared to MMS containing 30 mg of iron (standard UNIMMAP formulation) on maternal moderate or severe anemia. This study will help inform countries like Tanzania that currently use IFA containing 60 mg of iron regarding the dose of iron to use in MMS.


Eligibility Criteria:
Inclusion Criteria:

* Attending first ANC visit at study clinics
* Pregnant women \< 20 weeks gestation by last menstrual period (LMP)
* Aged ≥ 18 years old
* Intending to stay in Dar es Salaam until 6 weeks post delivery
* Provides informed consent

Exclusion Criteria:

* Severe anemia (defined as hemoglobin \< 8.5 g/dL per Tanzania standard of care)
* Sickle cell disease (SS and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC
* Concurrently enrolled in another nutritional clinical trial
* Pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.
[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects

The purpose of this study is to study a radioactive tracer, a type of imaging drug that is injected into the body to see how it is taken up in sites of active infection using an imaging procedure called Positron Emission Tomography/Computed Tomography (PET/CT).


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Known or suspected bacterial infection, per clinical documentation of suspected infection (e.g. lab results, pathology results, physician progress notes, clinical symptoms of infection)
* Able to understand the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures

Exclusion Criteria:

* Antibiotic therapy with trimethoprim within 48h of the baseline PET/CT scan
* Inability to tolerate imaging procedures, in the opinion of an investigator or treating physician
* Unstable or other severe medical or psychological comorbidities that would compromise the subject's safety or successful participation in the study, in the opinion of an investigator or treating physician
* Pregnant or breast feeding patients; a urine pregnancy test will be performed in women of child-bearing potential prior to \[18F\]F-TMP injection, to confirm non-pregnant status
Safety, Tolerability, and Efficacy Study of CLL442 in Patients With Cutaneous Squamous Cell Carcinoma in Situ (SCCis)

The purpose of this first in human and proof of concept study is to characterize the safety, tolerability and initial efficacy of CLL442 in patients with Squamous Cell Carcinoma in situ (SCCis) to enable further clinical development of CLL442.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent has been obtained.
2. Male and female patients, age ≥ 18 to ≤ 90 years (at the time of the screening visit).
3. A primary, clinically diagnosed and histologically confirmed cutaneous SCC in situ lesion, with or without the involvement of the follicular unit, and histologically diagnosed within 30 days of the screening visit. The post-biopsy residual SCCis lesion must be visually evident and at least 3 mm in either length or width.
4. The lesion must be located in a place easily accessible for topical application by the patient or their caregiver, excluding the genitals, perianal area, sub-ungual area, eyelids, ear and must be \>1 cm away from the eyes and mouth.

Exclusion Criteria:

1. Evidence of dermatological disease or histological evidence of a confounding skin condition in the treatment area, including but not limited to BCC, worse level/grade of SCC, rosacea, psoriasis, atopic dermatitis, eczema, xeroderma pigmentosa, verrucous lesions or any other tumor in the biopsy specimen. Lesions with atypical histology such as: spindle cell SCC, acantholytic SCC, clear cell SCC, adenosquamous SCC, desmoplastic SCC or lesions that have been present for a short time and have been fast growing.
2. Treatment of the target SCCis lesion within 8 weeks of screening visit by any of the following treatments: Liquid nitrogen, Photochemotherapy (PUVA), Long wave ultra violet radiation (UVB light), surgical excision or curettage within 1 cm of target lesion.; Systemic retinoids.; Ionizing radiation or interlesional injections or; Undergone a facial resurfacing procedure, i.e., chemical peel, laser resurfacing, dermabrasion, within the target lesion;
3. Treatment with the following topical agents within the 4 weeks prior to the screening visit: Levulanic acid, 5-fluorouracil, corticosteroids, retinoids, diclofenac, hyaluronic acid, imiquimod.
4. History of recurrence of the target SCCis lesion.
5. Systemic use of immunosuppressive drugs within 4 weeks prior to screening visit or during the treatment period - Photodynamic therapy or immunomodulators, cytotoxic drugs, or interferon/interferon inducers within 4 weeks prior to study entry or expected during the study.
6. Women of child-bearing potential, unless they are using at least basic methods of contraception during dosing of investigational drug.
7. Pregnant or nursing (lactating) women.
A Multimodal Enhanced Recovery Program in Anorectal Surgery

The goal of this study is to establish whether an opioid-sparing Enhanced Recovery After Surgery (ERAS) program in ambulatory anorectal surgery can be safely introduced at a single tertiary referral center without an increase in postoperative pain or negative impact on the patient experience. A single-center, single-blinded randomized control trial is proposed, where patients will be assigned in a 1:1 ratio to either usual care, which includes extended opioids (control group) or the enhanced recovery group (experimental), which includes preemptive pain control, targeted education, and multimodal opioid-sparing pain management during the intraoperative and postoperative periods. The expected outcome is that the enhanced recovery program will significantly reduce opioid utilization with comparable pain scores and patient satisfaction after anorectal surgery.

There is an opioid epidemic in the United States, and the epidemic continues to worsen. The rate of opioids prescribed, distributed, and deaths from opioid overdoses continue to increase steadily. Opioids also have the costs of abuse, dependence, diversion of unused medication, and can serve as a gateway to other illegal substances. Opioid use often begins with treatment of acute postoperative pain, and the surgical episode can be a 'gateway' to the opioid crisis. Opioids remain ubiquitous in patients undergoing surgical procedures. Among opioid-naïve patients, persistent use after surgery occurs in 6-10%.

Ambulatory surgery cases are rarely mentioned in the context of this public health crisis, but are a major contributor to the problem. Opioids are ubiquitous after ambulatory anorectal surgery and prescribed in large quantities, often several times more than what is needed or taken by patients. As patients take a fraction of the opioids prescribed, this adds to issues of opioid diversion. In colorectal surgery, ambulatory anorectal procedures are common and frequent procedures, with the potential to impact a large number of patients when implementing quality improvement. Thus, study into ERAS and ways to reduce opioids after ambulatory anorectal surgery is warranted.

This application challenges the notion that inpatient surgery should be the only target for enhanced recovery and opioid interventions. It seeks to shift the clinical practice paradigm that extended opioids are necessary after ambulatory anorectal surgery. This new application of ERAS to ambulatory anorectal surgery could address a critical barrier to progress in reducing opioids in procedures that are common but underrepresented in current research.

Eligibility Criteria:
Inclusion Criteria:

* Patients in whom surgery is planned via an anorectal approach for hemorrhoids, fissures, or fistula disease.

Exclusion Criteria:

* Patients are not eligible if currently or chronically (more than 7 days prior to presentation) on opioid medication or opioid-receptor antagonist medication.