cyrilzakka/clinical-trials huggingface dataset:
A Proof-of-Mechanism Study to Determine the Effect of Danicopan on C3 Levels in Participants With C3G or IC-MPGN

The primary objective of this study was to determine whether ACH-0144471 (also known as danicopan and ALXN2040) increases blood C3 complement protein (C3) levels in participants with low C3 levels due to either C3G or IC-MPGN.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have had clinical diagnosis of C3G (C3 glomerulonephritis or dense deposit disease, the 2 types of C3G) or idiopathic IC-MPGN by renal biopsy for at least 3 months prior to dosing, with the pathologic diagnosis verified by a review of the renal biopsy by the study central pathologist
* C3 must have been \<50% of the lower limit of normal
* C4 complement protein (C4) must have been \>90% of the lower limit of normal
* Must have been willing to comply with study-specific vaccination requirements for Haemophilus influenzae, Streptococcus pneumoniae, and Neisseria meningitidis strains A, C, W, and Y
* Negative pregnancy test for females prior to dosing and throughout the study

Key Exclusion Criteria:

* History of a major organ transplant (for example, heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant. Individuals receiving renal replacement therapy were also excluded
* Evidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which C3G or IC-MPGN may have been secondary
* Estimated glomerular filtration rate (using Modification of Diet in Renal Disease equation) \<45 milliliters/minute/1.73 square meters at the time of Screening or at any time over the preceding 4 weeks
* Receipt of eculizumab at any dose or interval within the past 75 days prior to dosing
* Use of tacrolimus or cyclosporine within 2 weeks of the first dose of danicopan
* History of febrile illness, a body temperature \>38°Celsius, or other evidence of a clinically significant active infection, within 14 days prior to study drug administration
* History of meningococcal infection, or a first-degree relative or household contact with a history of meningococcal infection
* Females who were pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration or participants with a female partner who was pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration
DSLT Performance in Treatment-naïve Patients With Newly Diagnosed Open Angle Glaucoma

DSLT demonstrates a ≥ 20% reduction of IOP from pre-treatment baseline in POAG patients naïve of previous glaucoma treatment at 12 months.

DSLT enables newly diagnosed patients to remain well controlled and off medications

Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma
* Patients age 30 or greater with an IOP of 18-26 mmHg
* Mild to moderate POAG patients (mild or moderate according to the AAO PPP Guidelines)
* DSLT procedure

Exclusion Criteria:

* History of prior glaucoma treatment - this includes past medication use (in either eye), previous lasers or incisional surgery
* Angle closure patients
* Ocular Hypertension
* Baseline VF MD of worse than -12dB
* Uncontrolled systemic microvascular disease (eg. HTN, DM)
* Subjects with peri-limbal findings (e.g. melanosis, tumors, extensive pterygium, significant senile arcus and pterygium)
Reducing Sedentary Time in Fibromyalgia Patients

This study evaluates the feasibility of a behavioral intervention designed to replace sedentary behavior with light physical activity in veterans with Fibromyalgia. The study will also evaluate the acceptability of the intervention among veterans and intervention effects on pain and physical function.

Recent research suggests that individuals with Fibromyalgia (FM) who spend more time in sedentary behavior and less time in light physical activity experience greater clinical pain and overall impact of FM, irrespective of time spent in moderate to vigorous physical activity. To date, no studies have investigated the potential impact of reducing sedentary behavior on key clinical and physical function outcomes in FM. The overall objective of the pilot project is to design and evaluate the feasibility of an 8-week behavioral intervention designed to replace sedentary behavior with light physical activity in veterans with FM. Mixed (quantitative and qualitative) methods will be used to evaluate the behavioral intervention, which is based on constructs from social cognitive and self-regulatory theories that consistently identify important drivers of behavior change as: education, goal-setting, self-monitoring and behavioral prompts to move via an activity tracker and phone app, and feedback on behavior via weekly meetings.

Eligibility Criteria:
Inclusion Criteria:

Veterans will be eligible if they have:

* 2010 American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia: Widespread Pain Index (WPI) greater than 7 and Symptom Severity Scale (SS) greater than 5 or WPI 3-6 and SS greater than 9.
* Symptoms have been present at a similar level for at least 3 months
* The subject does not have a disorder that would otherwise explain the pain
* Moderate pain severity (pain severity score greater than 5)
* No changes in fibromyalgia medications for last 4 weeks
* Self-reporting at least 8 hours per day sitting on 5 or more days per week
* Having access to either an Android or iPhone smart phone with access to internet

Exclusion Criteria:

* Significant cardiovascular disease
* chronic obstructive pulmonary disease (COPD) or asthma needing home oxygen
* Stroke or transient ischemic attack (TIA) in last 6 months
* Cancer (other than skin cancer) and receiving treatment for it
* Active psychosis
* Active suicidal ideation
* Moderate to severe cognitive impairment
* Engaging in more than 30 minutes of moderate to vigorous physical activity 3 or more days per week
* Currently using an app or activity tracker to track physical activity
* Enrolled in another research study related to pain or exercise
Comparing the Impact of 2 Different Techniques in Management of Hydrosalpinx on Pregnancy Rates Following ICSI

Assessment and comparing pregnancy outcomes in hydrosalpinx patients treated by hysteroscopic tubal occlusion and laparoscopic salpingectomy before ICSI.

Hydrosalpinx has a detrimental effect on the rates of implantation, pregnancy and early pregnancy loss following IVF. A meta-analysis demonstrated that the implantation rate and clinical pregnancy rate decreased by 50% in patients with hydrosalpinx. The negative consequences could be due to embryotoxic properties, a decrease in endometrial receptivity, and hydrosalpinx fluid mechanically flushing the embryo from the uterus.

Although laparoscopic salpingectomy and laparoscopic proximal ligation increase ongoing pregnancy rates in women with hydrosalpinges, those interventions are invasive and carry anaesthetic and surgical risks, especially in the presence of extensive adhesions, often seen in women with hydrosalpinges. In view of the possible adverse effects of laparoscopic surgery, an alternative less-invasive treatment for hydrosalpinges prior to IVF would be useful.

The effectiveness of hysteroscopic tubal occlusion when compared with salpingectomy has not been established. Randomized clinical trials comparing both procedures prior to IVF are lacking.

The present study was designed to compare hysteroscopic tubal occlusion and laparoscopic salpingectomy in the treatment of hydrosalpinges prior to IVF.

This study hypothesized that in women scheduled for IVF/ICSI hysteroscopic proximal occlusion of hydrosalpinges would be non-inferior to laparoscopic salpingectomy in terms of ongoing pregnancy rates following IVF/ICSI.

Eligibility Criteria:
Inclusion Criteria:

* primary or secondary infertility cases
* unilateral or bilateral hydrosalpinx proved by HSG (hystersalpingogram) or by TVUS(transvaginal ultrasound) .

Exclusion Criteria:

* Uterine factor of infertility
* male factor of infertility
* preexisting ovarian pathology
* Presence of septic focus
* medical or surgical conditions that contraindicated pregnancy
Prevention of Neurosurgical Wound Infections

The goal of this study is to determine whether injecting the antibiotic vancomycin directly into surgical wounds can decrease the rate of infection following implantation of neurosurgical devices.


Eligibility Criteria:
Inclusion Criteria:

* deep brain stimulators (DBS)
* spinal cord stimulators (SCS)
* motor cortex stimulators (MCS)
* vagus nerve stimulators (VNS)
* peripheral nerve stimulators (PNS)

Exclusion Criteria:

* allergies to vancomycin
* immunocompromise or taking immunosuppressant drugs
* currently taking aminoglycoside antibiotics, such as amikacin, gentamicin, neomycin, streptomycin or tobramycin
* diagnosed renal failure
* currently undergoing chemotherapy
* pregnancy
* non-english speakers
* unable to return for follow-up, or unable to be contacted by telephone
Androgen Metabolism and Reproductive Outcome

The aim of this study is to determine maternal androgen metabolism during pregnancy and the impact of androgen disorders on mothers and infants.

Women with polycystic ovary syndrome (PCOS) have an impaired fertility and significant higher complication rates during infertility treatment, pregnancy and the perinatal period. Complications include the occurrence of multiple gestations, ovarian hyper stimulation syndrome, early pregnancy loss, gestational diabetes, pregnancy-induced hypertension, pre-eclampsia and need for caesarean section. Moreover, their infants are more frequently born preterm, have higher perinatal mortality rates and are more often admitted to a neonatal intensive care unit. The etiology of PCOS is not particularly mapped, but a genetic background can be assumed by analyzing PCOS families. In utero androgen excess has also been suspected to be an important risk factor. Animal studies have demonstrated that intrauterine hyperandrogenic environment affects the offspring by leading to biochemical and morphological features of PCOS. Sex differences in prenatal androgen levels have been observed and testosterone levels in umbilical cord blood and in amniotic fluid are higher in healthy male babies than in healthy female babies. There are just a few reporting on the relation between maternal androgen levels during pregnancy and the respective offspring. The aim of this clinical study is to determine maternal androgen metabolism and the impact of androgen disorders on mothers and infants.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with and without PCOS

Exclusion Criteria:

* unable to consent
Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?

The hypothesis is if administration of acetaminophen during labor will reduce the amount of neuraxial pain medication required for comfort. For the study, Acetaminophen or placebo capsules will be administered at the time of neuraxial analgesia placement and then administered every 6 hours until delivery. Overall consumption of neuraxial pain medication will be determined.

Acetaminophen 1000 mg or placebo capsules will be administered at the time of neuraxial analgesia placement and continued every 6 hours until delivery. Vital signs, scores for pain, nausea, itching, and sleepiness will be also obtained. Evaluation of consumption of neuraxial analgesic medication will be included in the final analysis for the differences between the 2 groups

Eligibility Criteria:
Inclusion Criteria:

* \>/= 18 years of age not allergic to study medications

Exclusion Criteria:

* pre-eclampsia in labor AND with demonstrated significant abnormal liver enzyme function changes non-English speaking subjects
Correlation of Structure and Function in Glaucoma

The aim of the study is to correlate structure and function in patients with glaucoma. To this end, a cross-sectional study unsing perimetry and optical coherence tomography is performed.


Eligibility Criteria:
Inclusion Criteria:

- Diagnosis of glaucomatous optic neuropathy

Exclusion Criteria:

* Age \< 18 years
* Diabetes
* Pregnancy
* Hypertensive retinopathy
* Smoking
* Intraocular surgery 1 month prior to study entry
* Systemic or ocular disease, excluding glaucoma, which the investigator believes could affect the test results
* Insufficient quality of the optical coherence tomography imaging
* Insufficient cooperation during examinations or measurements
Effects of Dark vs. White Chocolate on the Postprandial Increase in Portal Pressure in Cirrhosis

This study was aimed at testing the hypothesis that supplementing a meal with dark chocolate, which holds potent antioxidant properties, might attenuate the postprandial increase in the hepatic venous pressure gradient (HVPG, clinical equivalent of portal pressure) in patients with cirrhosis

Previous studies showed that the intrahepatic circulation in cirrhosis is not able to adapt to sudden increases in blood flow, such as that occurring after a meal, due to endothelial dysfunction. This leads to a brisk increase in portal pressure (estimated by the HVPG). This method is therefore useful to assess the efficacy of compounds potentially ameliorating intrahepatic endothelial dysfunction. Dark chocolate, which contains a high proportion of cocoa flavonoids such as cathechin and epicatechin- powerful antioxidants, increases NO availability in the systemic circulation and improves systemic endothelial function. We hypothesised that the antioxidant properties of dark chocolate could be beneficial in patients with cirrhosis, since they might improve intrahepatic endothelial dysfunction. Consequently, the aim of this study was to evaluate whether a dark chocolate-containing test meal may attenuate the post-prandial increase in HVPG in patients with cirrhosis and portal hypertension.

HVPG was measured at baseline and 30 minutes after the administration of a test meal supplemented by either dark or white chocolate. Portal vein blood flow and hepatic artery blood flow were measured by Doppler ultrasound. Catechins and NOx were determined for both timepoints.

Eligibility Criteria:
Inclusion Criteria:

1. age over 18 years
2. diagnosis of cirrhosis (proven by biopsy or clinical, laboratory and imaging procedures)
3. presence of esophageal varices of any grade
4. HVPG ≥ 10 mmHg during the hemodynamic study

Exclusion Criteria:

1. food allergy to chocolate
2. ongoing treatment with ascorbic acid and/or other antioxidants
3. diffuse or multinodular hepatocellular carcinoma
4. pregnancy
5. advanced hepatic failure (defined as prothrombin ratio \< 40% and bilirubin \> 5 mg/dL)
6. renal failure (defined by a serum creatinine level \> 1.5 mg/dL)
7. portal vein thrombosis
8. cardiac or respiratory failure
9. previous surgical or transjugular intrahepatic portosystemic shunt
Genetic Polymorphisms Associated With Vertebral Osteochondrosis

The present study is proposed for the identification of phenotype, biochemical and genetic markers in adult symptomatic spinal osteochondrosis to promote the early diagnosis of this pathological condition and to establish possible therapeutic targets that favor a conservative approach aimed at treating patients.

The primary outcome is to determine the association between specific phenotypic characteristics of osteochondrosis, in particular linked to osteo-cartilaginous degeneration, with the identified vitamin D receptor genotypes.

The secondary outcomes are to evaluate the circulating levels of the osteo-cartilage degradation markers, of the vitamin D and to evaluate the association of the osteochondrosis phenotype with variants in genes involved in inflammatory processes.

Eligibility Criteria:
Inclusion criteria

* males and females
* 18≤age ≤ 65 years old
* patients with adult spinal osteochondrosis Exclusion criteria
* age \< 18 or \> 65 years old
* chronic major diseases such as diabetes, autoimmune diseases, cardiovascular diseases, malignancies
Daylight-mediated Photodynamic Therapy of Actinic Keratoses:Comparing 0.2%HAL With 16%MAL

This pilot study compares two photosensitizers, hexylaminolaevulinate (HAL) and methylaminolaevulinate (MAL), in treatment of actinic keratoses. Study is conducted using randomized split-face design. Efficacy is assessed clinically, and histologically at 3 and 12 months. Pain during and after treatments and adverse reactions at one week are recorded.

Study recruites 16-20 voluuntering patients with symmetrical actinic damage on face or scalp. Treatment sites are randomized to receive either hexylaminolaevulinate 0.2% or methylaminolaevulinate ( 16% MAL) as photosensitizers (0.25mm-thick layer). A web-based validated program (Research Randomizer) generated a randomized list to define the treatment sides. The randomization results were kept blinded from the investigators who conducted the follow-up visits, from the pathologist, and the patients. Pre-treatment procedures include application of sunscreen for 15 minutes and curettage of the treatment area. Illumination is performed using 2 hours daylight-exposure. Efficacy is assessed clinically, and histologically at 3 and 12 months by blinded observers. Pain during and after treatments and adverse reactions at one week are recorded.

Eligibility Criteria:
Inclusion Criteria:

-Symmetrical actinic damage on face or scalp

Exclusion Criteria:

* Pregnancy
* Lactation
* Allergy to photosensitizer
* Photodermatose
Safety Study of Abatacept to Treat Rheumatoid Arthritis (B)

The purpose of this study is to compare the incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Diagnosis of rheumatoid arthritis
* \> 18 years at index treatment initiation or switch
* Starting treatment with abatacept or new disease-modifying anti-rheumatic drug (including switching or adding) or biologic disease modifying drug.
* Read/write English

Exclusion Criteria:

* None
Clinical Practice Guidelines and Impact of Audit and Feedback in the Emergency Department

This study will develop and test an intervention given to emergency medicine providers to improve adherence to clinical practice guidelines (CPGs) for pneumonia and sepsis.

This study will be performed at Denver Health Medical Center, a 477-bed urban, safety-net, acute-care hospital located in Denver, Colorado. The adult ED is staffed by board-certified emergency physicians at all times. These physicians supervise the care of all patients being managed by resident physicians, nurse practitioners, physician assistants, and medical students. Approximately 430 patients are admitted to the hospital from the ED each year with community-acquired pneumonia (CAP) and severe sepsis (SS).

Adherence to CPGs will be measured at the level of the attending emergency physician. All employed, attending emergency physicians working clinically in the adult ED at Denver Health Medical Center at the start of the study will be included.

The investigators will use a step-wedge design to randomize physicians into clusters. Randomization of physicians into clusters and randomization of clusters to intervention timing will occur one week prior to delivery of the intervention to cluster one. he intervention will consist of monthly audit and feedback on adherence to CPGs for CAP and SS. Once a cluster enters its first intervention month, all physicians in that cluster will receive an email detailing their adherence to both CAP and SS CPG for every month since the start of the study. Adherence to the entire CPG as well as each component of the CPG will be provided. In addition, physicians will be shown the median prevalence of adherence for all physicians as well as where their adherence ranks among their physician group. Lastly, in a separate secure email, physicians will be given patient identifiers (i.e., name, MRN, date of visit) for each patient that received non-adherent care and will be told which component of care was not adherent to the respective CPG so that they can review the case themselves, if desired.

Eligibility Criteria:
Inclusion Criteria:

* Attending emergency medicine physicians working clinically in the Adult Emergency Department at Denver Health Medical Center at the start of the study.

Exclusion Criteria:

* None. All eligible physicians will be included.
Early Mobility Bundle to Prevent Hospital Acquired Pneumonia (HAP) in Medical Inpatients

Hospital acquired pneumonia (HAP) is a common complication of extended hospital stay. In surgical specialities and critical care early physiotherapy is a recognised way of preventing such infections, and reducing length of hospital stay (LOS), however prevention of this problem is less well studied in medical inpatients.

The investigators propose a pilot study to assess the impact of introducing an early mobilisation strategy to general medical and respiratory wards at an acute Trust in the United Kingdom (UK). The investigators will recruit all new admissions to each of 2 respiratory and 2 elderly care wards - 1 of each ward type will be allocated to receive extra physiotherapy input targeting new admissions for early mobilisation. Patients' usual mobility, current mobility and actual activity levels will be studied by accelerometer and simple patient questionnaire in the first 48 hours of admission, and compared between groups. Incidence of HAP and total LOS will be recorded and compared between groups.

The investigators hypotheses are that the physiotherapy intervention will increase activity levels, reduce incidence of HAP and reduce LOS. The latter may result in cost savings to the National Health Service (NHS), which the investigators will model using local tariff data.

The investigators plan to use our data to power a larger randomised controlled study, or if the intervention is a marked success, such that a control group would be unethical, then a wider service development and evaluation programme.


Eligibility Criteria:
Inclusion Criteria:

* Any medical inpatient

Exclusion Criteria:

* Nil for main study
* Immobile patients and those unable to consent will be excluded from the sub-study using activity reporting and monitoring by Actigraph
Return to Golf After Orthopaedic Surgery

The GOLF study is a multicenter, prospective study with the goal to investigate golfers' return to the sport following hip, knee or shoulder arthroplasty. The prevalence of return to golf, by level of returning to golf will be assessed at 6 weeks, 3 months, 6 months, and 12 months postoperatively. Patients who are active golfers undergoing joint replacement will be identified from outpatient clinics and pre-assessment clinics and given information about the study at least two weeks prior to surgery. Participants in this study must have a desire to return to golf after surgery. Previous studies have only been able to report the return to golf after arthroplasty retrospectively; the prospective nature of this study will allow for a greater understanding of this process.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+ years
* A self-reported golfer
* Able to consent to treatment
* Indicated for one of the following surgical procedures: total hip arthroplasty, hip resurfacing, revision hip arthroplasty, total knee arthroplasty, unicompartmental knee arthroplasty, revision knee arthroplasty, total shoulder arthroplasty, reverse shoulder arthroplasty, shoulder resurfacing arthroplasty, revision shoulder arthroplasty

Exclusion Criteria:

* Inability to complete follow-up questionnaires
* Declining operative management
* No desire to return to golf postoperatively
* Medical problem that affects the patient's ability to play golf (e.g., angina, shortness of breath, etc.)