cyrilzakka/clinical-trials huggingface dataset:
Use of Cesarean Birth at Private Health Facilities in Lilongwe and Blantyre, Malawi

The purpose of the research study is to collect preliminary data to which future outcomes after implementing quality improvement projects or research will be compared. There will be observation of the labor and delivery services received and resulting outcomes of women and infants who deliver at private health facilities in urban Malawi. Data will be collected at admission, delivery, and discharge from women and providers on patient characteristics, labor and obstetric characteristics, delivery factors, and pregnancy outcomes that result during the course of the hospitalization. This will include the vital status of the mother and the infant. The overall hypothesis is that cesarean birth rates will be higher than the ecologically supported 10% cesarean birth rate, and that there may be cesareans that are performed without clear medical indication.

Background:

Cesarean birth is the most commonly performed surgery in the world. It is a major abdominal procedure that can save maternal and perinatal lives when properly indicated, but when performed without medical necessity, is associated with adverse outcomes. Global cesarean birth rates are increasing, but there has been a less pronounced rise in sub-Saharan Africa (SSA) where rates tend to be below 5.0%. However, in Sub-Saharan Africa (SSA) and other low- and middle-income countries (LMIC), there is a recognition that significant in-country disparities in the use of cesarean birth exist. Rates are higher in urban settings, and there is evidence that they are higher in private versus public facilities.

Objective and Aims:

The main objective of this prospective, cross-sectional, observational study is to observe the use of cesarean birth at three private health facilities in urban Malawi by the end of the study. This will be achieved by getting an understanding of the current delivery practices and patient characteristics, as well as associated outcomes of women who choose to deliver at these private facilities in order to understand how and under what circumstances the surgery is being used.

Aim 1: Observe prevalence of and indications for cesarean birth in three private health facilities in urban Malawi in the overall cohort and in ten mutually exclusive subgroups defined by the WHO-endorsed Robson Classification for cesarean birth

Aim 2: Determine risk factors associated with cesarean birth among Robson subpopulations of women at study sites, and the distribution of adverse pregnancy outcomes across those subgroups

Aim 3: Identify target modifiable risk factors or areas for potential quality improvement or prospective research studies to optimize the use of cesarean birth within these facilities that may have generalizable implications

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy
* Admitted for delivery or observation

Exclusion Criteria:

-
Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects

Administration of a single 50 mg or 200 mg dose of tigecycline will not cause a change in QT/QTc intervals.

evaluation of effect of tigecycline on QT/QTc in healthy volunteers

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Body mass index 17.5 - 30.5 kg
* Total body weight greater than 50 kg

Exclusion Criteria:

* Recent history of diarrhea
* Use of oral antibiotics in the last 2 weeks
* History of risk factors for QT prolongation pregnant females
* Nursing females
A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™

Goal of the Clinical Trial:

The purpose of this clinical trial is to learn whether Xperience™ surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections (SSIs) following implant-based breast reconstruction in female patients, aged 18 and older. It will also assess the safety and overall surgical outcomes when using Xperience™ compared to povidone-iodine.

Main Questions the Study Aims to Answer:

* Does the use of Xperience™ decrease the incidence of surgical site infections compared to povidone-iodine?
* What are the differences in the rates of premature implant removal due to infection between patients treated with Xperience™ and those treated with povidone-iodine?
* Are there fewer post-surgical complications with Xperience™ compared to povidone-iodine?

Study Design:

Participants in this study will be randomly assigned to receive either Xperience™ or a dilute povidone-iodine solution during their bilateral implant-based breast reconstruction. Only the research team will know which irrgiation is given- the participant will not know.

Participant Will:

* Undergo the surgical procedure using one of the two irrigation solutions.
* Receive regular post-operative check-ups to monitor for signs of infection and other complications.
* Have data collected on any post-surgical complications, the necessity for early implant removal, and overall surgical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old
* Willing to comply with all study-related procedures
* Available for the duration of the study
* Participants undergoing double mastectomy surgery followed by one of the following: (1) Immediate reconstruction with tissue expander placement, (2) Delayed reconstruction with tissue expander or implant placement, (3) Immediate reconstruction with implant placement, (4) Second-stage reconstruction with tissue expander to implant exchange

Exclusion Criteria:

* Participants unable to participate in follow-up visits
* Participants undergoing unilateral mastectomy
* Tissue expanders placed by a surgeon outside of the UNC Chapel Hill Hospital System
* Undergoing autologous reconstruction
* Participant is unable to provide signed and dated informed consent
* Unwilling or unable to comply with all study-related procedures.
* Known history of sensitivity or allergic reaction to any of the components of the Xperience™ irrigation solution or dilute povidone-iodine irrigation
* Participant with any conditions that would be a contraindication to receiving surgery such as contraindications to general anesthesia
* Pregnant, planning to become pregnant or breast feeding participants
* Individuals providing informed consent with any mental impairment or condition that would make them unable to properly consent without use of legally authorized representative (LAR) or additional participant protections.
* Incarcerated participants
Diamine Oxidase and Adverse Pregnancy Outcomes

In normal pregnancies, blood histamine concentration remains within normal values; however, the serum histaminolytic activity is increased. Histamine is mainly produced by mast cells, platelets, basophils, neurons and enterochromatin cells, where it is stored and released when required. Reduced DAO activities have been found in high-risk pregnancies. Lower DAO activity has been associated to miscarriage, fetal demise, preeclampsia, low birthweight and preterm birth. The placenta is very rich in DAO activity and is the principal source of increased histaminolytic activity in normal pregnancies.

First-trimester screening for preeclampsia (PE) is a routine screening which is performed in the first trimester. Women with a positive result are at a greater risk of PE but also other pregnancy complications such as stillbirth, preterm birth and low birthweight. These cases are prescribed aspirin until term. This intervention has demonstrated to significantly reduce the risk of PE and other complications. Unfortunately, aspirin does not avoid all cases with adverse outcomes, indicating that additional mechanisms may be involved in the development of such pregnancy complications, such as DAO decreased activity.


Eligibility Criteria:
Inclusion Criteria:

* Single pregnancy
* Maternal age ≥18
* High risk (≥1/50) in the first-trimester screening for preeclampsia
* Gestational age between 11+0 and 16+6 weeks of gestation

Exclusion Criteria:

* Fetal malformation
* Fetal death
* Maternal digestive inflammatory disease or intolerance
* Refusal to give informed consent
Awareness, Care & Treatment in Obesity Management (ACTION) Study

The ACTION (Awareness, Care, and Treatment In Obesity management) study aims to identify perceptions, attitudes, behaviours, and potential barriers to effective obesity care across three respondent types: 1) People with Obesity, 2) Healthcare Providers and 3) Employer Representatives in the US. Data is collected via online surveys using a cross-sectional, US-based stratified sample design.


Eligibility Criteria:
Inclusion Criteria:

* GENERAL POPULATION
* Agrees to AE reporting
* Age at least 18 years
* Lives in the US
* Current BMI at least 30 kg/sqm
* HEALTH CARE PROFESSIONALS
* Agrees to AE reporting
* Physician and board certified or NP/PA
* Facility located in the U.S. and not Vermont
* Spends at least 70% of time in direct patient care
* Seen at least 100 patients in past month
* Seen at least 10 patients in past month needing weight management
* In practice 2-35 years
* Not competitively employed
* Primary Care Providers
* Specialty is FP, IM, GP
* Less than 50% patients seen for obesity
* Obesity Specialists
* Obesity medicine or weight loss specialist or at least 50% of patients seen for obesity
* In practice 2-35 years
* EMPLOYERS
* Age at least 18 years
* Works in the US
* Director, Administrator, CHRO, VP or other title
* Responsible for making or influencing decisions about health insurance or health and wellness programs
* Company employs 500 or more full-time employees
* Believes there is a weight issue at their company
* Not competitively employed

Exclusion Criteria:

- None
FST-100 in the Treatment of Acute Viral Conjunctivitis

This randomized, double masked, multi-center study is being conducted to support the safety and efficacy of FST-100 for the treatment of acute viral conjunctivitis. The study intends to show superiority of FST-100 ophthalmic suspension compared to vehicle for clinical resolution of acute viral conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of suspected acute viral conjunctivitis in at least one eye

Exclusion Criteria:

* Have a known sensitivity to any of the components of FST-100 or FST-100 vehicle
Clinical Significance of Heterozygosity for Mutations of the SLC12A3 Gene Coding for the Thiazide Sensitive Na-Cl Cotransporter

Gitelman syndrome is a salt wasting tubulopathy caused by mutations in the SLC12A3 gene coding for the thiazide sensitive sodium chloride cotransporter. This disease mimics the chronic treatment with thiazide diuretics and is characterized by renal hypokalemia, low to normal blood pressure, hypocalciuria and hypomagnesemia. The purpose of this study is to determine whether the heterozygous carriers present the metabolic risks and/or the benefits of this disease.

Gitelman syndrome (GS), is an autosomal recessive salt wasting tubulopathy caused mainly by loss of function mutations in the SLC12A3 gene coding for the thiazide sensitive sodium-chloride cotransporter (NCC). Thus, GS mimics a chronic treatment with high doses of thiazide diuretics. NCC is expressed in the distal convoluted tubule, which is responsible for 7% of NaCl reabsorption. GS is the more frequent hereditary tubulopathie with estimated prevalence of 1/40000, which implicates that 1% of general population are heterozygous carriers (600 000 in France). Previous publications suggest that the apparently asymptomatic heterozygous carriers could present some clinical traits of GS or chronic thiazide treatment. These including: beneficial aspects (low blood pressure, low urinary calcium excretions) or metabolic risks (hypokalemia, insulin resistance). Nevertheless, these studies do not evaluate all the aspects and blood pressure was evaluated once in hospital setting. This study aims to compare home monitoring blood pressure; salt balance; potassium, glucose lipid and mineral metabolism and vascular function in 80 heterozygous carriers, 80 GS patients and 80 controls persons (without mutations in SLC12A3 gene).

Eligibility Criteria:
Gitelman syndrome patients, relatives carrying heterozygous mutations and relatives or healthy voluntarees without mutations.
Optimizing tDCS Protocol for Clinical Use in Major Depressive Disorder

In this project, the efficacy of different tDCS protocols in major depression will be investigated. The tDCS protocols have already been investigated in humans, and results showed that stimulation intensity has a different effect on tDCS long-term aftereffects based on the human motor cortex model. The project has three major goals: first, we want to see if the differential outcome of tDCS dosage, as present in healthy populations, can be translated to patients with major depression. Second, we want to compare the efficacy of a multi-channel novel protocol with conventional tDCS modules. Lastly, we are interested in the safety and tolerability of optimized multi-channel. The project output will be an optimized tDCS protocol for major depression treatment.


Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-5 criteria for a moderate-to-severe major depression, with Hamilton Rating Scale for Depression (HAMD) score of ≥14 and \<24 administered by a psychiatrist.
* being 18-60 years old
* providing written informed consent
* If female, negative urine pregnancy test
* Treatment naïve or on a stable standard antidepressant regimen (including selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MOAIs) or tricyclic's (TCAs)) with no change in treatment 6-weeks prior to and during the tDCS intervention

Exclusion Criteria:

* smoker
* pregnancy
* alcohol or substance dependence
* history of seizure
* history of neurological disorder
* comorbid Schizophrenia Axis I disorder, bipolar disorder, substance abuse or dependence, dementia, personality disorder
* history of head injury
* currently receiving any form of Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, or Acceptance and Commitment Therapy
* Presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments)
Pulmonary Function After Hyperbaric Oxygen Therapy

Patients receiving hyperbaric oxygen therapy (HBOT) for any indication at the Hyperbaric Medicine Unit (University Health Network, Toronto, ON, Canada) from 2016-2021 were recruited to this prospective cohort study. While receiving HBOT (at 2.0-2.4 ATA, with 1-3 "air breaks", with specific treatment details determined on a case-by-case basis and directed by the clinical team), enrolled patients underwent pulmonary function testing prior to HBOT treatment and serially after each 20 completed treatment cycles.

Patients receiving hyperbaric oxygen therapy (HBOT) at the Hyperbaric Medicine Unit (University Health Network, Toronto, ON, Canada) from 2016-2021 were recruited with informed consent to this prospective cohort study. All included patients underwent HBOT in one of three monoplace chambers (Sechrist 3600H and Sechrist 4100H, Sechrist Industries Inc., Anaheim, CA, USA; PAH-S1-3200, Pan-America Hyperbarics Inc., Plano, TX, USA) or via a plastic hood in a multiplace chamber (Hyperbaric System, Fink Engineering PTY-LTD, Warana, Australia). HBOT was performed with 100% oxygen at 2.0-2.4 ATA, with 1-3 "air breaks", typically at 5 sessions per week, with limited variation depending on the treatment indication and patient/clinician decision.

Study participants completed pulmonary function testing (PFTs) at several intervals during their HBOT treatment: prior to the first HBOT session, and serially after every 20 subsequent treatments. PFTs were performed using a KoKo Trek USB Spirometer software and pneumotachometer (KoKo, USA), with the assistance of a trained technician and in accordance with industry norms.

Retrospectively, PFT data was collected from all enrolled patients' electronic and paper medical charts. This data included anonymized patient demographics, as well as percentage of predicted forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and forced mid-expiratory flow rates (FEF25-75). PFT values underwent statistical analysis to identify potential effects of HBOT on pulmonary function.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to receive at least ten cycles of HBOT (for any indication)

Exclusion Criteria:

* Inability to provide informed consent
Efficacy, Tolerability and Safety of ALNA® in Patients With Benign Prostatic Syndrome (BPS)

Study to assess efficacy, tolerability and safety parameters of a one month ALNA® - treatment after switch from Terazosin-treatment


Eligibility Criteria:
Inclusion Criteria:

* Suffering from BPS symptoms
* Preceding treating with Terazosin for at least one month
* IPSS sum score \>= 8 points prior to treatment start with ALNA® or complaints due to BP reduction by Terazosin
* Indication for a switch to treatment with ALNA® according to its Summary of Product Characteristics (SPC) for a minimum period of one month

Exclusion Criteria:

* Patients fulfilling one of the general or specific contraindications listed in the ALNA® SPC, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredients of the product, orthostatic dysregulation or severe liver insufficiency could not be included in the Post Marketing Surveillance (PMS) study
Virtual Training Role-Plays to Improve Patient Suicide Outcomes in Primary Care Settings

SIMmersion, in collaboration with the Institute for Family Health (IFH) and the Educational Development Center (EDC) propose to develop a web-based training product, Suicide Prevention Role-plays for Interactive Training (SPiRIT), a series of 4 modules to train providers to more effectively manage patients who screen positive for risk of suicide in this Phase I/Phase II fast-track application. If funded, the team will develop the Risk Assessment module in Phase I and utilize a within group pre-post design to evaluate its feasibility. Twenty practicing clinicians will be recruited to utilize the module and complete a pre-post knowledge test. In Phase II, the team will develop Safety Planning, Access to Lethal Means, and Willingness to Accept a Referral modules. The efficacy of the product to positively influence patient outcomes will be tested with a Historically Controlled Trial (HCT) enlisting 65 practicing clinicians across five IFH sites. All providers will be trained and patient outcomes will be tracked for 6 months post training. This data set will be compared to 6 months of historical data for the same provider group. Primary outcomes of this study will measure the participants' ability in obtain improved patient outcomes related to: 1) rate of same-day C-SSRS Screening; 2) rate of suicide being added to the problem list; 3) rate of same-day safety planning; 4) rate of same day C-SSRS Lifeline/Recent Completion; 5) rate of same-day Risk Assessment; 6) rate of acceptance and attendance to within-Institute referrals for post intervention patients who are offered the referral at the first visit; 7) and lower rates of documented suicide attempts. Ultimately, the development and successful testing of this product would provide the US health care system a novel technology to scale up a clinician's confidence and skill to better manage patients who identify as at-risk for suicide. Additionally, if effective, this product will have a direct impact on patient outcomes, a vital component to any training product that attempts to train health care professionals. The utility and scalability of the proposed product will move health care systems toward the goal of zero deaths from suicide consistent with the Zero suicide approach.


Eligibility Criteria:
Inclusion Criteria:

(1) Hold an active license issued by the State of New York for their profession and be in good standing; (2) actively see patients at an IFH site; and (3) have completed IFH's mandated suicide prevention training.

Exclusion Criteria:

(1) have not completed their IFH Suicide Prevention Training as outlined in the IFH's Suicide Prevention Training Policy; or (2) have uncorrected vision or hearing problems that prevent the person from using the software. Specific to Phase II an additional criteria is (3)participated in the Phase 1 feasibility testing.
FallSensing Multiplayer Games for Fall Risk Prevention in Senior Care Centers

Fall prevention programs should include strength and balance training, home hazard assessment and intervention, vision assessment and referral and also medication review with modification/withdrawal. Evidence exists that a tailored exercise program can reduce falls by as much as 54%.

The FallSensing games software include 3 mini-games to be played by two teams with up to 3 players each will compete against each other alternately.

The players will perform an initial evaluation with FallSensing screening tool, 16 sessions of group games (2 times a week/8weeks) with FallSensing multiplayer games and a final evaluation also with FallSensing screening tool.

Both initial and final evaluation include six functional tests (Grip Strength, Timed Up and Go, 30 seconds Sit-to-Stand, Step test, 4 Stage Balance test "modified" and 10 meters Walking Speed) and a questionnaire concerning self-efficacy for Exercise.


Eligibility Criteria:
Inclusion Criteria:

* adults aged 50 years or over;
* Community-dweller;
* independent to be standing and walking, with or without walking aids;
* interest to participate in the study.

Exclusion Criteria:

* individuals with severe sensorial impairments (deafness or blindness)
* individuals with cognitive impairments which precludes the ability to comprehend the questionnaire, functional tests and exercises included in the protocol.
A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)

The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.

Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1 and Month 3 after the second implantation). The second implantation occurred within 30 days of the first.

Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent;
* Able to attend postoperative examinations per protocol schedule;
* Diagnosed with bilateral cataracts;
* Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL);
* Preoperative astigmatism ≤ 2.5 diopter;
* Good ocular health, with the exception of cataracts;
* Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and Acri.LISA package inserts;
* Able to undergo second eye surgery within one month of the first eye surgery;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Previous corneal surgery;
* Planned multiple procedures during cataract/IOL implantation surgery;
* Any ocular disease and/or condition that may compromise study results;
* Pregnant or planning pregnancy during course of study;
* History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
* Diabetic retinopathy;
* Macular degeneration;
* History of retinal detachment;
* Other protocol-defined exclusion criteria may apply.