cyrilzakka/clinical-trials huggingface dataset:
The Use of Disinfectants Among Women in Egypt and the Toxicity by Bleach During the Coronavirus Lock-down.

This study examines the use of disinfectants by Egyptian women during the coronavirus lockdown. Data will be collected via an online self-administered questionnaire that will be distributed to Egyptian women via social media channels. Questions in the questionnaire will assess types of disinfectants frequently used and how often they have been used for household disinfection during the 2020 coronavirus pandemic. The investigators hypothesized that the frequent use of disinfectants in deep household cleaning during the lockdown has been associated with increased incidents of toxicity by bleach and similar products. At the same time, people were advised to stay home and refrain from seeking in-person medical care to avoid catching the coronavirus. Therefore, many people used social media to receive medical advice not necessarily from the right sources nor qualified experts.

This study examines the use of disinfectants by Egyptian women during the coronavirus lockdown. Data will be collected via an online self-administered questionnaire that will be distributed to Egyptian women via social media channels such as (Facebook and WhatsApp).

Google Forms tool will be used to conduct the questionnaire as questions in the questionnaire will assess types of disinfectants frequently used and how often they have been used for household disinfection during the 2020 coronavirus pandemic. Questions will also assess the occurrence of adverse effects related to the increased use of disinfectants during the lockdown and how women reached out for medical care for their family members in cases of accidental toxicity.

The investigators hypothesized that the frequent use of disinfectants in deep household cleaning during the lockdown has been associated with increased incidents of toxicity by bleach and similar products. At the same time, people were advised to stay home and refrain from seeking in-person medical care to avoid catching the coronavirus. Therefore, many people used social media to receive medical advice not necessarily from the right sources nor qualified experts.

The questionnaire is designed by the primary investigator (Dr. Maha Farid) and was reviewed by other experts in the field of forensic medicine and clinical toxicology. The questions were developed in English and then translated in Arabic to be distributed to the target population in Arabic.

The inclusion criteria for women participating in this survey will include adult females living in Egypt during the time of lockdown due to coronavirus pandemic that started in Egypt in March 2020.

The questionnaire will be open for a month or till we reach the desired sample size, whichever comes first.

The data collected via this questionnaire will be then tabulated and analyzed using the proper statistical analysis methods.

Eligibility Criteria:
Inclusion Criteria:

* Adult women living in Egypt the coronavirus lockdown started in March 2020

Exclusion Criteria

* Men living in Egypt
* Adult women not living in Egypt during the coronavirus lockdown started in March 2020.
Digital Life Coaching for Myeloma Patients Undergoing Transplantation

This is the first study of digital life coaching (DLC) to engage patients during the peri-HCT period that is punctuated by intensive life changes. DLC may circumvent these limitations by combining the integrative cross-dimensional nature of life coaching with the advantages of mobile health technology. The purpose of this study is to evaluate whether ongoing participant engagement with a DLC platform is feasible for multiple myeloma (MM) patients actively undergoing hematopoietic stem cell transplantation (HCT).

Participants will receive unlimited access to Pack Health's DLC platform during a 16-week period encompassing pre-HCT conditioning chemotherapy, post-HCT recovery, and 100-day follow-up. Participants will engage with Pack Health's DLC platform and complete quality of life assessments for 16 weeks beginning from enrollment. At the conclusion of the treatment period, participants will be asked to rate their satisfaction with the DLC platform

Primary Objective:

To evaluate the rate of ongoing participant engagement with a DLC platform during the study period

Secondary Objectives:

* To assess quality of life among participants during the study period
* To assess psychosocial distress among participants during the study period
* To assess sleep disturbances among participants during the study period
* To assess participant satisfaction with the DLC platform at the end of the study period

Exploratory Objectives:

* To assess benzodiazepine and zolpidem-class drug usage for anxiety or insomnia among participants during the study period
* To assess communications with treatment teams among participants during the study period
* To assess 100-day clinical outcomes among participants at the end of the study period

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of one of the following (all referred to as MM in this protocol):

  * Multiple myeloma (ICD-10 code: C90.0)
  * Extramedullary plasmacytoma (ICD-10 code: C90.2)
* Planned receipt of autologous HCT at our institution

  * Patients undergoing outpatient HCT will be eligible
  * Patients who received chemomobilization will be eligible
* Age ≥ 18, as life coaches employed by the DLC vendor are not currently trained to work with pediatric patients

Exclusion Criteria:

* Prior autologous HCT for any indication
* Physician-assessed lack of sufficient English proficiency
* Lack of ownership of a personal smartphone
* Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with participant's safety, provision of informed consent, or compliance with study procedures
Anecortave Acetate Injection to Treat Steroid-responsive Intraocular Pressure Increase in Cornea Transplant Patients

This study will investigate the use of anecortave acetate injection to reduce intraocular pressure (IOP) in corneal transplant recipients who are experiencing steroid-associated pressure control problems. Alternative methods of IOP control have been shown to entail serious risks. For example, reduction of topical steroids increases the risk of graft rejection, and use of glaucoma medications or glaucoma surgery increases the risk of graft failure. This study is designed to have sufficient power to detect whether a single injection can induce a clinically significant IOP reduction.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* corneal transplant recipient with intraocular pressure (IOP) greater than 24 mmHg and with relative increase in IOP of at least 10 mmHg over the pre-graft baseline

Exclusion Criteria:

* not pregnant or lactating
* intraocular surgery in the study eye within 30 days before enrolling in the study
* use of any investigational drug or treatment within 30 days before receipt of study medication
* clinical evidence of scleral thinning
A Study to Assess ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Participants

This will be an open-label, 3-sequence, 3-period crossover study in healthy adult participants to assess the relative bioavailability of ACH-0145228 when administered as an immediate release tablet versus powder-in-capsule.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening.
2. No clinically significant history or presence of electrocardiogram findings at screening.
3. Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
4. Female participants must be of non-childbearing potential and need not employ a method of contraception.

Exclusion Criteria:

1. Clinically significant laboratory abnormalities.
2. History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
3. History or presence of drug or alcohol abuse within previous 2 years, current tobacco user, and positive drugs-of-abuse screen and alcohol screen at screening or Day -1 of Period 1.
4. History or presence of clinically significant seizures, head injury, or head trauma.
5. History of procedures that could alter absorption or excretion of orally administered drugs.
6. History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
7. A history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
8. Body temperature ≥ 38.0°Celsius at screening or prior to first dosing in Period 1 or history of febrile illness, or other evidence of infection, within 14 days prior to (first) dosing.
9. Is a female of childbearing potential.
10. Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, and receipt of blood products within 6 months prior to first dosing.
11. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days before first dosing, whichever is longer.
The Study of Gut Microbiota in Hypertensive Patients

Recent animal and human studies have found the relationship between the composition of the gut microbiota and hypertension, but some studies did not have a detailed evaluation of the diet content, which could be an important effect on gut microbiota. Moreover, most of these studies were finished in Western countries, in which the dietary patterns were significantly different from those in Chinese regions. This study intends to establish Taiwanese local data to explore the differences in the composition of gut microbiota among hypertensive patients and normotensive subjects.

The investigators plan to enroll total 70 hypertensive and normotensive cases from the elderly health examination in Cathay General Hospital, who are aged from 65 to 80 years. Body mass index and blood samples for biochemical analysis such as blood sugar and cholesterol levels are taken, and fecal samples are collected for analysis of gut microbiota, which is characterized by 16S ribosomal RNA gene sequencing. Besides, the diet and nutrients intake are recorded and calculated by licensed dietitian. Through the exploration of gut microbiota in hypertensive patients, the results can be the reference for clinical treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age 65\~80 years old
2. People who join the Elderly Health Examination Program in Cathay General Hospital in 2021

Exclusion Criteria:

1. Antibiotics use within one month
2. Acute gastrointestinal illness within one week, such as vomiting and diarrhea
3. History of gastrointestinal surgery
4. History of inflammatory bowel disease
5. Chronic gastrointestinal disease under medication treatment
6. Cannot finish dietary record
Multicenter, Randomized, Open-label Study to Assess Whether Treatment With Mycophenolate Sodium (MPS) Allows Higher Dose Optimization Versus Mycophenolate Mofetil (MMF) Leading to a Dose Reduction of Tacrolimus. Maximiza Study.

Multicenter, Randomized, Open-label Study to Assess Whether Treatment With Mycophenolate sodium (MPS) Allows Higher Dose Optimization Versus Mycophenolate mofetil (MMF) Leading to a Dose Reduction of Tacrolimus. Maximiza Study.


Eligibility Criteria:
Inclusion criteria

1. Renal transplant recipients ≥ 1 year and ≤ 5 years prior1 to inclusion in the study.
2. Patients who were receiving an immunosuppressive regimen including MMF ≤1000 mg/day and ≥ 250 mg/day 4 and Prograf®1 or Advagraf®6 (levels ≥7 ng/ml).
3. Patients who had been receiving the current maintenance immunosuppressive regimen with stable doses of MMF for at least the past 3 months.2
4. Patients included must have had Prograf® or Advagraf® levels ≥ 7ng/ml4 for at least one month prior to inclusion in the trial.2
5. Patients with low immunological risk, in the investigator's opinion.
6. Patients with an estimated glomerular filtration rate based on the MDRD formula of \> 30 ml/min x 1.73 m2.1
7. Patients over 18 years of age.1
8. Patients who were able to understand the study information and give written informed consent.
9. Patients who were able to meet all study requirements, including completing questionnaires and attending study visits.

Exclusion criteria

1. Patients with GI symptoms known or assumed not to be caused by mycophenolic acid (MPA) treatment (e.g. oral bisphosphonate-induced infectious diarrhoea).
2. Patients with chronic inflammatory bowel disease.
3. Diabetic patients.
4. Acute rejection \< 1 month prior to inclusion in the study.
5. Patients with leukopenia (\< 3500 cells/mm3) or thrombocytopenia (\< 100,000 cells/mm3).
6. Women of childbearing potential who were planning to become pregnant, were pregnant and/or breastfeeding, or who did not wish to use effective contraception \[hormonal contraceptives (implantation, patches, oral) and double-barrier methods (any double combination of: IUD, male or female condoms with spermicidal gel, diaphragm, contraceptive sponge, cervical cap)\].
7. Presence of psychiatric illness (such as schizophrenia, major depression) that, in the investigator's opinion, could interfere with study requirements.
8. Patients who were undergoing surgery for an acute condition or who were hospitalised.
9. Any other medical condition that, in the investigator's opinion based on blood counts or chart review, could interfere with completion of the study, including but not limited to visual problems or cognitive impairment.
10. Patients who were receiving or had received any investigational medicinal product during the 30 days prior to inclusion in the study.
Immunogenicity and Safety Study of SCB-2023 Vaccine as a Booster in Adults

The purpose of this study is to assess the immunogenicity and safety of SCB-2023 trivalent vaccine compared to the prototype SCB-2019 monovalent vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years of age.
* Individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.
* Individuals willing and able to give an informed consent, prior to screening.
* Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.
* Individuals who received three doses of inactivated COVID-19 vaccine.

Exclusion Criteria:

* Body temperature \>37.8°C (axillary), or any acute illness at baseline.
* Confirmed SARS-CoV-2 infectionor with known history of COVID-19.
* Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for inactivated COVID-19 vaccine).
* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
* Any progressive unstable or uncontrolled clinical conditions.
* Individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period.
* History of severe adverse reaction associated with a vaccine or severe allergic reaction.
* History of malignancy within 1 year before screening.
* Individuals who have received any other investigational product.
* Individuals who have received any other licensed vaccines within 14 days prior to enrollment.
* Treatment with Rituximab or any other anti-CD20 monoclonal antibodies.
* Known bleeding disorder that would, in the opinion of the investigator, contraindicate i.m. injection.
* Administration of intravenous immunoglobulins and/or any blood products.
* Any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant.
Focused Registry SmartFix

20 patients having received an AO large external fixator at the tibia will be equipped with a data logger device (AO Fracture Monitor) attached post-operation to a connection rod of the external fixator. The device continuously measures deformation of the fixator frame due to weight bearing for up to 6 months by means of a strain gauge. Several parameters are calculated from the recorded change in the strain signal and are stored at a regular interval.

Maturation of fracture callus leads to unloading of the fracture fixation hardware due to an increased load-share of the repair tissue. A novel data logger device (AO Fracture Monitor) continuously measures the decline in fixation hardware deflection under physiological loading as indirect indicator for the healing progress. Parameters obtained from the data logger device carry potential to significantly improve the assessment of fracture healing in the future. Meaningful interpretation of measurements requires a set of clinical reference data.

20 patients having received an AO large external fixator at the tibia will be equipped with a data logger device (AO Fracture Monitor) attached post-operation to a connection rod of the external fixator. The device continuously measures deformation of the fixator frame due to weight bearing for up to 4 months by means of a strain gauge. Several parameters are calculated from the recorded change in the strain signal and are stored at a regular interval. Data is collected from the AO Fracture Monitor at follow-up visits of the patient by wireless data transfer. Together with additional variables such as treatment details, fracture healing and pain reported by the patient, the collected data is used to build up a database. Data from the AO Fracture Monitor will be correlated with patient data to investigate the relevance and reliability of the data derived from the AO Fracture Monitor.

In this phase, the study does not imply changes on the operational treatment, nor does it allow for therapeutic consequences based on the derived data.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Diagnosis of Femoral or tibial fracture (AO 41-43)
* External fracture fixation with AO large external fixator
* Capable of at least partial weight-bearing
* Informed consent obtained, i.e.:

  * Ability to understand the content of the patient information/Informed Consent Form (ICF)
  * Willingness and ability to participate in the Focused Registry according to the Registry Plan (RP)
  * Signed and dated Ethics Committee (EC) approved written informed consent

Exclusion Criteria:

Preoperative exclusion criteria:

* External fixation as temporary stabilization
* Joint-bridging external fixation
* Any not medically managed severe systemic disease
* Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
* Pregnancy or nursing mother
* Emergency patient
* Prisoner
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
A Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks

The purpose of this study is to evaluate the rate of "add-on" solifenacin treatment and its persistency in men with over active bladder symptoms after tamsulosin monotherapy for 4 weeks.

This is a multi-center study to evaluate the efficacy, safety, and persistency of solifenacin treatment in male patients with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence who are receiving tamsulosin monotherapy for LUTS at a stable dose for 4 weeks in real life practice. Also proportion of patients and predictive factors with persistent OAB symptoms after tamsulosin monotherapy will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* IPSS ≥ 12
* Symptoms of OAB as verified by the V8 (≥8)
* Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:

  * Mean urinary frequency ≥8 times/24 hours
  * Mean number of micturition-related urgency episodes ≥3 episode/24 hours (with a Urinary Sensation Scale rating of ≥3 marked for the corresponding micturition in the bladder diary)

Exclusion Criteria:

* Treatment within the 14 days preceding treatment with any alpha blocker drugs
* A known history of bladder outlet obstruction due to: bladder neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor
Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement

The purpose of this study is to determine the best way to feed children after they have a gastrostomy tube placed. The study compares bolus feeding to continuous feeding.

This study will consist of a prospective, randomized comparison of bolus versus continuous enteral feeding protocols in pediatric patients with gastrostomy tubes

Eligibility Criteria:
Inclusion Criteria:

* Less than 18 years of age
* Admitted for gastrostomy tube placement, with or without Nissen Fundoplication

Exclusion Criteria:

* Immunocompromised patients
* Short Bowel Syndrome (SBS)
Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context

The purpose of the study is to investigate how a medication called eptinezumab (Vyepti) given to patients in the Emergency Department (ED) might help prevent migraines from happening again. The results of this study may help inform better ways to manage patients with migraines in the ED.

Eptinezumab is currently approved by Health Canada for the preventive treatment of migraine, but its short-term effectiveness in the ED context is unknown. Unlike other migraine treatments used in the ED, eptinezumab can rapidly interrupt the migraine process, potentially also preventing migraine from coming back in the short term.

Most patients with a diagnosis of migraine have no access to preventative therapies. This study will be able to provide access to preventative therapy at the earliest stages of a migraine attack. Administering this medication in the ED may stop the attack more effectively compared to current therapies.

This study wants to see if eptinezumab could help stop migraines from coming back after individuals have been treated in the ED. The study will also explore whether eptinezumab could reduce how often individuals with migraine might need to come back to the ED, what other medications they might need alongside eptinezumab, and how they feel overall.


Eligibility Criteria:
Inclusion Criteria:

1. Adults between the ages of 19-75 with a history of migraines, as established at the time of presentation to the ED or known from the patient's chart;
2. Presenting to the emergency department with a migraine that meets ICHD-3 migraine headache criteria;
3. Provided signed informed consent;
4. Sufficient literacy and cognitive capacity to understand and complete patient self-rated questionnaires in English.

Exclusion Criteria:

1. Secondary headaches caused by an injury or underlying illness, such as a concussion, bleeding in the brain, an infection or a brain tumor
2. Current or history of severe cardiovascular disease or renal dysfunction
3. A systemic condition in the stage of active treatment (vasculitis, etc.)
4. Pregnant or at risk of becoming pregnant (absent contraception)
5. Currently enrolled in another investigational drug trial
6. Dosed with eptinezumab within the past 3 months
7. Currently on anti-CGRP therapy with monoclonal antibodies
8. Currently involved in active litigation
9. Any other condition which, in the opinion of the Investigator, would exclude the participant due to reasons of safety or data integrity
10. Hypersensitivity to the active substance or to any of the excipients