cyrilzakka/clinical-trials huggingface dataset:
Post Vaccination Adverse Events in Covid-19 Vaccine Recipients

Covid-19 pandemic is caused by Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-Cov-2) since its outbreak 2019. Protection against Covid-19 can be achieved through global immunization. Various vaccines for SARS-Cov-2 has been registered and approved for administration in humans. It is important to understand the safety and efficacy of vaccines during robust research to develop global immunity against SARS-Cov-2. This study aimed to collect data on post vaccination adverse events in regional population of District Bahawalpur.

Bahawalpur District of Punjab province has population of 3.998 million and among these 2.6 million above 12 years of age are eligible for vaccination against SARS-Cov-2. 28 centers were established for vaccination within the districts at designated sites for Covid-19 vaccination. 87% targeted population has been vaccinated till 15th February 2022. Investigators designed this study to collect and evaluate data on adverse effects after vaccination of Covid-19. Investigators aimed to collect information through interviewing participants in general places of designated sites of vaccination centers established in District Bahawalpur. History will be recorded from participants and in case of adverse events detailed available history will be recorded including following adverse effects from available records on following.

* Cardiovascular adverse effects
* Cerebrospinal adverse events
* Respiratory disturbances
* Hepatobiliary disorders
* Urogenital adverse effects
* Musculoskeletal adverse effect
* Psychological diseases
* Blood biomarkers changes
* Autoimmune adverse events
* Allergic reactions and hypersensitivity Collected data will be summarized to get percentage of adverse effects in general population. Recorded adverse events will be assessed for their frequency in participants and association with vaccination will be assessed through employing statistical methods. Subsequent information on handling of adverse events will be recorded including
* Nature of adverse event
* Hospitalization and severity of adverse events
* Mortality / morbidity caused by vaccination
* Days of hospitalization
* Changes in Blood biomarkers
* Interventions adopted for adverse events
* Diseased period
* Covid-19 infection positivity through RT-PCR / imaging for round glass opacities / Covid-19 changes Overall efficacy and safety of vaccination will be assessed through collected data.

Eligibility Criteria:
Inclusion Criteria:

Age \>12 year Vaccinated (Single Dose, Double Dose, Booster Dose) Clinical diagnosis of Allergic reactions and hypersentivity, Cardiovascular diseases Musculoskeletal diseases Respiratory disease Immunological disease Kidney diseases

Exclusion Criteria:

Age \<12 years of age Not vaccinated History of disease before vaccination

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Efficacy of Tomosynthesis in the BIRADS 3 Population

There are three main objectives, centering on those patients targeted for surveillance imaging. The first objective is to compare image quality and specificity of breast tomosynthesis and conventional 2D mammography in a BIRADS 3 diagnostic population. The second objective is to compare image quality and ability to determine post-surgical and post-radiation changes from recurrence in a post-cancer subset of a BIRADS 3 population having undergone conservation therapy (lumpectomy with or without radiation. The final objective is to compare image quality and the ability to determine chemoresponsiveness in a post-cancer subset of a BIRADS 3 population, who are undergoing neoadjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

GROUP 1

* female of any race and ethnicity
* 35 years or older
* after routine and diagnostic imaging, subject is categorized as a BI-RADS 3 and will undergo study imaging within 30 days of routine or diagnostic imaging.
* subject is returning for surveillance imaging after a categorization of a BI-RADS 3 and will undergo study imaging within 30 days of surveillance imaging GROUP 2
* female of any race and ethnicity
* 26 years or older
* subject has completed cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging
* subject will undergo study imaging within 30 days of surveillance imaging GROUP 3
* female of any race and ethnicity
* 26 years or older
* subject is currently undergoing cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging OR
* subject will undergo study imaging within 30 days of surveillance imaging

Exclusion Criteria:

* GROUP 1, 2 and 3
* subjects unable or unwilling to participate
* subjects who are unable or unwilling to tolerate compression
* subjects who are pregnant or who think they may be pregnant
* subjects who are breastfeeding
Remote Ischemic Preconditioning During Lower Limb Revascularization

The aim of this study is to evaluate the role of remote ischemic preconditioning (RIPC) in preventing acute kidney injury after lower limb revascularization.

Remote ischemic preconditioning(RIPC) is a simple, cost-free and non invasive procedure (transient upper limb ischemia/reperfusion) that could provide organ protection (Heart, Brain and Kidney) following ischemia injuries.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for open limb revascularization

Exclusion Criteria:

* Peripheral vascular disease affecting upper limbs
* Chronic kidney disease in stage 4 or 5 (eGFR\<30 ml/min/1,73m2)
* Patients underwent contrast-enhanced radiological exams in the previous 7 days
* Treatment with glibencamide or prostaglandins
Innate Immunity Stimulation Via TLR9 in Early AD

This single-center, double-blind, placebo-controlled study will recruit in total 39 participants with either Mild Cognitive Impairment due to Alzheimer's disease (MCI) or Mild Alzheimer's disease dementia (mild AD). There will be 3 Dose levels. An initial cohort of 13 subjects will be randomized to a Dose level 1 (0.1 mg/kg vs. placebo) lasting 8 weeks. An additional 13 subjects will be recruited and randomized into Dose level 2 (0.25 mg/kg vs. placebo) for 8 weeks and 13 subjects for the last Dose level 3 (0.5 mg/kg vs. placebo) for 8 weeks. The primary objective will be to assess safety and tolerability of CpG 1018.


Eligibility Criteria:
Inclusion Criteria:

1. 65-85 years of age
2. MCI due to AD or mild AD dementia per NIA-AA specified criteria published in 2018
3. Montreal Cognitive Assessment (MoCA) score ≥17 AND;
4. Positive Florbetaben PET amyloid scan, or other positive PET amyloid scan performed within one year of study enrollment
5. Must be able to provide consent or assent (If applicable).
6. Must be willing and able to participate in all study related procedures.
7. Must have a reliable study partner to provide information on the subject's cognitive and functional status. Study partner must have sufficient contact with the subject, as determined by the PI, and be available to accompany the subject to clinic visits or by phone.

Exclusion Criteria:

1. History of psychiatric illness (e.g. hallucinations, major depression, suicidal ideation or delusions) that could interfere with completion of study related procedures as determined by PI
2. History of autoimmune disorders or antibody-mediated disease, severe asthma, or other serious infection or systemic illness, as determined by PI
3. Use of corticosteroids or immunosuppressive drugs within 30 days of study entry
4. History of splenectomy
5. Renal impairment
6. Use of chloroquine within 8 weeks of study entry
7. Inability to undergo MRI imaging
8. History of TIA, stroke or seizures within 12 months of screening
9. Any neurological condition other than AD that could contribute to cognitive impairment (including related to possible "long COVID") as determined by PI
10. Participation in any other current AD investigational interventional trial
11. Current use of an anti-coagulant
12. Current use of drugs that are major substrates of cytochrome P450 (CYP) enzyme 1A2
13. Recent exposure to COVID-19 infection within 14 days or recent onset of symptoms within 14 days that may be related to COVID-19 infection
A Prospective Study Evaluating the Impact of Conservative Management on Retained Products of Conception and EMV

The goal of this observational study is to learn about the therapeutic effects of the conservative treatment approach on pepole with retained products of conception (RPOC) and Enhanced myometrial vascularity (EMV).

The main question it aims to answer is: Is it possible to achieve the natural resolution of RPOC by combining it with EMV through conservative treatment？ Participants will receive conservative treatment (such as mifepristone, GnRH-a, or expectant management) following the initial diagnosis of RPOC and EMV, and the therapeutic efficacy of the conservative approach will be assessed after the completion of two menstrual cycles.


Eligibility Criteria:
Inclusion Criteria:

* Recent history of miscarriage or delivery (within the past 8 weeks)
* Strong willingness to undergo conservative management
* Hemodynamically stable
* Signed informed consent form

Exclusion Criteria:

* Heavy vaginal bleeding (requiring immediate surgical intervention)
* Active pelvic or systemic infection (e.g., fever \>38°C, elevated CRP/WBC)
* Severe dysfunction of vital organs (heart, liver, or kidney)
* Known drug allergies or contraindications to proposed medications (e.g., misoprostol intolerance)
* Suspected ectopic pregnancy or gestational trophoblastic disease (confirmed by ultrasound or β-hCG levels)
* Placenta accreta spectrum disorders diagnosed during current pregnancy
* History of uterine artery embolization
Intravenous(IV) vs. Erector Spinae Plane Blocks in Cardiac Surgery

Interfascial plane blocks have been developed for analgesia, among which the erector spinae plane (ESP) has gained popularity. The ESP block has been hypothesized to provide truncal analgesia by spread of local anesthetic into the paravertebral space. Recent studies have contested this idea showing unreliability in the spread of the local anesthetic into the paravertebral space.

Post-operative pain is a significant issue following open heart surgeries and poorly controlled pain can result in significant cardiorespiratory morbidity. Many patients suffer pain both at rest (49%) and on movement (62%) following open heart surgeries via sternotomy and adequate pain management requires closer re-assessment and treatment. The intensity of pain is noted to be higher in the first 48 hours post surgery and hence modalities to control pain may make the greatest difference in the first 2 days after surgery.

Enhanced recovery pathways utilizing multimodal analgesia have shown significant analgesic and opioid sparing benefit while minimizing ICU and length of hospital stays. Some multimodal regimens have also incorporated regional blocks but the optimal analgesic regimen remains elusive. The ESP block has been hypothesized to provide truncal anesthesia by spread of local anesthetic into the paravertebral space, but recent studies contest this idea. Bilateral paravertebral blocks can result in higher than acceptable levels of local anesthetic in both cardiac and non-cardiac surgical patients and this may be true following bilateral erector spinae plane (ESP) as well. Hence, the pharmacokinetic profile of administered local anesthetics is necessary given the lack of information about the local anesthetic systemic levels following bilateral ESP.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing elective cardiac surgery for coronary artery bypass graft (CABG) or valve surgery via sternotomy.
* English speaking

Exclusion Criteria:

* Emergency surgery
* Allergy to medications (ie lidocaine)
* BMI less than 20 or greater than 50
* Major liver or kidney dysfunction or other pre-existing major organ dysfunction
* Revision cardiac surgery
* Surgery via thoracotomy
* Off-pump coronary artery bypass
* Narcotic dependent (Opioid intake morphine equivalents greater than 10mg/day for more than 3 months
* Chronic pain (ie fibromyalgia)
* Significant central nervous system or respiratory disease
* Hematological disorders or de-ranged coagulation parameters
* Psychiatric illness that impedes subject from providing informed consent
* Pre-operative neurological deficits
* Language barrier
* Inability to provide informed consent
* Prisoner status
* Pregnancy
Laronidase (Aldurazyme TM) Enzyme Replacement Therapy With Hematopoietic Stem Cell Transplant for Hurler Syndrome

This is a standard of care treatment guideline for patients with the diagnosis of mucopolysaccharidosis type IH (MPS I, Hurler syndrome) who are being considered as candidates for first hematopoietic stem cell transplantation (HSCT) according to a University of Minnesota myeloablative HSCT protocol.

Laronidase Enzyme Replacement Therapy will be performed using laronidase once a week for 12 weeks prior to hematopoietic stem cell transplantation and for 8 weeks post-transplant to reduce pulmonary complications.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mucopolysaccharidosis type IH (MPS I, Hurler syndrome) and being considered as a candidate for first transplant according to a University of Minnesota myeloablative hematopoietic stem cell transplant (HSCT) protocol

Exclusion Criteria:

* No prior therapy with laronidase enzyme replacement therapy (ERT)
Vaginal Hysterectomy Versus Laparoscopically Assisted Vaginal Hysterectomy for Large Uteri

The investigators compare between Vaginal Hysterectomy and Laparoscopically assisted vaginal hysterectomy in cases of large uteri weighing more than 280 gm regarding operative and Postoperative outcomes

Study setting : Ain Shams University Maternity Hospital Study Design : Pilot prospective randomized clinical trial Study population: The patients will be recruited from women presenting to the outpatient clinic of Ain Shams University Maternity Hospital planned to undergo hysterectomy for benign cause according to inclusion/ exclusion criteria which will be mentioned later.

Study duration : the study will be carried out during the period from August 2014 to August 2016.

Sample size: total of 50 cases will be included in the study to be divided into two groups, the first group will undergo vaginal hysterectomy and the second will undergo Laparoscopic assisted vaginal hysterectomy.

intervention: after approval of the ethical committee, a detailed explanation of the procedure will be informed to the participant and after her approval to involve in the study, an informed written consent will be taken. Detailed medical history will be obtained from all participants recruited in the study along with complete clinical examination and necessary laboratory and radiological investigations. Each patient will have a case record form in which the data regarding history, examination, investigations, operation costs and postoperative events will be recorded

Eligibility Criteria:
Inclusion Criteria:

1. Age between 40 and 70 years.
2. Uterine weight more than 280gm. the weight will be estimated sonographically using algebraic formula by Kung and Chang expressed in weights and measurements: weight(g)= 50+(4/3 x π(Pi) x L/2 x W/2 x AP/2) where (L) is the length of the uterus from the dome of the fundus to the level of the external os and (W) is the maximum width of the uterus at the level of the cornua and (AP) is the anteroposterior diameter of the uterus . Both (W) and (AP) will be taken perpendicular to the axis of the uterine length.
3. Presence of a benign cause for hysterectomy. e.g: fibroid uterus, simple endometrial hyperplasia not responding to medical treatment and adenomyosis.

Exclusion Criteria:

1. Patients medically unfit for laparoscopy as severely compromised cardiac patients.
2. Obese patients (BMI\>30).
3. Presence of endometriosis.
4. Previous myomectomy
5. Presence of adnexal mass
6. Known or suspected gynecological malignancy.
Phase I Study of the Volitinib (HMPL-504) in Patients With Advanced Solid Tumors

The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of volitinib administered to patients with locally advanced or metastatic solid tumors and determine MTD (Maximum Tolerated Dose) or RPTD(recommended Phase 2 dose).

The primary endpoint is evaluation of safety and tolerability during all the study of therapy following the initiation of multiple dosing of HMPL-504. The safety and tolerability variables to be evaluated in this study are adverse events, physical examinations, vital signs (specifically including blood pressure), clinical laboratory evaluations including serum chemistry, hematology (Maximum Tolerated Dose), and urinalysis (with detailed sediment analysis, proteinuria, and 24-hour urine for collection for protein), and electrocardiograms (ECGs) in triplicate, Incidence and nature of DLTs (Dose-Limiting Toxicity), to determine the MTD (Maximum Tolerated Dose).

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Age≥18 years
* Histologically or cytologically documented(include both dose escalation stage and dose expansion stage), incurable, locally advanced, or metastatic solid malignancy
* In the dose escalation stage: patients with any malignant solid tumor type for whom standard therapy either has proven to be ineffective (progressed on, or failed to respond to) or intolerable, have no access to standard systemic therapy or standard systemic therapy does not exist.
* In the dose expansion stage:

Metastatic or locally advanced gastric cancer patients with cMet positive b)Metastatic or locally advanced EGFR wild type NSCLC patients and with cMet positive.

* ECOG performance status of 0, or 1
* Male or female patients of child-producing potential must agree to use double barrier contraception, condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD), contraceptives (oral or parenteral), Implanon, injectables or other avoidance of pregnancy measures during the study and for 90 days after the last day of treatment

Exclusion Criteria:

* Absolute neutrophil count \<1500 cells/uL, hemoglobin \<9 g/dL or platelet count \< 100,000/mm3
* Total bilirubin \> 1.5×the the upper limit of normal(ULN).
* Herbal therapy \<1 week prior to Day 1
* Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia
* Clinical significant active infection
* Known clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
* Known human immunodeficiency virus infection
* Pregnant (positive pregnancy test) or lactating women
* Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease
* Involved in other clinical trials \< 4weeks prior to Day 1.
I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms

This study is a randomized, controlled trial (RCT) to evaluate the effect of Brain CareNotes (a mobile health application) on the burden experienced by unpaid caregivers of patients with dementia and on the behavioral and psychological symptoms of dementia (BPSD) displayed by care recipients. Over 39 months, the trial will enroll 160 caregivers of community-dwelling patients diagnosed with Alzheimer's disease or a related dementia (ADRD). Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for 12 months, with usage reminders.

This study is a hybrid efficacy-effectiveness RCT to evaluate the effect of Brain CareNotes on unpaid caregiver burden and patient BPSD. Over 39 months, the trial will enroll 160 caregivers. Participants will be randomized to use the Brain CareNotes app or an attention control education-only app (Dementia Guide Expert) for 12 months.

The primary objective is to test the effect of Brain CareNotes on a) caregiver burden and b) patient BPSD at 12 months. The investigators hypothesize that caregiver burden and patient BPSD will be lower among those participants randomized to the Brain CareNotes intervention compared to those randomized to the education-only attention control app at 12 months. The primary, powered outcomes are calculated using the caregiver-reported Neuropsychiatric Inventory (NPI); the total NPI score measures patient BSPD and the caregiver distress sub-score measures caregiver burden. The investigators will obtain NPI responses from caregivers at baseline, six, and 12 months.

The secondary objective is to test the effect of Brain CareNotes on a) caregiver depressive symptoms and b) patient and caregiver acute care utilization at 12 months. The investigators hypothesize that participants randomized to the Brain CareNotes intervention will have lower caregiver depressive symptoms and decreased acute care utilization compared to those randomized to the control app. For caregiver depressive symptoms, investigators will use the researcher-administered Patient Health Questionnaire-9 (PHQ-9) at baseline, six, and 12 months. Acute care utilization data will be obtained from self-reports or Indiana's statewide Health Information Exchange (HIE), known as the Indiana Network for Patient Care (INPC), to identify both caregivers' and patients' hospital and ER visits that occurred within 12 months of enrollment.

Eligibility Criteria:
Caregiver Inclusion Criteria:

* Self-identified primary unpaid caregiver of a person diagnosed with ADRD (at any stage) who are:
* Receiving primary care and
* Community-dwelling;
* English literate;
* Age ≥ 18 years

Caregiver Exclusion Criteria:

* Care recipient is a permanent resident of an extended care facility (nursing home);
* Involvement in another clinical trial that would prevent or interfere with study objectives;
* Sensory or other impairment prohibiting the use of a mobile touchscreen device or other study activity (after correction)
Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Décolleté

Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.

This is a prospective, single-center study. Baseline Fabi/Bolton 5-Point Chest Wrinkle scale scores and chest measurements will be assessed prior to study treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Female, aged 35 to 60 years.
* Subject in good health.
* Moderate to severe (grade of ≥3 on Fabi/Bolton scale) skin laxity on the décolleté.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Scarring in areas to be treated.
* Tattoos in the areas to be treated.
* Patients with ports or defibrillators.
* Breast size \>400cc each as measured by water displacement method.
* History of breast reduction surgery.
* Any open wounds or lesions in the area.
* Active and severe inflammatory acne in the region to be treated.
* Patients who have a history with keloid formation or hypertropic scarring