cyrilzakka/clinical-trials huggingface dataset:
Erector Spinae Plane Block in Radical Cystectomy

The aim of this research is to study and compare the efficacy and safety of bilateral single injection erector spinae plane block (ESPB) compared with intravenous patient-controlled analgesia (IV-PCA) in managing postoperative pain after radical cystectomy.

Radical cystectomy (RC) is one of the most challenging surgical techniques in Urology. Acute postsurgical pain is frequently detrimental in a patient's recovery and quality of life.

Intravenous patient-controlled analgesia (IV-PCA) is one of the most commonly used strategies in clinical practice for controlling postoperative pain. It involves continuous administration of a programmed dose of analgesics, while also allowing patients to receive additional, need-based doses.

One such avenue is the erector spinae plane block (ESPB), a novel analgesic technique first described in 2016 by Forero et al. Although the mechanism of action of the ESPB is unknown, a proposed mechanism is via blockade of the dorsal and ventral rami of thoracic/lumbar spinal nerves. ESPB has been used as analgesia in rib fractures and other thoracic procedures as well as in abdominal surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Age of the patient between 21 to 65 years.
* Both sexes.
* Body mass index (BMI): 20 - 40 kg/m2.
* American Society of Anesthesiologists (ASA) physical status II-III.
* Elective radical cystectomy.

Exclusion Criteria:

* Patient refusal.
* Psychiatric and cognitive disorders.
* Local infection at the site of injection.
* Allergy to study medications.
* Anatomic abnormalities.
* Inability to comprehend or participate in pain scoring system.
Healthy Transitions in Late Stage Kidney Disease

Improve health and outcome for people with late stage chronic kidney disease by providing patient centered nursing services in addition to a Nephrologist's routine patient care.


Eligibility Criteria:
Inclusion Criteria:

* Stage 4-5 Chronic Kidney Disease (CKD), defined as estimated glomerular filtration rate (eGFR) between 0-30 ml/minute
* 18 years of age or older

Exclusion Criteria:

* Cognitive impairment that is clinically apparent
Efficacy of Lappa Arctium (Homoeopathic Medicine) in Treatment of Acne Vulgaris

Acne is one of the most common skin problems in teenagers and adolescents. There are many lesser known homoeopathic medicines which have been mentioned in the literature for treatment of acne but their potential has not been properly assessed /documented and therefore these medicines don't form a part of many prescriptions. As a part of this study,efficacy of Lappa Arctium will be studied in the treatment of Acne vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Males and females between 12 to 25 years of age
* Presence of inflammatory and non-inflammatory lesions
* Able to follow-up according to protocol
* Patients not taking any medication for treatment of Acne in preceding one month.

Exclusion Criteria:

* Acne Conglobata
* Pregnant or Breast feeding females or females having intention of becoming pregnant
* Significant systemic disease
* Any drug/ alcohol addiction
* History of chronic diseases treated with medications in the preceding month which might affect acne condition and treatment outcome
Mel vs BUCY+VP-16 Conditioning Regimen for MM Undergoing Auto-HSCT

The purpose of this study is to evaluate the safety and efficacy of Melphalan and BUCY+VP-16 myeloablative conditioning regimens in multiple myeloma undergoing autologous hematopoietic stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Multiple Myeloma patients
* Achieving at least VGPR after chemotherapy, then mobilizing and collecting of peripheral blood stem cells

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision
Assessment of Fluoroscopy Times With Surgeon Versus Technologist Control

This is a prospective randomized trial to study the effect of assigning the control of the fluoroscopic x-ray activation to the surgeon as compared to the radiation technologist. Radiation exposure will be assessed from the collected data, fluoroscopy time, and dose parameters (cumulative absorbed dose and dose area product). From exposure data, entrance skin dose (ESD) and midline absorbed dose (MLD) will be calculated. The primary outcome in this study will be total fluoroscopy time for the procedure. A secondary outcome will be the ESD. The investigators will further analyze the contribution of clinical predictors (e.g. stone size/location) and procedural predictors on fluoroscopy times and ESD.

It is hypothesized that a 30% reduction in fluoroscopy time will occur when the operating surgeon is controlling the activation of the x-ray beam.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing ureteroscopy for urolithiasis
* 5 years to 25 years old

Exclusion Criteria:

* Pregnant
* Less than 5 years old or older than 25 years old
NYC Cancer Outreach Network in Neighborhoods for Equity and Community Translation

NYC CONNECT will carry out a randomized controlled trial (RCT) which will assess the relative effectiveness of two evidence-based strategies to increase cancer screening rates for breast, cervical, and colorectal cancer. The RCT will compare the effectiveness of using a combination of 1) culturally and linguistically tailored cancer education materials and 2) community health workers (CHWs) to provide navigation services for cancer screening (the "patient navigation" \[PN\] arm) versus providing culturally and linguistically tailored cancer education only (the "less intensive" \[LI\] arm). The study population will include individuals who are due for breast, cervical, or colorectal cancer screening. All individuals recruited to the study will be provided navigation for unmet social determinants of health (SDH) needs.


Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 21 and 75 years;
* Men between the ages of 45 and 75 years;
* Women (40-74 years) who have not had a mammogram in the past 12 months, a Pap smear in the last 3 years (21-64 years old) or HPV test in the last 5 years (30-64 years old), or women 45-75 years old who are not up-to-date on colorectal cancer screening (Fecal occult blood test (FOBT)/Fecal immunochemical test (FIT) past year, computerized tomography (CT) colonography or sigmoidoscopy past 5 years, or colonoscopy past 10 years);
* Men not up-to-date on colorectal cancer screening (FOBT/FIT past year, computerized tomography (CT) colonography or sigmoidoscopy past 5 years, or colonoscopy past 10 years);
* Must speak either English, Spanish, Haitian-Creole, French, or Chinese (Mandarin and Cantonese);
* Lives in East Flatbush (zip codes: 11236, 11203, 11212, 11226); Sunset Park (zip codes: 11215, 11220, 11232); Highbridge (zip code 10452, 10455, 10451); or Morrisania (zip codes: 10456, 10459)

Exclusion Criteria:

* Previous or current diagnosis of any cancer;
* Pregnancy (breast and cervical cancer only);
* Current participation in an existing cancer navigation program;
* Currently in hospice care;
* At least 66 years of age with advanced illness or frailty or who live in long-term institution for more than 90 days;
* Bilateral mastectomy or right and left unilateral mastectomy (breast cancer only);
* Hysterectomy with no residual cervix (cervical cancer only);
* Total colectomy (colorectal cancer only).
COVID 19 Preventive Measures Among Mansoura Nursing Students

This study aims to identify nursing students knowledge gaps, risk perceptions and adherence to COVID 19 preventive measures during written exam period and In addition due to the possibility of being infected with COVID-19 during exams this study will evaluate covid-19 symptoms rate during exam period and factors affecting its development .

As of june,27,2020, Egypt lift most COVID-19 restrictions and government decided to held written exams for final year students with precautionary measures. Students reported fears regarding the possibility of being infected during exams period and want to postpone or cancel exams due to possible contact during transportation and meeting in classes. Education have been provided to population in general and students in special through social media, social networks, community leaders to take precautionary measures during exams.

Studies provide support for the notion of increased vulnerability to respiratory tract infections with exposure to psychological stress . one of specific stress is Academic Exam stress that has been linked with immuno-suppression.

Exams are stressful experience and a place for student gathering , moreover there is no research about adherence level or factors affecting adherence to COVID-19 precautions among nursing students during exam period. Nursing students are future professionals who can address new emerging infectious diseases.

the study aims to analyze students adherence to COVID 19 preventive measures and to to identify the knowledge gaps, risk perceptions and factors affecting students adherence which could guide the design of better nursing education curricula regarding COVID-19 as a preparation for final year nursing students to internship year which will be on September 2020 . In addition due to the possibility of being infected with COVID-19 during exams or during their internship year this study will evaluate covid-19 symptoms rate during exam period and factors affecting its development .

Eligibility Criteria:
Inclusion Criteria:

* Students who agree to participate.
* Students of both gender .
* Students who have access to internet and have whatsapp account

Exclusion Criteria:

* Students diagnosed with COVID-19 before.
MK-6194 Site of Injection Study in Healthy Adult Participants (MK-6194-013)

The goal of this study is to learn what happens to MK-6194 in a healthy person's body when different injection sites are used. Researchers will compare what happens to MK-6194 in a healthy person's body when it is injected into the abdomen and when it is injected into the thigh. Researchers think that the average amount of MK-6194 in a person's body over time will be similar when injected into the thigh or abdomen. They also want to learn if it is safe to inject MK-6194 into the abdomen and thigh, and if people tolerate it.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health
* Has a body mass index (BMI) within 18 to 35 kg/m2 and weighs at least 50 kg

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer
Value of Diffusion Weighted Magnetic Resonance Imaging in Detection of Recurrent Disease in Surgically Treated Cervical and Endometrial Cancer Patients

Endometrial and cervical cancers are one of the most common malignancies seen in females. Identification of recurrent disease in early phases of treatment carries a primary importance on the outcome of patients. Diffusion-weighted magnetic resonance imaging (DWI) is a new technique recently started to be performed in body imaging and has potential ability to detect recurrent disease. The aim of this study is to investigate the diagnostic impact of DWI in detection of recurrent disease in patients treated with curative surgery in endometrial and cervical cancer.

Endometrial and cervical cancers are one of the most common malignancies seen in female genital tract. Although, surgical resection is the treatment of choice for both, adjuvant or neo-adjuvant chemotherapy or radiotherapy and curative radiotherapy are alternative treatment options depending on the stage.

Identification of recurrent disease in early phases carries a primary importance on the prognosis.

Diffusion-weighted MRI (DWI), a new technique recently started to be performed in body imaging has potential ability to distinguish recurrent disease from normal tissue or fibrosis. Our aim in this study is to investigate the diagnostic impact of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.

All patients who had curative surgery due to endometrial or cervical cancer will be included to the study. Patients will be examined with DWI in addition to routine sequences including contrast enhanced dynamic studies. The sensitivity, specificity, accuracy as well as positive and negative predictive values of the study will be investigated from the data derived from DWI studies and will be correlated with data obtained by conventional radiologic, nuclear imaging studies including PET-CT, as well as pathologic verifications during follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of cervical or endometrial cancer.
* Patients treated with curative surgery (hysterectomy)will be involved on a voluntary basis.

Exclusion Criteria:

* Contraindications for MRI examination (cardiac pacemakers, metallic objects, cochlear implants, claustrophobic patients)
Effect of Pectoralis Block on Analgesia After Simple Mastectomy

The pectoralis block, including pecs I and II block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.

The pectoralis block, including pecs I and II block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The concept involves injecting local anesthetic near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II). This is a prospective, double-blinded, randomized controlled trial in subjects undergoing mastectomy under general anesthesia. The research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1, 2, and 3 patients (According to ASA classification of comorbid conditions and general health)
* Patients undergoing simple mastectomy

Exclusion Criteria:

* -Patient Refusal
* Allergy to local anesthetics
* Inability to communicate in English
* Use of 8 mg morphine equivalents or greater currently and for a period of longer then 2 weeks prior to surgery
* Existing nerve injuries or sensory deficits
* Conversion to anesthesia via an endotracheal tube
Chemopreventive Action of Mesalazine on Colorectal Cancer: a Pilot Study for an "in Vivo" Evaluation of the Molecular Effects on β-catenin Signaling Pathway.

The purpose of this study is to obtain an "in vivo" confirmation that mesalazine induces the gene expression of μ-protocadherin and other related genes in the colon mucosa, as demonstrated in some "in vitro" experiments. .

Pilot Trial, single-blind, parallel group on biopsy specimens of healthy colon mucosa in patients with precancerous lesions of the colon and rectum (adenomas) treated with mesalazine.

Eligibility Criteria:
Inclusion Criteria:

* Patients with precancerous colorectal lesions (polypoid or nonpolypoid adenomas) that needs of an endoscopic exam of control after 3 months from the removal of the lesions (determined on the basis of the morphological and histological characteristics of the lesions and of the removal technique)
* Ability and willingness to adhere to study regimen
* Written informed consent

The following inclusion criteria was deleted according to Amendment n. 01 approved by the Ethical Committee on 19/dec/2014:

- diverticular disease/diverticular colitis;

The rationale of this change is that the presence of diverticular disease/diverticular colitis does not contribute to the definition of the trial primary end-points and represents a critical point during the patient selection with an impact on duration and conduction of the study.

Exclusion Criteria:

* Patients under therapy with Aspirin (\>100 mg/die) or other FANS
* Inflammatory bowel disease (IBD)
* Hypersensitivity to Mesalazine.
* Pregnant or nursing (lactating) women
* Patients who belonging to the category n. 4 of the ASA physical status classification system
* contraindications to mesalazine therapy
Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

The objectives of this study were to evaluate the safety and efficacy of Zimura intravitreal (IVT) administration when administered in participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

Participants will receive monthly intravitreal injections of Zimura or Sham for 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Participants of either gender aged ≥ 50 years
* Diagnosis of Non-foveal GA secondary to dry AMD

Exclusion Criteria:

* Evidence of Choroidal Neovascularization (CNV)
* GA secondary to any condition other than AMD
* Any prior treatment for AMD or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals
* Any intraocular surgery or thermal laser within three (3) months of trial entry
* Any prior thermal laser in the macular region, regardless of indication
* Any ocular or periocular infection in the twelve (12) weeks
* Previous therapeutic radiation in the region of the study eye
* Any sign of diabetic retinopathy in either eye
Characteristics of Different Types of Safety Lancets on Blood Volume and Perceived Pain in Male and Female Volunteers

The study was a randomized, single blind, uni-center pivotal study in male and female healthy volunteers, to determine capillary blood volume and pain perception obtained in a process of puncturing with different safety lancets.

A group of one hundred (100) healthy Caucasian male and female Subjects (aged \> 18 to \< 65 years old was randomized ) who were in good physical and mental condition. The Subjects had 4 (four) fingers (two fingers from each hand) lanced each with a different type of safety lancet. Overall, 4 (four) different safety lancets were investigated per each Subject.

Overall, 16 (sixteen) different safety lancets (4 different safety lancets per one Subject) were investigated, the capillary blood volume and pain were measured.


Eligibility Criteria:
Inclusion Criteria:

* Willing to sign the informed consent.
* Male and female volunteers.
* Age between 18 and 65 inclusive.
* Able to communicate well with the Investigator and comply with the requirements of the study.
* Volunteers who are in good physical and mental health.

Exclusion Criteria:

* Pregnancy or breastfeeding (self-reported).
* Confirmed or suspected malignant cancer History of poor blood circulation.
* Any skin condition on his or her fingers that prevents blood sampling.
* Anxiety with needles or finger pricks.
* Clotting disorders (including bleeding) in medical history.
* Neuropathy or other condition affecting sensation in the hands.
* History of blood borne infection (e.g., HIV, hepatitis B or C, syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, T lymphotropic virus Type 1, Creutzfeldt-Jakob disease).
* Currently participating in another study.
* History of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse.
* Intake of alcohol within 48 hours prior to the start of the study (self-reporting).
* Donation or loss of 400 mL or more of blood within 4 weeks prior to the start of the study.
* Any other condition that in the Investigator opinion may negatively influence Subject's participation in the study.
* Intake of medicines that affect blood coagulability (including anticoagulants such as vitamin K, antivirals and anticoagulants such as heparin, aspirin, thrombin inhibitors, vitamin K antagonists).
Abbott DBS Post-Market Study of Outcomes for Indications Over Time

The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.

ADROIT is an international, prospective, multicenter, observational, post-market study intended to collect worldwide long-term safety and effectiveness data on subjects implanted with market-released Abbott DBS systems in routine clinical practice.

Subjects will be followed for 5 years after the initial programming visit.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 180 days.
2. Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.

Exclusion Criteria:

1. Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.
2. Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
3. Study center is located in the United States, and indication for DBS implant is not Parkinson's disease or disabling tremor.
4. Study center is located in the United States, and the intended lead implant location is not at, or in close proximity to, the STN, GPi, or VIM thalamus.
GAUSS: A Study of Obinutuzumab (RO5072759) in Patients With Indolent Non-Hodgkin's Lymphoma

This study will investigate the efficacy of weekly intravenous obinutuzumab \[GA101 (RO5072759)\] monotherapy, in patients with relapsed CD20+ indolent Non-Hodgkin's Lymphoma. Patients will be randomized to receive either GA101 or rituximab, given as four weekly infusions. At the conclusion of the initial trial patients may be eligible to continue therapy up to 24 months. The anticipated time on study treatment is 3- 24 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age
* relapsed CD20+ indolent B-cell non-Hodgkin's lymphoma
* documented history of response of \>/= 6 months duration from last rituximab-containing regimen
* clinical indication for treatment as determined by the investigator
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

* prior use of any investigational monoclonal antibody within 6 months of study start
* prior use of any anti-cancer vaccine
* prior use of rituximab within 8 weeks of study entry
* radioimmunotherapy within 3 months prior to study entry
* Central Nervous System (CNS) lymphoma or evidence of transformation to high-grade or diffuse large B-cell lymphoma