cyrilzakka/clinical-trials huggingface dataset:
Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients

This is a multi-center trial for rasburicase in children at high risk of tumor lysis syndrome who have a history of asthma/atopy. The main purpose of this study is to establish the safety of this drug in patients with a history of asthma or severe allergies.

Because they were excluded from most of the clinical trials of non-recombinant urate oxidase and rasburicase, the safety of rasburicase in this population is not known, though preliminary data indicates that the drug is safe. The primary objective of this study is to estimate the proportion of grade 3 or 4 allergic reactions to rasburicase in patients with a history of asthma or severe allergy (to antigens other than rasburicase or other urate oxidases) treated with rasburicase for the prevention or treatment of malignancy or chemotherapy-induced hyperuricemia. Patients at risk of tumor lysis syndrome with a history of asthma/atopy will be treated with rasburicase according to standard practice and observed for allergic reactions.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of hematologic malignancy.
* Existing hyperuricemia or high risk of developing hyperuricemia of malignancy.
* The treating clinician plans to treat the patient with rasburicase. A patient is only eligible for RASALL if the clinician has already decided to use rasburicase. Rasburicase should not be given in order to make a patient eligible for this non-therapeutic observational study.
* No prior exposure to rasburicase or other urate oxidase.
* A history of asthma or significant allergy.

Exclusion Criteria

* Wheezing or an active hypersensitivity reaction at entry.
* Hypersensitivity to Aspergillus proteins.
Non-curative ESDs: Assessing the Rates and Risk Factors for Residual Neoplasia

Short and long outcomes of ESD are well described, particularly in Eastern series. However, the outcome of non-curative ESDs is scarcely reported in the west (particularly among non-gastric or submucosal lesions). Therefore, the aim of this project is to describe the European experience with non-curative ESDs, analysing all the consecutive ESDs performed in several reference centers, assessing the presence of residual lesion in the endoscopic follow-up or in the surgical specimen.


Eligibility Criteria:
Inclusion Criteria:

* All patients submitted to ESD due to neoplastic lesions of the gastrointestinal tract

Exclusion Criteria:

* Patients without endoscopic follow-up or surgery will be excluded from the analysis
Contribution of Multimodal Imaging in Early Coarctation

The CT-Coarct-PED study is a multicentred observational study aiming to describe the population of early coarctation during the last 10 years in South of France. The secondary objective is to assess the importance of cross-sectional imaging in the surgical management of aortic coarctation in the first year of life

Coarctation of the aorta is one of the most common congenital heart diseases (5 to 8%). This heart disease can clinically result in two major clinical presentation: a neonatal form, early and potentially severe, which will require urgent care. And a later form, the discovery of which may be fortuitous. Even in it neonatal presentation, aortic coarctation will not occur during the pregnancy. But the performance of prenatal screening makes it possible to predict a "risk of coarctation" based on criteria that have been clarified with practice and time. (hypoplasia of the left cavities, isthmus / canal ratio etc.) Surgically, there are multiple techniques that will take into account the anatomy of the aortic arch and whether or not it is hypoplastic, the associated heart defects and the patient's characteristics. The choice of this surgical technique is one of the predominant elements of the future prognosis of this heart disease (recoarctation, arterial hypertension, etc.) It is in this context that the contribution of multimodal imaging (echocardiography, angiography CT scan and cardiac MRI), can be a determining element in the choice made by the surgeon of the aortic plastic surgery technique, by detailing the anatomical but also hemodynamic specificities Despite the lack of technical difficulty in performing a cardiac ultrasound in a newborn or an infant, the use of a cross sectional imaging (as CT angiography) is common in order to obtain a more comprehensive assessment of the aortic arch using 2D or 3D reconstruction techniques.

However, current practices in terms of radiation protection encourage us to limit the irradiation of our patients especially if the are to be expose potentially repeatedly to radiation during their medical care.

Thus, this multicenter study aims to clarify the role of cross-sectional imaging in the surgical management of aortic coarctation in the first year of life

Eligibility Criteria:
Inclusion criteria:

* Patients \<1 years old
* Aortic coarctation in the first year of life
* Surgical management in one of the four participating centers
* No associated heart defect

Exclusion criteria

- age \> 1 years
Public Support for COVID-19 Test Allocation

In a randomized survey experiment, investigators will assess public support or opposition towards one of three potential government plans for allocating at-home coronavirus disease 2019 (COVID-19) tests to United States residents: 1) first come, first served; 2) a random draw; or 3) a random draw with 20% of tests reserved for disadvantaged areas. Investigators will also examine public attitudes surrounding other logistical and equity-related aspects of these allocation plans.

Complementing other efforts to increase access to COVID-19 testing in the United States, the federal government recently announced the purchase of 500,000,000 at home COVID-19 to be distributed for free "to Americans that want them". A central logistical element in matching supply with demand will be a website, on which people will register their interest in getting tests delivered to their home address. However, it is still unclear how supply will be matched with demand. Three main candidate options are first come, first served (FCFS), in which people are sent tests in the order in which they make requests; a random draw, such as a lottery; or a combination of a random draw with a guaranteed reserved amount for more disadvantaged populations. FCFS is a widely known and practiced rationing principle, but it has shown to exacerbate inequities in, for example, the allocation of vaccine appointments. Random draws can mitigate this impact, but, in the present context, might be insufficiently sensitive to the fact that not everyone has internet access, and that the need for testing is greater among more disadvantaged communities. Combining a lottery with a disadvantage reserve system using measures such as the CDC's Social Vulnerability Index is a practical way of promoting equity, and it was already used by the majority of US states in allocating vaccines. The main objective of this study is to assess public support for each of these three allocation plans and describe differences by demographic characteristics. Investigators will also assess public attitudes toward specific details of these allocation plans. The study, which is expected to take approximately 5 minutes to complete, will be administered as part of an omnibus online survey.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old or older, United States resident

Exclusion Criteria:

* None
Rosuvastatin/Amlodipine vs Atorvastatin/Amlodipine in Hypertension Patient With Dyslipidemia

This study is to Compare the Efficacy and Safety of Rosuvastatin/Amlodipine Combination Therapy Versus Atorvastatin/Amlodipine Combination Therapy in Hypertension patient with Dyslipidemia


Eligibility Criteria:
Inclusion Criteria:

* Both man and woman who is over 19 years old
* Patient with dyslipidemia and hypertension
* Written informed consent

Exclusion Criteria:

* Triglyceride ≥ 400 mg/dL at screening
* Hypertensive patients who need antihypertensive medication except Amlodipine, β-blockers, RAS inhibitors
* sSBP difference is ≥20 mmHg or sDBP difference is ≥10 mmHg
* A history of rhabdomyolysis, myopathy
* Patient with hypersensitivity to Statin or Amlodipine
* Patients undergoing eGFR \<30 mL/min/1.73 m2 (MDRD) at screening
* AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease
* Creatine kinase (CK) level ≥ 5x ULN (upper limit of normal range)
* Contraindications stated in the Label of Rosuampin or Caduet
* Those participating in other clinical trials for investigational products at screening
* Patients deemed to be ineligible to participate in the trial by investigator
Rectal Versus Oral Diclofenac Sodium in Relieving Post Episiotomy Pain

Current study aims to compare oral diclofenac sodium with it's rectal form for analgesia of pain after episiotomy.

* Episiotomy is a surgical incision of the perineum and the posterior vaginal wall.
* it can be done at a 60 degree angle from the vulva towards the anus or at an angle from the posterior end of the vulva.
* usually under local anesthetic and is sutured after delivery.
* It is done during second stage of labor to enlarge the opening for the baby to pass through to avoid soft-tissue tearing which may involve the anal sphincter and rectum.
* Perineal pain after episiotomy has immediate and long-term negative effects for women and their babies. These effects can interfere with breastfeeding and the care of the infant.
* Usually women undergo episiotomy need a good analgesic to overcome pain resulting from the analgesic.
* Previous study by Faiza shafi, Shazia sayed, Naheed bano, Rizwana chaudhri, Holy family hospital, Rawalpindi, Pakistan, The study was published in journal of Rawalpindi medical college and concluded that rectal diclofenac should be further promoted , for pain relief, in women following episiotomy.

Eligibility Criteria:
Inclusion Criteria:

1. age: 20:35 years.
2. Primigravidae as elective procedure.
3. face to pubis delivery.
4. Big baby.
5. Narrow pelvic arch.
6. Elderly primigravida.
7. old perineal scar as episiotomy or perineorrhaphy.
8. Manipulative delivery.
9. To cut short second stage cases such as pre eclampsia.
10. Premature baby.
11. Fetal distress.

Exclusion Criteria:

1. more than 35 years.
2. pelvic inflammatory disease.
A Study to Describe the Breast Cancer Patient Population, Treatment, and Results in Indian Patients Receiving Combinations of the Medicines Called Palbociclib for Advanced Breast Cancer

The purpose of this clinical study is to describe the patient population, breast cancer treatment, and breast cancer treatment results of adult female patients who have received palbociclib combination treatments for advanced or metastatic breast cancer in India.

There are two groups of patients this study will describe. The first group of patients will have received palbociclib in combination with aromatase inhibitor (as prescribed by the Physician) for the treatment of postmenopausal women with HR+/HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease. The second group of patients will have received palbociclib for the treatment of hormone receptor HR+/HER2- advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy.


Eligibility Criteria:
Inclusion Criteria:

* HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease
* Received palbociclib with aromatase inhibitor (as prescribed by the Physician) as initial endocrine therapy in postmenopausal metastatic breast cancer (MBC) patients or with fulvestrant in patients who have progressed on prior endocrine therapy
* Patients on Leutinizing Hormone Releasing Hormone (LHRH) agonists for ovarian function suppression in pre- or perimenopausal stage only if prescribed palbociclib with fulvestrant
* No prior or current enrolment in an interventional clinical trial for advanced/metastatic breast cancer
* Minimum of 3 months of follow up data since palbociclib with fulvestrant initiation, or minimum of 6 months of follow up data since palbociclib with aromatase inhibitor initiation

Exclusion Criteria:

* Cancers other than breast cancer
* Male breast cancer
* Visceral crisis
Phamacokinetics and Safety Profiles of DA-1229_01 2.5/500mg in Healthy Subjects at Fed State

This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01(2.5/500 mg x1 tablets) at fed state


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* BMI between 18 and 30 kg/m2
* Body weight : Male≥50kg, Female≥45kg

Exclusion Criteria:

* Allergy or Drug hypersensitivity
* Clinically significant Medical History
Comparison of McGrath Videolaryngoscope, Pentax Airway Scope and Macintosh Laryngoscope in Manikin by Novice

The purpose of this study is to compare the intubation time and success rate between videolaryngoscopes (McGrath MAC videolaryngoscope, Pentax Airway Scope) and Macintosh laryngoscope in tracheal intubation in a normal and cervical immobilized manikin by novice airway managers.


Eligibility Criteria:
Inclusion Criteria:

* nurse without experience in tracheal intubation

Exclusion Criteria:

* refusal to consent
Neighbourhood Team Development (NTD) Program

The purpose of this study is to evaluate the implementation and the effects of the Neighbourhood Team Development (NTD) Program, an innovative multi-component program that aims to provide resident centred care in long term facilities (LTC). As Canadians age, there is an increasing demand for LTC services. Older people residing in LTC homes and their families expect excellent care and services. However, literature and anecdotal evidence clearly indicate that LTC is not necessarily resident and family centred, nor are the care providers always collaborating as a team, thereby compromising the residents' quality of life.1-5 Residents with Alzheimer's Disease or Related Dementias (ADRD), who may have difficulty voicing their concerns, are at particular risk of receiving poor resident centred care.6,7 Decisions such as mealtimes in large dining rooms or early bedtimes are seldom in line with the residents' needs or wishes and add to the growing concern that the current LTC system is ill-designed and outdated. The NTD Program, designed by the investigators, aims to both enhance team development and resident centredness in LTC. The Program has three components, designed to modify the physical environment, the organization and delivery of services, and the alignment of staff members, to function independently and collaboratively in providing resident-centred care.


Eligibility Criteria:
* Long-stay resident, family member, or staff member in Schlegel Villages (chain of long-term care homes in Ontario, Canada)
* Able to obtain informed consent
Intracameral Gas SF6 (Sulfur Hexafluoride) Injection for Acute Hydrops in Keratoconus

Intracameral Gas SF6 (Sulfur Hexafluoride) Injection for Acute Hydrops in Keratoconus


Eligibility Criteria:
Inclusion Criteria:

* Hydrops

Exclusion Criteria:

* Age \< 18 years old
Pharmacokinetics and Safety of WAL2014 (Talsaclidine) Administered Orally to Healthy Adult Male Volunteers

Study to assess the pharmacokinetics and safety of WAL2014 capsules administered orally as a multiple dose to healthy adult male volunteers in double blind manner.


Eligibility Criteria:
Inclusion Criteria:

Subjects for the study are healthy male adult volunteers who meet all the inclusion criteria listed below and do not fall into the exclusion criteria.

1. Age: 20-30 years old
2. Body weight: 50-80 kg
3. Obesity index: within +/-20% of the standard body weight \[standard body weight = (height - 100) x 0.9\]
4. Those who have received screening examinations listed in Table 1 within one month prior to the start of the clinical study and have been judged as eligible by the investigator. Results of the simple test for gastric acidity are not used as the basis of the judgment.
5. Those who belong to volunteer members' association which has an office in Clinical Pharmacology Center, Ohsaki Clinic

Exclusion Criteria:

1. Those who have a history of allergic reaction or hypersensitivity to drugs
2. Those who have received any kind of drug(s) within one week prior to the administration of the investigational product.
3. Those who have ingested alcoholic drink within two days before the administration of the investigational product
4. Those who have been admitted to a hospital, undergone surgery or donated blood within 3 months before the administration of the investigational product
5. Those who have participated in a phase I clinical study of a drug which contains a new active ingredient or a similar study within 4 months before the administration of the investigational product
6. Those who participated in Phase I single dose study of the investigational product
7. Those who have a history of liver or renal disease
8. Those who are judged as ineligible for the clinical study by the investigator
Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver

The primary purpose of this study is to evaluate the efficacy of adefovir (ADV) in preventing de novo Hepatitis B in patients who receive Hepatitis B core antibody (HBcAb) positive grafts but who are not Hepatitis B Surface antigen (HBsAg) positive prior to transplant (Hepatitis B naive patients). The second objective is to evaluate the efficacy of accelerated vaccination with Hepatitis B in inducing innate immunity, thereby obviating the need for life-long antiviral therapy.

The investigators will conduct a prospective, open-label study of Hepatitis B naive patients who received HBcAb + livers and adefovir prophylaxis post-transplant. At one year to 18 months following transplantation, all study patients will then be vaccinated with standard Hepatitis B vaccine at double dose on a monthly basis for three months, at which point they will be tested for Hepatitis B surface antibody (HBsAb). Any study patients that have developed a sufficient antibody response (HBsAb \>500 IU) will be given the option to discontinue anti-viral treatment in a monitored setting.

Eligibility Criteria:
Inclusion Criteria:

* Recipients who do not have evidence of hepatitis B surface antigen, regardless of HBcAb and HBsAb status, who:

  1. received liver transplantation with hepatitis B core antibody positive (and HBsAg negative) grafts,
  2. received adefovir treatment post transplantation, and
  3. who have not reached the 18 month post transplantation time period.

Exclusion Criteria:

* Recipients with hepatitis B surface antigen positivity prior to liver transplant.
* Grafts from hepatitis B surface antigen positive patients.
* Previous intolerance to ADV therapy
* Recipients with pre-transplant creatinine \> 1.6 mg/dL
* Patients younger than 21 years of age
* Patients who are pregnant or breastfeeding
norUrsodeoxycholic Acid vs Placebo in PSC

Double-blind, randomized, multi-center, placebo-controlled, comparative, phase III trial. The study will be conducted with two treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d norursodeoxycholic acid capsules or placebo capsules for the treatment of Primary Sclerosing Cholangitis.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* verified PSC
* Liver Biopsy available for Review
* If pre-treated with UDCA Patient must be on stable dose not exceeding 20mg/kg/bw
* Patients with or without concomittant IBD

Exclusion Criteria:

* History or presence of other concomitant liver diseases
* Presence of Cholangiocarcinoma
* Secondary causes of Sclerosing Cholangitis
* Small Duct Cholangitis in the absence of large duct disease
* Any known relevant infectious disease
* Abnormal renal function
* Any active malignant disease
* Known intolerance/hypersensitivity to study drug
Effect of Hyaluronic Acid on the Therapy of Alveolar Osteitis

Alveolar osteitis (AO; syn. dry socket) is one of the most frequent complications following tooth removal and it is defined as presence of severe postoperative pain in and around the extraction site, which increases in severity at any time between one and three days after extraction, accompanied by a partially or completely disintegrated blood cloth within the alveolar socket, with or without halitosis, and at the same time excluding any other cause for the pain (Blum 2002). To enhance standard treatment of AO, which consists of curettage of the dry socket, rinsing with saline solution, and inducing bleeding from the exposed alveolar bone walls, numerous products have been tested. One of them is hyaluronic acid (HY). The aim of the present study is to investigate the potential effect of HY gel application in the treatment of AO. Specifically, the application of HY only (HY test group; n = 20) or the combination of HY and an absorbable collagen sponge (HY+C test group; n = 20) will be compared to standard treatment (blood clot; control group, n=20). Clinical and patient related outcome parameters will be recorded for up to 14 days after treatment. A more stable blood clot and thus improved wound healing with faster pain reduction is expected through the use of HY.


Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years;
2. Untreated AO after extraction of a permanent tooth (excluding wisdom teeth);
3. Diagnosis of AO based on the criteria of Blum (Blum 2002)

   Exclusion Criteria:
4. Patients with chronic diseases and/or taking any medication, influencing hard and soft tissue healing;
5. Pregnancy;
6. History of hypersensitivity or allergy to HY;
7. Inability to attend follow-up appointments; Intake of preoperative antibiotics.
A Common But Unknown Disease; Nave Sliding (NS)

The present study is a case series study, conducted to introduce a common disease of abdominal wall which has received less attention in scientific resources. The study population was all patients who following repeated hospital visits did not improve, and for their last try, they visited a traditional clinic, and were diagnosed with umbilical hernia.

Background: The present study is conducted to introduce a common disease of abdominal wall which has received less attention in scientific resources. In traditional medicine sources Some scholars believe that this condition occurs due to the movement of the abdominal muscle near the umbilicus or nave laterally movement of nave.

Design: A case series study Method: This study was a case series study. The study population was all patients who following repeated hospital visits did not improve, and for their last try, they visited a traditional clinic, and were diagnosed with umbilical hernia during a period of 5 months.

Eligibility Criteria:
inclusion Criteria:

* Clinical diagnosis of nave sliding
* Must be able to provide a complete health history information

Exclusion Criteria:

* unwillingness to continue
* any unexpected complication of traditional treatment