cyrilzakka/clinical-trials huggingface dataset:
Significance of an Elimination and Provocation Diet in Patients With Chronic Urticaria

Patients with chronic urticaria undertake a five week elimination diet (pseudoallergen free diet). The efficacy of the diet will be determined by symptom score, by the use of rescue medication (oral antihistamines and glucocorticosteroids) and by a Quality of Life Questionnaire on week 0 and week 5. All patients with sufficient response (regarding the urticaria score) enter a second dietary part over six weeks, whereas a provocation diet is carried out. Each diet week a choice of pseudoallergen rich food is added, sorted by the type of pseudoallergens (e.g. biogenic amines, organic acids, flavours, additives). This study is conducted to investigate if the provocation diet could be a new diagnostic intervention to elucidate clinical relevant pseudoallergens.

Chronic urticaria is defined as a daily or almost daily spontaneous occurrence of wheals that cause itching and lasting for at least six weeks. If there is no indication of a possible eliciting agent and because approximately 70% of patients benefit from it, a low-pseudoallergen diet should be carried out for 5 weeks. Although the low-pseudoallergen diet is successful, no explanation of the underlying mechanisms exists. On DBPC oral provocation testing with known food additives, only a small amount of patients, who experienced remission after a low-pseudoallergen diet react with new wheals and/or angioedema. For this discrepancy, natural food ingredients and new food additives are included in the dietary diagnostic. The high amount of substances, which are administrated within oral provocation testing can not reflect a realistic diet situation. Often it is impossible to ingest corresponding amounts of foods to reach the same concentration such as the provocation amount. Recording change reactions between food ingredients and the individual metabolism of the patients, the "step by step" food provocation method reveals itself to be most effective. In addition, individual predilections, amounts and frequency of ingested foods, are taken into consideration.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* chronic urticaria (duration: at least 6 weeks)
* patients who suffered from urticaria and/or angio oedema at least once a week for a duration of at least 4 weeks)
* Males and females, age between 7 and 80 years
* inpatients and outpatients
* oral antihistamines and glucocorticosteroids are allowed as concomitant medication (if needed)

Exclusion Criteria:

* pregnant or breastfeeding woman
* patients suffering from diabetes mellitus
* patients with cachexia
* known food allergies of food which will be administrated within the elimination diet (e.g. milk, cereals)
* isolated urticaria with known aetiology (e.g. physical urticaria, aquagene urticaria, urticaria factitia, cholinergic urticaria), Urticaria pigmentosa mastocytoses)
* patients, seemed to be uncompliant under suspicion of the investigator
Optimal Dosage of Caspofungin in Critically Ill Patients

Intensive care unit (ICU) patients are especially at risk for invasive candidiasis due to the presence of risk factors. It is known that in critically ill patients, alterations in function of various organs and body systems can influence the pharmacokinetics and hence the plasma concentration of a drug. A study of caspofungin in ICU patients has found a high inter- and intra-individual variability in caspofungin concentration. Factors that caused subtherapeutic caspofungin plasma concentrations were body weight \> 75 kg and hypoalbuminemia. Furthermore, an efficacy study showed a lower response rate for caspofungin among patients with a higher disease severity score.

As a result of the altered pharmacokinetics, under- or over-exposure of caspofungin can occur in critically ill patients and an adjusted dosage might be necessary in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Treatment with caspofungin.
* Admission to an ICU.
* Age ≥ 18 years.
* Suspected invasive candidiasis, established by the physician.

Exclusion Criteria:

* Blood sampling by central venous catheter or peripheral cannula not possible.
A Study to Describe Mothers' and Babies' Outcomes After Exposure to HyQvia During Pregnancy

The main aim of this study is to provide further information on the safety profile of HyQvia during pregnancy. This will be done by checking the characteristics of the mother and their babies. They will also be checked for any safety outcomes that will occur when exposed to HyQvia during pregnancy.

This is a non-interventional, retrospective, case series of commercially insured pregnant women exposed to HyQvia during their pregnancy identified according to the MarketScan Research Database. This study will assess maternal characteristics, patterns of HyQvia utilization and pregnancy outcomes in all pregnancies exposed to HyQvia during pregnancy.

This study will enroll approximately at least 7 patients based on feasibility assessment. Participants will be enrolled in the following cohort:

• HyQvia

This study will have a retrospective data collection from 1 January 2014 to 31 December 2020. This study would be conducted in the US.

The overall time for data collection in this study will be approximately 7 years.

Eligibility Criteria:
Inclusion criteria • Exposed to HyQvia in the etiologic window defined as 90 days prior to the LMP until the end of pregnancy.

Exclusion criteria

• NA
Sensory Processing Associated With Motor Skills

In the study, sensory processing skills of 1-year-old preterm and term children will be evaluated. The relationship between sensory processing skills and gross and fine motor development will be investigated.


Eligibility Criteria:
Inclusion Criteria:

Premature group: Healthy children with a gestational age below 34 weeks Term group: Healthy children with gestational age between 37-41 weeks

Exclusion Criteria:

they had major congenital malformations, had genetic or chromosomal abnormalities, had known metabolic disorders, or had seizures.
Safety, Pharmacokinetics, and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab (BGB-A317) in Participants With Advanced Solid Tumors

This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BGB-B167 monotherapy and in combination with tislelizumab (BGB-A317) in participants with select advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors previously treated with standard systemic therapy or for whom treatment is not available, not tolerated, or refused, or not expected to provide significant clinical benefit or be tolerated in the medical judgement of the investigator
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
* Adequate organ function as indicated by laboratory values during screening or ≤ 7 days before the first dose of study drug(s)

Exclusion Criteria:

* Active leptomeningeal disease or uncontrolled, untreated brain metastasis
* Active autoimmune diseases or history of autoimmune diseases that may relapse
* Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
* History of severe hypersensitivity reactions to other monoclonal antibody products or their excipients
* Women who are pregnant or are breastfeeding

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Early Versus Delayed Operation for Perforated Appendicitis

The objective of this study is to scientifically evaluate two different operative strategies for perforated appendicitis with abscess.

The hypothesis is that the increased difficulty of early operation is balanced by the immense patient investment with delayed operation.

This will be a single institution, prospective, randomized clinical trial involving patients who present to the hospital with perforated appendicitis with abscess. This will be a pilot study.

Power calculations are not used for a pilot study. One group will undergo a primary laparoscopic appendectomy. The other group will receive intravenous antibiotics with drainage if possible and a laparoscopic appendectomy 10 weeks after initiation of treatment at presentation. All 7 general pediatric surgeons will be involved with the operations, who are all comfortable with these management arms. The surgeon will not induce a significant confounding variable into this study. The laparoscopic appendectomy is approached in the same manner by all members of our group. Those named on the form are qualified by the IRB to obtain consent and/or will be accountable for overseeing the study.

Both groups will have the same antibiotic regiment. All data will be analyzed on intention-to-treat basis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with perforated appendicitis and an abdominal abscess diagnosed on CT scan.
* Children of any age will be included.

Exclusion Criteria:

* Patients with immune deficiency
* Another condition affecting surgical decision making or recovery (e.g. hemophilia, severe cardiac or respiratory co-morbidities).
* Acute sepsis or severe pain from perforation not allowing for delayed management.
Intensive Interdisciplinary Treatment Program for Individuals With Stroke-Induced Aphasia

An intensive, interdisciplinary treatment program was administered during the summer as part of regular clinic services in the Aphasia Resource Center (ARC) at Sargent College. This program was run program as described for three years. Not more than six native English speakers with mild or moderate profiles of aphasia and multidisciplinary rehabilitation needs (OT,PT, SLP and nutrition) were recruited from the Boston community to participate in an intensive interdisciplinary treatment program for four weeks during the month of June 2013. The program consists of approximately six hours of interdisciplinary treatment each day, five days per week over a four-week interval. Treatment is individualized using current evidence-based treatment approaches, which are commonly accepted protocols in clinical practice and will be administered by clinical faculty and staff from Speech-Language and Hearing Sciences, Occupational Therapy (OT), Physical Therapy (PT), the Center for Neurorehabilitation and Nutrition. Segments of these types of treatments are available for a small fee as part of our service in the Aphasia Resource Center; however, this comprehensive, interdisciplinary program is not available of this research study.

Approximately 30 hours of therapy per week are provided -- 6 hours per day over 5 days consisting of Speech-language Pathology, Physical Therapy, Occupational Therapy, and Nutrition Counseling.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild or moderate profile of aphasia secondary to a single stroke, as diagnosed by a certified speech-language pathologist.
* Must be able to demonstrate auditory comprehension at a level that is functional for conversation.
* Must demonstrate mobility or sensory deficits as a result of the stroke.
* Must demonstrate cardiac/nutritional needs.
* Must be able to ambulate without the physical assistance of another person for at least 500 feet.
* Must be able to negotiate elevator and stairs independently
* Must be able to manage bathroom needs without assistance.
* Must be more than twelve months post-onset of stroke.
* Must be between 18 and 75 years of age.
* Must be native speakers of English
* Must have 8th grade level of education or higher.
* Must have adequate vision for functional reading
* Must have adequate hearing for conversation

Exclusion Criteria:

* Subjects who meet the above inclusion criteria, but who are also bilingual, and/or have concomitant neurological disease will be excluded from the study.
LifE Style, Nutrition and Oral Health in Care Givers (LENTO)

The LENTO study sample includes the caregivers and their clients living in eastern Finland. The aims of this study are

1. to study the nutritional status, oral health, coping, functional capacity and quality of life
2. to find out how individual nutrition and oral health counseling received for caregivers affect on the nutritional status and oral health of caregivers and their clients
3. develop an operating model to maintain good nutrition and oral health.

In Finland, the aim is to reduce the institutional care of older people and caring them in their own homes. The goal of shifting the focus of services to open services is difficult to implement if the health of the caregivers is inadequate. In order to achieve this goal, it is important to influence the health and performance of caregivers. Information is needed to support this, among others, about how the nutrition and oral health of caregivers can be promoted and to what extent this affects the performance and quality of life of their clients. A randomly of 220 caregivers over 65 years old and their clients is selected for this study. The caregivers are randomized to either treatment or control groups. At the beginning of the study is estimated the nutritional status and oral health of the caregivers. Based on the results, the nutritionist and dental hygienist give individual advice to optimize the nutrition and oral health of the caregivers in the intervention group. After six months, the same measurements are made as at the beginning of the study. Monitoring measurements will be made one year after the start of the intervention. The results of this project provide information on the health, well-being, and ability to the function of the caregivers. Based on the results, is developed an operating model that is intended to be wide as use as possible. Improving the nutrition and oral health of caregivers has a significant impact on their own and their clients health and well-being as well as the long-term care costs presumably.

Eligibility Criteria:
Inclusion Criteria:

* caregivers who have a caregiver´s contract valid on 1 January 2019
* care recipients living at home

Exclusion Criteria:

* in terminal care
Bedside Respiratory Patient Monitoring System - Sensor Off Study

Use of an investigational oximetry system to evaluate the triggering of the "sensor off" status with the marketed off-the-shelf sensors.

The Multi-functional Patient Monitoring PCBA is an electronic circuit board in the monitoring system that performs calculations.

The study will evaluate the performance of the Sensor Off New Patient Monitoring system by exposing the sensor to an ambient light source, sensor slipping off the finger with the light emitter and detector facing each other or a sensor slipping off under a blanket.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 years or older (inclusive)
* Subject is able to participate for the duration of the study
* Subject is willing to sign an informed consent

Exclusion Criteria:

* Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors.
* Physiologic abnormalities that prevent proper application of pulse oximetry sensor.
* Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine

The purpose of the study is to evaluate the immunogenicity and safety of Poliorix™ when administered to healthy Chinese infants at 2, 3 and 4 months of age.


Eligibility Criteria:
Inclusion Criteria:

* A male or female infant between, and including, 60 and 90 days of age at the time of the first vaccination.
* Born after a gestation period of 36 to 42 weeks inclusive.
* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (LAR) (s) can and will comply with the requirements of the protocol.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with exception of DTP, Hib and/or hepatitis B vaccine(s).
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Evidence of previous or intercurrent poliomyelitis disease or vaccination.
* History of seizures or progressive neurological disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
* Major congenital defects or serious chronic illness.
* Child in care.

The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved and if no other exclusion criteria are met:

• Current febrile illness or axillary temperature \> 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Checkpoint Blockade Immunotherapy Combined With Stereotactic Body Radiation in Advanced Metastatic Disease

The purpose of this study is to determine whether stereotactic body radiation therapy (SBRT) combined with checkpoint blockaded immunotherapy (CBI) will improve the response to the anticancer treatment compared to CBI alone in patients with advanced metastatic cancer.

Patients who will receive anti-PD-1/PD-L1 immunotherapy with at least 1 site of measurable metastatic disease which will not be irradiated will be candidates for the study. Patients will be randomized (1:1) to CBI combined with SBRT or CBI alone. SBRT at 9.5Gy x3 fractions will be delivered within 1-21 days of the start of first cycle of CBI. The first six patients will be treated and observed for toxicity in the safety run-in phase for 30 days after radiation before continuing with further accrual. Radiation dose reduction is allowed if necessary to meet tissue constraints (6Gyx3 Minimum Dose). Response rates will be determined from the non-irradiated lesion/lesions. Blood draws will be obtained to analyze anti-tumor immune responses.

Eligibility Criteria:
Inclusion Criteria:

* Patient has one lesion that is treatable with SBRT.
* Patient has at least 1 site of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria on computed tomography (CT) or Magnetic resonance imaging (MRI) which will not be irradiated.
* Histological confirmation of malignancy (primary or metastatic tumor).
* Patient may have any prior therapy allowed aside from having had prior radiotherapy to the treatment site.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Patient's screening laboratory values must meet protocol limits.
* Patient must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patient has had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
* Patient receiving any investigational or experimental agents other than immunotherapy.
* Patient who has had any prior radiotherapy to the treatment site(s).
* Patient is a pregnant woman (pregnant women are excluded from this study because radiation treatment has known potential for teratogenic or abortifacient effects).
* Patient refuses to sign informed consent.
Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer

Advanced epithelial ovarian cancer has high morbidity and mortality. Patients presenting with advanced stage ovarian cancer often have cancer spread to regional lymph nodes. Imaging strategies to depict involved lymph nodes are currently not successful. The purpose of this study is to evaluate if magnetic resonance imaging (MRI) with gadofosveset trisodium contrast enhancement (GDF-MRI) and diffusion weighted imaging (DW-MRI) is able to identify involved lymph nodes in a preoperative setting. This could guide the surgeon during surgery to dissect lymph nodes which could lead to an optimal diagnosis/staging with the lowest possible morbidity. We want to determine the optimal imaging settings and feasibility of MRI for the detection of pathological lymph nodes in women with advanced (FIGO stage IIB-IV) ovarian cancer undergoing primary debulking surgery and compare this to conventional imaging with computer tomography (CT).


Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant female
* Expected FIGO stage IIB-IV epithelial ovarian carcinoma
* Scheduled for primary debulking surgery
* Written informed consent
* At least 18 years of age.

Exclusion Criteria:

* Patients estimated to have more benefit from neoadjuvant chemotherapy
* Ineligibility to undergo MRI

  * Non-MR compatible metallic implants or foreign bodies (ferromagnetic aneurysm clip, pacemaker, neurostimulation system, etcetera).
  * Claustrophobia
* Ineligibility to receive gadofosveset contrast (history of contrast allergy,

  * History of a prior allergic reaction to the active substance or to any of the excipients of Ablavar™.
  * Impaired kidney function (Glomerular Filtration Rate \<30 ml/min/1.73m2).
* Previous para-aortic or pelvic lymphadenectomy
* History of a malignant tumour.
* Pregnant or lactating patients. Incapacitated subjects