cyrilzakka/clinical-trials huggingface dataset:
Rare Tumours in Children and Adolescents (STEP)

The aim of the STEP registry is to collect and evaluate experience and data on the diagnosis and treatment of rare childhood tumors in order to use the knowledge gained to improve the treatment prospects for our patients. The rarity of a disease should not be a disadvantage for the young patients.

The objective of the STEP registry is to optimise the diagnosis and treatment of patients with rare tumour diseases in childhood and adolescence. Therefore, a continuous prospective collection of clinical data on rare paediatric tumours is conducted to improve the understanding of these tumours. Beyond analysis of clinical data, further scientific research on the biological and molecular genetic characteristics of these tumours is performed. These data and a close collaboration with international partners, especially the European EXPeRT group, enable the improvement of treatment recommendations for these tumours along with establishment a global interdisciplinary network of rare tumour specialists.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a rare solid tumor
* Age at diagnosis: Neonatal period to 18 years (In the case of young adults, registration in the database and/or referral to advisory contact persons within the framework of the competence network can take place upon request and after declaration of consent.)
* Information, education, written consent of the patient or the guardian
* Not recorded in any of the existing clinical studies/ registers of the German Society for Pediatric Oncology and Hematology (GPOH)

Exclusion Criteria:

* Registration of the tumor diagnosis in a prospective therapy study/ another clinical registry of the GPOH
* Lack of information, explanation and/or written consent of the patient or the legal guardian.
How Infant Diets Would Affect Growth in Early Childhood

The investigators research group conducted a feeding study in 2012 (IRB 07-0003) that included breastfed infants consuming different infant solid foods. The investigators results showed that different solid foods, especially the protein content of the food, is important on infant's gut bacteria profile and growth. Although the first year of life is critical in obesity development later in life, data are very limited on the effect of protein from solid foods, an important component of infant diet, especially in breast-fed infants. In this study, the investigators will re-contact these participants, who are now in their early childhood (\~5 years old), to evaluate the long-term effect of various macronutrient quantities in solid foods, by assessing the participants' growth, body composition, and gut bacteria profile.


Eligibility Criteria:
Inclusion Criteria:

* Those participants who completed the initial trial when they were infants.

Exclusion Criteria:

* None
Evaluation of Oxygenation Parameters in Patients Undergoing Rhinoplasty Under General Anesthesia

The investigators are planning to compare the oxygenation values (Pao2/fio2, lactate etc.) in patients who underwent TCI and inhalation anesthesia in rhinoplasty operation.

Total intravenous anesthesia (TIVA) is a common anesthesia method used today as an alternative to inhalation anesthesia. Loss of consciousness is two important components of general anesthesia, in order to give the patient safe analgesia and not to remember any adverse events related to the operation. While the depth of anesthesia can be controlled by monitoring the minimum alveolar concentration (MAK) in the ventilator devices in the operating room we use modernly, there was no more objective method than measuring the plasma level of drugs in intravenous anesthesia. The schemes created by the anesthetists according to plasma drug levels were used when administering total intravenous anesthesia. Target Controlled Anesthesia (TCI) devices, on the other hand, are pumps that have been used more frequently recently and that can deliver the required blood concentration of a drug in bolus and infusion form according to pharmacokinetics models calculated with personal data. In TCI anesthesia, intravenous infusion of anesthetics provides a more stable drug concentration in the plasma and at the site of action compared to repeated bolus techniques. Thus, it is ensured that the drug remains in the therapeutic range, avoiding the consequences such as over- or under-administration of the drugs. The subject of the study is to determine which of the 2 routinely used methods in rhinoplasty operations affects respiratory functions less.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years and younger than 60 years of age who will be operated under general anesthesia
* Patients in I, II risk groups according to the American Society of Anesthesiologists (ASA) classification

Exclusion Criteria:

* ASA III and above patients
* Patients for whom Intensive Care Unit (ICU) indication is prescribed
* Chronic obstructive pulmonary disease
* Having a personal or family history of malignant hyperthermia,
* morbid obesity
* Alcohol or drug addiction
* Have a history of liver or kidney disease
* Coronary artery disease or heart failure
* Anemia
* Hemoglobinopathy
* Sepsis
EBV-Tscm Cytotoxic T Cells (CTLs) for EBV- Driven Lymphomas/ Diseases

In this multi-center open-label, non-randomized phase I/II intervention study three consecutive doses of donor-derived EBV Tscm-CTLs will be administered to 10 patients with treatment-refractory EBV lymphoma, diseases or PTLDs. EBV Tscm-CTLs will derive from hematopoietic cell transplant (HCT) or third-party donors.

Epstein Barr virus (EBV)-driven lymphomas and diseases are associated with poor prognosis. EBV proteins are recognized by T cells providing opportunities for EBV-specific T-cell therapy. Recent findings show that early differentiated T cells (T memory stem cells, Tscm) improve the prognosis in chronic viral diseases and are associated with effective tumor cell killing in melanoma patients. Tscm might be superior to highly differentiated T cells because of their longevity, robust proliferative potential, and capacity to reconstitute a wide T-cell receptor (TCR) diversity. This project will test the hypothesis that Tscm are efficacious for EBV-specific T-cell therapy. Clinical-grade enriched EBV-specific Tscm-CTLs will be prepared and used to treat patients with primary EBV lymphomas, diseases or post-transplant lymphoproliferative disease (PTLD) with limited other treatment options.

Eligibility Criteria:
Patients' inclusion criteria:

* Group A: Patients with EBV driven lymphomas (e.g., NK/T-cell lymphoma), with EBV complications (e.g. HLH, CAEBV) or patients with primary immunodeficiency disorders with high risk for EBV complications (e.g. SCID) with planned allogeneic HCT
* Group B: EBV-driven PTLD that develop after a HCT or SOT

For both groups:

* All age groups
* Negative pregnancy test in female patients of childbearing potential.
* Signed written informed consent of patient or/and parents

Patients' exclusion criteria:

* Patients receiving anti-thymocyte globulin or Campath within 28 days of infusion
* Patients with active, acute GvHD grades III-IV
* Previous severe reaction to dimethylsulfoxide (DMSO)

Donors' inclusion criteria:

* EBV positive serology (VCA and Epstein-Barr nuclear antigen (EBNA) immunoglobulin G (IgG) positive)
* Detectable interferon (IFN)-y-secreting T cells (\>100 SFC/10e6 PBMC) measured by Elispot to the EBV consensus peptide pool
* Suitability for blood or HCT donation meeting requirements of local institutional guidelines
* An informed consent for EBV Tscm CTL manufacturing
* Age \> 18 years

Donors' exclusion criteria:

* Detectable IFN-y-secreting T-cells \<100 spot-forming cell (SFC)/10e6 PBMC measured by Elispot to EBV select
* Unwilling and/or unable to donate, according to the donor center
Efficacy of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders

To assess the effect of a probiotic product, when co-administered with antibiotics, on gastrointestinal symptoms following antibiotic treatment in children.


Eligibility Criteria:
Inclusion Criteria:

* Children at the age of 1-11 years that have been prescribed antibiotic treatment.
* Problems with loose stools during earlier antibiotic treatments.
* Children whose parents or legal caregivers have signed the informed consent to participate in the study.

Exclusion Criteria:

* Chronic intestinal disease, immunodeficiency or immunosuppressive treatment.
* Chronic or acute diarrheal disease.
* Use of laxatives the week before inclusion in the study.
* Antibiotic treatment for the last four weeks before inclusion in the study.
* Intake of probiotic products for the last two weeks before inclusion in the study.
* Known hypersensitivity to any of the ingredients in the probiotic product or the placebo (potato starch ± bacterial culture that may contain traces of soy).
* Patient requiring hospitalisation.
mFit: The Mobile Fitness Project

BACKGROUND: The nascent field of mobile health (mHealth) is expanding with impressive speed. In March 2012, experts estimated that 40,000 health related smartphone applications were on the market but little is known about the effectiveness of these programs. To our knowledge, no studies have evaluated whether weight loss can be successfully achieved through use of a smartphone application or how these applications could be used in primary care practice.

PURPOSE: To evaluate the effectiveness of a popular, free smartphone application for weight loss and calorie counting in a primary care setting.

METHODS: The first phase of this study involved a community based participatory approach to select the intervention. Patient focus groups were conducted and analyzed to explore patients' preferences regarding various text-message versus smartphone programs. The second phase of this study, described here, will be a randomized controlled trial with overweight primary care patients exposed to one of two conditions for 6 months: (1) usual care; (2) usual care plus smartphone application, which includes instructing participants on how to use the application and encouraging them to use the applications' reminders and social networking features. The primary outcome of interest is weight change at 3 and 6 months. Two-sample t-test or Wilcoxon rank sum test will be used to compare weight change between groups, as appropriate. ANCOVA models will be used to examine weight change after adjusting for covariates such as education, sex and age. Repeated measures analysis will be carried out to compare weight change between the groups using baseline, 3 month and 6 month data. In addition to an intent-to-treat analysis, the investigators will also conduct a "treatment received" analysis, adjusting for the extent of application use in both the intervention and control arms.

CONCLUSIONS: This study will demonstrate whether a smartphone application introduced in primary care settings and incorporated into the visit can produce weight loss. Study findings could inform a national discourse on the value of smartphone applications in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* primary care patient at UCLA Family Health Center or 16th Street Internal Medicine
* age 18 or older,
* English speaking,
* BMI \> 25,
* interested in losing weight,
* smartphone ownership,
* valid email address.

Exclusion Criteria:

* current, planned or previous pregnancy within 6 months,
* currently using a smartphone app for dieting,
* hemodialysis,
* terminal illness
Interleukin-2 in Treating Patients With Mycosis Fungoides or Sezary Syndrome

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill lymphoma cells.

PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides or Sezary syndrome.

OBJECTIVES:

* Determine the response rate in patients with mycosis fungoides or Sezary syndrome treated with interleukin-2 (IL-2).
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive interleukin-2 subcutaneously for 4 consecutive days a week for 6 consecutive weeks. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response or stable disease continue treatment for 2 courses past best response. Patients who demonstrate a persistent partial response continue treatment in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 15-35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven mycosis fungoides or Sezary syndrome

  * Any stage
* Measurable disease with 1 or more indicator lesions

  * Evaluable disease for erythrodermic patients only
* At least 2 weeks since prior therapy, if documented progressive disease (PD)
* At least 4 weeks since prior therapy, if best response achieved without clear evidence of PD

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* WBC at least 3,000/mm\^3
* Absolute granulocyte count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 2.2 mg/dL

Renal:

* Creatinine no greater than 2.0 mg/dL

Cardiovascular:

* No New York Heart Association class III or IV heart disease
* No cardiac pacemaker
* No clinically significant peripheral venous insufficiency

Other:

* No other malignancy within the past 5 years except:

  * Treated squamous cell or basal cell skin cancer
  * Treated carcinoma in situ of the cervix
  * Surgically treated other cancer
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection
* HIV negative
* No poorly controlled diabetes mellitus

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* No concurrent steroids

Radiotherapy:

* See Disease Characteristics
* No concurrent radiotherapy

Surgery:

* Not specified

Other:

* No other concurrent proven or investigational antineoplastic therapy
A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma."


Eligibility Criteria:
Inclusion Criteria:

* Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.
* Measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1, or 2
* Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug

Exclusion Criteria:

* Prior development of disease progression during high-dose dexamethasone containing therapy
* Pregnant or lactating females
* The development of a desquamating rash while taking thalidomide
* Use of any standard/experimental anti-myeloma therapy within 28 days of randomization or use of any experimental non-drug therapy within 56 days of initiation of drug treatment
* Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm3
* Laboratory abnormalities: Platelet count \< 75,000/mm3
* Laboratory abnormalities: Serum creatinine \> 2.5 mg/dL
* Laboratory abnormalities: Serum Serum glutamic oxaloacetic transaminase (SGOT)/Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine aminotransferase (ALT) \> 3.0 x upper limit of normal
* Laboratory abnormalities: Serum total bilirubin \> 2.0 mg/dL
* Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for ≥ 3 years.
The Effect of "Eye Drop Guide" on the Success Rate of Eye Drops Self-instillation in Glaucoma Patients

To investigate if the Eye Drop Guide more effective than carefully instructed routine technique for chronic glaucoma patients to self-instill eye drops.

And what factors are associated with the failure of self-instillation eye drops with the Eye Drop Guide?

The participants are randomized into 2 groups. For group I; the participants will be instructed to use the Eye Drop Guide first while for group II; the participants will be instructed to use the routine self-instillation technique first. The instruction will be given to all participants by the same investigator. The participants are allowed to practice until confidence in the techniques to which they are assigned. The participants then are instructed to use only that technique to instill eye drops in both eyes every day and keep the diary to document the date, time of practice, and number of bottles use in each eye for practice at home. The investigators make a telephone visit at 1 week to remind the practice routine and the follow up schedule. The 2 week follow up will be scheduled to evaluate the self-instillation performance using the techniques to which they are assigned by the VDO recordings under the same setting as Day 1.

After VDO recordings the participants will be switched to receive the other technique with the same instruction as the other group. Allow the same period of practice in the hospital and at home. The investigators again will make a 1-week telephone visit and 2-week follow up after self-practice at home. At week 4 the VDO recordings of self-instillation performance will be taken again under the same setting as previous records.

Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed of chronic glaucoma for 3 months or longer
* Age of 18 years or over
* Self-administer eye drops regularly

Exclusion Criteria:

* Perioperative patients
* Patients who were blind from other diseases
* Patients with ophthalmic conditions that affect the eye drop instillation e.g. nystagmus, ptosis, exophthalmos, enophthalmos, microphthalmos, symblepharon, restrictive ophthalmoplegia
* Patients whose underlying conditions would affect the patient's adherence to the protocol e.g. dementia, psychosis, mental retardation, neurological conditions resulting in tremor or paralysis, rheumatoid arthritis, hand deformities
* Patients who are allergic to artificial tears eye drop
* Patients who are not able to return for the follow-up schedule
High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth

This is a study to investigate whether it is feasible to conduct a randomized controlled trial (RCT) of a high dose of oxytocin versus the standard low-dose oxytocin. Further the investigators, aim to assess whether there are differences in health outcomes between both arms of the study.

Due to risks of postpartum hemorrhage, defined by the American College of Obstetricians and Gynecologists, as an estimated or quantitative blood loss of greater than 1000 milliliters, uterotonics, or medications aimed at increasing uterine tone and reducing blood loss at the time of birth, are commonly administered. Based on a Cochrane network meta-analysis, most organizations endorse the administration of 10 international units (IU) of oxytocin during delivery. However, the World Health Organization specifies that during a cesarean birth, the 10 IU should be administered using a bolus dose and an infusion, though an optimal infusion rate has yet to be agreed upon.

The use of a higher rate of oxytocin may confer a reduction in overall blood loss and subsequent maternal health outcomes (e.g., postoperative anemia, hypotension) and healthcare resource utilization (e.g., need for additional uterotonics and surgical procedures to control bleeding, administration of blood products). However, it is unknown whether it is feasible to conduct a randomized controlled trial to investigate the use of high (i.e., oxytocin rate of 900 mL/hr immediately after the delivery of the placenta) versus low-dose oxytocin (i.e., 300 mL/hr for planned cesarean births or 600 mL/hr for intrapartum cesarean births).

Eligibility Criteria:
Inclusion criteria.

* Age 18 or greater
* English or Spanish speaking
* Individuals undergoing a scheduled or unscheduled cesarean delivery

Exclusion criteria

* Patient on therapeutic anticoagulation
* Patient with hypertensive disorder of pregnancy or chronic hypertension
* Patient with preexisting bleeding disorder
* Patient with preexisting cardiac disease
* Patient with severe asthma, defined as the need for two or more agents for disease control, or bronchospasm
* Patient undergoing planned cesarean hysterectomy
Effectiveness of Kaltenborn End Range Joint Mobilization Technique and Post FacilitationStretch in Shoulder Impingement Syndrome

This study is a experimental one to observe the efficacy of joint mobilization and post facilitation techniques in shoulder impingement syndrome

his study is a experimental one to observe the efficacy of Kalternborn end range joint mobilization and post facilitation techniques in shoulder impingement syndrome. Goniometer, shoulder disability index will be the tool used for evaluation

Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* Age 25 to 45
* Diagnosed Rotator cuff impingement from ortho, neuro and musculoskeletal department
* Hawkin kennedy test positive
* Neer's test positive
* Jobe's test positive

Exclusion Criteria:

* Cervical spine disorder
* Fractures
* Major upper limb surgery
* Tumor or wound
* Diagnosed acromial malformations