cyrilzakka/clinical-trials huggingface dataset:
GM-CSF and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma

RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving GM-CSF together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.

OBJECTIVES:

Primary

* Evaluate the clinical efficacy of sargramostim (GM-CSF) and rituximab, in terms of overall objective complete and partial response rates, in patients with previously untreated follicular non-Hodgkin lymphoma.

Secondary

* Evaluate the time to progression in patients treated with this regimen.
* Evaluate the overall survival of patients treated with this regimen.
* Evaluate the duration of response in patients treated with this regimen.
* Evaluate the safety profile of this regimen in these patients.
* Evaluate the influence of FcγR polymorphisms on clinical response.
* Monitor FcγR-expressing cells in peripheral blood during treatment.
* Monitor the molecular biological marker bcl2 \[t(14;18)\] in peripheral blood and bone marrow.

OUTLINE: This is a multicenter study.

* Induction therapy: Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-5 and rituximab IV on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
* Maintenance therapy: Patients receive GM-CSF SC on days 1-5 and rituximab IV on day 1. Treatment repeats every 8 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Blood and bone marrow samples are collected at baseline and periodically during study for analysis of bcl2 rearrangement by PCR assay; FcγR expression by immunophenotyping; and FcγR polymorphisms.

After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for up to 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically and immunophenotypically confirmed CD20+ follicular lymphoma according to WHO classification

  * Grade 1-3a disease
  * Stage II-IV disease
  * Non-bulky disease
* Must have undergone initial nodal biopsy within the past 4 months
* At least 1 measurable lesion
* Low tumor-burden, as defined by the following GELF criteria:

  * Nodal or extranodal tumor mass (diameter \< 7 cm)
  * No systemic B symptoms
  * No increased LDH and β2 microglobulinemia
  * No substantial splenic enlargement
  * No serous effusion
  * No compression syndrome

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active hepatitis

PRIOR CONCURRENT THERAPY:

* No prior treatment, including steroids and radiotherapy
Migraine and Infertility

The purpose of this study is to determine the prevalence of migraine in infertile women and during in Vitro Fertilization protocol. Migraine is two to three times as common in women as in men. Migraine has considerable impact on quality of life. In Vitro Fertilization has become a common therapeutic modality in modern fertility medicines. Treatment protocols are associated with exaggerated hormonal fluctuations. Estrogen is considered to be closely linked to migraine and its fluctuations have been considered to trigger migrainous headaches.

In Vitro Fertilization has become a common therapeutic modality in modern fertility medicines. Treatment protocols are associated with exaggerated hormonal fluctuations. Estrogen is considered to be closely linked to migraine and its fluctuations have been considered to trigger migrainous headaches.

Both migraine and infertility are associated with impaired quality of life.

Objectives: to assess the prevalence of migraine in infertile women and during in Vitro Fertilization protocol in order to improve the management of these patients.

Protocol:

Women coming to consult at the Port Royal infertility center and meeting the inclusion (infertile women without long-term analgesic treatment) criteria will be offered the study. The information note and no objection form will be given by the gynecologist receiving them for consultation. After collecting their non-opposition, a self-questionnaire will be given to them. This questionnaire is validated in the literature concerning the diagnosis of migraine. It includes questions about medical history and possible headaches. The patient fills it immediately and gives it to the investigator. As part of the usual management, and regardless of their answers to the questionnaire, some of the patients will be reviewed in consultation for the programming of an IVF. During this "incoming" consultation with one of the midwives of the unit, a schedule of migraine headaches will be given to the patients. They will keep it, will complete it in case of migraine, and will give it to the gynecologist during the embryo transfer or the doctor receiving the couple in consultation on day 7 in case of absence of embryo transfer.

Eligibility Criteria:
Inclusion Criteria:

* infertile women supported in reproductive medical assistance at the Port Royal infertility center
* aged between 18 and 40 years old

Exclusion Criteria:

* long-term analgesic treatment
* women under guardianship or curatorship
Understanding Public Attitudes Towards the COVID-19 Vaccination

The objective of this study is to better understand public attitudes towards coronavirus disease 2019 (COVID-19) vaccination. This understanding will inform the development of community engagement strategies to be used in future interventions and studies aimed at addressing factors that impact the disproportionate burden of COVID-19 in under-served and vulnerable communities.

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly instigated a global pandemic. As of this writing, there are more than 33 million documented cases of infection in the United States (US). Furthermore, in the US, COVID-19 has disrupted the economy, overwhelmed the healthcare system, led to widespread school cancellations, and caused more than 595,000 deaths since March 2020.

The availability of three highly effective vaccines against COVID-19 within a year of the start of the pandemic is an extraordinary achievement and cause for great optimism. However, a significant proportion of adults in the U.S. have not accepted vaccination against COVID-19. Efforts are needed to identify effective messages and communication strategies to overcome COVID-19 vaccine hesitancy.

To address this need, the investigators plan to conduct two rapid surveys among Massachusetts residents, to assess attitudes towards COVID-19 vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Massachusetts resident
* Adult (age 18 and over)
* English or Spanish speaking

Exclusion Criteria:

• Non-English or Spanish speaking
Structured Education and Multidisciplinary Team

It is well-known that pre-operative education has a positive effect on patient recovery. This study was conducted to evaluate the impact of structured education given by a multidisciplinary team (surgeon, anesthesiologist, and nurse) on pain, anxiety, and activities of daily living in patients undergoing laparoscopic cholecystectomy.

In this randomized controlled study was conducted with 60 patients undergoing elective laparoscopic cholecystectomy in a training and research hospital in Turkey between March and August 2019. The participants were divided into two equal groups. Verbal structured education and written documents were given to the training group before surgery by a multidisciplinary team. The control group had the routine education. Data were collected using a Patient Information Form, the State Anxiety Inventory, a visual analog scale, and the Barthel Index for Activities of Daily Living.

Eligibility Criteria:
Inclusion Criteria:

* undergoing an elective laparoscopic cholecystectomy
* no loss of sensation related to vision and hearing
* opening to communication and cooperation
* no cancer diagnosis
* no chronic pain-related treatment
* no psychological disease diagnosis
* agreeing to participate in the study

Exclusion Criteria:

* undergoing emergency surgery
* hospitalized in the intensive care unit
* average score below 62 by Barthel Index
Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease

The goal of this clinical trial is to test titrated oxygen in prehospital patients with suspected acute exacerbation of chronic obstructive pulmonary disease (AECOPD) treated with inhaled bronchodilators. The main question it aims to answer is:

* To determine whether prehospital titrated oxygen strategy in patients with suspected AECOPD will decrease 30-day mortality compared to patients receiving standard care.

Participants in the intervention will receive titrated oxygen - a mix of supplemental oxygen and compressed atmospheric air as driver for inhaled bronchodilators to target SpO2 (oxygen saturation) 88-92%. The intervention will be compared to standard treatment, using compressed oxygen (100%) as driver for inhaled bronchodilators.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 40
* EMT or Paramedic suspected AECOPD
* Confirmed suspicion of COPD

Exclusion Criteria:

* Bronchospasm due to asthma, allergic reaction or non-COPD conditions
* Known or suspected pregnancy
* Prehospital Non-invasive, invasive or assisted bag mask ventilation
* Allergy to inhaled bronchodilators (Salbutamol)
* Inter-hospital transfer
* More than 2 doses (5 mg salbutamol) inhalation drug, acute treatment by EMS (emergency medical service) personnel, before allocated treatment is initiated
* Suspicion of acute coronary syndrome
The Effect of Nebulization Positions in Asthmatic Children

The purpose of this study was to establish the effect on pulse rate, oxygen saturation, respiratory rate, pain and anxiety levels of Fowler's and the forward-leaning positions during nebulization in children experiencing asthma attacks.

In the first stage, data on the children who agreed to participate in the study were recorded on the "Patient Identification Form" 10 minutes before the procedure by the researcher during a face-to-face interview. The children's body temperature, oxygen saturation, pulse rate and respiratory rate were measured. Upon explaining the FPS-R, the children were asked whether they had experienced pain before treatment, and to point at the pain level felt from among the faces on the scale. Then, CSA was explained and the children, and their level of anxiety on the scale was recorded. The pre-nebulization findings were recorded.

In the second stage, the salbutamol therapy prescribed by the physician was administered to the participating children with a nebulizer three times at 20-minute intervals. During nebulization, the study group patients were placed in forward-leaning position, placing a pillow on their knees, while the control group was placed in Fowler's position on a chair. Nebulization took an average of 10 minutes for each child. Oxygen saturation, pulse and respiratory rate were recorded immediately after the mask was removed. The children were allowed to rest for 20 minutes in Fowler's position.

In the third stage, oxygen saturation, pulse and respiratory rate were determined immediately after the mask was removed following a 10-minute second nebulization. The values determined were recorded, and the children were allowed to rest for 20 minutes in Fowler's position.

In the fourth stage, oxygen saturation, pulse and respiratory rate were determined immediately after the mask was removed following the 10-minute third nebulization. The children were asked whether they had pain, and to point at the pain level represented by the faces on the scale. The patients then marked their level of anxiety on the CSA. The post-nebulization findings were recorded.

Eligibility Criteria:
Inclusion Criteria:

* To be between 6-11 ages,
* Having a body temperature below 37.2°C at admission,
* Having been prescribed nebulized salbutamol by the physician during data collection,
* Having not using bronchodilators or corticosteroid drugs within the last 6 hours,
* Having no other respiratory system disease,
* Verbal and written consent of the child and parent to participate in the study.

Exclusion Criteria:

* Administering drugs other than nebulized salbutamol to the child during data collection,
* Having an obstacle for positioning (Lordosis, kyphosis, scoliosis, chest wall deformities, previous surgical procedure, etc.),
* Child and parent not knowing Turkish.
The Effect of Parental Anxiety Level on the Child's Anxiety Level and Postoperative Pain in Children Undergoing Surgery.

The aim of this prospective study is to investigate whether the anxiety levels of parents of children aged 2-6 years who will undergo inguinal area surgery have an effect on the child\&#39;s preoperative anxiety level and postoperative pain level.

Hospitalization of children for any health problem or treatment is a complex and difficult process that negatively affects the child and his family and creates stress. Surgical treatment in children can be planned or unplanned, minor or major, invasive or non-invasive, but every type of surgery is considered a stressful experience. Studies have shown that by controlling the anxiety and fear experienced in the preoperative period, children can achieve faster recovery in the postoperative period, better pain tolerance and earlier discharge. For this reason, we aim to contribute to the literature by investigating whether the anxiety levels of the parents of children aged 2-6 who will undergo inguinal area surgery affect the child\&#39;s preoperative anxiety level and postoperative pain level.

Eligibility Criteria:
Inclusion Criteria:

* The child is between the ages of 2-6
* Patients scheduled for surgery under general anesthesia due to inguinal area pathology
* Surgery performed as planned
* There is no mental or neurological disorder in both the mother and the child.
* There are no vision, hearing or speech problems in both the mother and the child.
* Parents and children who volunteer to participate in the research
* Children with ASA I

Exclusion Criteria:

* Not volunteering to participate in the study (those for whom parental consent cannot be obtained)
* Those who underwent surgery with a pathology other than the inguinal area
* Having emergency surgery
* Children at risk with ASA 2 and above
* Having a pathology that may cause difficulty in communicating with both the family and the child (such as mental retardation, neurological problem).
Amplification of Zinc Finger Protein 217 Gene in Multiple Myeloma

Multiple myeloma (MM) is blood disorder characterized by the detection of a monoclonal paraprotein in serum or urine, which is often associated with the presence of clonal plasma cells (PCs) mainly in the bone marrow (BM) .The zinc-finger protein 217 (ZNF217) is an oncogenic protein that plays deleterious functions in various human cancers. The ZNF217 gene is located at the 20q13 chromosomal region, which is frequently amplified in human tumors .

Multiple myeloma (MM) is blood disorder characterized by the detection of a monoclonal paraprotein in serum or urine, which is often associated with the presence of clonal plasma cells (PCs) mainly in the bone marrow (BM) . MM is the second most common hematologic malignancy and is expected to cause ∼13 000 new cases and 30 000 deaths in 2018. Myeloma is a genetically complex disorder characterized by multiple genetic changes, affecting different pathways, that have the ability to deregulate plasma cell biology leading to a broadly similar phenotypic manifestation of disease. From a genetic perspective, myeloma can be divided into those with and without a hyperdiploid karyotype .The zinc-finger protein 217 (ZNF217) is an oncogenic protein that plays deleterious functions in various human cancers. The ZNF217 gene is located at the 20q13 chromosomal region, which is frequently amplified in human tumors . This region also contains several oncogenes thought to confer selective advantages to cancer cells. Increased copy numbers of ZNF217 have been reported in various tumors and linked to poor outcome in some studies . ZNF217 can attenuate apoptotic signals resulting from telomere dysfunction and may promote neoplastic transformation and later stages of malignancy. ZNF217 was shown to be a prognostic biomarker and therapeutic target during breast cancer progression. In our best knowledge, No studies were done to detect ZNF217 in multiple myeloma.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed multiple myeloma patients, who fulfill the WHO criteria of myeloma diagnosis.

Exclusion Criteria:

* Patients with any other type of malignant or benign tumors should be excluded from our study.
Cleanoze® Irrigation Device With Powder Preparation Versus Conventional Irrigation Method for Chronic Rhinitis

The investigators proposed that the Cleanoze® is superior to the traditional nasal saline irrigation in term of the ease of use which will resulting in a better quality of life of the participants. This study will compared the efficacy, adverse reactions, complications and ease of use of Cleanoze® comparing with normal saline solution

Cleanoze® consists of a powder made up of Sodium chloride and Sodium Bicarbonate. This powder when dissolved in 250 ml of water is closely resembles the content of a body fluid which normally baths the outside of the cells of the body. This fluid is isotonic solution.

The nasal saline irrigation is the common procedure for upper respiratory tract infection patients including chronic rhinitis. The physician usually order the normal saline with appropriate medication e.g. anti-histamines, nasal steroids and anti-biotics to treat this condition.

The investigators proposed that the Cleanoze® is superior to the traditional nasal saline irrigation in term of the ease of use which will resulting in a better quality of life of the participants. This study will compared the efficacy, adverse reactions, complications and ease of use of Cleanoze® comparing with normal saline solution.

Study Population: Any patients with chronic rhinitis (e.g. allergic rhinitis, vasomotor rhinitis) will be randomized to receive the study or control medication. The investigators will include the children 5 years and above which able to doing the lavage under the parents assistant or by them self.

Study Design: Phase III randomized controlled trial

Sample Size: Estimate from pilot study, the 71 patients per arm was estimated (142 participants totally).

Study Duration:

* Duration of enrollment is 1 year.
* The patients will be followed up to 1 months depend on the disease conditions.
* The data analysis will take 3 additional months
* The full report will complete after the data analysis within 3 months
* The total of 1 year and 6 months period needed for this study.

Primary Objective: To compare the satisfaction of the patients using Cleanoze® versus conventional device

Secondary Objective(s):

* The adherence to Cleanoze® device
* The durability of the Cleanoze® device
* The patient symptom score (VAS)
* The SNOT-22 questionaire for evaluating the quality of life of the patients

Eligibility Criteria:
Inclusion Criteria:

* Any patients with chronic rhinitis conditions regardless of any cause (e.g. allergic, irritant, infection)

Exclusion Criteria:

* Acute or chronic rhinosinusitis
* Acute nasopharyngitis (common cold)
* Patients with a tendency to aspirate such as cerebrovascular accident, cranio-facial diseases.
* Sinunasal, nasopharyngeal and skull base tumors
* Age under 5 years old.
* Cannot administer a saline irrigation under the assistant of a care giver.
Circle Game Collaborative--Freddie the Frog

Families who have children with disabilities experience more challenges in interacting with their children than families who have children without disabilities. This increased level of burden results in higher rates of emotional stress and hardship for those families. Motivated by the idea of making deeper connections between children with disabilities and their parents, our gaming platform is designed around two key concepts - human touch and collaborative play. Using wearable sensors, conductive fabrics, microcontrollers, and wireless communication, our gaming platform will register and interpret "touch" as a way to interface with game apps and the devices they are installed on. In other words, touch is translated into player input. Thus, rather than interact with an iPad directly, children and their parents interact with each other instead. Our platform engages both parents and children with disabilities equally in order to better focus on their shared physical expression. As touch can be registered from any part of the body, our platform can be used with children with any type of disability and allows for both active and passive participation by children with a severe disability.


Eligibility Criteria:
Inclusion Criteria:

Group 1: Children without disabilities between the ages of 5-9 years. Any parent/caregiver to the child

Group 2: Adolescents with mild to moderate physical or cognitive disability between the ages of 10-17 years. Any parent/caregiver to the child

Group 3: Adolescents with moderate to severe physical and/or cognitive disability between the ages of 10-17 years. Any parent/caregiver to the child

Exclusion Criteria:

All groups:

* Parents who do not understand and speak English
* Parents with a disability
Balance Measures During Stance and Gait: Comparison of Gyroscopic Measurements of Trunk Sway

To investigate whether an extended version of Valedo®Motion (termed Sensoro for brand management purposes), has the same trunk sway measures similar normal reference values of SwayStar. Offline data analysis of data obtained from Sensoro will be compared to data obtained by SwayStar, a highly accurate and widely accepted system for measuring balance control.

1. Determine a long time recording (over 60s) description of any differences in the drift and noise for the 2 systems during simultaneous recordings with the systems aligned with each other at rest.
2. Compare Sensoro trunk sway measures with those of SwayStar for a battery of 17 stance and gait tasks. The tasks to range from tasks with small velocities (standing on 2 legs eyes open, ca 0.1 deg/s or eyes closed on foam ca.10 deg/s) through tandem and gait tasks with velocities of ca 70 deg/s to the most dynamic with high velocities (rising from a chair, ca 150 deg/sec).
3. Estimate the additional value of adding trunk sway values for the yaw axis as an outcome measure of balance control.
4. Estimate the advantage of adding one or two sensors on the legs to help identify gait balance events and body posture.

Eligibility Criteria:
Inclusion Criteria:

* self reported lack of balance problems (checked by the ability to stand on 1 leg, eyes closed, for at least 14 secs).

Exclusion Criteria:

* orthopaedic problems
* presence of diseases which cause balance problems.