cyrilzakka/clinical-trials huggingface dataset:
Intravenous Gammaglobulin for Sickle Cell Pain Crises

The purpose of this study is to determine whether intravenous immune globulin is safe and effective in the acute treatment of pain crises in sickle cell disease.

Funding Source: Food and Drug Administration (FDA), Office of Orphan Products Development (OOPD)

Patients will be randomized to a single dose of IVIG versus normal saline placebo during an uncomplicated pain crisis. Length of VOC and other secondary endpoints will be monitored.

Eligibility Criteria:
Each subject must fulfill each of the following Inclusion/Exclusion criteria at screening and continue to fulfill these criteria prior to dosing:

Inclusion Criteria:

* Documented Sickle Cell Disease (SS or S-β thalassemia genotype)
* Age 12-65 years for Phase 1 (Completed), 6-13.99 years for Phase 2 (Ongoing)
* Normal stroke risk as assessed by transcranial Doppler (TCD). A normal TCD in subjects 16 years of age and younger within the year prior to study drug administration are required
* Uncomplicated acute vaso-occlusive crisis requiring hospital admission and parenteral narcotic analgesics
* If prescribed Voxelotor: Consistent daily use of voxelotor in the past week AND able to continue Voxelotor inpatient OR no reported use in prior week

Exclusion Criteria:

* Concomitant acute process, including acute chest syndrome, potential serious infection, or clinically significant bleeding
* Fever \> 38.5° C and clinical suspicion of infection
* Serum alanine aminotransferase \>4x Upper Limit of Normal (ULN)
* Serum creatinine ≥1.3 mg/dL (or \> than 95th percentile for age) or \>300 mg/dL protein in spot urinalysis
* Known condition associated with renal dysfunction including but not limited to diabetes mellitus, uncontrolled hypertension, multiple myeloma, and congestive heart failure
* Any clinical evidence of prior stroke
* Prior thromboses or current estrogen use
* Current estrogen use
* Hb \< 5 g/dL or \> 10 g/dL
* Known Immunoglobulin A (IgA) deficiency or known allergy to gamma globulin
* Pregnancy or breastfeeding
* Current participation in another investigational drug study
* Current enrollment in a hypertransfusion program
* Previous participation in current study less than 3 months ago
* Current treatment with chronic transfusion
* Vaccination with a live attenuated virus in the preceding 6 weeks
* Documented history of illicit (e.g., heroin, cocaine) drug abuse
* Subject is otherwise not an appropriate study candidate, in the investigator's judgement, such as concern for opioid addiction or comorbid psychiatric diagnoses that may contribute to secondary gain in prolonged use of opioids or hospital stay
* Greater than 24 hours from time of presentation to the hospital for VOC
* Atrial fibrillation
* Right to left cardiac shunting due to patent foramen ovale or other anatomic cause
* Known magnetic resonance imaging/angiography (MRI/A) evidence of stroke or clinically significant central nervous system (CNS) vasculopathy at any age (Imaging done if clinically indicated)
Are Serious Games Scenarios Specifically Designed for Learning Non Technical Skills More Effective Than Baseline Scenarios in Soft Skills Training

The aim of the study is to assess if a training on post-partum hemorrhage management with serious game scenarios specifically designed to teach non technical skills improve non technical skills scoring in a high-fidelity simulation session.

This study aims to answer the following problematic: How to improve the learning of Non Technical Skills (communication, teamwork, leadership ...) in simulation. This study tests non technical skills learning in a serious game on Postpartum Hemorrhage (PPH) management and the interest of specifically designed scenarios.

36 students in midwifery in 5th (and last) year will participate in the experiment. They will be randomized into 3 groups:

* Serious game Control group (12 participants): The participants spend on three different scenarios from the game "PerinatSims"; basic scenarios designed to train Technical Skills (management of post partum hemorrhage according to the algorithm).
* Serious game Experimental group (12 participants): The participants spend on three "PerinatSims" scenarios in which "critical situations" have been implemented, aiming to mobilize some of the non-technical skills of the learners: situation awareness, decision making, communication...
* Classical teaching group (12 participants): the students received the classical teaching of postpartum hemorrhage management and a reminder of the algorithm before the high-fidelity simulation session.

For the serious games groups, at the end of each scenario the participant has access to a debriefing of his technical skills, integrated into the game. At the end of the 3 scenarios, the participant has a debriefing with a simulation teacher.

Finally, each participant of the three groups will be asked to participate to a post partum hemorrhage scenario in High Fidelity simulation. This final award will enable us to validate the investigator's working hypothesis: to check if the non-technical skills mobilized during the sessions on the serious game PerinatSims have been acquired and are beneficial for the participants. A debriefing will be done at the end of the simulation.

The objective of this experiment is to assess if the type of scenario (with or without critical events) improves non-technical skills learning.

The evaluation tools will be the following:

* 3 hetero evaluation scales: Anesthetist's Non Technical Skills (ANTS), Observational Teamwork Assessment for Surgery (OTAS) and a checklist specially developped.
* Electrophysiology: Eye tracking (for the screen-based simulation), Heart rate monitor
* Auto evaluation scales: Flow scale, Stress scale (DASS), Leadership scale (BAT), Mental load scale (NASA TLX), Scale of technological acceptability (SUS)

The High Fidelity simulation will be evaluated according to the same tools outside the eye-tracking.

Eligibility Criteria:
Inclusion Criteria:

* Students in midwifery in 4th or 5th year (last year of the french curriculum)

Exclusion Criteria:

* Midwifery students who did not receive theoretical training on postpartum hemorrhage
Follicular Flushing

Patients with infertility often undergo in vitro fertilization (IVF) to achieve a pregnancy, which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm insemination, embryo culture and embryo transfer.

The oocytes are removed during surgery by aspirating the follicles using a single lumen needle with an ultrasound to guide the procedure. There is some data that flushing the follicles with embryo culture media before aspiration using a double lumen needle increases the number of oocytes retrieved, particularly among poor responding patients for whom each additional oocyte recovered may substantially alter the outcome of that IVF cycle.

The objective of the research is to evaluate the effect of follicular flushing in poor responders on IVF cycle outcomes.

Patients with infertility often undergo in vitro fertilization (IVF) to achieve a pregnancy, which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm insemination, embryo culture and embryo transfer. The number of embryos obtained is dependent on the number of oocytes retrieved.

The objective of the research is to evaluate the effect of follicular flushing in poor responders on IVF cycle outcomes, including the number of oocytes retrieved, number of mature oocytes, fertilization rate, number of embryos transferred, implantation rate, miscarriage rate, live birth rate, operating room time, and luteal estradiol and progesterone levels.

The research entails a prospective, randomized, controlled trial of poor-responder patients who are undergoing IVF treatment at The Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine, defined as patients who have ≤ 4 follicles that are ≥ 12mm on the day of hCG trigger.

Patients identified as poor responders will be consented and randomized to follicular flushing versus aspiration without flushing. A 2-5mL flush using embryo culture media followed by aspiration of the follicle will be performed in the patients randomized to the flushing group, with subsequent flushes until an oocyte is identified or up to 4 flushes maximum.

Patients being enrolled in this research study will undergo IVF regardless of participation in this research study.

Randomization:

A series of randomized blocks of 2 will be generated for the study. This will provide assurance that after two patients are enrolled, there will be one patient assigned to each group- follicular flushing versus aspiration without flushing. This process of blocked randomization ensures an equal distribution between the two study arms of patients.

Eligibility Criteria:
Inclusion Criteria:

* Pts ages 18-45 undergoing IVF
* Pts with ≤ 4 follicles that are ≥ 12mm on day of HCG

Exclusion Criteria:

* Pts undergoing natural cycles (i.e. those with intentionally low # of follicles)
The Effect of an Anti-inflammatory Diet in Patients With Rheumatoid Arthritis

Rheumatoid arthritis (RA) is an autoimmune disease that affects 0.5-1% of the population and in which his remission is not always achieved, affecting physical and mental well-being and quality of life (QL). As a complement to pharmacotherapy, dietary intervention should be evaluated as a treatment option.

The main objective of this parallel controlled randomized clinical trial is to check the effect of an anti-inflammatory dietary intervention, compared to a diet based on the principles of the Mediterranean diet (control), on disease activity (AD) and improving QL.

Patients will be instructed to follow an anti-inflammatory diet (DAI) or a control diet (DC) for 6 months. The AD and QL will be evaluated at the end of the intervention.

As there are no dietary guidelines for RA, this study aims to provide scientific evidence about the impact of diet therapy on reducing AD and improving QL.

The main objective of this trial is to check the effect of an DAI, compared to a DC, on reducing AD and improving QL.

As secondary objectives, it is intended to investigate the relationship of DAI with inflammatory markers and with the modulation of the composition / diversity of the intestinal microbiota, in comparison with a DC.

This study combines all dietary components with an anti-inflammatory effect, thus allowing the possibility of evaluating the full potential of dietary treatment in the disease, including intestinal microbiota modulation.

These results are intended to further contribute to clinical decision making and better evidence-based treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years;
* Presence of active disease, (DAS28≥ 2.6), under adequate control and medication.
* Able to sign informed consent

Exclusion Criteria:

* Any type of psychological deficiency, dementia or eating disorder;
* Presence of food allergies and / or intolerances;
* Be vegetarian or use Phytotherapy or other supplements (namely, pre and probiotics);
* Use of antibiotics im the last 6 months;
* Have had previous nutritional monitoring or change in eating habits in the last 6 months.
Building on a Point-of-purchase Intervention to Encourage Healthy Food Choices

This study builds on the framework of a previously implemented color-coded food labeling intervention in a hospital cafeteria by testing the incremental effectiveness of providing employees with individual feedback and incentives for increasing healthy purchases in a 3-arm randomized controlled trial. The investigators hypothesize that employees assigned to receive feedback will increase healthy purchases more than employees who receive no contact and that employees who receive feedback plus incentives will increase healthy purchases more than those who receive feedback alone.


Eligibility Criteria:
Inclusion Criteria:

* Employee at Massachusetts General Hospital who uses a cafeteria debit card to pay for cafeteria purchases

Exclusion Criteria:

* Employees who do not have a cafeteria debit card
* Employees with cafeteria debit card but who use it fewer than 3 times a month for the 3 months prior to start of trial
A Study to Learn How Safe and Tolerable Vonsetamig is in Adult Patients With Chronic Kidney Disease (CKD) Who Need Kidney Transplantation and Are Highly Sensitized to Human Leukocyte Antigen (HLA)

The purpose of this study is to determine whether vonsetamig will safely decrease anti-HLA antibodies to allow for kidney transplantation.

Vonsetamig is being studied for treatment of patients in need of kidney transplantation who are highly sensitized to HLA.

The study is looking at several other research questions, including:

* Side effects that may be experienced from taking vonsetamig
* How vonsetamig works in the body
* How much vonsetamig is present in the blood
* If vonsetamig works to lower levels of antibodies to HLA


Eligibility Criteria:
Key Inclusion Criteria:

1. Has Chronic Kidney Disease (CKD) requiring hemodialysis, and awaiting kidney transplant on the United Network for Organ Sharing (UNOS), with a cPRA ≥99.9%, or those with a cPRA \>98% (98.1% to 99.8%) who have spent 5 years or longer on the waitlist, as defined in the protocol
2. Adequate hematologic and adequate hepatic function as defined in the protocol
3. Willing and able to comply with clinic visits and study-related procedures

Key Exclusion Criteria:

1. Current or active malignancy not in remission for at least 1 year
2. Central nervous system (CNS) pathology or history of CNS neurodegenerative or movement disorders
3. Patients who have had their spleen removed, including patients with functional asplenia
4. Patients who have received a stem cell transplantation within 5 years
5. Use of investigational agents within 8 weeks or 5 half-lives of study drug administration (whichever is larger)
6. Total plasma IgG \<300 mg/dL at screening
7. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone (or anti-inflammatory equivalent) within 72 hours of start of study drug administration
8. Received a calcineurin inhibitor (eg, tacrolimus, cyclosporine) within 30 days of study drug administration
9. Received cyclophosphamide, rituximab, obinutuzumab, other anti-CD20 or B cell-depleting agents, or proteasome inhibitors or anti-CD38 therapies (eg, isatuximab, daratumumab) within 12 months of study drug administration
10. Prior treatment with any anti-BCMA antibody (including antibody drug conjugate or bsAb) or BCMA-directed CAR-T cell therapy, as described in the protocol
11. Has received a COVID-19 vaccination, as described in the protocol

Note: Other protocol defined inclusion / exclusion criteria apply
Dietary Choice in Active Older Adult Women

The present study aimed to determine the effects of negative-calorie diet supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie diet with exercise among elderly adult women with abnormal weight gain.

Background: Negative-calorie diet is among the popular dieting guides for weight loss; however, there is still little knowledge about this method.

Objectives: The present study aimed to determine the effects of negative-calorie diet supplemented with exercise, on weight loss and lipid profile, and to compare its efficiency with low-calorie diet with exercise among elderly adult women with abnormal weight gain.

Material and Methods: Participants included sedentary women (age 45-75 years) with overweight or obesity (n=111). They were randomly divided into two groups including negative calorie diet with exercise, and low-calorie diet with exercise. Of all 111 participants, 90 persons completed the treatment. The weight assessment parameters including change in weight and body composition, blood sample tests were performed pre- and three month post-intervention.

Eligibility Criteria:
Inclusion Criteria:

Non-smokers and weight-stable (± 2 kg, for more than one year) with no history of regular exercise in at least three months before the study.

Exclusion Criteria:

History of CVD and other disorders such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals. Subjects with abnormality in thyroid or Electrocardiograph, any history of anti-obesity medication or weight loss drugs or dietary supplementations for weight control.
Diffusion-weighted Magnetic Resonance Imaging (DW-MRI )for Early Response Assessment in Patients With Esophageal Cancer

Esophageal carcinoma is a lethal disease, causing more than 400,000 deaths annually worldwide. Primary surgery results in microscopically positive resection margins (R1) in 25% patients, and the 5-year overall survival(OS) for such patients rarely exceeds 40%. Concurrent chemoradiation followed by surgery results in better survival than single-modality treatments, and thus National Comprehensive Cancer Network(NCCN) recommends concurrent chemoradiation as preoperative or definitive treatment for patients with stage II or III esophageal cancer. However, neoadjuvant chemoradiation may not be effective in some subgroup of these patients, and its toxicity can increase perioperative mortality and delay or preclude surgery. The ability to distinguish tumors that will respond or not respond to such therapy remains an urgent priority. Diffusion-weighted magnetic resonance imaging(DW-MRI) is based on the extent of mobility of water protons, as quantified by the apparent diffusion coefficient (ADC). The ADC is a measure of the extent of free diffusion of water molecules within tissues, which is mainly influenced by cell organization, size, and density. Cell death leads to a loss of cell membrane integrity and density and leads to increases in ADC values. The ADC has emerged as a potential biomarker of response to cancer therapy. However, no one has published findings regarding the potential correlation between changes in ADC and response of esophageal cancer to chemoradiation. Clarifying the potential predictive value of DW-MRI for predicting response to such therapy is important for the delivery of appropriately tailored treatment.

Investigators hypothesized that DW-MRI can predict the success (or failure) of neoadjuvant chemoradiation in esophageal squamous cell carcinoma（ESCC）, hence identify patients at high risk of treatment failure from such therapy. Investigators will test this hypothesis with two specific aims: (1) assess the ability of ADC to predict pathologic response to treatment; and (2) assess the ability of ADC to predict disease-free survival and overall survival.


Eligibility Criteria:
Inclusion Criteria:

* T1bN+ M0(T1b means that tumor invades submucosa) or T2-T4aN0/+ M0 (T4a means resectable tumor invading pleura, pericardium, or diaphragm) according to American Joint Committee on Cancer （AJCC）Cancer Stage 7th
* Pathological identified esophageal squamous cell cancer
* Karnofsky Performance Status（KPS）≥70
* Tolerable and agree for Intensity-Modulated Radiation Therapy（IMRT） and concurrent chemoradiotherapy
* Without severe other diseases
* Informed consent

Exclusion Criteria:

* Cervical esophagus cancer;
* Had received prior chemotherapy and thoracic radiotherapy
* Distant metastasis before treatment, including: pleural, pericardial or peritoneal cytology ,involvement of distant organs including the lungs, liver, bone, brain or non-regional lymph nodes
* Pregnant and lactating women
* Serious complications
* Other primary malignancies
* Cannot perform DW-MRI at specified time
Tissue Collection Study for Patients With Non-Small Cell Lung Cancer With Resectable Disease

A 15-gene lung signature was created to identify predictive and prognostic biomarkers for Non-Small Cell Lung Cancer (NSCLC) patients. The 15-gene signature was validated using a microarray platform with fresh frozen tumor tissue to place NSCLC patients into high risk and low risk cohorts with significantly different survivals.

Using fresh frozen tissue can be challenging, so this study attempts simplify the process by migrating the 15-gene signature from fresh frozen to two alternative tissue formats: Formalin Fixed Paraffin Embedded (FFPE) and RNAlater.

The gene expressions of the different tissue formats will be compared to see if the fresh frozen tissue results are similar to the alternative tissue formats.

Patients with early stage NSCLC will be consented prior to surgery so that any excess tissue collected during surgery can be collected in one of the three tissue formats (Fresh Frozen, FFPE, RNAlater) and sent to the Sponsor for testing.

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of stage I or II Non-Small Cell Lung Cancer (NSCLC)
* Must have resectable disease and complete surgical resection planned
* Histologically or cytologically confirmed adenocarcinoma, squamous or large cell carcinoma NSCLC
* No prior chemotherapy, biologic/molecular targeted therapy or radiation therapy for this cancer
* Tumor specimen samples must be collected within 1 hour of surgery
* Patient must be at least 18 years of age
* Patient must sign and date an approved study consent form

Exclusion Criteria:

* Patients with psychiatric or addictive disorders that would preclude obtaining study consent
* Informed consent obtained the same day as surgery
* Absence of histological diagnosis of lung cancer
* Known infectious disease
* History of chemotherapy, biologic/molecular targeted therapy or radiation therapy for this cancer or any prior cancer or any other non-cancer diseases or illnesses, i.e. rheumatoid arthritis
Acupuncture on Anxiety and Inflammatory Events Following Surgery of Mandibular Third Molars

The aim of this study was to compare the effect of acupuncture and placebo acupuncture for the control of pain, edema, and trismus following the extraction of third molars and control of preoperative anxiety. Patients who met the study criteria were randomized to the type of acupuncture (active acupuncture or placebo acupuncture) and to the side of the first surgery (right or left).

Studies using acupuncture have shown promising results in the control of pain, edema, trismus and anxiety control. The use of this technique is interesting considering the negative effects of excessive use of medicines and the side effects of medications which are the most common treatment used for the control of these complications. However, there are no reports in the literature that evaluated the effects of acupuncture on the control of these variables following mandibular third molar extraction, using the placebo-needle design and blinding the patients, operators, and evaluators. Therefore, the aim of this split-mouth randomized triple-blind clinical trial was to compare the efficacy of acupuncture and placebo acupuncture for the control of pain, edema, trismus and preoperative anxiety in the extraction of third molars.

Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for bilateral extraction of asymptomatic mandibular third molars in the position class IIB, according to the classification of Pell \& Gregory (1933).

Exclusion Criteria:

* Previous use of any type of medication in the 15 days prior to the study;
* Hypersensitivity to drugs, substances or any materials used in this experiment;
* Pregnancy or lactation;
* Previous case of pericoronitis;
* People who have previously undergone any kind of acupuncture treatment.
Relationship of Metabolic Syndrome and Its Components With Thyroid Cancer

The purpose of this study is to investigate the association between metabolic syndrome (MS), body mass index (BMI), hyperglycemia, dyslipidemia, hypertension and thyroid cancer. Screen for the risk factors that affect the incidence of thyroid cancer.


Eligibility Criteria:
Inclusion Criteria:

1. patients undergone thyroid surgery
2. signed the informed consent

Exclusion Criteria:

1.patients with no surgery