cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Tolerability of Virtual Reality to Treat Gastroparesis

The purpose of this study is to determine if virtual reality therapy is safe and tolerable in treating gastroparesis.

After informed consent patients will be randomized to a 4 week treatment program comparing active VR treatment to sham VR treatment. Symptoms will be measured at baseline and at 2 and 4 weeks using validated questionnaires. A short questionnaire will be answered daily to evaluate changes in nausea.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, men and women ages 18-75.
* Documented gastroparesis (idiopathic or diabetic).
* Patients who have had an upper endoscopy within the past 3 years not showing evidence of an organic disorder that could cause symptoms and a 4-hour scintigraphic gastric emptying scan showing evidence of delayed gastric emptying.
* Patients will be identified as direct referrals to the general GI clinic or the motility clinic, and will undergo screening history and physical examination by the PI or co-investigator.

Exclusion Criteria:

* Patients whose symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease).
* If the patients have known uncontrolled diabetes (HgbA1c \> 11), GERD, esophagitis, eosinophilic esophagitis, H. pylori, cannabinoid hyperemesis syndrome, celiac artery compression syndrome, or SMA syndrome.
* Patients with prior surgery to the esophagus, stomach or duodenum.
* Patients taking opioids will also be excluded.
* Alcohol and tobacco use will be assessed, as will the presence of psychiatric conditions, such as anxiety, depression, post-traumatic stress disorder, bipolar disorders, and eating disorders, such as anorexia nervosa and bulimia. However, no patient will be excluded based on reported substance use or presence of a psychiatric comorbidity, unless their psychological status represents potential harm to themselves, others, or represents an impediment to treatment.
* Any patient identified as having a significant problem with alcohol or anxiety or depression will be referred back to their primary care provider for further evaluation and treatment.
* Patients with motion sickness, vertigo, or a seizure disorder will be excluded to prevent the theoretical risk of inducing or exacerbating symptoms related to the aforementioned conditions with VR.
A Study of CYP-001 in Combination with Corticosteroids in Adults with High-risk AGvHD

This study is a prospective randomized placebo-controlled phase 2 study to compare CYP-001 plus corticosteroids (CS) to placebo plus CS in allogeneic hematologic stem cell transplant recipients with HR-aGvHD. Severity of GvHD will be assessed at screening and throughout the study using Mount Sinai Acute GvHD International Consortium (MAGIC) guidelines. Eligible subjects will be randomized to receive either CYP-001 IV infusion on Days 0 and 4 or placebo on the same days. All subjects will receive ongoing CS therapy as appropriate per institutional guidelines. Subjects will have study visits up to Day 100 during the Primary Evaluation Period. During the Follow-Up Period, subjects will have study visits up to 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Undergone allogeneic hematopoietic stem cell transplant (HSCT)
* Clinically diagnosed with acute GvHD requiring systemic therapy with corticosteroids.
* HR-aGvHD must meet one of the following clinical features within 72 hours prior to randomization: (a) high-risk as per Refined Minnesota Criteria; OR (b) One of the following: (i) isolated stage 2 involvement of the lower GI tract; (ii) Stage 1 lower GI tract disease with skin involvement
* Evidence of myeloid engraftment post allogeneic HSCT
* Life expectancy of at least one month

Exclusion Criteria:

* Received any systemic treatment for aGvHD other than corticosteroids +/- calcineurin inhibitors
* Chronic GvHD or overlap syndrome with both acute and chronic features of GvHD
* Relapsed primary malignancy since
* received more than one allogeneic HSCT
* Clinically significant respiratory, renal or cardiac disease
* Cholestatic disorders or sinusoidal obstructive syndrome/veno-occlusive disease of the liver
* Any active uncontrolled infection requiring treatment and likely to impact on the ability of the subject to participate in the trial.
* Known infection with CMV, EBV, HHV-6, HBV, HCV, HIV or Tuberculosis. If the treatment for CMV, EBV, HHV-6, HBV, HCV has commenced the subject is eligible.
* Known sensitivity to dimethylsulfoxide (DMSO) or any other component of CYP-001.
* Received any investigational treatment agent within 30 days or within 5 half-lives of Screening, whichever is greater.
Diabetes Mellitus and Vulvovaginal Candidiasis

Clinical and mycological response to oral fluconazole and boric acid suppositories was assessed in patients with diabetes mellitus and vulvovaginal candidiasis.

A high proportion of vulvovaginal candidiasis is due to C.glabrata that responds poorly to fluconazole therapy. We assessed the clinical relief and mycological cure in response to oral fluconazole and boric acid suppositories in patients with diabetes mellitus and vulvovaginal candidiasis given in a Randomized trial. Fluconazole was given in standard oral single dose (150 mg) fluconazole and boric acid vaginal suppositories was given in dose of 600 mg/daily for 14 uninterrupted days.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with diabetes mellitus attending Endocrine OPD of All India Institute of Medical Sciences and in whom the diagnosis of vulvovaginal candidiasis was based on presence of clinical signs and symptoms and growth of Candida species on culture of high vaginal swab (HVS).

Exclusion Criteria:

* Patients with vaginal discharge in whom Candida growth was not detected on fungal culture were excluded.
* Subjects also excluded were those with pregnancy,
* Sexually inactive girls,
* Age \> 65 years, renal failure and steroid therapy.
* Patients who did not give consent for pelvic examination,
* Those who were treated for any kind of vaginal discharge during the past three months and who did not comply with boric acid therapy or did not report on 15th day for repeat examination excluded.
Postoperative Sensitivity Following Placement with Different Restorative Materials in Vital Posterior Teeth

There is a lack of long-term clinical studies comparing different restorative materials; most of the available studies have only looked at class I cavities or examined post-operative sensitivity in non-caries cervical lesions. The purpose of this study is to measure postoperative sensitivity in clinical settings at 3-month intervals for class 1 and 2 direct posterior restoration


Eligibility Criteria:
Inclusion Criteria:

Either gender Minimum age 18 years, maximum age 40 years. Class I \& II Cavity on maxillary and mandibular 1st and 2nd molars. Vital maxillary and mandibular molar teeth that had occlusal contact with antagonist teeth.

Exclusion Criteria:

Irreversible Pulpitis diagnosed clinically and radiographically. Class I \& Class II cavity of premolars and third molars Patients taking analgesic prior to treatment. History of allergic reaction to any dental material used in the study. History of parafunctional habits (bruxism and/or clenching) Malocclusion
Bringing Awareness Into Eating

The purpose of this study is to test an app-based mindful eating intervention to decrease the reward value of unhealthy food.

Eating healthily is highly beneficial. However, changing eating habits is notoriously difficult. Individuals often believe that they simply need to "restrain" their eating impulses in order to eat more healthily. However, such an approach has not only been shown to be quite ineffective over long time spans, it is also associated with aversive feelings: It simply does not feel good to struggle with one's own impulses.

Investigators are testing a new approach to overcoming unhealthy eating habits, which utilizes mindful eating to change the reward value of unhealthy food. The hypothesis is that if people pay attention to how unhealthy food (e.g. "junk" food) makes them feel in their bodies, their liking it and desire to eat it will decrease naturally. Participants might become aware, for example, that eating a whole bag of chips leads to nausea, while eating a salad makes them feel fresh and energetic.

Investigators will assess whether and how the anticipated and actual satisfaction associated with unhealthy food will decrease the more often participants use this intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Craves \& overeats a food at least 4 times/week (can be a specific food or food category - i.e. salty or sweet)
2. Desire to change eating habits
3. Owns a smartphone
4. Fluency in English

Exclusion Criteria:

1. Current eating disorder
2. Current strict diet (e.g. paleo, keto, vegan, calorie restriction)
3. Pregnancy
4. Current insulin use
5. Previous use of the EatRightNow application
The Risk of Acute Myeloid Leukaemia in Patients with Ewing's Sarcoma

Ewing's sarcoma is an uncommon yet vital malignancy of bone. It demonstrates a predilection for the pediatric and young adult population. Chemotherapy is considered an important treatment modality for Ewing's sarcoma. However, the development of therapy-related leukemia, especially acute myeloid leukemia following treatment, is attributed to the use of substances such as alkylating agents and topoisomerase inhibitors which are genotoxic. There is a very few studies elaborating on the incidence rates of such complications. So, our aim is to quantify the risk of developing acute myeloid leukemia in Ewing sarcoma patients and provide an updated evidence to the literature.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Ewing sarcoma
* Latency exclusion period of 6 months
* Sequence 0 or 1

Exclusion Criteria:

* patients lacking age documentation or age reported only on death certificates or autopsies
Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease

The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination therapy in subjects 12 years and older with CF and advanced lung disease and who are homozygous for the F508del CFTR mutation


Eligibility Criteria:
Inclusion Criteria:

* Homozygous for the F508del-CFTR mutation; historical genotype must be documented in the participant's source documents.
* Percent predicted FEV1 \<40 of adjusted for age, sex, and height at Screening

Exclusion Criteria:

* Participant currently receiving invasive mechanical ventilation.
* History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant
* Any clinically significant laboratory abnormalities at screening that would interfere with the study assessments or pose an undue risk for the subject
* A 12-lead electrocardiograms (ECG) demonstrating QTcF \>450 msec at Screening
* History of solid organ or hematological transplantation
* History of alcohol or drug abuse in the past year
* Ongoing or prior participation in an investigational drug study (including studies investigating lumacaftor and/or ivacaftor) within 30 days of screening.
* Use of strong inhibitors, moderate inducers, or strong inducers of CYP3A
* Pregnant and nursing females: Females of childbearing potential must have a negative pregnancy test at Screening and Day 1.
* Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements
* Use of beta blockers or the equivalent at Screening.
Herpesvirus in Idiopathic Pulmonary Fibrosis

The purpose of this study is to: 1) to develop a method to quantify Epstein Barr Virus (EBV) load in lung tissue of humans and to determine whether EBV viral load is significantly higher in lung tissue from patients with idiopathic pulmonary fibrosis (IPF) than in control lung tissue; 2) to determine whether EBV localized to epithelial cells in IPF lungs and to relate epithelial positivity to tissue viral load; 3) to measure viral load in induced sputum from IPF subjects over time in order to determine whether periodic active herpes virus replication occurred in the respiratory tract; and 4) to compare longitudinal measures of viral load in induced sputum with simultaneously collected saliva in order to assess the clinical utility of the two approaches.

IPF is a progressive disease where there is no proven treatment, other than lung transplant. Doctors do not know what causes IPF. We think that IPF is caused by a viral infection, particularly herpes virus. The goal of this experiment is to build the case for a causal link between IPF and herpes virus. This information is important to help us develop new therapies to treat patients with IPF.

We will collect lung tissue at the time of lung transplant surgery from IPF patients and from organ donors as controls. Control lung tissue was collected if it was removed as a part of regular care or would otherwise be discarded. No extra tissue was taken solely for this research project.

We will also perform a prospective longitudinal study on IPF patients and their household partners. IPF subjects are included if they have no other pulmonary disease and the diagnosis of IPF is confirmed by lung biopsy or by clinical and chest CT findings. The control group will consist of subjects without respiratory symptoms or pulmonary diseases who are the household partner or spouse of an enrolled IPF subject and who accompanies the IPF patient to outpatient clinic visits. If there is no household partner, or if the partner is unwilling to participate, we will still enroll the IPF subject who qualifies for the study and is willing to participate. Saliva, induced sputum, and venous blood will be collected from IPF and control subjects after informed consent at each clinic visit. Visits usually are at approximately 3-4 month intervals over a one year period.

Eligibility Criteria:
For the study on lung tissue, eligible subjects were IPF patients undergoing lung transplant surgery and from organ donors who died from non-pulmonary causes. For the study in clinic, subjects were IPF patients who had no other pulmonary disease other than IPF and the diagnosis of IPF was confirmed by lung biopsy or by clinical and chest CT findings. The control group consisted of subjects without respiratory symptoms or pulmonary diseases who were the household partner or spouse of an enrolled IPF subject and accompanied the IPF patient to outpatient clinic visits.

Exclusion Criteria:

* Failure of the patient to provide informed consent.
Comparison of Learning Models in Physical Therapy Education

With the pandemic affecting the world, education systems have been subjected to mandatory changes without sufficient thought on teaching content, delivery and pedagogy. In this process, physiotherapy courses involving psychomotor skills such as manual therapy became difficult to teach and evaluate. Although the pandemic is over, it is suggested that technological approaches should be used in learning systems and incorporated into physiotherapy education. These technology-supported education models are called blended education models. The use of the flipped training model, a variant of blended training models, can improve practical skill performance. In this study, it was aimed to determine the effect of two different models on the quality of teaching and learning in cervical region manual therapy teaching. Suleyman Demirel University Physiotherapy and Rehabilitation senior students (n=100) will be randomly divided into two groups. The control group (n=49) will be given monologue education with in-class team-based traditional education model. The practical part of the course will be taught in the classroom and applied with patient-clinician role model technique. Homework will be assigned for students to read scientific articles and analyze case examples. The entire six-week teaching program will take place in the classroom. The experimental group (n=51) will be applied the flipped model. The theoretical and practical knowledge of the course will be provided at home with the EdPuzzle education platform. They will be encouraged to read articles and analyze cases at home. The classroom environment will be used to ask questions related to the theoretical part of the course and to practice the practical application as a patient/clinician role model. The seven-week teaching program is planned in the classroom and home environment. In the evaluation of the research, explanatory sequential design method from mixed research methods will be applied. Pre-test/post-test/knowledge retention test, instructional materials motivation questionnaire and skill level/performance evaluation form will be used to evaluate the quantitative data. A lesson observation form will be used to evaluate whether the trainer provided the same competence to both groups. Semi-structured case study will be used to evaluate the reverse-face model to the experimental group with qualitative data.


Eligibility Criteria:
Inclusion Criteria:

* Not to have participated in a vocational course program on manual therapy of the cervical region,
* Sufficient internet access,
* Acceptance of distance education if included in the experimental group,
* Having and actively using a cell phone or computer with a smart operating system,
* Volunteering to participate in the study

Exclusion Criteria:

* The student wants to quit the study and does not fill in the data collection forms
PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections

Primary

- To evaluate the efficacy of Pulmonaron in the decrease of interleukin-4/interferon gamma after second period of treatment

Secondary

* To evaluate the efficacy of Pulmonarom in the prevention of upper respiratory tract infections symptoms through patient evaluation of fever or respiratory presence after second period of treatment
* To evaluate loss of working or study days after second period of treatment
* To evaluate the safety and tolerability of Pulmonarom in the population under study


Eligibility Criteria:
Inclusion Criteria:

* Patients with history of relapse or recurrence of respiratory infections or disease
* Patients with chronic respiratory disease as asthma, bronchitis or sinusitis

Exclusion Criteria:

* Patients unlikely to comply with the protocol, for example, uncooperativeness or impossibility to return for follow-up visits
* Patients who are participating or who have participated in another clinical trial during the previous 3 months
* Patients who have received immunology response stimulants during the previous 30 days
* Hypersensitivity

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes

The primary objective of this study is to test the hypothesis that glycemic control, as measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2 diabetes who are naïve to antidiabetes agents, or patients who are being treated with metformin, an SU, or a combination of metformin and an SU


Eligibility Criteria:
Inclusion Criteria-patients are eligible to be included in the study only if they meet all of the following criteria:

* are a male or a female between ages 10 to 17 years, inclusive. The number of patients ≥17 years of age will be limited to no more than 10% of patients in each treatment arm
* have a history of type 2 diabetes with the original diagnosis based on at least one American Diabetes Association (ADA) diagnostic criteria
* have been treated with metformin, an SU, or both metformin and an SU (with or without diet and exercise), for at least 3 months or are naïve to anti-diabetes agents and being treated with diet and exercise alone. The dose of oral agent(s) should be stable for the 30 days prior to the screening visit
* have fasting C-peptide \>0.6 ng/mL
* have HbA1c between 6.5% and 10.5%, inclusive.

Disease Diagnostic Criteria-for the purposes of this study, patients with type 2 diabetes are defined by:

* diagnosis of type 2 diabetes, as determined by ADA diagnostic criteria and antibody testing, documented and confirmed in the patient's medical record, which includes laboratory determinations consistent with one or more of the following in the patient's medical history
* fasting blood glucose 126 mg/dL (7.0 mmol/L)
* random blood glucose 200 mg/dL (11.1 mmol/L)
* two-hour OGTT (Oral Glucose Tolerance Test) ≥ 200 mg/dL (11.1 mmol/L) AND one or more of the following: no antibodies to GAD65 OR no antibodies to islet cell antigen (ICA512).

Exclusion Criteria-patients will be excluded from the study if they meet any of the following criteria:

* have previously been exposed to exenatide or, completed or withdrawn from this study or any other study investigating exenatide
* are unwilling or unable to inject the study medication
* currently use inhaled steroids at a dose equal to or above 1000g Flovent (fluticasone propionate) daily
* have used oral steroids within the last 60 days or more than 20 days use within the past year
* have used any weight loss medication(s) within 30 days of screening
* have used insulin for more than 10 weeks during the 3 months prior to screening
* have history of renal disease, or serum creatinine \>1.6 mg/dL (141.4 µmol/L) (males) or \>1.4 mg/dL (123.8 µmol/L) (females)
* have hepatic dysfunction, defined by aspartate (AST) or alanine (ALT) transaminase \>3.0 times the upper limit of normal (ULN).
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Participants, Participants With Generalized Anxiety Disorder (GAD) and Participants With Bipolar Disorder (BPD)

The purpose of this study is to assess the pharmacokinetics, safety, and tolerability following multiple ascending oral doses of ABBV-932 or placebo in healthy adult participants, participants with Generalized Anxiety Disorder (GAD), and participants with bipolar disorder (BPD).


Eligibility Criteria:
Inclusion Criteria:

* For healthy volunteer cohort:

  -- Body mass index (BMI) is \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal.
* For participants with generalized anxiety disorder (GAD) or bipolar disorder (BPD)

  * Participants with GAD or BPD (as confirmed by MINI) meet participant psychiatric history criteria described in the protocol.

Exclusion Criteria:

- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.