cyrilzakka/clinical-trials huggingface dataset:
Gluten Ingestion Biomarkers in Patients w Gluten Sensitivity and Healthy Controls Peptides in Patients With Non-celiac Gluten Sensitivity and Healthy Patients: A Placebo-controlled Study

Non-celiac gluten sensitivity (NCGS) is an emerging clinical entity defined as the presence of intestinal and/or extraintestinal symptoms induced by the ingestion or gluten and relieved by a gluten free diet (GFD) in patients without celiac disease or wheat allergy. The pathologic mechanism of the disorder is unknown, and there are no known biomarkers or associated histopathologic findings. In this prospective, randomized controlled trail, we are investigating the utility of patient reported symptom questionnaires, as well as stool gluten and urine quantification tools in patients with NCGS and healthy controls.


Eligibility Criteria:
Inclusion criteria include

* Patients \> 18 years of age
* Patients willing to maintain gluten free diet for 6 weeks

Exclusion Criteria (NCGS):

* Patients \< 18 years of age
* Patients with positive serology suggestive of celiac disease and/or biopsy-proven celiac disease and/or Human leukocyte antigen (HLA) DQ2 or DQ8 positivity.
* Patients with a diagnosis of inflammatory bowel disease
* Patients with a diagnosis of acute gastroenteritis
* Patients who are pregnant
* Type 1 Diabetes Mellitus

Exclusion criteria (healthy controls):

* NCGS
* Celiac disease
* Inflammatory bowel disease
* Irritable bowel syndrome
* Acute gastroenteritis
* Patients who are pregnant
* Type 1 Diabetes Mellitus
RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults.

A total of 96 subjects will be recruited into 5 groups. Each subject will receive either two vaccinations with MVA-BN-RSV vaccine or placebo.


Eligibility Criteria:
Inclusion Criteria:

* signed and dated an informed consent form and HIPAA.
* Subjects without symptomatic cardiopulmonary and/or metabolic disease.
* Body mass index (BMI) ≥ 18.5 and ≤ 34.9.
* Negative human immunodeficiency virus antibody test (anti-HIV), HBsAG and HCV virus.
* Electrocardiogram (ECG) without clinically significant acute findings.
* WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each vaccination.

Exclusion Criteria:

* History of nasal or sinus surgery within six months prior to screening or planned nasal or sinus surgery during the trial
* Active or recent history (within 6 months prior to screening) of chronic sinusitis, nasopharyngeal abnormalities and/or symptoms such as polyps or deviated septum
* pregnant or breast-feeding women.
* History or current clinical manifestation of any serious medical condition.
* History of or active autoimmune disease.
* Known or suspected impairment of immunologic functions including, but not limited to chronic inflammatory bowel disorders, diabetes mellitus type I.
* Knowledge/history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* History of anaphylaxis or severe allergic reaction to any vaccine.
* Chronic systemic administration defined as more than 14 days of \> 5 mg prednisone per day
Essential Fatty Acids During Complementary Feeding

The objective of this intervention study is to examine the effect of n-3 LCPUFA on growth and body composition, intestinal health and microbiotic composition, immune function and risk markers for later diseases in 9-18 months old infants and toddlers.


Eligibility Criteria:
Inclusion Criteria:

* Singleton infants, 9 mo +/- 2 wk, born \>= 37 wk of gestation
* Birth weight \>=2500g, a 5-min Apgar score \>= 7, birth weight \>= 5th percentile for gestational age

Exclusion Criteria:

* Chronic diseases expected to influence growth and dietary intake
* Use of medicine expected to influence growth and dietary intake
* Fish oil supplementation
New Technologies to Determine Carotid Plaque Vulnerability in Patients With Significant Carotid Plaques

The researchers are trying to determine if the characterization of "vulnerable" carotid artery plaques can be accomplished with ultrasound-based methods that look for vessels in the plaque and measure the plaque stiffness.

All participants will receive a one time Carotid contrast-enhanced Ultrasound (CEUS) examination that may take 30-60 minutes. Follow up calls will be made to the Participants at 6, 12 ,24 and 36 months to ask about occurrence of major adverse cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

* Subject has carotid plaque with \> 50% stenosis
* Subject is able to understand the study procedure and provide informed consent

Exclusion Criteria:

* Subject is pregnant or breast feeding
* Subject is unable to provide informed consent
* Subject has contraindication to the use of the Lumason contrast agent.
Psychological Counselling in Diagnostic Screening

Diagnostic tests have a deep emotional impact on oncology patients. Anxiety and worries can lead people to avoid screening tests, with high risks for health. A single arm, pilot study was organized to evaluate the feasibility and efficacy of psychological counselling for cancer patients who demonstrated anxiety for diagnostic tests. The hypothesis was that taking part in Psychoeducative Training could offer a new modality to reduce anxiety, before and during tests, and also the possibility to reinforce coping strategies.

The Psychoeducative Training was organized in 6 weekly meetings lasting two hours. Each group was composed of 6 participants. The Training follows the cognitive-behavioural model. In the first part of every meeting, theoretical aspects about stress and anxiety were explained, while in the second part some relaxation techniques were taught. During relaxation, we used a selected music that was also going to be used during the diagnostic tests. Since the first meeting, patients experienced these relaxing techniques in order to learn them. In order to support the adaptability, at the end of every meeting the participants received some homework. They had to take notes on how many times they repeated the relaxation exercises and on the anxiety level before and after the training.

For the study, 43 people were recruited. Anxiety was measured with Beck Anxiety Inventory (BAI); it values the seriousness of the physiological behaviour connected with anxiety. This test an "anxiety gauge", which allows us to obtain numerical data on emotional changes. The test is composed of 4 interpretative levels: serious, moderate, small and minimal anxiety.

The coping style was measured with Coping Orientation to Problems Experienced-New Italian Version (COPE-NIV); this test evaluates the way in which people resolve and face traumatic or usual stressful situations.

The research project was approved by the Ethics Committee of Veneto Institute of Oncology.

Every patient signed a written informed consent to process the data for research purposes and to publish it.

Forty-three patients who had to undergo one or more diagnostic tests (PET, TAC, fMRI, Mammography, Endoscopy, Colonoscopy) took part in the study. The average age was 52.4 and 61.5% were married.

Eligibility Criteria:
Inclusion Criteria:

* age: 25 to 65 years cancer patients who must undergo diagnostic tests: TAC, PET, fMRI, Mammography, Endoscopy and Colonoscopy.
* an anxiety level greater than 5 (in a scale from 0=very calm to 10=very anxious; using a self-reporting instrument created ad hoc)
* signed informed consent

Exclusion Criteria:

* healthy people
The Effect of Using a Birth Ball and Squatting Position During Labor

The aim of the study was to evaluate the effect of using the birth ball and squatting position during labor on labor pain, duration of labor and satisfaction. The research is a randomized controlled experimental study. The sample of the study consisted of a total of 159 pregnant women, 53 in the birthing ball application group, 53 in the squatting group, and 53 in the control group, who met the criteria for inclusion in the study.


Eligibility Criteria:
Inclusion Criteria:

* No risky pregnancy
* Gestational week between 37-42
* Unopened amniotic membrane
* Those who will give birth vaginally
* In active phase
* Fluent in Turkish
* Singleton pregnancy
* Primiparous

Exclusion Criteria:

* Any complication development
* Cesarean section status
Ketamine Infusion for Treatment-resistant Major Depressive Disorder

Ketamine infusion has been shown to have rapid antidepressant properties, however the possible use of ketamine in treatment-resistant depression as augmentation has not been investigated. The overall aim of this study is to assess the feasibility, safety and tolerability, efficacy and duration of the effect of intravenous N-methyl-D-aspartate antagonist ketamine as augmentation of antidepressants for chronic suicidal ideation in subjects with severe treatment-resistant depression (TRD).

This is an open-label study (pilot).

Patients will undergo two weeks of prospective observation, they will then receive ketamine IV 0.5mg/kg over 45 minutes as augmentation of their ongoing antidepressant regimen; after three infusions this dose will be increased increase to 0.75 mg/kg in non-responders. The schedule of administration will be twice a week for 3 weeks. After this phase, the patient will be followed with assessments every two weeks for three months.

Total duration of the study is 5 months.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients with severe treatment-resistant MDD
* Currently depressed
* Currently under regular psychiatric care
* On an aggressive antidepressant regimen, stable for 4 weeks

Exclusion Criteria:

* No history of other major psychiatric illnesses, including bipolar disorder
* No history of psychosis
* No history of drug abuse
* No major medical illness or unstable medical conditions
A Mobile Integrated Health Intervention to Manage Congestive Health Failure and Chronic Obstructive Pulmonary Disease

Episodic and disjointed medical care for older, community-dwelling adults with chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF) leave them vulnerable to adverse events such as worsening disease trajectories, frequent emergency department (ED) utilization, and avoidable hospital admissions. It is imperative that an alternative means of health delivery be developed, establishing a coordinated, flexible care model to connect patients with the appropriate resources to address their acute needs and integrate with their medical homes to navigate fraught moments in their disease management.

The Mobile integrated health (MIH) care delivery model may offer a solution by providing flexible and innovative on-demand care in the comfort of patients' homes. The MIH paradigm expands the use of highly trained paramedics outside of their traditional EMS role, by dispatching them into the community to perform in-home medical evaluations and treatment(s) in consultation with an actively involved, remotely located, supervising physician. These "community paramedics" evaluate patients and render care using mobile diagnostics and a variety of medications, allowing patients to remain in place until they can be evaluated definitively on an ambulatory basis.

Utilizing a model of on-demand community paramedic visits paired with a telehealth consultation with a physician, this intervention will manage patients in place until they can access planned ambulatory follow up, decreasing the use of prehospital emergency transport services, emergency department utilizations, and hospital admissions as well as limiting transitions of care and allowing ambulatory providers to maintain longitudinal oversight of disease management

The objective of this project is to study the feasibility of the refined MIH model for the care of community dwelling patients with congestive heart failure and chronic obstructive pulmonary disease. Investigators will conduct a small pre/post pilot intervention trial enrolling 50 patients into a pilot MIH program. Primary outcomes will include participant satisfaction, patient activation, and subject retention. Investigators will also collect outcomes data including ED visits, hospitalizations, and hospital lengths of stay.


Eligibility Criteria:
Inclusion Criteria:

* Community Dwelling
* Residing in the catchment area of Worcester and Shrewsbury Massachusetts
* member of the UMMHC accountable care organization for at least one year prior to the implementation of the intervention
* Carry a diagnosis of congestive heart failure or chronic obstructive pulmonary disease
* Adult over eighteen
* Fluent in English
* Able to participate in a verbal interview either in-person or via zoom video conference
* Able to provide informed consent to participate in the study

Exclusion Criteria:

* Adults unable to consent
* Non-English-speaking adults
* Prisoners
* Patients under age 18 years
* Trainees, including medical students, resident physicians, and fellows will be excluded from this study.
Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Brain Injury.

The aim of this study is to determine effect of proprioceptive stimulation with passive gait training on the cortical activity in patients with severe brain injury, demonstrated as changes in EEG (electroencephalogram)and ERP (Event Related Potentials).

Hypotheses: 1) Proprioceptive stimulation increases EEG-frequency in patients with impaired consciousness due to severe brain injury.

2) Proprioceptive stimulation increases conductivity speed of the cognitive P300-component of ERP in patients with impaired consciousness due to severe brain injury.

Design: Prospective controlled non-randomized study. Materials and methods: 45 patients with severe brain injury and 15 healthy volunteers will be included in this study.

The study design is illustrated below:

1. Baseline measurement of electroencephalography (EEG) and event related potentials (ERP)
2. Gait training in the tilt table with integrated stepping system(20 min).
3. Control measurement of EEG and ERP Effect parameters: se outcome measures. Statistical evaluation: All collected data will be tested with reference to normal distribution. If the data is not distributed normally, then we will use either a logarithmic transformation before we use parametric statistics, or we will use non-parametric statistics for further calculations.

Further analysis of the data will be done with the help of variance analysis with an inter-individually factor as a group (patients vs control persons) and intra-individually factors as: 1) experimental condition (before vs after training), 2) topographic distribution (anterior vs central vs posterior).

Significance level is set to 0.05 for all effect parameters.

Eligibility Criteria:
Inclusion Criteria:

Patient Goup:

1. Severe Brain Injury
2. Ongoing Impaired State of Consciousness (RLAS\<4)
3. Stable Vital Functions
4. Written Consent from Relatives/Legal Guardian

Control Group:

1. No History of Neurological Diseases in the Past
2. Age over 18 years
3. Written Consent -

Exclusion Criteria:

Patient and Control Goup:

1. Age older than 80 years
2. Other Neurological Diseases
3. Lack of BAEP
4. Severe Co-morbidity
5. Pregnancy
6. Tilt table contraindications: orthostatic circulatory problems, unstable fractures, severe osteoporosis, sken problems, joint problems, severe asymmetry (major difference in leg length over 2 cm), co-operation problems (psychotic illnesses or neurotic disturbances), adjustment problems (i.e. integrated stepping system cannot be safely adjusted to the patient)
Effect of Modulated Auditory Stimulation on Interaural Auditory Perception

This study analyzes the effect of an equalizer-modulated auditory intervention on the asymmetry of interaural auditory perception in groups with different emotional states such as well-being, anxiety, depression and mixed anxiety-depression.

The present study follows a randomized, double-blind (investigator and outcome assessor), parallel and controlled design. The auditory intervention consisted of listening to classical music modulated by an equalizer for 30 minutes, 2 sessions a day separated by at least 3 hours, for 10 days (Monday to Friday for 2 weeks). Participants assigned to the control group are cited to the Health centre, but they do not received any intervention. These subjects follow the same evaluation and data collection process.

Once randomized, all participants will make a first control visit in which a pure-tone audiometry was carry out and completed the various psychiatric evaluation tests to classify into different groups: Goldberg Anxiety and Depression Scale (GADS), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D), and Sociodemographic variables (age, gender, nationality, education, working status, noise exposure, use of ear protection, and present or past use of any analgesic, anxiolytic or antidepressant for longer than a week).

The study variables collected at 3 months were pure-tone audiometry (air conduction).

Eligibility Criteria:
Inclusion Criteria:

* Recruited from Health Centre Mejorada del Campo (Madrid, Spain)

Exclusion Criteria:

* Having significant hearing loss
* Having acute otological process
* Having psychotic disease
* Having epilepsy
* Having serious illness
* Having pregnancy
* Used to try alcohol or drugs
Cranberry Enhances Human Immune Function and Reduces Illness

The purpose of this study is to determine whether consuming a beverage made with cranberry polyphenols and proanthocyanidins is effective in modifying immune function by enhancing immune cell proliferation, cytokine production, and antioxidant capacity. If immune cell proliferation is improved, the subjects are expected to have fewer cold and flu symptoms.

The study will be conducted as a randomized, double blind, placebo-controlled parallel trial. Subjects will be randomly assigned to either the Treatment (cranberry beverage) group or the Placebo group and each will be instructed to consume the test beverages twice a day for 70 days. The beverage is not commercially prepared juice, but is a beverage prepared with an extract of cranberry that contains polyphenols and proanthocyanidins. Blood is taken at baseline, and day 70. Subjects are given a diary to keep a record of their cold and flu symptoms. Serum is used to determine the antioxidant activity by the ORAC method. Peripheral blood mononuclear cells are isolated from the blood draw and used fresh, cultured for 24 hours or cultured for 10 days. Freshly isolated cells will be used to determine αβ-T, γδ-T, B and NK cell numbers and then cultured in autologous serum for 10 days to determine how well they proliferate. The supernatant of 24 hour cultures will be used for cytokine determination. If cells have been primed by the beverage made with cranberry compounds, the investigators expect the cells to proliferate to a greater extent and have modified cytokine production compared to placebo. If the beverage made with cranberry compounds enhances the proliferation of one or more of these cell types (αβ-T, γδ T, B or NK cell), then it is possible that there will be fewer cold and flu symptoms in the group consuming the cranberry beverage. Incidence of illness is not expected to change, only the severity of the illness.

Eligibility Criteria:
Inclusion Criteria:

* Health male or non-pregnant female
* Between the ages of 21 and 50
* BMI between 18 and 35

Exclusion Criteria:

* High blood pressure define as 140/90
* Ongoing or chronic illness or infection
* On hypertensive medication, immunosuppressive drugs, antibiotics, or chronic use of NSAIDS
* Taking plant-based dietary supplements, antioxidant supplements, or probiotics
* Vegetarian or strict vegan
* Consume more than 1 cup of tea (iced or hot) per day
* Consumes more than 2 glasses of alcoholic beverages per day
* Consume more than 7 fruits and vegetables per day
Correlation of Clitoral Hood and Labia Minora Measurements and Female Genital Self Image Scale (FGSIS) Scores in Women

To evaluate the relationship between women's labium minora and clitoral hood measurements and Female Genital Self Image Scale (FGSIS) scores.

The main purpose of our study is to measure the labium minora and clitoral hood in women who apply to our clinic with gynecological disorders, evaluate them with FGSIS (Female Genital Self Image Scale) scores, and look at the relationship between genital area perception and labium minora and clitoral hood dimensions.

Eligibility Criteria:
Inclusion Criteria:

* Women who apply for outpatient gynecological control, are between the ages of 18-45, are sexually active, do not have additional endocrinological or malignant diseases, and are not pregnant or in menopause.

Exclusion Criteria:

* Those who are not sexually active, have varying degrees of pelvic organ prolapse or urinary incontinence, have a malignancy, or have an endocrinological disease
Antenatal Relaxation Group for Anxiety and Depression Management

Approximately 20% of pregnant women experience depression. Untreated depression during pregnancy is linked to decreased prenatal care, difficulties in the pregnancy, poorer outcomes for the baby, and developmental, language, and behaviour problems in the older child.

While medication can often offer relief, pregnant women suffering with depression are often reluctant to take medications that may affect the unborn baby. There is little research about the effectiveness of other treatments such as support groups.

The investigators project will provide relaxation groups for pregnant women with anxiety and depression. The group will provide a chance to get support from other pregnant women. Two health care specialists will provide information about anxiety and depression. They will also teach the skills for women to manage their symptoms. Women will be asked to complete a few questionnaires to evaluate their symptoms before, during, and after they join the group. They will also be asked to evaluate how the group met their needs.

Pregnant women between 15-28 weeks, who speak english are invited to join an 8 week group to relieve anxiety and depression.

We have collected sociodemographic data, as well as social support, life events.

Outcome measures are a decrease in anxiety and depression-as measured by the Edinburgh Postnatal Depression Scale, the Cambridge Worry Scale, and the STAI-Trait Scale.

Eligibility Criteria:
Inclusion Criteria:

* 15 to 28 weeks pregnant and English speaking

Exclusion Criteria:

* Non-English speaking