cyrilzakka/clinical-trials huggingface dataset:
Efficacy of the "Milk Ladder" Intervention in the Development of Tolerance and the Recognition of B Cell Epitopes in Babies Who Are Allergic to Cow's Milk Proteins

Food allergies have become a relevant health problem in westernized societies, particularly, with children. Cow's milk (CM), along with hen's eggs, are the most common foods eliciting allergic reactions in children under 4 years of age. The main objective of this intervention study is to evaluate the safety and efficacy of the intervention known as "The Milk Ladder" in the development of tolerance by children with CM allergies. This will be compared to an historical cohort (CoALE), which investigated the natural history of this allergy. Additionally, the ability of informative epitopes will be evaluated for their potential to predict tolerance and their correlation against clinical variables.

The "Milk Ladder" will be evaluated within a prospective cohort of CM allergic children. This intervention is enacted through the introduction of meals cooked with progressively increasing amounts of cow's milk into the participant's diet. The primary outcome will be the development of tolerance which will be evaluated through a double-blind placebo-controlled food challenge. IgE and IgG4 epitopes will be described using a peptide microarray immunoassay. Quality of life will be determined by administering the FAQLQ-PF disease-specific questionnaire. Finally, within a subgroup of study participants, the ability of different peptides to activate basophils will be analyzed, and CM T cell epitopes will be studied by means of T-cell proliferation and cytokine production assays.


Eligibility Criteria:
Inclusion Criteria:

* Babies of both sexes.
* Age \< 12 months.
* Clinical history of immediate reaction (\<2 hours) after the intake of baby's formula and/or foods containing cow's milk.
* Sensitization to cow's milk proteins demonstrated by:

  * sIgE to cow's milk, alpha-Lactoabumin, beta-Lactoglobulin and/or Casein \>0.1KU/l (ImmunoCAP®, ThemoFisher) and/or
  * Skin prick test to cow's milk, alpha-Lactoabumin, beta-Lactoglobulin and/or Casein ≥3mm
* If the reaction to milk occurred over 3 months before the recruitment, it will be mandatory to confirm reactivity to milk with an oral food test.
* Parents / legal representatives of the participant voluntary accept to participate.

Exclusion Criteria:

* Delayed reactions (\> 2 h) after milk intake.
* Contact urticaria to milk if ingestion is well tolerated.
* Previous participation in oral tolerance induction/desensitization protocols.
* Treatment with any medication that might interfere the evaluation of the primary outcome or any study procedure.
* Any disease or condition which presents a contraindication to perform an oral challenge, either open or double-blind or any other study procedure.
* Social circumstances that might interfere with protocol adherence.
* Egg and/or wheat allergy (this exclusion criterion shall be verified before the beginning of the intervention).
A Drug-drug Interaction Study of SHR2150 on Healthy Chinese Volunteers

The study is a single-centre, open-label, fixed-sequence, self-controlled clinical trial. It is planned to enroll 20 healthy adult subjects.

Subjects will take SHR2150 on Day 1 and Day 21, and take efavirenz from Day 7 to Day 26.


Eligibility Criteria:
Inclusion Criteria:

1. The subject can communicate well with the researcher, understand and comply with the requirements of this study, and understand and sign the informed consent;
2. Healthy subjects aged 18 \~ 45 (including the boundary value), male and female;
3. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, body mass index (BMI) within the range of 18 \~ 26 kg/m2 (including the boundary value) (BMI= weight (kg)/height 2 (m2));
4. The physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal B-ultrasound, and chest radiograph are normal or have no clinical significance;
5. The subjects with reproduction ability must agree to take effective contraceptive measures after signing the informed consent form and within 7 months (for female) or 4 months (for male) until the last medication.

Exclusion Criteria:

1. Anyone who has suffered from any clinical serious disease such as the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities, or any other disease which can affect the study results;
2. Those who have undergone surgery within 3 months before the trial, or plan to perform surgery during the study period;
3. Those whose 12-lead ECG is abnormal with clinically significant or ECG QT interval (QTcF) ≥ 450 ms (for male) or \> 460 ms (for female) or \< 300 ms;
4. Those who donated blood or suffered heavy blood loss (≥400 mL), received blood transfusions, or used blood products within 3 months before enrollment;
5. Have a history of allergies to drugs, food or other substances;
6. Those who have used soft drugs or hard drugs; or those with positive results in urine drug abuse screening;
7. Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration;
8. Those who have taken any medicine within 1 month before the first administration (including prescription medicines, non-prescription medicines, Chinese herbal medicines, vitamins, calcium tablets and other food supplements), especially the drugs which have any effect on CYP3A4;
9. Regular drinkers within 3 months before the test, that is, drinking more than 15 g of alcohol per day (15 g alcohol = 450 mL of beer, or 50 mL of spirits, or 150 mL of wine), and any alcohol-containing products cannot be stopped during the study;
10. Hepatitis B virus surface antigen is positive, or hepatitis C virus antibody is positive, or treponema pallidum antibody is positive, or human immunodeficiency virus antibody is positive;
11. Women with pregnancy or within lactation period.
Application of AS101 for the Treatment of Thrombocytopenia in Solid Tumor Patients

Chemotherapy Induced Thrombocytopenia is a common side-effect of bone marrow suppression as a result of a chemotherapy treatment. AS101 is a tellurium based small compound with immunomodulating characteristics which attributed to the direct inhibition of the anti-inflammatory cytokine IL-10. AS101 was previously shown to induce a significant reduction in thrombocytopenia that accompany cancer therapy with no major toxicity . This phase II randomized open study will evaluate the efficacy of AS101 for the treatment of chemotherapy induced thrombocytopenia in patients with various solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Appropriate histology of solid tumors.
* Platelet counts \< 70,000/μl.
* Performance Status (PS) of 0-2
* Adequate renal function: Serum creatinine ≤1.5 mg/dL
* Adequate liver function: Serum (total) bilirubin ≤ 1.5 ULN. AST, ALT ≤ 2.5 x ULN in patients without liver metastases, ≤ 5 x ULN in patients with liver metastases. Albumin ≥ 2.5 g/dL (Only for patients who will receive AS101).
* INR ≤ 1.5 and PTT ≤ 1.5 x ULN (Only for patients who will receive AS101).

Exclusion Criteria:

* Patients unable to provide fully informed consent.
* Women who are pregnant or breast feeding.
* The patient is participating in another trial of an investigational drug or has done so within 28 days prior to the pre-treatment visit.
* The patient has congestive heart failure-New York Heart Association (CHF-NYHA) grade II or higher, and/or myocardial infarction within the last 12 months, or any cardiac disorder which in the opinion of the Investigator would put the patient at risk.
* The patient has a history of chronic alcohol or drug abuse within the last 5 years.
* The patient has any other clinically significant medical condition, psychiatric condition or laboratory abnormality which would, in the judgment of the Investigator, interfere with the patient's ability to participate in the trial.
Parent-mediated Social-communication Therapy for Young Children Living in Poverty in Brazil

Exposure to adverse environments such as socioeconomic disadvantage and psychosocial deprivation are risk-factors for neurodevelopmental problems in childhood. Children exposed to such environments may benefit from interventions that target social-communication abilities, since these skills act as protective factors for healthy neurodevelopment in vulnerable children. One early childhood intervention that has shown efficacy in improving early social-communication development is Paediatric Autism Communication Therapy (PACT). However, there are no studies testing the efficacy of PACT in Latin American countries where environmental risk factors are common. This randomized controlled trial will test the efficacy of PACT in improving social-communication development in young children at risk for neurodevelopmental difficulties due to living in socio-economically disadvantaged regions of São Paulo, Brazil.

Methods: Participants will be 160 children aged 2 years 0 months to 4 years 11 months with low social-communication abilities and their primary caregivers. Child-caregiver dyads will be recruited from public early childhood education centers in impoverished urban regions of the city of São Paulo, Brazil. Low social-communication abilities will be defined by Standard Scores \<84 on the Socialization and/or Communication domains of the Vineland Adaptive Behavior Scales. Child-caregiver dyads will be randomized to receive 12 sessions (five months) of the PACT intervention (N=80) or five months of community support as usual plus psychoeducation (N=80). The primary outcome (parent-child interaction) and secondary outcomes (social-communication abilities assessed with the Vineland, neurophysiological activity during a live social interaction) will be measured pre- and post-intervention. All procedures will be performed in accordance with the CONSORT declaration for non-pharmacological interventions.


Eligibility Criteria:
Inclusion Criteria:

* aged 2 years 0 months to 4 years 11 months
* low social-communication abilities indexed by Standardized Scores between 55 to 84 on the Socialization and/or Communication Domains of the Vineland Adaptive Behavior Scales - Third Edition
* parent/primary caregiver agrees to participate in the trial

Exclusion Criteria:

* known neurological condition such as epilepsy
* known genetic disorder such as Down Syndrome
* hearing or visual impairment in the parent or child that could interfere with the intervention
* self-reported current psychiatric or neurological disorder in the parent that could interfere with the intervention
The Study of Using Esophageal Pressure to Guide the PEEP Setting in Abdominal Hypertension Patients Who Undergoing Mechanical Ventilation

Intra-abdominal hypertension can increase the pleural pressure, and then end-expiratory transpulmonary pressures will be turn to negative, Pulmonary atelectasis/acute lung injury/acute respiratory distress syndrome will appear. In the group of people who suffering intra-abdominal hypertension, the investigators use the pressure of esophagus to speculate the Intrathoracic pressure, and to setting PEEP in order to decrease the happening of ALI/ARDS, which may decrease morbidity in this population.


Eligibility Criteria:
Inclusion Criteria:

* intra-abdominal hypertension
* mechanical ventilation
* sedation

Exclusion Criteria:

* underlying pulmonary disease
* age older than 60 years and younger than 18 years
* vital signs were not stable
* non voluntary
Motivating Campus Change Project Pilot Study

This study tests the optimization and delivery feasibility of personalized feedback interventions to address harmful alcohol use among college students.

This study builds upon the latest alcohol intervention literature to develop and test the next wave of personalized feedback interventions (PFIs) to address harmful alcohol use among college students. The purpose of this research is to determine optimal configuration of PFIs to take advantage of the clarity and initial impact of single-component PFIs and greater effect size and duration of personalized multi-component PFIs. The Investigators seek to increase and evaluate engagement with the PFI and text-message materials and boost innovation of both content and process of the intervention. In addition to PFI content and delivery, the investigators will use qualitative and quantitative methods to determine personal relevance of the chosen high-risk events among a sample of students who engage in heavy episodic drinking to better understand duration of PFI effects impacted by fluctuations in drinking associated with high-risk events. Prior interventions have targeted drinking in general or a single high-risk drinking event (e.g., Spring Break), but have not targeted both general and event-specific drinking together. These enhanced intervention effects, could have a significant impact on risks associated with college student drinking, and can be rapidly disseminated and implemented on campuses nationwide to address the public health problem posed by heavy episodic drinking among college students.

This study conducts a screening/baseline assessment to collect quantitative data on high risk drinking situations and related norms and screens participants for eligibility for the Pilot Feasibility Study. The purpose of the Pilot Feasibility Study is to test the feasibility of sending participants web-based personalized feedback targeting their general drinking behavior in a single dose (Simultaneous) versus broken up into 4 components administered one week apart (Sequential) with half of participants in each group also being randomly selected to receive a text message booster component targeting drinking during their upcoming birthday celebration.

Eligibility Criteria:
Inclusion Criteria:

* birthday that falls withing summer/ fall 2018 assessment window
* at least 1 heavy episodic drinking episode in the past month
* at least 3 negative alcohol related consequences on Rutgers Alcohol Problem Index/ Young Adult Alcohol Problems Screening Test in the past 3 months
* intend to consume alcohol over the week of their birthday
* Indicate they own a cell phone with text message capabilities and consent to receiving text messages

Exclusion Criteria:

* Doesn't meet inclusion criteria
* Unwillingness to participate
* Failure to provide consent
European Polyp Surveillance Trial

This protocol describes the epos (ancient greek (Επος) for "story") of a group of related clinical trials aiming at addressing one of the most important unsolved challenges in the prevention of colorectal cancer (one of our major cancer killers); the surveillance of patients with premalignant polyps in the large bowel.

This project is timely because large scale colorectal cancer screening programmes are currently rolled out in most Western countries. These programmes are diagnosing large numbers of individuals with premalignant polyps (adenomas and serrated polyps). This creates both a diagnostic and resource dilemma, because the optimal surveillance strategy for these individuals to reduce future cancer risk is currently unknown..

The EPoS trials will randomize or register more than 20,000 individuals in different European countries to different surveillance colonoscopy intervals to disentangle the most effective and cost-effective surveillance strategy for the population. Subjects will be randomized according to their presenting polyp chracteristics The EPoS I trial randomizes patients with low-risk adenomas into 5 or 10-year surveillance; ; EPoS II randomizes patients with high-risk adenomas into 3 or 5-yearly surveillance ; EPoS III will include patients with serrated polyps in a one-arm study with surveillance after 5 and 10 years. The primary endpoint for all three trials is incidence of colorectal cancer after 10 years of follow-up.

This EPoS trials are the largest in polyp surveillance ever conducted. They address a clinical problem affecting hundreds of thousand individuals in Europe and the US each year, it has a large size, and should thus provide definitive results.


Eligibility Criteria:
Inclusion Criteria:

* Cecal intubation (preferably documented by images/videoof the apendiceal orifice and the ileocecal valve; but not required).
* Adequate colonic cleansing, with Boston Bowel Cleansing Score equal or higher than 2 points in all colonic segments.
* Complete excision of all polyps at baseline colonoscopy findings (as judged by the trial endoscopists).

Exclusion Criteria:

* Lack of consent
* History of CRC or adenomas
* History of serrated polyps ≥ 10 mm in diameter at any colorectal location or ≥ 5 mm if located proximal to the splenic flexure
* Incomplete colonoscopy
* Incomplete endoscopic excision of polyps
* Genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
* Inflammatory bowel disease
* History of surgical colon resection for any reason
* Severe co-morbidity with reduced life expectancy (NYHA 3-4)
* On-going cytotoxic treatment or radiotherapy for malignant disease
* Long-lasting attention and nursing services (somatic or psychosocial, mental retardation).
Study of Opioid-Induced Constipation 1 Project

The aim of the project is to investigate opioid-induced constipation (OIC) in a real world / diverse group of patients with cancer.

The objectives of the project are to determine: a) prevalence of OIC; b) clinical features / impact of OIC; c) management of OIC.

StOIC-1 is an observational study, and will involve a single visit (see below for schedule).

The following data will be collected: a) demographic data - age, gender, ethnicity; b) cancer diagnosis; c) opioid medications - drug, formulation, dose; d) laxative medications - drug, formulation, dose; e) other medications; f) Eastern Co-operative Oncology Group performance status

The participants will be asked the following questions:

1. Simple question - "Are you constipated?" \[Options - yes / no / unsure\]
2. European Association for Palliative Care definition question - "Does the following question describe your bowel function: 'the passage of small, hard faeces infrequently and with difficulty?' \[Options - yes / no / unsure\]
3. Camilleri definition question - "Does the following statement describe your bowel function: 'a change since initiating opioid therapy from baseline bowel habits that is characterised by any of the following: reduced bowel movement frequency, development or worsening of straining to pass bowel movements, a sense of incomplete rectal evacuation, harder stool consistency?' \[Options - yes / no / unsure
4. Rome IV diagnostic criteria for OIC

The participants will also be asked to complete:

1. Bowel function index (BFI). The BFI is a validated, 3 item, patient-reported tool for assessing the treatment of OIC. A BFI score of ≥30 indicates suboptimally treated OIC.
2. Patient Assessment of Constipation - Quality of Life Questionnaire (PAC-QOL). The PAC-QOL is a validated, 28-item, patient-reported tool for assessing the impact of constipation over time.
3. Memorial Symptom Assessment Scale - Short Form (MSAS-SF). The MSAS-SF is a validated, 32 item, patient-reported tool for assessing physical and psychological symptoms in cancer patients.

The participant will also undergo a palliative care specialist assessment for constipation / OIC. The palliative care specialist will be asked to review the patient with regard to their bowel function, and then asked the following questions: a) does the patient have constipation? \[Options - yes / no / unsure\]; b) (if appropriate) does the patient have opioid-induced constipation? \[Options - yes / no / unsure\]; c) (if appropriate) does the patient have additional causes of constipation? \[Options - yes / no / unsure\]; d) (if appropriate) what additional causes of constipation?I

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18yr; diagnosis of cancer; diagnosis of cancer pain; receipt of regular opioids for at least one week

Exclusion Criteria:

* Inability to give informed consent; inability to complete questionnaire
A Study to Evaluate Time in Range in Type 2 Diabetics Using Afrezza® Plus Basal Insulin Compared to Multiple Daily Injections

The purpose of this study is to collect CGM, A1c and Quality of Life data in subjects with Type 2 diabetes before and after transitioning from Multiple Daily Injections to Basal plus Bolus with Afrezza® inhaled insulin. The primary objective is to evaluate the percentage of time spent in goal range without significant hypoglycemia. Additional objectives include evaluation of A1c and Quality of Life data. The expected outcomes are improvement of time in range, no change or improvement in A1c and favorable Quality of Life data


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Diagnosed with Type 2 diabetes mellitus treated with multiple daily injections
3. Screening A1c 7.5 % - 11.5% inclusive
4. Willing and able to wear CGM system during the study
5. Willing to use only inhaled insulin (Afrezza®) at meals and for correction
6. Able to understand, speak, read and write English
7. Female of child-bearing potential willing to use contraceptive measures to prevent pregnancy

Exclusion Criteria:

1. Diagnosed with COPD
2. Is an active smoker , or has smoked in the past 6 months
3. Diagnosed with asthma
4. Pregnancy, breast-feeding or planning to become pregnant during study period
5. Have a disease or condition that, in the opinion of the Investigator, could affect subject safety or interfere with their participation in the study
6. Use of oral or injected corticosteroid within 6 weeks of study enrollment
7. Enrollment in another investigational trial at the time of screening
ADDITIONAL EFFECTS OF MOBILIZATION WITH MOVEMENT WITH UPPER QUADRANT CORE STRENGTHENING IN ROTATOR CUFF RELATED PAIN:A RANDOMIZED CONTROLLED TRAIL

This study is a randomised control trial and the purpose of this study is to determine the additional effects of mobilization with movement with upper quadrant core strengthening in rotator cuff related pain

.

The purpose of this study is to determine the effects of mobilization with movement with upper quadrant core strengthening in rotator cuff related shoulder pain on A. Pain B. Range of motion C. Propioception D. Kinesiophobia

Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Recruited participants will be allocated to either of the groups through a sealed opaque envelope method.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Both genders
* Unilateral shoulder pain of traumatic origin
* Scoring should be less than 8 on numeric pain rating scale
* Symptoms lasting more than 6 weeks
* Pain on active shoulder movement
* Pain provoked by atleast three of the following tests. A. Neer test B. Hawkins-Kennedy test C. Empty Can test D. Full Can test E. Painfull Arc test F. Resisted external rotation test
* Patients reffered by a rehabilitation and orthopedic specialistwith diagnosis of rotator cuff injury, subacromial impingement syndrome, subacromial pain

Exclusion Criteria:

* History and Clinical presentation compatible with complete rotator cuff or bicep brachia rupture
* Adhesive capsulitis
* History of dislocation
* Glenohumeral osteoarthritis
* Cancer
* Auto-immune inflammatory conditions and infection
* Positive joint integrity tests ( Ant. and Post. Drawer tests)
* Hill sachs lesions
* Bankarts lesions
* Cervical rib
* Previous shoulder or neck surgery or fracture
* Familiar pain provoked by neck movements
* Presence of radicular sign
* Diagnosis of fibromyalgia
* Clinical depression
* Rheumatoid arthritis
* Poor bone quality ( osteoporosis)
* Vertobrobasilar insufficiency test