cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Girls

Study design:

Double blind, randomized, placebo controlled study. Participants will be randomly assigned either to the intervention group or the placebo control group. Randomization for the two study groups will be made in a ratio of 1:1.

The primary objective of the study is to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean female adolescents on weight Standard Deviation Score (SDS) and height SDS The Secondary Objectives of the study are to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean female adolescents on BMI SDS, growth velocity, time to puberty, quality of life and self-esteem The study will continue for 6 months of intervention versus active placebo, with additional optional 6 months (an extension period), in which participants at both groups, the intervention and the placebo, will be offered to continue their participation in the study with the study supplement. All analyses of the effect's on primary and secondary outcome measurements will take into account the consumption rate of the study formula/placebo


Eligibility Criteria:
Inclusion Criteria:

* Girls aged ≥9 years old
* Prepubertal - Tanner stage 1. (gonadarche) Breast at Tanner stage 1)
* Height and weight ≤ 10th percentile for age and gender.
* Height-SDS ≥ -2.5 SDS
* BMI-SDS\>-2 SDS
* Low proportion between weight and height
* Signing inform consent forms

Exclusion Criteria:

* Diagnosis of Growth Hormone (GH) Deficiency or treatment with GH
* Any known chronic disease or dysmorphic syndrome including: bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems
* Any known gastrointestinal disease including malabsorption
* Any known organic reason for growth retardation
* Any chronic treatment with medication that might affect appetite, weight or growth (for example SSRI's).
Effect of a Home-based Versus Supervised Exercise Program in Patients With Migraine

Migraine is a common primary headache with documented impacts on the patient, the economy, and society. A growing number of studies have reported that people with migraines are more likely to experience neck pain and neck dysfunction. The coexistence of migraine and neck pain is also associated with a higher frequency of migraine attacks, greater susceptibility to certification. It has been reported that they present decreased cervical mobility, as well as decreased strength, resistance, and coordination of the cervical musculature of the skull. The objective of this study is to evaluate the possible clinical effects in migraineurs of supervised craniocervical and axioscapular exercises versus home-based exercises.

This study will aim to verify the effect of home versus supervised exercise programs in migraine patients. The primary outcomes will be changes in the Visual Analog Scale (VAS) (0-10) and Migraine Disability Assessment Scores (MIDAS). Secondary outcomes will be changes in cervical range of motion; change in muscle endurance test; neck disability index (NDI), Headache Impact Test (HIT-6) score, Patient Health Questionnaire (PHQ-9) scores, Generalized Anxiety Disorder (GAD-7) scores.

Volunteers for the study will be included if they are between 18 and 55 years old, are of either sex, have been diagnosed with migraine according to the third edition of the International Classification of Headache, and have exhibited at least 3 days with migraine attacks in the previous month, then will be randomly assigned into two groups. A single therapist will administer the interventions twice a week for 8 weeks. The experimental group (supervised) will carry out a supervised exercises program twice a week in comparison with the control group (no supervised) and will carry out a home-based exercise program twice a week. These volunteers will be recruited at the University of Gran Rosario, (Rosario, Argentina). Primary and secondary outcomes will be measured at both groups' baseline and the end of the treatment. All the evaluations will be performed by a blinded physiotherapist

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of migraine according to the beta version of the third edition of the International Classification of Headache Disorders (ICHD), with or without pharmacological treatment.
* Age ranging between 18 to 55 years, both genders

Exclusion Criteria:

* Patients with neurological disorders (neuropathic pain or neurodegenerative disease),
* Whiplash associated disorders,
* Specific neck pain (radicular pain),
* Recent dental or physical therapy.
* If patients are taking medication to relieve pain during the study, they will be encouraged to report it.
E-Socket, Diagnostic Monitoring

The long-term goal of this research is a socket-embedded prosthesis use and socket fit monitor (E-Socket) that facilitates clinical decision-making in the diagnosis and prognosis of health issues faced by people with transtibial amputation. The overall strategy is to enhance the E-socket to include additional metrics that we identified needed from studies to date (Aim #1). Then we conduct a randomized control trial testing the diagnostic utility of the E-socket data in clinical care (Aim #2). From the data collected in that study, we develop the prognostic capability of the system (Aim #3).

Aim 3 will not involve human subject testing as it will focus on the development of the system in preparation for a future aim involving participants' own clinicians.

Note: we use the term "diagnostic" throughout our application in a general sense. The device will not be diagnosing specific diseases or medical conditions.


Eligibility Criteria:
Inclusion Criteria:

-

Prosthesis Users:

Aims 1 and 2

* Over 18 years of age
* Unilateral or bilateral trans-tibial amputation at least 12 months prior
* Have a limb of length 9 cm or greater
* Are capable of at least 5 minutes of continuous walking
* Regularly use a definitive prosthesis
* Do not regularly use assistive devices (e.g., cane, walker) for ambulation
* Do not have open wounds on their residual limb at the time of enrollment

Aim 2

-Regularly visit their prosthetist at least twice a year,

Exclusion Criteria:

-

Prosthesis Users:

Aims 1 and 2

* Reduced skin sensation
* Presence of skin breakdown
* Regular use of an assistive device
* Persons with trans-femoral amputation

Aim 1 Only

-Vacuum suspension users
Can Genetic Markers Predict Weight Loss After Gastric By-pass Surgery

There is a variability in weight loss after gastric bypass surgery for obesity despite a standardised surgical procedure. This study aims to investigate if genetic markers can predict outcome after gastric by-pass surgery in treatment of obesity. The investigators will also study if adenovirus infection can influence the outcome after surgery. In a subgroup of patients, hormonal changes after gastric by-pass surgery will be assessed. Lipid and protein patterns will be assessed in plasma and tissues. Omental and subcutaneous fat as well as liver biopsies and whole blood are stored in a biobank. The same tissues will be collected from non-obese controls undergoing gallbladder surgery.


Eligibility Criteria:
Inclusion Criteria:

* laparoscopic gastric by-pass with BMI greater than 35

Exclusion Criteria:

* unable to understand swedish
Determine the Effect of Administering Periostat(R) Twice Daily on Patients With Acne Rosacea

The purpose of this study is to determine whether Periostat(R), Doxycycline Hyclate 20 mg Tablets, taken twice daily is effective in reducing the red and white heads and overall redness associated with rosacea.


Eligibility Criteria:
Inclusion Criteria

* Healthy, post-pubescent male and females \> age 18, with rosacea, 10 to 30, \[papules and pustules\] and \< 2 nodules.
* Presence of moderate to severe erythema.
* Presence of telangiectasia.
* Female patients must utilize one of the following methods of birth control throughout the study: IUD, diaphragm, a condom plus the use of a spermicidal gel or foam, oral contraceptives (provided patient has been utilizing this method for at least 4 months prior to baseline and has not changed the brand within this period). Patients may also participate if they are surgically sterilized, in a monogamous relationship with a sterile partner, or sign an agreement that they will abstain from sexual intercourse during the course of a study.
* Patients must sign an informed consent form.
* Negative pregnancy test and non-lactating.

Exclusion Criteria

* The initiation of a hormonal method of contraception within 4 months of baseline; or discontinuation during the course of study; or change in the actual product within 4 months of baseline or during the study.
* The use of topical acne treatments within 2 weeks of baseline.
* The use of systemic antibiotics within 4 weeks of baseline.
* The use of an investigational drug with 90 days of baseline.
* Pregnant women or women of child-bearing potential who are not using an adequate form of birth control as described in Item 4 of the Inclusion Criteria.
* Nursing women.
* Patients with a known hypersensitivity to tetracyclines.
* Patients on clinically significant, concomitant drug therapy (See section below).
* The use of any acne treatment during the course of the study.
* The use of topical steroids 6 weeks prior to baseline and during the study.
* The use of systemic corticosteroids 6 weeks prior to baseline and during the study.
* The use of vasodilators 6 weeks prior to baseline or during the study.
* The use of α-adrenergic receptor-blocking agents 6 weeks prior to baseline and during the study.

Prohibited Medications:

* Chronic use (\> 14 days) of sulfa drugs, erythromycin, cephalosporins, and quinolones.
* The use of tetracycline antibiotics is prohibited.
* Use of any acne treatment during the course of the study, including spironolactone.
* Chronic use (\> 14 days) of NSAIDs. Chronic use of aspirin at sub-analgesic doses (\< 325 mg q.d.) may be used by those patient requiring platelet aggregation inhibitor.
* Penicillin antibiotics should NOT be used during the course of this trial since the bacteriostatic action of doxycycline may interfere with the bactericidal action of penicillins.
* Antacids and vitamins containing aluminum, calcium, or magnesium may impair drug absorption and should be taken at least 1.5 hours before or 3.0 hours after taking study medication.
Peer-led Psycho-education for Schizophrenia

Profession-led psycho-education programs for people with schizophrenia are evidenced to improve patients' knowledge about the illness, mental state and relapse rate. Nevertheless, other benefits to patients, for example, their functioning and insight into illness or to be substantive in a longer term (\>12 months) are inconsistent and uncertain, especially in Asian populations. This single-blind multi-site randomized clinical trial was to test the effects of a peer-expert-led psycho-education group intervention (in addition to usual care) for adult patients with schizophrenia spectrum disorders over a 24-month follow-up, in comparison to a profession-led psycho-education group or treatment-as-usual only.

Objectives: This study is to test the effectiveness of a peer-expert-led psycho-education group programme for Chinese outpatients with schizophrenia spectrum disorders over an 24-month follow-up. The program is an integrated,psycho-education program that addresses patients' knowledge and self-management of schizophrenia and problem-solving skills. Methods: A single-blind, multi-site randomized controlled trial will be conducted with 342 Chinese patients with schizophrenia in Hong Kong, China and Taiwan. In each of three study sites, the participants will be randomly selected from the eligible patient list (i.e., 114 subjects from each study site) and after baseline measurement, be assigned to either the peer-led psycho-education program, profession-led psycho-education group, or usual psychiatric care. The patients' mental and psychosocial functioning, insights into illness, and their re-hospitalization rates will be measured at recruitment and at one week, and 6, 12 and 24 months after completing the interventions. Hypothesis: The patients in the peer-led psycho-education program will report significantly greater improvements in their symptoms and re-hospitalisation rates (primary outcomes) and other secondary outcomes (e.g., insight into illness and functioning) over the 24-month follow-up, when compared with those in profession-led psycho-education group and/or usual care. Conclusions: The findings will provide evidence whether the peer-led psycho-education group program can better improve Chinese schizophrenia sufferers' psychosocial functioning and reduce their illness relapse.

Eligibility Criteria:
Inclusion Criteria:

* patients, aged 18+, attending one psychiatric outpatient clinic under study;
* diagnosed as schizophrenia and its subtypes according to the Diagnostic and Statistical Manual, 4th Text-Revised Edition, as ascertained by the Structured Clinical Interview (SCID-I);
* having onset of the illness for not \>5 years; and
* able to communicate in Cantonese language.

Exclusion Criteria:

* mentally unstable and unfit for study participation at recruitment;
* with co-morbidity of other severe mental health problems such as depression and substance misuse; and
* have recently received or are receiving any structured psychosocial intervention.
Confirmatory Study of BK1310 in Healthy Infants

The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with co-administration of ActHIB® and Tetrabik, as well as efficacy and safety, in healthy infants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants aged ≥2 and \<43 months at the first vaccination of the study drug (recommended: ≥2 and \<7 months)
* Written informed consent is obtained from a legal guardian (parent)

Exclusion Criteria:

* Possibility of anaphylaxis due to food or pharmaceuticals
* With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis
* With experience of Hib, diphteria, pertussis, tetanus or polio vaccination.
* Participated in other studies within 12 weeks before obtaining consent
* Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment

Additional screening criteria check may apply for qualification.
Decision Impact Study of PreciseDx Breast

The investigator's developed a digital LDT to predict invasive breast cancer (IBC) recurrence within 6 years by combining histologic features extracted from an H\&E image of the patients IBC with clinical data including the patients age, tumor size, stage and number of positive lymph nodes. The development of an artificial-intelligent (AI)-grade provides not only an objective, quantitative advancement of classical breast cancer grading but also improves upon the accuracy and utility of clinical risk. The investigator's sought to understand how such a PreciseDx Breast would be used in clinical practice post-surgical resection for women with early-stage IBC.

Female breast cancer (BC) has surpassed lung cancer as the most commonly diagnosed cancer worldwide, which translates into 24.5% of all cancer diagnoses and 15.5% of all cancer death. In the United States, it is estimated that 290,560 Americans will be diagnosed with breast cancer in 2022 and 43,780 will die of disease. Given these statistics, the 2022 National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), and College of American Pathologists (CAP) clinical practice guidelines continue to stress the critical importance of the pathology assessment at diagnosis to establish extent of disease and features that reflect a biological potential for recurrence such as histologic grade and stage.

Precise Dx Breast Assay (PDxBR™) is an in vitro prognostic clinically approved test by the NYSDOH to predict breast cancer recurrence for patients diagnosed with early-stage IBC. The test utilizes a digital scan of a representative H\&E-stained resection specimen from the patient. Using advances in applied artificial intelligence (AI) outcome-based image analysis, selected features of the invasive cancer are acquired and combined with clinical variables to produce a risk score predicting likelihood of having breast cancer recurrence within 6-years. With the advent of computational methods, the investigator's investigated whether AI interrogation of whole slide images (WSI) could be used to improve on the characterization and accuracy of IBC histopathology. The approach was based on the generation of quantitative, discreet morphology features within a tissue section (Morphology Feature Array, MFA) and the use of machine learning to create AI models that predict risk of recurrence in early-stage disease. The investigator's developed a test that improves risk stratification of IBC relative to the use of clinical features as well as re-classification of standard breast histologic grade into low- and high-risk groups using MFA-enabled AI models.

Eligibility Criteria:
Inclusion Criteria:

* Invasive breast cancer (ductal / mixed ductal-lobular)

Exclusion Criteria:

* Prior history of invasive breast cancer
* Neoadjuvant therapy
Colorectal Cancer Awareness, Research, Education and Screening (CARES)

There are two parts to this study: (1) an information gathering phase leading to the development of new educational materials; and (2) a study to test the newly developed material. The information gathering phase has been completed. The purpose of this part of the research study is to test the usefulness and acceptability of new educational materials investigators have developed. Investigators will compare the new educational material to another widely available educational brochure. The goal is to see if the new educational material will change knowledge and behaviors about colorectal cancer and colorectal screening.

Federally qualified health centers (FQHCs) and other community health clinics (CHCs) provide comprehensive primary health care for underserved patients. Recently, high-sensitivity and high-specificity fecal occult blood tests (FOBT) and fecal immunochemical tests (FIT) have emerged as a preferred initial screening modality within clinics due to convenience, ease of use, and low cost compared with colonoscopy. FOBT/FIT may help to reduce colorectal cancer screening (CRC) screening disparities and overcome several previously mentioned factors that often account for suboptimal CRC screening rates.

Eligibility Criteria:
Inclusion Criteria:

* Racially-ethnically diverse adult men and women
* Average risk individuals who have no personal diagnosis, or presumptive symptoms of colorectal cancer (CRC), or are not at high risk
* Self-report as not current on screening
* Provide at least two forms of contact information and contact information of a relative (not living with respondent) to facilitate follow-up contacts
* Are able to speak, read and write English because the instruments and CARES intervention are available only in English at this time. We recognize that interventions are needed for non-English speaking populations, therefore, once we find promise in the English language CARES intervention materials, we will move forward with conducting other studies that involve translation of measures and cultural adaptation of the CARES intervention materials into Spanish or Haitian Creole.

Exclusion Criteria:

* Individuals who have participated in a CRCS research study in the past 1 year will not be eligible for this study.
* Recent screening criteria relates to not having had I-FOBT within the previous year, flex sig within the previous 5 years, a double-contrast barium enema (DCBE) x-ray with the previous 5 years, or a colonoscopy within the previous 10 years.
* Within the recruitment and intervention frame, high risk individuals (due to strong family history, ulcerative colitis, polyposis syndromes) are excluded because they may be eligible for CRC screening before age 50, and the preferred screening option is certainly colonoscopy which is beyond the primary focus of the current study.
Study to Evaluate the Effect of Repeat-Dose Rifampin on the Pharmacokinetics (PK) of PF-06651600

Study to Evaluate the Effect of Repeat-Dose Rifampin on the pharmacokinetics (PK) of PF-06651600.


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female participants who are healthy as determined by medical evaluation including medical history, full physical examination which includes BP and pulse rate measurements, clinical laboratory tests, and 12-lead ECG.
* BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* Systemic therapy with any of the medications that are moderate or strong CYP3A4 and/or CYP2C19 inhibitors within 28 days or 5 half-lives (whichever is longer) or moderate or strong CYP3A and/or CYP2C19 inducers within 28 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
* Known participation in a clinical trial of PF-06651600 within 60 days prior to the first dose of investigational product; participation in any clinical trail of PF-06651600 and the participant experienced AE that led to discontinuation, or had SAE, that in the judgment of the investigator were PF-06651600-related.
the Effectiveness of Probiotics on Atopic Dermatitis With Cow Milk Allergy

There is not enough evidence to support the use of probiotics for prevention or treatment of AD in children in clinical practice.

The purpose of this study is to determine whether probiotics is effective in the treatment of atopic dermatitis with cow milk allergy.


Eligibility Criteria:
Inclusion Criteria:

* Under the 2 years old, 36 children
* Mild to moderate atopic dermatitis with cow milk allergy
* Volunteers who agreed by their parents.
* The severity of their disease was assessed by modified SCORAD index

Exclusion Criteria:

* Severe atopic dermatitis
* Patients on systemic steroids, immune-suppression or Korean herbal medicine during the previous 6 weeks
* Anaphylaxis, Angioedema, or severe allergic reaction to the cow milk
* Chronic diarrhea