cyrilzakka/clinical-trials huggingface dataset:
Infant Abdominal Massage on Postnatal Stress Level

The goal of this randomized control trial is to find out the effects of infant abdominal massage on postnatal stress level among Chinese parents in Hong Kong with babies under 1 year old. The main question\[s\] it aims to answer are:

* examine the effects of infant abdominal massage on postnatal stress level among Chinese parents in Hong Kong
* the relationship between the compliance of the intervention and the change of parental stress level Participants in intervention group will receive a abdominal massage training session and will perform on their baby. Parental stress level will be assess week 0 and four weeks .

If there is a comparison group: Researchers will compare wait-listed control group to see if there is any change on their parental stress level

same as above

Eligibility Criteria:
Inclusion Criteria:

1. Parents aged 18 or above.
2. Parents with 0-1 year old full term babies without medical treatment of colic.
3. Able to communicate or read Chinese and have not tried applying infant massage on their babies.

Exclusion Criteria:

1. Parents with babies who had abdominal surgery.
2. Currently participating in any other massage related studies.
Fluciclovine and PSMA PET/CT for the Classification and Improved Staging of Invasive Lobular Breast Cancer

This phase I trial studies how well fluciclovine positron emission tomography (PET)/computed tomography (CT) and PSMA PET/CT work in helping doctors understand and classify invasive lobular breast cancer in patients with invasive lobular breast cancer that is suspicious for or has spread to other places in the body (metastasized). Fluciclovine and PSMA are radiotracers used in PET/CT imaging scans that emit radiation. The PET/CT scan than picks up the radiation being released to create a picture from within the body. Information learned from this study may help researchers learn how to better identify metastatic disease in invasive lobular breast cancer patients which will impact appropriate staging.

PRIMARY OBJECTIVES:

I. Improve detection of metastasis with fluciclovine F18 (fluciclovine) and gallium Ga 68-labeled PSMA-11 (PSMA) PET versus best standard of care conventional imaging, as confirmed with histology.

II. Determine concordance and discordance of invasive lobular breast cancer (ILC) detection with PSMA versus fluciclovine PET, as confirmed with histology.

EXPLORATORY OBJECTIVE:

I. Establish the role of circulating tumor deoxyribonucleic acid (DNA) (ctDNA) directed to ESR1 and PI3K DNA in characterizing the degree of tumor burden as identified by metabolic amino acid transport and tumor neovasculature receptor imaging.

OUTLINE:

Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) and undergo a PET/computed tomography (CT) scan over 30 minutes. On a separate day, patients receive fluciclovine F18 IV and undergo a PET/CT scan over 30 minutes.

After completion of study, patients are followed up in 5-10 business days, and then up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Treatment naive biopsy proven ILC patients with ILC
* Either: a) clinical or imaging suspicion of metastatic disease; or b) proven metastatic disease but in whom there is suspicion of an even greater tumor burden that could change therapy approach
* Ability and willingness to undergo biopsy if needed per standard of care for possible metastasis which could change therapy approach

Exclusion Criteria:

* Pregnancy. Qualitative or quantitative serum or urine pregnancy test will be done in women of childbearing potential within 24 hours before PET

  * A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (if age \> 55 years); if the female subject is \< 55 years and she has been naturally postmenopausal for \> 1 year her reproductive status has to be verified by additional lab tests (\< 20 estradiol OR estradiol \< 40 with follicle-stimulating hormone \[FSH\] \> 40 in women not on estrogen replacement therapy)
Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets

This is a study to evaluate bioequivalence between adagrasib reference tablets and high drug load tablets in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult participants without clinically significant deviation from normal in medical history physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory assessments as determined by the investigator.
* Body mass index of 18.0 kg/m2 to 32.0 kg/m\^2, inclusive, (BMI may be rounded, eg, a participant with a BMI of 32.4 kg/m\^2 would qualify; a participant with a BMI of 32.5 kg/m\^2 or higher would not qualify). BMI = weight (kg)/(height \[m\])\^2.
* Total body weight ≥ 50 kg.
* Individuals of childbearing potential (IOCBP) and male (as assigned at birth) participants who are sexually active with IOCBP must agree to follow instructions for method(s) of contraception as included in the ICF.
* A female (as assigned at birth) is eligible to participate if she is not pregnant or breastfeeding and at least 1 of the following conditions applies:

  1. Is not an IOCBP, OR
  2. Is an IOCBP and using a non-hormonal contraceptive method that is highly effective (with a failure rate of \< 1% per year).

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator.
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, any components of the IMP, or other substance (not including seasonal allergies), unless approved by the investigator and medical monitor.
* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions.
* History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study, including any of the following:

  i. History of myocardial infarction ii. Heart failure iii. Unstable angina (within 6 months of Day -1) iv. High-risk or symptomatic cardiac arrhythmias (eg, sustained ventricular tachycardia, second- or third-degree atrioventricular block without a pacemaker) v. Hypertension.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Cross-validation of a Predictive Model of Response to Anti-TNF Alpha Based on Oxylipin Response in Rheumatoid Arthritis

The goal of this clinical trial is to use a blood test to predict whether a participant diagnosed with rheumatoid arthritis will respond to anti-TNF alpha treatment . The main questions it aims to answer is:

Is the predictive model created using oxylipins effective?

Participants starting anti-TNF alpha treatment will have a blood sample taken before starting treatment and 6 months afterwards.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient aged 18 years or older with rheumatoid arthritis according to ACR EULAR 2010 criteria
* Active disease as defined by DAS-28-CRP\>3.2
* Naive to targeted biologic or synthetic therapy
* Rheumatologist's decision to start anti-TNFα treatment
* Stable corticosteroid therapy ≤ 10 mg/day
* Patient enrolled in or benefiting from a social security scheme
* Patient who has given written informed consent to participate in the study

Exclusion Criteria:

* Contraindication to biological treatment (cancer or history of cancer)
* Treatment with non-steroidal anti-inflammatory drugs in the 2 weeks prior to enrolment
* Protected persons (pregnant and/or breastfeeding women, persons under guardianship or conservatorship)
A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RA

This study was a Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to that of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects with Rheumatoid Arthritis. This Phase II, 6-week blinded study was planned for 60 subjects with moderate to severe rheumatoid arthritis (RA).

The primary objective of this study was to:

• Compare the response of CRx-102 plus DMARD therapy to placebo plus DMARD therapy in lowering CRP levels in rheumatoid arthritis subjects.

The secondary objectives of this study were to:

* Evaluate the changes in inflammatory cytokines in subjects treated with CRx-102 plus DMARD therapy to placebo plus DMARD therapy.
* Evaluate the efficacy of CRx-102 plus DMARD therapy to placebo plus DMARD therapy using ACR-20 and DAS28 indices as well as fatigue scales.

Eligibility Criteria:
Inclusion Criteria:

* Was 18 years of age of older
* Had moderate to severe RA
* Had at least 3 swollen joints (maximum 28) and 3 tender joints (maximum 28)
* Had a Baseline CRP level of at least 2.2 mg/L and a DAS28 score \>4.5
* Had been on DMARD therapy for at least 3 months and have been on a stable dose of DMARD therapy for at least 28 days prior to enrollment
* Had a negative pregnancy test (females)
* Was not taking glucocorticoids at screening

Exclusion Criteria:

* Female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (barriers or abstinence). Female subjects using hormonal birth control are not to be enrolled.
* Subject is currently taking any steroids (glucocorticoids). All glucocorticoids must be discontinued for at least one month prior to entering study. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study.
* Subject is currently taking more than 81 mg of aspirin daily.
* Subject is currently taking a statin, unless she/he has been on a stable dose of the same statin for at least 3 months prior to entering into the trial.
* Subject has any active infections or recent surgical procedures within 30 days of study initiation.
* Subject has uncontrolled diabetes mellitus as defined by a HbA1C value ≥ 7.0%.
* Subject knowingly has HIV or Hepatitis.
* Subject has undergone administration of any investigational drug within 30 days of study initiation.
* Subject has a history of hypersensitivity to steroids and/or dipyridamole.
* Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.
Panadol Osteo Pharmaceuticals Benefit Scheme (PBS) Claims Cohort Study

The aim of this observational study is to compare the use of an extended release paracetamol formulation with standard paracetamol in a cohort of Australian concessional patients with osteoarthritis (OA), to assess differences in prescribing patterns and patient compliance.

This retrospective analysis of physician prescribing data (long-term concessional cohort from the Medicare Australia PBS claims dataset for the time period 2008-2011 (4 years) will compare the use of extended release paracetamol (Panadol Osteo) with standard paracetamol 500mg in a cohort of Australian concessional patients with OA, to assess differences in prescribing patterns and patient compliance.

Eligibility Criteria:
Inclusion Criteria:

* Participants prescribed with a paracetamol product and categorized as a concessional patient
* Participants with new episodes of OA (no history of OA paracetamol in previous 12 months) or suffering from chronic OA (history of OA paracetamol in the previous 12 months)

Exclusion Criteria:

* Participants with Rheumatoid arthritis or other auto-immune inflammatory conditions
* Participants receiving the following anti-rheumatoid therapies:Immunimodulators such as methotrexate, leflunamide and TNF blockers
* Participants receiving treatment for cancer pain
Prevalence of Anemia and Growth Assessment in Acute Gastroenteritis

1. Assessment of the growth parameters in infants admitted with acute gastroenteritis.
2. Determine the prevalence of anemia in infants admitted with acute gastroenteritis.

Gastroenteritis is inflammation of the stomach, small intestine, or large intestine, leading to a combination of abdominal pain, cramping, nausea, vomiting, and diarrhea. Acute gastroenteritis usually lasts fewer than 14 days. Worldwide, gastroenteritis affects 3 to 5 billion children each year. Up to 40% of children aged less than 5 years with diarrhea are hospitalized with rotavirus. Also, some microorganisms have been found predominantly in resource-constrained nations, including Shigella spp, Vibrio cholerae, and the protozoan infections. Malnutrition, immunosuppression, young age, and an increase in the preceding diarrhea burdens are risk factors for the development of persistent diarrhea. A substantial proportion of global malnutrition is due to impaired intestinal absorptive function resulting from multiple and repeated enteric infections. These include recurrent acute infections as well as persistent infections, even those without overt liquid diarrhea.

Child growth is internationally recognized as the best global indicator of physical well-being in children because poor feeding practices-both in quantity and quality-and infections, or more often a combination of the two, are major factors that affect physical growth and mental development in children. The most important measurements needed for growth assessment are recumbent length or height, weight and head circumference. These fundamental anthropometric measures should be obtained and interpreted at each well child visit, and are typically sufficient for growth assessment.

In this study, the prevalence of anemia and growth of infants admitted with acute gastroenteritis at Assiut University Children Hospital will be assessed. Anemia is a global public health problem, with important consequences for human health and the social and economic development of each nation. It results from single or multiple causes that act simultaneously, influencing children's health, their cognitive and physical development, and immunity, increasing the risk of infections and infant mortality.

Eligibility Criteria:
Inclusion Criteria:

* Infants with acute gastroenteritis.
* Infants aged from 1 month and up to 2 years.

Exclusion Criteria:

* Infants aged less than 1 month and more than 2 years.
* Infants with persistent and chronic diarrhea.
* Infants with acute gastroenteritis in association with chronic disease
Analysis of Factors and Treatment Related to Chronic Cough After Pulmonary Resection

Surgical resection is the primary treatment for pulmonary tumors. Surgeons has been frequently concerned about effectiveness, safety, and minimal invasive techniques. However, persistent cough, one of the most common complications of lung surgery, has received insufficient attention. This study set out to investigate the risk factors and treatment related to persistent cough after pulmonary resection.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who received pulmonary resection;
2. 18-to 85-year-old;
3. Pathologically diagnosed as NSCLC or benign tumor.

Exclusion Criteria:

1. Multiple malignancy in other parts of body;
2. Refuse to participate in this study;
3. Other situations evaluated by investigators not meet the enrollment.
Taxoprexin Treatment for Advanced Skin Melanoma

To evaluate objective response rate and duration of response to weekly Taxoprexin®.

To evaluate the safety profile of weekly Taxoprexin® in this patient population.

To evaluate overall survival in the same patient population. To evaluate time to disease progression, and the time to treatment failure in patients with metastatic malignant melanoma being treated with weekly Taxoprexin® Injection.

This is a Phase II open-label study of weekly Taxoprexin® Injection in patients with metastatic malignant melanoma who have not received cytotoxic agents for advanced disease. Patients may have been previously treated with immunological agents including IL-2 and vaccines. Patients will receive Taxoprexin® Injection at a dose of 500mg/m2 intravenously by 1-hour infusion weekly for the first five weeks of a six week cycle. Treatment will continue until progression of disease, intolerable toxicity, refusal of continued treatment by patient or Investigator decision.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have malignant skin/mucosal (non-choroidal) melanoma, and documented metastatic disease.
2. Patients must have at least one measurable lesion.
3. Patients must not have received prior systemic chemotherapy for metastatic disease. Prior treatment with immunotherapy or vaccine therapy is allowed.
4. At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy.
5. At least 4 weeks (28 days) since prior radiotherapy to \> 20% of the bone marrow and prior adjuvant chemotherapy.
6. Patients must have ECOG performance status of 0 - 2.
7. Patients must be \> 13 years of age. The safety of Taxoprexin has not been adequately studied in younger patients.
8. Patients must have adequate liver and renal function.
9. Patients must have adequate bone marrow function.
10. Life expatancy of at least 3 months
11. Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.

Exclusion Criteria:

1. Patients who have received prior therapy with any taxane.
2. Patients whose primary site was the choroid (eye).
3. Patients who have a past or current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers treated for cure and with a disease-free survival longer than 5 years.
4. Patients with symptomatic brain metastasis (es).
5. Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. Patients may not breastfeed while on this study.
6. Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
7. Patients with current peripheral neuropathy of any etiology that is greater than grade one (1).
8. Patients with unstable or serious concurrent medical conditions are excluded.
9. Patients with a known hypersensitivity to Cremophor.
Parkinson's Disease in Home Rehabilitation Services

Introduction: Home rehabilitation is a form of care that is part of most health systems. Patients with Parkinson's disease can be referred to these Home Rehabilitation Services given the characteristics of the pathology they suffer.

Objective: know and analyse the clinical-epidemiological characteristics of patients with Parkinson's disease referred to a Home Rehabilitation Service belonging to health Area V of Gijón, Asturias, Spain.

Study Design: This project proposes an observational and retrospective study.

Study population: The subjects that will be part of this study will be men and women with Parkinson's disease who have been referred to the Home Rehabilitation Service from 2015 to 2021.

Introduction:

Home-based rehabilitation is a care modality that is part of most healthcare systems. In most cases, patients are referred from hospitals, by the rehabilitation services themselves or by the specialist physicians who have treated them. Patients who may be candidates for home rehabilitation often have difficulties in accessing a hospital or outpatient centre independently, due to difficulty in walking and/or architectural barriers within or outside the home, so that in order to travel to outpatient centres, they need means of transport such as ambulances, which entails high costs. Patients with Parkinson's Disease can be referred to these Home Rehabilitation Services.

Objectives:

General:

Know and analyse the clinical-epidemiological characteristics of patients with Parkinson's Disease referred to a Home Rehabilitation Service belonging to the Health Area V of Gijón.

Specific:

Assess the distribution of patients by age group, sex, social conditions and degree of functional impairment.

Find out the time needed for recovery or completion of treatment, as well as the criteria for discharge.

Obtain information on the social assessment and architectural barriers of Parkinson's disease patients referred to a Home Rehabilitation Service.

Study design:

The present project proposes to carry out an observational, ex post facto, retrospective study.

The subjects who will be part of this study will be men and women with Parkinson's disease who have been referred to the Home Rehabilitation Service from 2015 to 2021. Available data from the entire population of patients with Parkinson's disease who meet the inclusion criteria will be analysed.

Limitations:

The limitations of the present study are that the patients will be analysed within a specific setting, such as a Home Rehabilitation Service, so it is possible that some results cannot be generalized.

Eligibility Criteria:
Inclusion Criteria:

* Men and women with Parkinson's disease
* Patients belonging to Health Area V of the Health System of the Principality of Asturias, Spain.
* Subjects who have been referred at some point to home rehabilitation.

Exclusion Criteria:

- Patients who have been discharged at the first medical visit.
A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration

This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.


Eligibility Criteria:
Inclusion Criteria:

* Ethnically Japanese
* Diagnosis of wet age-related macular degeneration in at least 1 eye
* Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye

Exclusion Criteria:

* Hypersensitivity, allergy, or anaphylactic reaction to iodine or shellfish
* Cataract or refractive surgery within the last 3 months
* History of vitrectomy
Tacrolimus Blood Levels After Topical Application of Tacrolimus on Healthy Skin

This is a phase I trial to evaluate tacrolimus blood levels after topical application of tacrolimus twice daily on healthy skin.

The purpose of this trial is to assess the safety of a topical formulation of tacrolimus.

Tacrolimus is commonly used in T-cell medicated diseases. It is expected that 24 subjects will be enrolled in the trial and will be assigned to receive topical application of tacrolimus twice daily for 14 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male and female subjects between 18 and 60 years of age, with a body mass index (BMI) between 18.5 and 30 kg/m2 inclusive
* Female subjects of childbearing potential must be confirmed not pregnant at the screening visit and use highly effective contraception during the trial.

Key Exclusion Criteria:

* Treatment with the following medications: Topical immunosuppressive drugs (e.g. tacrolimus, corticosteroids), systemic immunosuppressive/immunomodulating drugs
* Extensive UV radiation or sunlight on the application sites
* Skin diseases
* Wounded or damaged skin at the application site
* Immunosuppressed or immunocompromised individuals
* Renal or hepatic impairment or insufficiency
* Known allergy or known or suspected hypersensitivity to any component(s) of the topical formulation of tacrolimus
* Female subjects who are pregnant or lactating