cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial of the Study Medicine (PF-07081532) in People With Diabetes and Kidney Dysfunction

The purpose of this study is to understand the effects of kidney functional impairment may have on the study medicine (PF-07081532). People with certain level of kidney functional impairment may process PF-07081532 differently from healthy people. PF-07081532 is developed as a potential treatment for type II diabetes.

Participants will take the study medicine as a tablet by mouth once at the study clinic and then will stay at the study clinic for about 7 days. During that time, the study team will monitor their treatment experience and take some blood samples to test the level of PF-07081532. This will help us understand if certain degree of kidney functional impairment will have an effect on the study medicine PF-07081532.


Eligibility Criteria:
Inclusion Criteria:

1. Stable renal function (for participants not on dialysis) defined as ≤25% difference between 2 measurements of BSA-unnormalized eGFR
2. A prior diagnosis of T2DM with an HbA1c ≥6% and ≤10.5%
3. Women may be of child-bearing potential
4. BMI of 17.5 to 45.4 kg/m2
5. NORMAL FUNCTION (GROUP 1): Normal renal function (mean eGFR ≥90 mL/min) based on an average of measures from Screening visits S1 and S2 (eGFR should be calculated using the 2021 CKD EPI Scr-Scys combined equation:

   * Demographically comparable to participants with impaired renal function at Screening
   * A body weight within ±15 kg of the mean body weight of the pooled renal impairment groups (Groups 2, 3 and 4)
   * An age within ±10 years of the mean age of the pooled renal impairment groups (Groups 2, 3 and 4)
   * Attempts will be made to ensure that the male to female distribution in Group 1 is comparable to that in the pooled renal impairment groups (Groups 2, 3 and 4).

Exclusion Criteria:

1. Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes, or history of diabetic ketoacidosis.
2. History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II-IV heart failure, or transient ischemic attack within 3 months of Screening
3. Personal or family history of MTC or MEN2, or participants with suspected MTC per the investigator's judgement.
4. History of acute pancreatitis within 6 months before Screening or any history of chronic pancreatitis.
5. Urinary incontinence.
6. Participants with acute renal disease.
7. Renal allograft recipients.
8. Participants who have previously received a kidney, liver, or heart transplant.
Anticipating Decline and Providing Therapy

This pilot feasibility study will be a randomized control trial of usual care following Intensive Care Unit (ICU) discharge compared to the Anticipating Decline and Providing Therapy (ADAPT) screening and support intervention. The trial aims to enroll 120 older adults (age 60 or older).

Anticipating Decline and Providing Therapy (ADAPT) is a program designed to support the implementation of a routine post-ICU cognitive impairment screening and support intervention. The program includes a routine validated cognitive screen for high-risk older adults at 6 weeks and 6 months post-ICU discharge. Patients with a screening assessment that may be consistent with cognitive impairment or dementia will receive additional resources including a specialized care plan developed by the Sticht Center for Healthy Aging and Alzheimer's Prevention. The specialized care plan is adapted from a health system-based dementia care intervention and designed to support post-ICU cognitive concerns. It was adapted with input from geriatrics, intensive care, and outpatient primary care clinicians. Also conducted are semi-structured interviews with 22 older adult ICU survivors and 6 primary care physicians to elicit preferences and the intervention was further adapted based on these results.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 and older at time of discharge from intensive care unit
* Minimum 72 hour Intensive Care Unit stay in an ICU at Atrium Health Wake Forest Baptist
* Delirium during ICU stay as determined by positive Confusion Assessment Method (CAM)-ICU score, review of clinical - documentation, or discussion with clinical team
* Primary care provider in the Atrium Health Wake Forest system or intention to follow with Primary Care Physician in Atrium Health system
* English speaking

Exclusion Criteria:

* Death during initial hospitalization and/or discharge to Hospice
* Life-expectancy \< 6 months from pre-existing illness (defined as diagnosis of metastatic cancer, cirrhosis, advanced heart failure, prior palliative care referral)
* Acute Traumatic Brain Injury
* Continued residence in skilled nursing facility or rehab that prevents ability to complete study telephone call at time of first cognitive screen attempt
* Prior history of dementia in electronic health record
* Language or communication barrier that prohibits intervention participation
* Participant cannot identify family or caregiver contact or family/caregiver unwilling to participate
* Subject or legally authorized representative (LAR) decline consent
* Unstable telephone service for contact after hospital discharge
* Primary residence outside of North Carolina
Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention

Investigation of the combination of neonatal neurobehaviourism and motor behavior in the assessment and ultra-early physical therapy intervention of premature neonates and parental support.

Developments in neonatology and perinatal medicine in recent years have resulted in a remarkable development of the survival of premature infants. At the same time, several evaluation and intervention protocols have been developed, aiming at early diagnosis and intervention, but also and studies that are concluding and highlight the need for future well planed and in-depth research, mainly in areas related to early intervention. T. Brazeltons' (1973) Neonatal Behavioural Assessment Scale (NBAS) has been used in many studies of assessment and intervention in newborn-infant and their families and respectively H.R. Prechtls' (1979) Qualitative Assessment of General Movements (GMs) in assessment studies, as a valid and reliable non-invasive procedure. However, the combination of their basic principles and guidelines has not been developed and tested in the context of ultra-early physiotherapy intervention in premature infants.

The evaluation and strengthening of ultra-early physiotherapy intervention by combining basic principles of neonatal neuro-behavior (based on Brazelton T.) and motor behavior (based on Prechtl H.F.R.), in the context of individualized and developmental supportive care of premature neonates and infants and enhancing parental self-confidence.

The research is based upon on three different researches: a) the cross-cultural adaptation of Karitane Parental Confidence Scale (KPCS) questionnaire. The sample will be parents of infants up to one year, b) the effect of ultra-early intervention on parental confidence of preterm infant parents. An experimental randomized controlled trial which will be conducted in the Neonatal Intensive Care Unit (NICU) until maternity hospital discharge. The sample will be premature infants and their parents and c) the effect of ultra-early intervention and parental confidence, on the development of premature infants up to the age of three months. An experimental randomized controlled trial which will be conducted in the Neonatal Intensive Care Unit (NICU) and upon their discharge from the maternity hospital up to the age of 3 months. The study sample will be premature infants and their parents.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age under 34 weeks
* Premature newborns hospitalised in the NICU for at least eight days
* (for parents) be able to speak and read Greek or English

Exclusion Criteria:

* Newborns with congenital and chromosomal abnormalities.
* Newborns with severe accompanying pathological problems and congenital infections.
* (for parents) with known history of drug or alcohol abuse or serious psychiatric disorders
Non-invasive Liquid Biopsy Analysis of Epigenomics Signatures in Multiple Cancer Types

Bluestar Genomics is developing a test from whole blood for the early detection of multiple cancers. The goal of this study is to employ genomics, epigenomics and proteomics methodology for the detection of cancer signal in the blood of subjects with solid tumors. The study will include subjects without cancers that will be followed up every 6-months for up to 3-years from blood draw.

Epigenomic changes in cancer cells can provide a rich source of biomarker signals for the detection of disease. As cancer cells manifest their epigenomic changes in blood due to cell death, DNA and protein molecules can be probed using specific molecular analytic approaches. Bluestar Genomics employs epigenomic technologies to measure dynamic changes in DNA demethylation events via direct measurement of 5-hydroxymethyl-cytosine residues in cfDNA. Companion assays are also run to provide information on cfDNA digestion patterns and protein-based changes in plasma. This information, combined in a machine learning framework, enable the provision of prediction models that report on the presence of cancer and the determination of the tissue of tumor origin. This study will build predictive models and test performance of these models to detect the presence of cancer and tissue of origin in several cancer type by using a matched case-control study design.

Eligibility Criteria:
Inclusion Criteria

1. Subjects must be between 45 - 75 years of age at the time of enrollment
2. Patient fully consented
3. Cancer diagnosis OR high clinical suspicion for cancer, based on the participating site's and practitioner's standards of care (SOC)
4. No previous history of cancer and treatment naïve at time of enrollment

Exclusion Criteria

1. Age \< 45 OR \> 75 years of age
2. Any prior cancer diagnosis with or without treatment (with the exception of non-melanoma skin cancers resolved/treated \> 1 year prior to enrollment)
3. Receipt of any cancer therapy including chemotherapy, radiation, palliative radiation, hormonal or naturopathic therapies
4. In situ carcinoma without an invasive component
5. Any surgery requiring general anesthesia within 2 months of collection. Anesthesia used in procedures such as colonoscopy and EBUS is acceptable.
6. Dental Novocain within 1 week of collection
7. Receipt of systemic immunomodulation therapy within past 12 months
8. Currently pregnant, or pregnancy within last 12 months
9. Organ transplantation
10. Received dialysis
11. Blood transfusion within 1 month
12. HIV/AIDs, Hepatitis A, D, or E, TB, any kind of prion disorder (e.g., CJD) or other infectious pathogens currently present or present in past 5 years.
Preventive Effects of Different Volumes of High-Intensity Interval Training on Risk Factors for MS in Overweight Young Women

This study investigates the effects of different volumes of high-intensity interval training on risk factors for metabolic syndrome in overweight young women.

The sedentary and inactive female overweight subjects, aged 18 to 30 years, were randomly divided into three groups: high volume high-intensity interval training group (4HIIT group), low volume high-intensity interval training group (1HIIT group) and control group (CON group). Human morphological measures, blood pressure, insulin resistance, blood analysis, and cardiorespiratory fitness were measured at baseline and after exercise intervention.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-30 years;
* BMI≥24kg/m2, indicating overweight and high risk of metabolic syndrome;
* Maintaining a stable body weight for the three months prior to the study.

Exclusion Criteria:

* Regular participation in physical exercise (≥3 times/week, exercise time≥30min/time);
* Any respiratory, musculoskeletal, or cardiovascular diseases;
* Medical or other contraindications for exercise;
* Taking medications that affect metabolism;
* Smoking and/or drinking habits.
Altered Drug Disposition and Biomarkers for Diagnosis of Chronic Inflammatory Liver Disease

One-third of the U.S. population suffers from non-alcoholic fatty liver disease (NAFLD). NAFLD is caused by diabetes and obesity, and is becoming more common. Although many people have this disease, the change in how the liver handles drugs and compounds in the body has not been studied. The purpose of this study is to investigate how advanced NAFLD changes the ability of the liver to handle both endogenous and exogenous compounds.


Eligibility Criteria:
Inclusion Criteria:

General:

* Man or woman between 18 and 65 years of age
* Negative pregnancy test for women of childbearing potential
* Negative urine drug screen

Healthy Subjects:

* Normal liver function tests
* Normal kidney function and lipid panel

Nonalcoholic Steatohepatitis Patients:

* Recent liver biopsy with nonalcoholic fatty liver disease activity score at least 4

Exclusion Criteria:

General:

* History of significant alcohol use (\>20 g/day) and/or illicit drug use
* Inability to abstain from alcohol for 48 prior to study
* Use of drugs associated with a clinical or histological picture consistent with fatty liver disease or NASH for more than 12 consecutive weeks in the year prior to screening; these include amiodarone, tamoxifen, methotrexate, glucocorticoids, anabolic steroids, tetracyclines, estrogens (at doses greater than those used for hormone replacement) or valproate/valproic acid
* Type 2 diabetes treated with oral agents other than metformin; these include secretagogues, thiazolidinediones, alpha-glucosidase inhibitors, exenatide and pramlintide.
* Current or recent use of bile acid sequestrants, bile acid derivatives (i.e. ursodiol) or fibric acid derivatives.
* Current use of antioxidants such as silymarin, vitamin C, glutathione, or non-prescribed complementary alternative medications (including dietary supplements, megadose vitamins, herbal preparations, and special teas) within 30 days prior to screening.
* Previous liver biopsy that demonstrated presence of cirrhosis.
* Radiologic imaging consistent with cirrhosis or portal hypertension.
* Serum creatinine of 2.0 mg/dL or greater, or on dialysis, at screening.
* History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, severe psoriasis, rheumatoid arthritis) that could affect the assessment of biomarkers (bile acids or inflammation).
* History of bariatric surgery.
* BMI \> 45 kg/m\^2 at screening.
* Any known hypersensitivity to opiates, opiate antagonists, or ondansetron.

Healthy Subjects:

* Taking concomitant medications, both prescription and non-prescription (including herbal products and over-the-counter medications), other than oral contraceptives and multivitamins (women stabilized on hormonal methods of birth control will be allowed to participate)
* History or other evidence of liver disease in the opinion of the study investigators.
* BMI \> 30 kg/m\^2 at screening.
Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries

This study will evaluate the efficacy and safety of intrathecal non-preservative-free morphine and its effect on pain in patients undergoing unilateral inguinal hernia surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-65 years old.
* Both genders.
* ASA I and II class.

Exclusion Criteria:

* Patient refusal.
* Known local anesthetic (LA) allergy.
* Skin lesions or infections at the site of needle insertion.
* Contraindications to spinal anesthesia.
* Failure of spinal anesthesia.
* ASA III and VI class.
* Central or peripheral neuropathies.
* Severe respiratory or cardiac diseases.
Tackling Postnatal Depression: Culturally Adapted Learning Through Play Plus (LTP+) Intervention for British Mothers of African and Caribbean Origin

By 2030, depression will be the leading global disease burden. Postnatal depression due to childbirth/parenting leads to long-term negative consequences for mothers, their children and their families. The British African/Caribbean communities are worse hit by the unprecedented impact of post-Covid-19-syndromes, leading to an exponential increase in postnatal depression. Yet, the uptake of mental healthcare by British mothers of African and Caribbean origin is low due to limited access to culturally appropriate care. Theories of attachment and cognitivism were innovatively integrated to examine Learning-Through-Play plus (LTP+) intervention for postnatal depression using a pilot randomised controlled trial. The proposed LTP+ is co-developed and ecologically friendly because it is manualised and can be delivered by non-mental health specialists such as trained community health workers who are more culturally knowledgeable. Findings will be disseminated through academic publications/presentations, policy briefs, original animated videos and podcast series laying the foundations for a psychosocial approach to tackling postnatal depression


Eligibility Criteria:
Inclusion Criteria

Only British mothers of African and Caribbean heritage:

* experiencing emotional distress due to childbirth or parenting and scored 5 or above on the patient health questionnaire (PHQ-9)
* who have children age 0-3 years
* residents of designated communities and available for follow-up
* are 18 years and above
* able to give informed consent.

Exclusion Criteria

Are mothers:

* with a medical condition that would prevent their participation such as active suicidal ideation, tuberculosis, or heart failure
* temporary residents are unlikely to be available for follow up
* who are less than 18 years
* unable to provide consent.
* with non-British African and Caribbean heritage.
Pathway CH-1 Long-Term Follow-Up

The objective of the study is to demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for stimulation of the sphenopalatine ganglion (SPG) in cluster headache subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject has been implanted with an ATI Neurostimulator as a part of the Pathway CH-1 trial.
* Subject has completed the Pathway CH-1 Open Label Final office visit and remains implanted with an ATI Neurostimulator.
* Subject has the ability to read, comprehend and to reliably record information as required by the Protocol.
* Subject is able to provide written informed consent prior to participation in the study.

Exclusion Criteria:

* Subject has or requires a pacemaker/defibrillator or other implantable device having a sense amplifier that is programmed 'On.'
* Subject is not suitable for the study for any reason in the judgment of the Investigator.
Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing

Although, a huge number of acute wounds is treated successfully every year, Health Care Professionals (HCPs) are facing more and more problems when treating skin damages or surgical incisions: The number of patients with fragile and/or sensitive skin is highly increasing. Such patients are having a skin integrity issue, meaning the skin is vulnerable to injury, often damaged, or unable to heal.

The investigational medical devices (IMDs) of the planned clinical evaluation, Leukomed® T skin sensitive and Leukomed® T plus skin sensitive have been developed for treatment of acute wounds on patients with fragile or sensitive skin to provide a reliable but skin-friendly fixation and wound care option.

The primary purpose of this clinical study is the evaluation of clinical performance to stay in place up to seven days and the safety of both dressings. Further, data on wearing comfort, product handling, pain during removal and quality of life are considered as secondary outcomes. The products will be used as part of routine wound care within the scope of their intended purpose without any additional invasive or burdensome examination.


Eligibility Criteria:
Inclusion Criteria:

* Men, women or diverse
* ≥ 65 years of age
* Patient is mentally and physically able to participate in this study
* Signed informed consent to participate in this study
* Fragile skin condition
* Acute wound (surgical wound or laceration), indicated for treatment with the investigational products for a time period of 7 days

Exclusion Criteria:

* Infection of the target wound
* Alcohol or drug addiction
* Known sensitivity or allergy to any component of the study product
* Patients who participate in any other clinical study investigating drugs or medical devices
Characteristics of Patients Diagnosed With NSAID Sensitivity in Thailand

Study clinical characteristics and phenotypes of patients diagnosed with NSAID sensitivity in Thailand


Eligibility Criteria:
Inclusion Criteria:

* Thai patients with a history of an immediate reaction to aspirin/paracetamol, or NSAIDs visiting King Chulalongkorn memorial Hospital

Exclusion Criteria:

* None
Evaluation of Treatment and Prophylaxis of Invasive Fungal Infections in Immuncompromised Patients in Austria (Study P05532)(WITHDRAWN)

The purpose of this program is to determine the frequency of the use of Posaconazole in immunocompromised patients refractory to first line therapy receiving therapeutic treatment based on different pathogens in comparison to other antifungal therapy.

A further objective is to determine the frequency of the use of Posaconazole in immunocompromised patients receiving prophylactic treatment in comparison to other antifungal prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Immunocompromised patients with refractory IFI
* Patients eligible for prophylactic treatment due to anticipated neutropenia for more than 7 days.

Exclusion Criteria:

* None
Increasing Access to Multiple Micronutrient Supplementation - A Pilot Intervention at up to 15 Clinics in Botswana

The purpose of this study is to pilot a clinic-level supplementation intervention at up to 15 antenatal clinics throughout Botswana. The overall objective of this study is to improve access to and uptake of MMS among pregnant women in Botswana. The investigators will evaluate both implementation outcomes (adoption, penetration, fidelity, and feasibility) and clinical outcomes (adverse birth outcomes, weight gain in pregnancy, and anemia) through linkage with the Tsepamo birth outcomes surveillance study.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women attending interventional antenatal clinics during the 6-month study

Exclusion Criteria:

* None
Impact of the CT Scan in Patients With Suspected Covid-19

The diagnostic performance of the scanner in the indication of suspected Covid-19 is not yet well known, especially in comparison with the results of RT-PCR.

The potential use of the scanner as a tool for quantifying the severity of Covid-19 disease is not yet well established, especially the variations between readers or between measurement techniques.

The impact of the scanner in predicting the fate of patients with confirmed Covid-19 is not yet known.


Eligibility Criteria:
Inclusion criteria

* Adult patient (≥18 years old)
* Patient admitted to Strasbourg University Hospitals for suspicion of Covid-19, between 03/01/2020 and 04/29/2020
* Availability of at least one chest CT scan during hospitalization
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Non-inclusion criteria

* Patient who expressed his opposition to participating in the study
* Patient under legal protection
* Patient under guardianship or guardianship