cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients

This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.


Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of type 2 diabetes mellitus prior to informed consent
2. Male and female patients on diet and exercise regimen who are drug-naïve (defined as absence of any oral antidiabetic therapy, glucagon like peptide-1 analog or insulin for 12 weeks prior to randomization) or pre-treated with metformin (=1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.
3. Glycosylated hemoglobin (HbA1c) = 7.0% and = 10.5% (= 53.0 mmol/mol and = 91.3 mmol/mol) at Visit 1 (screening)

Exclusion criteria:

1. Uncontrolled hyperglycemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day).
2. Any other antidiabetic drug within 12 weeks prior to randomization (except metformin background therapy as defined via inclusion criterion 2)
3. Acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction and unstable angina pectoris), stroke or (transient ischemic attack) TIA within 3 months prior to informed consent
Effect of Physical Therapy Exercises on Cardiorespiratory Fitness Level in COVID19 Patients After Recovery.

In some patients, lung function declined by about 20 to 30% after recovery. Computer tomography of COVID-19 patients revealed a ground glass opacity in both lungs. We will measure the Cardiorespiratory fitness according to American College of Sports medicine guidline and provide physiotherapy exercise to the patients to measure the improvement.

In December 2019, the first reports emerged of a novel severe acute respiratory syndrome (SARS) coronavirus 2 (SARS-CoV-2) in Wuhan, China. The virus, which causes atypical pneumonia progressing to acute lung injury and acute respiratory distress syndrome (ARDS) in some individuals, was named COVID-19. The burden of fibrotic lung disease following SARS-CoV-2 infection is likely to be high; therefore, given the scale of the pandemic, the global burden of fibrotic lung disease will probably increase considerably. The aim of this study is to check the cardiorespiratory fitness level and the effect of Physical therapy intervention to improve the Cardiorespiratory fitness level in patients recovered from COVID-19. Quality of life has also been affected due to COVID19 due to decreased Cardiorespiratory fitness level, and this study also aims to improve the quality of life of people recovered from COVID19.

Eligibility Criteria:
Inclusion Criteria:

* Recovered from COVID 19 disease (PCR report).
* Sub-normal performance as compared to normative data.
* Do not have any Respiratory Problem.
* Consent to participate in the study.
* Able to understand and perform the exercise.
* Age from 18 to 75.
* Dyspnea due to COVID19.
* Modified Borg Dyspnea Scale score at least 2 but less than 7.

Exclusion Criteria:

* Not suffered from COVID 19.
* Respiratory Problem.
* Resting Blood Pressure greater than 160/100 instead of taking medicine
* Greater than 1-month post COVID19 Recovery.
* Cardiorespiratory comorbidities which limit participation in exercise.
* Any Musculoskeletal problem which limit participation in Training.
* Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal blood pressure responses or ST-segment depression \> 2mm, symptomatic aortic stenosis, complex arrhythmias).
* Unstable angina
* Orthostatic blood pressure decrease of \>20 mmHg with symptoms
* Hypertropic cardiomyopathy
Topical Methotrexate with Fractional CO2 Laser in Treatment of Non Segmental Vitiligo

This prospective, within subject clinical trial aims to evaluate the efficacy of combining fractional CO2 laser with topical methotrexate versus topical methotrexate alone in treating non-segmental vitiligo. Patients with comparable lesions on both sides of their body will receive both treatments randomly assigned to each side. The study assesses repigmentation, safety, patient satisfaction, and quality of life over six months.

The study is a prospective, within subject, self-controlled, randomized clinical trial conducted at the Department of Dermatology, Assiut University. Participants are patients aged 18-65 with stable non-segmental vitiligo, having comparable lesions on both sides of their body. They must not have received corticosteroid or phototherapy treatments in the last three months and must provide informed consent. Exclusion criteria include other skin diseases, pregnancy, severe organ dysfunction, compromised immune function, and skin type 1 with phototherapy allergy.

Intervention and Follow-Up One side of each participant's body will receive fractional CO2 laser combined with methotrexate 1% gel, while the other side will receive topical methotrexate alone, with treatments randomized to avoid bias. The laser therapy consists of four sessions at three-week intervals using specific parameters. Participants will be followed up for six months, with assessments at baseline, during treatment, and post-treatment.

Outcome Measures The primary outcome is the percentage of repigmentation, assessed through standardized digital photographs evaluated by blinded dermatologists. Secondary outcomes include safety evaluation, patient satisfaction, the pattern of repigmentation, the Vitiligo Area Scoring Index (VASI) score, and quality of life measured using a validated questionnaire.

Methods for Evaluation Photographs will be taken under Wood's lamp examination at baseline, before each treatment session, and two months after the final treatment. The efficacy will be evaluated by comparing pre- and post-treatment photographs. Safety and patient satisfaction will be assessed throughout the study period. The study aims to provide evidence on the effectiveness of combining fractional CO2 laser with topical methotrexate for vitiligo treatment.

Eligibility Criteria:
Inclusion Criteria:

* Participants are patients aged 18-65 with stable non-segmental vitiligo, having comparable lesions on both sides of their body. They must not have received corticosteroid or phototherapy treatments in the last three months and must provide informed consent.

Exclusion Criteria:

* Exclusion criteria include other skin diseases, pregnancy, severe organ dysfunction, compro
uPAR PET/CT for Preoperative Staging of Breast Cancer Patients

The sensitivity and specificity of uPAR PET/CT for preoperative detection of lymph node metastases in breast cancer.

The sensitivity and specificity of uPAR PET/CT for detection of lymph node metastases will be tested by observer-blinded readings (two separate teams) and compared to diagnostic performance of conventional preoperative diagnostic workup procedures. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection (SN/ALND). Primary end point dichotomized: +/- lymph node metastases in ipsilateral axilla.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-verified breast cancer
* Primary tumor more than 2 cm (ultrasound or clinically)
* The participants must be capable of understanding and giving full informed written consent

Exclusion Criteria:

* Pregnancy
* Lactation/breast feeding
* Weight above 140 kg
* Treatment with neoadjuvant chemotherapy
* Known allergy towards the IMP
To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives

This survey is conducted in South America. The purpose is to identify the key psychosocial issues affecting patients with haemophilia.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 years or above with haemophilia A or B (with or without inhibitors) OR Parents/caregivers of children/adolescents younger than 18 years with haemophilia A or B (with or without inhibitors); only one subject per household will be able to participate
* Patients currently receiving one of the following treatments: a. replacement factor VIII therapy, b. replacement factor IX therapy, c. bypassing agents (recombinant factor VIIa or APCC) OR Patients with haemophilia, not receiving any kind of treatment with replacement factor VIII or IX or a bypassing agent (as appropriate), but who have had at least one spontaneous haemorrhage into one or more joints within the last 12 months
* The participants (patients with haemophilia and parents/caregivers for patients under 18 years old) must be able to complete a paper questionnaire in order to participate in the study
* Providing informed consent before the start of any study-related activities

Exclusion Criteria:

* Inability for the patients or parents/caregivers to understand and comply with verbal instructions, unless assisted by a member of the HTC (Haemophilia Treatment Center) or by a relative. (No other conditions were established for patients who cannot read or write to be able to participate in this study in addition to the need of help from a member of HTC or by a relative.)
Amniotic Membrane and Anterior Stromal Puncture to the Treatment of Symptomatic Bullous Keratopathy

The purpose of this study is to determine whether amniotic membrane transplantation is as effective as anterior stromal puncture in the relief of symptomatic bullous keratopathy.

Patients with symptomatic bullous keratopathy were randomized in 2 groups and submitted to amniotic membrane transplantation or anterior stromal puncture. The follow up was made with 1, 3, 6 and 12 months. Evaluation included complete ophthalmologic exam, esthesiometry, pachymetry, impression cytology and evaluation of pain.

Eligibility Criteria:
Inclusion Criteria:

* bullous keratopathy

Exclusion Criteria:

* age under 18 years old
* asymptomatic bullous keratopathy
* corneal infection
* ocular hypertension
Dose Escalation of Different Concentrations of ZK 245186 in Atopic Dermatitis

The purpose of this study is to determine the safety and efficacy of three concentrations of ZK 245186 ointment and vehicle on increasing body surface areas for the treatment of atopic dermatitis and to obtain dose-response information for the three concentrations.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of atopic dermatitis (Hanifin and Rajka criteria)
* mild to moderate atopic dermatitis at beginning of study
* wash-out periods for systemic and topical treatments for atopic dermatitis
* females must use effective contraception

Exclusion Criteria:

* pregnant or lactating women
* conditions that in the opinion of the investigator may pose a risk or interfere with the evaluation of the study
* wide-spread atopic dermatitis requiring systemic treatment
* diagnosed with immunocompromised status
* skin diseases - other than atopic dermatitis - in the treatment area
* mental handicap or legally incompetent
Stress and Coping in Caregivers of Younger Patients With Cancer

This research trial studies stress and coping in caregivers of younger patients with cancer. Learning how caregivers of children with cancer experience and cope with chronic stress may help to develop effective programs for reducing caregiver stress.

PRIMARY OBJECTIVES:

I. To determine how the experience of distress and use of positive emotion coping strategies by pediatric cancer caregivers differs from caregivers of children with no chronic illnesses.

II. To determine how relationships between positive coping strategies and caregiver distress change during the different phases of a child's illness.

III. To explore how chronic caregiver stress affects physiological reactivity to and recovery from an acute laboratory stressor.

IV. To explore how different positive coping mechanisms help chronically stressed caregivers recover from acute stressors and how these efficacies change during the different phases of the child's illness.

OUTLINE:

PART I:

Participants complete a questionnaire that measures several psychological constructs including stress, anxiety, depression, coping mechanisms, uncertainty, positive and negative emotions, and life satisfaction over 15-30 minutes.

PART II:

Participants undergo a Trier Social Stress Test during a laboratory session over 1.5 hours.

Eligibility Criteria:
Inclusion Criteria:

* Ability to read and speak English
* Must serve as a primary caregiver of their child (ages 0-17) - as reported by the participant
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* (Part 1 and Part 2): Must not have a family member who has already participated in the study
* (Part 2): Must not be pregnant or have a history of cardiovascular disease, hypertension, pituitary disorder, or adrenal disorder
* CONTROL PARTICIPANTS: (Part 1 and Part 2): Participants must not have a child with a chronic illness (e.g., diabetes, asthma, multiple sclerosis)
Comparison of Choosing Free ALT or Free PMT for Reconstruction With Head and Neck Cancer

This study was designed to compare the outcome of the anteromedial thigh (AMT) and anterolateral thigh (ALT) flaps in head and neck cancer reconstruction.

To compare the results of the AMT and ALT flaps, this study aimed to compare their outcomes in head and neck cancer reconstruction under the condition of attenuating baseline patient and operative characteristics with the selection of propensity score-matched patient cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent ALT or AMT free flap reconstruction after head and neck cancer surgery between March 1, 2008 and February 28, 2017.

Exclusion Criteria:

* Patients whose data were missing will be excluded.
Intrathecal Morphine Versus Intravenous Methadone for Postoperative Analgesia Following Retroperitoneal Lymph Node Dissection.

This randomization study is to compare both intrathecal morphine and intravenous methadone, which are both standard of care, for pain management in patients undergoing retroperitoneal lymph node dissections for primary testicular cancer. Investigators plan to compare their analgesic effectiveness at different postoperative time intervals.

In this study, investigators aim to compare intravenous methadone combined with standard multimodal analgesia and surgical infiltration of local anesthesia to intrathecal duramorph with standard multimodal analgesia and surgical infiltration of local anesthesia. In this single blinded prospective randomized control trial, investigators hypothesize that intravenous methadone will provide a significant reduction in patient opioid consumption when compared to intrathecal opioid analgesia in the first 24 hours in patients who undergo PC/RPLND.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a virgin (chemotherapy has not been used) or post- chemotherapy retroperitoneal lymph node dissection for primary testicular cancer at IU Health AAHC
* ASA Class 1, 2, 3
* Age 18 to 80 years; Male
* BMI less than 50kg/m2

Exclusion Criteria:

* Any contraindication for neuraxial analgesia
* Patient on home methadone at any dose
* Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
* Known true allergy to the study medications (morphine, bupivacaine, acetaminophen, methadone)
* Any history of substance abuse in the past 6 months which would include heroin or any other illegal street drugs
* End stage liver disease, end stage renal disease
* Patient staying intubated after surgery
* Patient (home dose) taking more than 30mg PO morphine equivalent (PME) per day
* Any additional surgical procedures to the patient with a different surgical incision compared to the standard laparotomy for the RPLND procedure, i.e. thoracic tumor reduction
Racial Inequality in Inhaler Fills for COPD - A Trial of Reduced Cost-Sharing

In partnership with a large Medicare Advantage (MA) insurer (Humana, Inc.) and as part of a Center for Medicare and Medicaid Innovation demonstration program of Value-Based Insurance Design (VBID), the investigators propose to study a randomized controlled quality improvement trial in which Humana randomized MA beneficiaries with COPD to receive proactive outreach for a VBID benefit that provided large reductions in cost-sharing for their maintenance inhalers and telephone-based COPD medication management services in 2020 and 2021. The investigators will analyze changes in racial disparities for inhaler fills, clinical outcomes, health care spending, and acute care utilization.


Eligibility Criteria:
Inclusion Criteria:

* Has COPD diagnosis
* Receives health services and prescription drug benefits through a Humana Medicare Advantage plan that includes Part D coverage
* Has at least one prior fill of a COPD maintenance inhaler in the prior 12 months
* Not fully adherent to maintenance inhaler (PDC \< 80%) in year prior to randomization

Exclusion Criteria:

* Enrolled in Part D Low-Income Subsidy program
* On hospice
* Has end-stage renal disease
* Has mild COPD (i.e., COPD diagnosis but no maintenance inhaler fill, no pulmonary function tests in year prior year, and no acute care use for COPD)
* Enrolled in Humana plan for less than 3 months
* In the coverage gap phase of MA plan at time of assignment
* Receives primary care at select locations of Humana subsidiaries (CenterWell or Conviva)
Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal Dysfunction

The purpose of this study is to determine the effect of renal impairment on pharmacokinetics (PK) of BMS-914143.

Primary purpose: Protocol designed to evaluate the effect of renal impairment on pharmacokinetics of BMS-914143

Eligibility Criteria:
Inclusion Criteria:

* Normal renal function or mild, moderate, severe or end-stage renal dysfunction

Exclusion Criteria:

* History of uncontrolled or unstable cardiovascular, respiratory, gastrointestinal, hepatic, endocrine, hematopoietic, psychiatric or neurological conditions within 6 months of Lambda administration
* History of chronic liver disease including cirrhosis, hepatitis B virus (HBV), hepatitis C virus (HCV), primary biliary cirrhosis, etc
* History of central nervous system or neuro-psychiatric disease. Subjects with severe depression and/or other uncontrolled psychiatric conditions should not be enrolled in this study
* History of of suicide attempt within the 5 years preceding BMS-914143 administration
* Inability to tolerate subcutaneous injections
* Donation of \>400 mL of blood within 8 weeks or plasma within 4 weeks of planned dosing
34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

Study of anatomical fixation with a 34mm proximal extension

The 34mm proximal extension stent graft is intended to augment the primary 28mm infrarenal bifurcated stent graft to accommodate patient anatomy (neck diameters up to 32mm) and provide an effective seal to prevent/repair proximal Type I endoleaks.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Informed consent understood and signed
* Will comply with protocol follow-up requirements
* Candidate for conventional open surgical repair
* Aneurysm outer diameter is one or more of the following:

  * greater than or equal to 4.0cm
  * greater than or equal to 3.0cm (saccular aneurysm)
  * greater than or equal to twice the normal aortic outer diameter
  * rapidly growing (greater than or equal to 5mm over 6 months)
* Proximal non-aneurysmal aortic neck fixation length greater than or equal to 1.5cm between the renal arteries and the aneurysm
* Non-aneurysmal proximal aortic neck inner diameter between 23 and 32mm
* Iliac artery internal diameter greater than or equal to 8 mm

Exclusion Criteria:

* Life expectancy \<2 years
* Participating in another clinical study
* Pregnant or lactating women
* Acutely ruptured/leaking aneurysm
* Traumatic vascular injury
* Other medical or psychiatric problems
* Contraindication to non-ionic contrast media or anticoagulants
* Coagulopathy or bleeding disorder
* Active systemic or localized groin infection
* Indispensable inferior mesenteric artery
* Connective tissue disease (e.g., Marfan's Syndrome)
* Creatinine level \>1.7 mg/dl
* Renal transplant patient
* Proximal attachment site \>60º angle to the aneurysm body
* Iliac arteries \>90º angle
* \<1.5 cm of non-aneurysmal common iliac artery above the iliac bifurcation on both sides \[One internal iliac artery is required to remain patent\]
* Thrombus \>30% at implantation site
A Small-molecule Carbonic Anhydrase IX Targeting PET Tracer in Clear Cell Renal Cell Carcinoma

The goal of this pilot clinical trial is to see the potential application of a CAIX targeted PET. tracer in patients with clear cell renal cell carcinoma. The main question\[s\] it aims to answer are:

* The biodistribution of the PET tracer
* Whether RCC lesions can be identified by the PET tracer Participants will undergo 68Ga-NY104 PET/CT scan and images will be reviewed by nuclear medicine specialists.

PET/CT imaging of three patients using 68Ga-NY104 for medical reasons will be performed. Patients received an intravenous injection of 68Ga-NY104. Images will be obtained at 0.5 h, 1 h, and 2 h after injection. A comparative 18F-FDG PET/CT scan will also be performed if necessary. The study will be carried out on a time-of-flight PET/CT scanner. SUVmax and SUVmean of normal organs and lesions, as well as tumor-to-background ratios, will be quantitatively assessed using a region-of-interest technique.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed or suspected metastatic ccRCC
2. Age ≥ 18 y
3. Written informed consent provided for participation in the trial
4. In the opinion of investigator, willing and able to comply with required study procedures.

Exclusion Criteria:

1. Patients on VEGF TKI treatment \< 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NY104 PET/CT is required.
2. Pregnancy or breastfeeding.
3. Severe claustrophobia.