cyrilzakka/clinical-trials huggingface dataset:
Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role

Leptin, a circulating hormone expressed abundantly in adipose tissue, has been reported to be a satiety factor. In addition, it has been shown to increase during pregnancy in maternal blood, parallel to increase in body fat mass, to correlate with fetal body weight gain and to fall down to basal levels after delivery.

Little is known about leptin levels in pregnant women with preexisting or gestational diabetes and their relationship with fetal and postnatal growth and perinatal complications.

Therefore, the proposed study aims to understand and characterize the role of leptin in gestational diabetes mellitus as well as the relationship between leptin, cytokines and the pathophysiological complications during diabetic pregnancy. Specifically, we will evaluate 60 pregnant women both in Germany and in Israel and evaluate serum levels and mRNA of leptin, cytokines (inflammatory as well as Th1 and Th2) and correlate them to maternal changes of body weight and birth weight in women of various degrees of glucose tolerance and with various degrees of metabolic control during pregnancy; relationship between serum and umbilical cord vein concentrations of leptin, cytokines and metabolic variables; placental expression of leptin, leptin receptor, selected cytokines, GLUT1 and 4 and relationship to leptin in serum and umbilical cord plasma; comparison between all above parameters of German and Israeli pregnant women.

The results of this new and systematic study will shed light on the role of leptin and cytokines in the development of glucose disturbances during pregnancy and the perinatal outcome of women with gestational or preexisting diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

random glucose challenge test (GCT): 50 g of glucose are orally given at any time of the day. The results are considered as positive if the capillary blood glucose concentrations 1 hour after the load are \>130 mg/dl. Those with normal results serve as control group

Exclusion Criteria:

-
Opioid Tapering After Spine Surgery

The effect of a tapering plan combined with telephone counselling to assist patients in opioid tapering after surgery remains unexplored. A prospective, randomized controlled trial investigating the effect of a tapering plan in combination with telephone counselling in patients scheduled for spine surgery on a degenerative basis is therefore conducted.

Background with aim:

Preoperative opioid-use is one of the strongest predictors for not tapering off opioids after discharge from surgery. In qualitative studies on chronic opioid use, patients call for further help and assistance in tapering opioids. The aim of this study is to investigate the effect of receiving a tapering plan at discharge and telephone counselling one week after discharge on short and long-term opioid-use in preoperative opioid-users who undergo scheduled spine surgery.

Methods:

One-hundred and ten adult patients scheduled for spine surgery will be included in an investigator-initiated, prospective, randomized, controlled trial with two arms: an intervention arm (receiving tapering plan at discharge and telephone counselling on opioid tapering 5-7 days after discharge) or a control arm (receiving no tapering plan or telephone counselling). The study is approved by the Danish Data Protection Agency (1-16-02-211-19) and the Central Denmark Region Committees on Health Research Ethics (1-10-72-138-19).

Hypothesis:

Our primary hypothesis is that a tapering plan and telephone counselling reduces the percentage of patients who exceed their preoperative opioid consumption from 25% to 5% one month after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Daily opioid consumption at least 14 days before surgery
* Planned degenerative cervical, thoracic or lumbar spine surgery

Exclusion Criteria:

* Severe physical co-morbidity or inability to participate (dementia, language problems or mental illness)
Ribomustin in the Second Line Therapy of Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the second line therapy of relapsed or refractory indolent B-cell non-Hodgkin's lymphoma


Eligibility Criteria:
Inclusion Criteria:

* Doctor's decision to prescribe Ribomustin and rituximab combined therapy for the treatment of relapsed or refractory indolent B-cell Non-Hodgkin's Lymphoma (iNHL)
* Informed Consent Form for personal data handling signed by the program participant, authorized by the Independent Ethics Committee
* Eastern Cooperative Oncology Group (ECOG) status \< 2.
* Confirmed relapse or disease progression of B-cell CD20+ Non-Hodgkin's Lymphoma (lymphocytic, lymphocytoplasmocytic, follicular, marginal zone) after minimum one line of iNHL treatment
* Patients with relapsed or refractory indolent B-cell Non-Hodgkin's Lymphoma with current or planned Ribomustin and rituximab combined therapy with following rituximab maintenance therapy

Exclusion Criteria:

* Indolent Non-Hodgkin's Lymphoma transformation
* Lymphoma with central nervous system (CNS) involvement
* Presence of second malignant tumor.
* Currently participating in any clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment.
* Contraindications for Ribomustin usage in accordance with product label
* Contradictions for rituximab usage in accordance with product label
Coronary Revascularisation by rePOT

The presence of a coronary bifurcation complicates percutaneous revascularization. Bifurcation stenting needs to take into account the difference of diameter between proximal and distal vessels and the necessity to limit the side branch obstruction. Provisional stenting techniques with balloon juxtaposition as Kissing Balloon Inflation (KBI) fail to demonstrate a clinical benefits. This is probably explain by the detrimental effect during these technics on the proximal segment with an arterial overstretch. A new sequential technique, named rePOT, demonstrated experimentally a mechanical superiority compared to juxtaposition balloon techniques included KBI. RePOT associates an initial proximal optimizing technique (POT), a side branch inflation and a final POT.

A first clinical study (n=106 patients) confirmed these excellent mechanical results with serial OCT analysis and demonstrated an excellent short term safety. Since 2017, rePOT is recommended in Europe in clinical practice.

This large registry is dedicated to confirm the clinical benefits at long term after bifurcation revascularization with rePOT technique before a large randomise trial.


Eligibility Criteria:
Inclusion Criteria:

* Discovery, during angiography, of a significant coronary lesion (by angiographic or functional assessment) including a bifurcation under a provisional stenting strategy. Bifurcation have to be significant according to the operator and the coronary anatomy (but the side branch diameter have to be greater than 1.75mm)
* Stable lesion without high thrombus burden
* Patient agreement to study participation and ≥ 18 years

Exclusion Criteria:

* Complex lesion or anatomy requiring revascularization strategy with more than one stent
* Contraindication to a double platelet anti-aggregation ≥ 6mois (recommended implantation of active stent)
* Unstable patient according to the operator (used of hemodynamic drug support, mechanical ventilation)
* Indication of cardiac surgery.
* Lesion culprit in ST- or non ST-elevation myocardial infarction \<12h.
* High thrombus burden in angiography or endocoronary imaging (IVUS, OCT).
* Pregnancy, loose of legal right
* Other interventional study participation \<30 jours.
MS PATHS COVID-19 Questionnaire Data Linkage Sub-Study

The primary objective of this sub-study is to supplement the Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS) dataset with coronavirus disease 2019 (COVID-19)-related health information obtained from periodic participant questionnaires administered by participating MS PATHS institutions.


Eligibility Criteria:
Key Inclusion Criteria:

1. Be enrolled in MS PATHS under Study 888MS001.
2. Completed one or more COVID-19 questionnaire at a participating MS PATHS institution.
3. Permission for data linkage either obtained when completing a local COVID-19 questionnaire or granted by waiver of informed consent from the local institutional review board (IRB) or ethics committee (EC).

Key Exclusion Criteria:

1. Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the participant unsuitable for participation in the sub-study. A participant only needs to complete the assessments deemed necessary by the Investigator.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Effect of Formoterol on the Counterregulatory Hormonal Response to Hypoglycemia in Type 1 Diabetes.

Insulin treatment often causes the blood glucose levels to fall too low. The body usually responds to low blood glucose levels by releasing hormones which act against the insulin to help correct the low blood glucose levels. However, this hormone response can be altered in people with diabetes. Currently there are no therapeutic agents that can be used to improve the recovery from hypoglycemia (low blood sugar). The aim of this study is to determine whether a formoterol inhaler can be used to improve and accelerate the recovery from hypoglycemia in patients with type 1 diabetes.

Note: Below is the original detailed description submitted in 2010. The recruitment for this study was stopped at 7 subjects in each study arm. The study design and outcome measures did not change for this study. See below for further details.

Original: 15 subjects with well controlled type 1 diabetes and regular hypoglycemia and 15 healthy volunteers will be recruited for this study.

If you agree to participate in this study, you will be asked to participate in a screening at Yale New Haven Hospital. Each study subject will undergo two hypoglycemic clamp studies (a procedure where the blood sugar is closely regulated with intravenous insulin and glucose.) In these hypoglycemic clamp studies, the subject will be given an inhaler. On one visit the inhaler will contain formoterol capsules and on the other visit, the subject will be given 'dummy' capsules. Subjects will be required to be admitted to the HRU the night before the study so that glucose levels can be stabilized and hypoglycemia avoided.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes (well controlled, 2-3 hypoglycemic episodes/wk)
* age 18-50
* BMI 18-30

Exclusion Criteria:

* pregnancy
* significant diabetes complications
* liver disease, cirrhosis
* cardiac disease
* neurological disorder
* autonomic neuropathy
* kidney disease
* lactose intolerance
Laser Therapy Prevents Mucositis Oral in Chemotherapy for Bone Marrow Transplantation?

Setting: Oral mucositis is a very common complication of cancer treatment, accounting, often at increased risk for infections and even the interruption of treatment, interfering with the prognosis of the disease. The low intensity laser therapy has been proposed as an alternative for the treatment and prevention of this side effect, with good results in terms of clinical and functional, speeding up the process of wound healing and reducing pain.

Objective: To evaluate the effectiveness of using low power laser in the prevention of oral mucositis in patients with hematological cancer, undergoing chemotherapy for bone marrow transplantation.

Methods: There will be a Clinical Trial Randomized, double-blind study to evaluate the effectiveness of using low power laser in the prevention of oral mucositis in patients with hematological cancer, undergoing chemotherapy for bone marrow transplantation. Participate in the study, patients who are in the condition mentioned above accepting participate and have aged over 18. Will be excluded from the study patients who have autoimmune disease, which present sensitivity to laser or who have already started treatment for oral mucositis prior to this study.The study variables are:-independent variable: whether or not the red laser of low power-dependent variables: oral mucositis, degree of mucositis, chemotherapy regimen, type of blood cancer. For determining the association between the independent variable and the dependent will be used chi-square tests of association (Pearson) and Fisher's exact test, if necessary. Will calculate the risk ratio (RR) as a measure of relative risk, with the confidence interval at 95% (IC95%).Also be calculated NNT (number needed to treat to obtain benefit) and NNH (number needed to harm getting). Will be adopted a significance level of 5%. The project was approved by the Ethics and Research iMIP. All patients will be appropriately informed about the objectives of the project and will only be included if they voluntarily agree to participate by signing the consent form.

Keywords: laser, prevention and control; oral mucositis, bone marrow transplant.

Inclusion Criteria: patients with blood cancers undergoing chemotherapy for

BMT; patients who agree to participate; patients older than 18 years.

Exclusion Criteria: patients with autoimmune diseases; patients who have sensitivity to the laser; patients who have already started treatment for mucositis prior to the research; HIV-positive patients.

Eligibility Criteria:
Inclusion Criteria:

* patients with hematologic cancers undergoing chemotherapy for

BMT;

* patients who agree to participate;
* patients older than 18 years.

Exclusion Criteria:

* patients with autoimmune diseases;
* patients who have sensitivity to the laser;
* patients who have already started treatment for mucositis prior to research.
Retrospective Evaluation of COPD Patient Care

The purpose of this project is to evaluate hospital utilisation, patient and service outcomes of a Respiratory Nursing Service to examine current clinical care of COPD. This evaluation aims to identify the important gaps in current clinical care of respiratory chronic disease nursing management. The primary outcomes of this evaluation is to determine the efficacy of clinical care in 2006, 2011, 2013 and 2015 and compare data to current Nursing Best practice guidelines for COPD through the quantification of hospital utilisation for hospital admission, average length of stay, readmission within 28 days, emergency service attendance, outpatient review, use of Hospital and Home (H@H), frequency of exacerbations, disease severity and progression (FEV1: GOLD Classification), number of contacts with the respiratory nursing service and type of contacts with the respiratory nursing service.

Study design: This study is a retrospective observational crosssectional study conducted through review of medical records, internal respiratory databases and electronic hospital patient record (OACIS \& HOMER) over 3x12 blocks.

Participants: COPD patients from The Queen Elizabeth Hospital(TQEH) Respiratory Nursing Service who were new patients in 2006, 2011, 2013 and 2015 (Jan 1st to Dec 31st ). Data collection: Demographics, clinical data, hospital service utilisation, and clinical outcomes such as exacerbation frequency and disease progression. All data will be extracted into a standardised data extraction form, which a random subset will be checked by a second researcher.

Demographic data will include comparison of % without comorbidities, impact of comorbid conditions using Charleston Comorbidity index isolating diabetes, heart failure, anxiety and depression. Demographic and descriptive data will be given in means + SD and compared using a two-tailed Student t-test. Categorical variables will be compared using chisquared or Fisher exact tests, and when appropriate the MannWhitney Utest for nonparametric data. Statistical significance will be determined using an alpha of p \<0.05. All analyses will be examined using SPSS software (version x).

Eligibility Criteria:
Inclusion Criteria

* any new client or new referral to the Respiratory Nursing Service in the years 2006, 2011, 2013 or 2015 only
* have a diagnosis of Chronic Obstructive Pulmonary Disease

Exclusion Criteria

* not a pre- existing client of the Respiratory Nursing Service
* not having a diagnosis of Chronic Obstructive Pulmonary Disease
Meditation for Older Adults With Chronic Low Back Pain

This pilot randomized controlled trial aims to recruit 66 community-dwelling older adults with chronic low back pain and follow up them for 8 weeks. This study aims to test the preliminary effect of a mindfulness-based meditation (MBM) intervention on pain and symptoms among community-dwelling older adults with chronic low back pain, and also to test the effect of the MBM intervention on the host Gut-Brain Axis (GBA).

Aim 1: to test the preliminary effect of a mindfulness-based meditation (MBM) intervention on pain and symptoms among community-dwelling older adults with chronic low back pain.

Hypothesis: We hypothesize that our active mindfulness-based meditation intervention will be feasible and acceptable to community-dwelling older adults with chronic low back pain and improve pain and symptoms to a greater extent than older adults randomized to a sham mindfulness-based meditation group.

Aim 2: to test the effect of the mindfulness-based meditation intervention on the host Gut-Brain Axis (GBA).

Hypothesis: We hypothesize that older adults randomized to the active mindfulness-based meditation intervention will have significantly improved compositional patterns and functional profiles of gut microbiota and increased pain-related cortical response measured by functional near-infrared spectroscopy (fNIRS) to a greater extent than older adults randomized to the sham mindfulness-based meditation group at 2-weeks post-intervention, and 8-weeks follow up.

Eligibility Criteria:
Inclusion Criteria:

1. aged 50 years older
2. intact cognition (examined by the Mini-Mental State Exam, ≥ 24)
3. experiencing moderate low back pain daily or almost every day at least the previous three months (≥3 out of 10 on numeric rating scale \[NRS\])
4. able to speak and read English
5. not intent to change medication regimens for pain throughout the trial

Exclusion Criteria:

1. serious underlying illness (e.g., malignant neoplasms, bloodborne illness, low blood platelet count, been in chemotherapy)
2. other concurrent chronic pain conditions (e.g., arthritis, headache, irritable bowel syndrome)
3. psychosis
4. inflammatory or malabsorptive intestinal diseases
5. function limitation precluded the meditation practice
6. participated meditation program before
7. no access to the internet
A Study to Learn About the Medicine (PF-07321332 or Nirmatrelvir/Ritonavir) in Healthy Lactating Women

The main purpose of this study is to measure the level of active ingredient of the study medicine (nirmatrelvir) that is secreted in human breast milk when it is given to healthy breastfeeding women. The study medicine consists of two medicines, nirmatrelvir and ritonavir. We are seeking female participants who are:

* Actively breast-feeding (lactating) at least 12 weeks postpartum;
* Age between 18 to 55 years and not currently pregnant;
* Have a Body Mass Index (BMI): 17.5 kg/m2; and a total body weight \>50 kg (110 lb).

Participants will take the study medicine by mouth for a total of 3 times over 2 days (2 morning doses and 1 evening dose) at the study clinic. We will periodically collect breast milk from day 2 to 4 to measure the level of nirmatrelvir and ritonavir in it. A safety follow up call will be conducted around 28-35 days from the last dose to monitor any reactions participants may have to the study medicine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy lactating females who are actively breast-feeding or expressing breast milk, at least 12 weeks post-partum and not currently pregnant between 18 and 55 years old
* Body Mass Index (BMI): 17.5 kg/m2; and a total body weight \>50 kg (110 lb)
* Infants of women enrolled in the study must be able to feed successfully from a bottle or other age-appropriate alternative feeding method prior to the start of the study and must be able to tolerate infant formula if the mother does not have a supply of stored breast milk sufficient to cover the duration of the study
* Participants must be willing to temporarily discontinue breast feeding their infants for a total of 4.5 days (108 hours)
* Participants must be willing to regularly pump breasts throughout the study and express milk according to a schedule designed to maintain lactation throughout the study period

Exclusion Criteria:

* Positive test result (RT-PCR) for SARS-CoV-2 infection at the time of screening or Day -1
* Evidence or history of clinically significant findings
* History of febrile illness or mastitis within 5 days prior to the first dose of study medication
* Participants who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period
* History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed
* Abnormal vital signs such as blood pressure, 12-lead electrocardiogram
* History of alcohol abuse and/or illicit drug use, tobacco use in excess of 5 cigarettes/day or 2 chews/day
* Blood donation within 60 days
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HCP1303 Capsules

The main objective of this study is to evaluate efficacy and safety of HCP1301 capsule in patients with Benign Prostatic Hyperplasia and Erectile Dysfunction

A multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of HCP1303 capsule

Eligibility Criteria:
Inclusion Criteria:

* At Visit 1

  1. ≥50 age
  2. BPH(Benign Prostatic Hyperplasia) + Total IPSS(International Prostate Symptom Score) ≥ 13
  3. Abnormal Erectile function ≥ at least 3months based on screening date
* At Visit 2 1. Total IPSS ≥ 13

Exclusion Criteria:

1. History of hypersensitivity to Tamsulosin or Tadalafil
2. History of allergy for Sulfonamide
3. PSA (Prostate Specific Antigen) ≥4ng/mL
Inspiratory Flow and Volumes in Bronchiectatics

Adequate administration of drugs via dry powder inhalers is dependent on adequate inspiratory flow rates and volumes. These vary according to the device being used and its resistance. The dry powder inhaler device under investigation is a device approved by the Therapeutic Goods Administration (ARTG no. 196255) for use with dry powder mannitol. Dry powder mannitol is currently being investigated as a treatment for bronchiectasis. We wish to measure the inspiratory flow characteristics of both the low and high resistance devices amongst a group of subjects with bronchiectasis.

We propose that the majority of subjects investigated with varying lung function will achieve adequate flow during a controlled inspiration.


Eligibility Criteria:
Inclusion Criteria:

* non-cf bronchiectasis
* aged 18-80 inclusive
* FEV1 greater or equal to 50% predicted and greater or equal to 1L

Exclusion Criteria:

* uncontrolled asthma
* CF bronchiectasis
* have any condition for which spirometry measurement would be contraindicated