cyrilzakka/clinical-trials huggingface dataset:
PROTOCOL 3: Role of the Renal Nerves in the Increase in EGP in Response to Glucosuria

Purpose/Objectives: Examining the effect of SGLT2 inhibition on EGP and plasma glucose concentration in diabetic and non-diabetic subjects after kidney transplantation (i.e. renal denervation) or in subjects after renal sympathectomy (63) can add insight about the possible role of a neural arc which mediates the changes in plasma glucagon and/or insulin concentration in response to glucosuria.

Purpose/Objectives: Examining the effect of SGLT2 inhibition on EGP and plasma glucose concentration in diabetic and non-diabetic subjects after kidney transplantation (i.e. renal denervation) or in subjects after renal sympathectomy (63) can add insight about the possible role of a neural arc which mediates the changes in plasma glucagon and/or insulin concentration in response to glucosuria.

Research Design/Plan: After screening, eligible subjects will receive 2 measurements of endogenous glucose production with a prime-continuous infusion of 3-3H-glucose. Each measurement will be performed on a separate day in random order after a 10-12 hour overnight fast and will last 8 hours (from 6 AM to 2 PM). After a 3-hour tracer equilibration period, each subject will receive one of the following medications in random order: (i) placebo and (ii) dapagliflozin 10 mg. Following the test medication at 9 AM, blood samples will be drawn every 20 minutes for an additional 5 hours and plasma glucose, insulin, C-peptide, glucagon, catecholamine concentrations and tritiated glucose sp act will be measured.

Methods: Visit 1: Screening Visit 2: Endogenous Glucose Production Measurement (EGP) Visit 3: After completing the first EGP measurement, subjects will return to the Diabetes Research Unit for the second study.

Eligibility Criteria:
Inclusion Criteria:

* age = 18-70 years
* BMI = 18.5-40 kg/m2
* HbA1c ≥ 7.0% and ≤10.0% for type 2 diabetics
* males or females
* Must be at least 3 months post renal transplantation and be on a stable dose of prednisone (≤5 mg/day), tacrolimus, and mycophenolate mofetil
* Not taking any antidiabetic medications or who are treated with metformin, sulfonylurea, dipeptidyl peptidase 4 (DPP4) inhibitor, thiazolidinedione or some combination
* Must be in good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, EKG and urinanalysis

Exclusion Criteria:

* Subjects who are taking insulin or SGLT2 inhibitor are excluded
* Only subjects whose body weight has not been stable (± 3 lbs) over the preceding three months and/or who participate in an excessively heavy exercise program will be excluded.
* Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine \>1.4 females or \>1.5 males (and eGFR \<45ml/min.1.73m2), or 24-hour urine albumin excretion \> 300 mg will be excluded.
Mindfulness-Based Physical Activity Intervention

The aims of this parallel two-arm pilot randomized controlled trial is to assess the feasibility and acceptability of an audio-recorded mindfulness-based intervention and to assess whether the intervention results in a clinically meaningful difference in physical activity compared to the control condition


Eligibility Criteria:
Inclusion Criteria:

* Reported less than 60-minutes of weekly moderate-to-vigorous physical activity (MVPA, moderate physical activity minutes + vigorous physical activity minutes\*2)
* Safe to exercise at moderate intensity without a doctor's approval according to American College of Sports Medicine Criteria
* Had a smart phone to access the audio-recorded mindfulness-based physical activity intervention
Observation of the Immune Response After COVID-19 Additional Vaccine Doses in Chronic Patients in Hemodialysis Therapy

Observation of humoral and cellular immune response after additional dose vaccine with different COVID-19 vaccines in ESKD patients in hemodialysis therapy.

In this open, prospective, observational trial the humoral and cellular immune response in ESKD patients undergoing hemodialysis shall be analyzed after administration of a fourth dose of vaccine. The total follow-up time per patient is up to 12 months after the fourth dose of vaccine.

In total, 340 patients (170 patients per country) shall be included. Only adult patients capable of giving consent will be enrolled. The humoral immune response will be analyzed in all patients, whereas the analysis of the cellular immune response will only be conducted in 15% of the enrolled patients.

The HD-COVID-IR-EU study shall be conducted in Portugal and in Spain.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated by study patient and investigator/authorized physician
* Minimum age of 18 years
* Ability to understand the nature and requirements of the study
* ESKD patients on maintenance hemodialysis with a minimum of 4hrs three times a week at the time of recruitment and a dialysis vintage ≥3 months in NC clinics
* Patients that already received three doses against COVID-19 as detailed in the manufacturer's instructions
* Patients that are scheduled to receive a fourth vaccine dose of either Comirnaty (BioNTech/Pfizer) or Spikevax (Moderna) after approval of respective national authority.

Exclusion Criteria:

* Any conditions which could interfere with the patient's ability to comply with the study
* Participation in an interventional clinical study during the preceding 30 days
* Previous participation in the same study
* Patients with proven current COVID-19 infection as identified by routine clinical practice
* Patient in therapy with immunosuppressive medications / immunomodulators
* Patients who already received a fourth COVID-19 vaccination dose
The Impact of Generic Labels on Compliance

Although generic drugs are pharmacologically equivalent to their brand-name counterparts, prejudices against the former remain strong among patients and doctors. In a randomized controlled field experiment, this research assesses the extent to which generic (versus brand-name) labels affect patients' consumption dosage, medication compliance and reported pain.

One hundred one patients scheduled to undergo invasive dental surgeries (i.e., dental implants) participated in the experiment. After dental surgery, patients were prescribed a once-daily analgesic regimen for up to 7 days. The intervention consisted of label manipulation. Patients were randomly assigned to either the brand-name analgesic or to its (purportedly) cheaper generic version. In reality, all participants obtained the same brand-name medication. The medication was provided at no cost, and patients were instructed to take the first pill while at the clinic. They were informed that they could (a) increase the dosage of the prescribed analgesic to twice daily if necessary and (b) stop taking the medication when no longer needed. Any other changes to the regimen were discouraged, and patients were instructed to consult with the dentist before any such changes. Telephone follow-ups were conducted at 24 hours, 4 days, and 7 days after surgery. Two main dependent variables were obtained: the number of prescribed analgesics consumed and the number of non-prescribed analgesics consumed. The patients also reported the pain felt during the period.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo dental implants and/or bone graft surgeries at the UFSC dental clinic

Exclusion Criteria:

* Patients not scheduled to undergo these treatments
Effect of Progesterone Administration on Severely Head Injured Patients

To investigate the effectiveness of progesterone as a neuroprotective in patients severe traumatic brain injury in clinical outcome


Eligibility Criteria:
Inclusion Criteria:patients with severe traumatic head injury GCS ≤8 both sexes.

\>16yrs,

-

Exclusion Criteria:

* -Tumor that may flare with progesterone.
* patients with spinal injuries with neurological deficits.
* severe chest trauma that causes shock and hypoxia.
* life-threatening systemic injuries that cause hemodynamic instability, cardiac arrest
* pegnancy
The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy

In order to provide a alternative treatment for relieving the pain and numbness of Diabetes Mellitus patients,Traditional Chinese Medicine powder was tested by subjective questionnaire and objective nerve conduction velocity study. Liver and kidney functions were tested to provided safety profiles.

120 participants with diabetic neuropathy were screened in endocrine and metabolism clinics of Taichung Veterans General Hospital and Chinese Medical University Hospital . Subjects were randomly distributed into a double-blind, 12 weeks, placebo-controlled procedure. Subjects were measured by MNSI, SF-BPI, SF-36, SF -MCQ, NCV, AC sugar, HbA1c, lipid profiles, liver and kidney functions.

Safety evaluations including GPT and creatinine revealed no deterioration after treatment. Several domains in MNSI, SF-BPI, SF-36, SF -MPQ questionnaires revealed significant improvements. F-wave in peroneal, tibial nerves and distal latency in tibial nerve in objective nerve conduction studies revealed significant improvements.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of DM
* Must have the symptoms of pain or numbness

Exclusion Criteria:

* Patient with pregnancy (or child bearing potential),or in lactation
* Patient currently taking concomitant TCM medications.
* Patient with Drug or alcohol addiction
* Patient with medical history of myocardial infarction, cerebro-vascular disease, major trauma, operation 6 months prior to enrollment
* Patient with liver dysfunction (SGOT or SGPT\>2x ULN)
* Patient with renal insufficiency (serum creatinine\>1.3mg/dL)
A Study of LY3437943 in Participants With Type 2 Diabetes Mellitus (T2DM)

The main purpose of this study is to learn about the side effects of LY3437943 when given to participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3437943, dulaglutide, or placebo given just under the skin. For each participant, the study will last up to about 5 months and will include 16 visits to the study center.


Eligibility Criteria:
Inclusion Criteria:

* Have T2DM for at least 3 months before screening and are without advanced known possible complications of diabetes mellitus
* Have a glycated hemoglobin (HbA1c) value at lead-in and screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening
* Have had a stable body weight for the 3 months prior to randomization (\<5% body weight change)
* Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive
* Male participants agree to use an effective method of contraception for the duration of the study plus 90 days, which corresponds to 4 months after the last investigational product dose
* Women not of childbearing potential may participate and include those who are: infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or those who are postmenopausal

Exclusion Criteria:

* Have type 1 diabetes mellitus or latent autoimmune diabetes in adults
* Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
* Have a known clinically significant gastric emptying abnormality
* Have had an episode of severe hypoglycemia
* Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of \>500 milligrams per deciliter (mg/dL) at screening and/or Day-2. If participant is on lipid-lowering therapies, doses must be stable for 30 days prior to screening
* Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) greater than 3X upper limit of normal (ULN) at screening and/or Day -2
Attenuated Inflammatory Response in Laparoscopic Colon Surgery

Pro-inflammatory responses following laparoscopic surgery.

Blood samples from 20 patient with colon cancer collected before and in 3 days following laparoscopic surgery. Analyzed for inflammatory cytokines and corresponding SOCS3 mRNA.

Eligibility Criteria:
Inclusion Criteria:Colon cancer stage I-III -

Exclusion Criteria:Colon cancer stage IV

-
The Effect of Intra-abdominal Pressure

The Effect of Intra-abdominal Pressure

The Effect of Intra-abdominal Pressure, Applied to the Patients Diagnosed with Diabetes Mellitus, Who Undergo Laparoscopic Surgery, on Hemodynamics

Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus
* laparoscopic surgery

Exclusion Criteria:

* hypertension
* hearth failure
* renal failure
* hepatic failure
* difficult intubation
* shock
MT-8554 for Reduction of Vasomotor Symptoms in Postmenopausal Women

The purpose of this study is to assess the efficacy and safety of MT-8554 for treatment of vasomotor symptoms (VMS) associated with menopause.

This is a Phase II randomized, double-blind, placebo-controlled study for dose selection in postmenopausal women with moderate to severe VMS, defined as follows:

* Moderate: sensation of heat with sweating, able to continue activity
* Severe: sensation of heat with sweating, causing cessation of activity This study is comprised of a screening period, a run-in period and a 12-week double-blind treatment period.

Eligibility Criteria:
Inclusion Criteria:

Additional screening criteria check may apply for qualification:

* Provide written informed consent to participate in this study
* Spontaneous amenorrhea for ≥12 months; or spontaneous amenorrhea for at least 6 months and with follicle stimulating hormone (FSH) levels \>40 mIU/mL; or documented bilateral salpingo oophorectomy ≥6 weeks, with or without hysterectomy
* 7 or more moderate to severe VMS per day, or 50 or more moderate to severe VMS per week
* Have a consistent bedtime on at least 5 nights per week
* Mean VMS frequency during the Placebo Run in period does not drop by more than 50% from the mean level reported for 2 weeks during the Screening period
* VMS diary compliance \>50%
* In the Investigator's opinion, subject is able to understand the nature of the study and any risk involved in participation, and is willing to cooperate and comply with the protocol restrictions and requirements

Exclusion Criteria:

Additional screening criteria check may apply for qualification:

* History of any cancer within 5 years except for basal cell carcinoma
* History of undiagnosed abnormal vaginal bleeding
* History of Hepatitis B, Hepatitis C or HIV
* History of psychiatric illness, excessive alcohol intake or use of recreational drugs who are unsuitable for study enrollment and compliance
* Presence or history of severe adverse reaction or allergy to any drug
* Peripheral vascular disease or disorders with associated vasculopathies
* Clinically significant conditions which could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator
* Endometrial thickness of \>=5 mm as measured by transvaginal ultrasound
* Abnormal result from baseline endometrial biopsy (i.e., endometrial hyperplasia or endometrial cancer)
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin ≥2.0 × upper limit of normal (ULN) above the reference range
* Subjects of childbearing potential
Acupuncture to Managed Pain During Induced Labor with Cook's Balloon

In France, labor induction rate is above 25.8%. Labor induction with Cook's balloon is a non-hormonal mechanical method but this technique can provide pain.

At Roubaix's maternity, midewifes can adminitred acupuncture therapy to help to manage this pain.

No studies where found about an effect of acupuncture therapy on pain provoked by labor induction with Cook's balloon.

Investigators aim to demonstate that acupuncture therapy during labor induction with Cook's balloon can reduced pain and improved patient's experience. Investigators will use 7 acupuncture points (YIN TANG/ 4 GI bilateral/ 36 E bilateral and 5TR bilateral) before the application of the balloon. A visual analog scale will be used before and after balloon insertion to collect pain level.

a questionnary will be filled by patient to collect their experiences. Investigators will collect data about analgesia, failed of induction and cesarean section to see effect of acupuncture on them.

Patients will be randomised.

Eligibility Criteria:
Inclusion Criteria:

* pregnant woman with a gestational age of 37 weeks and above
* age\>=18 years old
* having medical indication to be labor induced by Cook's Balloon
* speaking French
* agreeing to participate by signing informed consent form

Exclusion Criteria:

* patient having contraindication for the use of Cook's balloon
* patients under curatorship and/or guardianship
Effect of Metabolic Dysfunction in Branched-chain Amino Acids on Cardiac Function in Patients With Sepsis

The current project was designed to examine the effects of BCAA metabolic dysfunction on cardiac function in septic patients.

Patients with sepsis and with/without type 2 diabetes will be included. Patients prospectively collected the following indicators in the intensive care unit: 1. myocardial injury-related biomarkers: troponin T and B natriuretic peptide levels; 2. cardiac structure-related indicators: the size of the left and right ventricle, left ventricular ejection fraction, etc.3. septic cardiomyopathy incidence: Troponin T\>0.01ng/ml is the standard for the diagnosis of septic cardiomyopathy. Additionally, the investigators will collect the peripheral blood at preoperative, day 1, day 3, and day 5 after surgery. Peripheral blood plasma and PBMCs were separated by differential centrifugation: the concentration of BCAAs in serum and PBMCs; the expression of PBMCs BCAAs metabolic enzymes BCAT 1, BCKDH, and PP 2 Cm by WB; and the levels of AST, ALT, LDH, CK, and CK-MB

Eligibility Criteria:
Inclusion Criteria:

- patients diagnosed with sepsis with or without type 2 diabetes

Exclusion Criteria:

- patients with immunodeficient diseases patients who accept glucocorticoid or immunosuppressant patients with an age younger than 18 years patients who cannot provide informed consent
Bioavailability Evaluation of CurQ+ Curcumin Formulation

This study is intended to evaluate how significantly a proprietary curcumin formulation (curQ+®) results in greater bioavailability compared to 95% curcumin extract over a 6-hour time period following a single oral dose in healthy men \& women.

This study is intended to evaluate how significantly a proprietary curcumin formulation (curQ+®) results in greater bioavailability compared to 95% curcumin extract over a 6-hour time period following a single oral dose in healthy men \& women. Bioavailability will be based upon producing the greatest plasma curcumin concentration (AUC). Secondarily, this study is intended to evaluate the safety and tolerability of the curQ+® curcumin formulation.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female subjects must be 18-75 years of age at the time of Screening.
2. Subjects must be willing to refrain from consuming the spice turmeric or any dietary supplements containing turmeric or curcumin (except for the study products) throughout the entire study and for 14 days prior to screening.
3. Subjects must be available for and willing to attend all evaluation visits.
4. Subjects must be able and willing to give informed consent.
5. Subjects participating in prior studies evaluating curQ+® or curcumin can participate in the present study so long as they are not currently taking a curcumin-containing supplement (including turmeric) and have not done so for 14 days prior to screening.

Exclusion Criteria:

1. Subject is currently receiving therapy with remission-inducing drugs (i.e. methotrexate, TNF biologics, etc.), immunosuppressive drugs (i.e. corticosteroids, transplantation medications, etc.).
2. Subjects must not have taken turmeric- or curcumin-containing dietary supplements within 14 days prior to screening evaluation.
3. Subject has been diagnosed with any clinically significant confounding metabolic disease or condition that would interfere with the study evaluation, as judged by the clinical investigator (slow or fast metabolism resulting from hypo- or hyper-thyroidism, Cushing's Syndrome, Diabetes (except for fully resolved gestational diabetes), etc.) or any conditions that would affect absorption in the GI tract (i.e. inflammatory bowel disease, celiac disease, Behçet's Syndrome, systemic sclerosis, etc.).
4. Subject has known allergy to any of the investigational products, including but not limited to turmeric, curcumin, coconut or coconut oil, and sunflower oil. If any subject becomes sensitive during the study, they will immediately be excluded from continuing in the study.
5. Subject's body weight is greater than 300 pounds (136.1 kg) at the time of Screening.
6. Subject is involved in any other research study involving an investigational product (drug, device or biologic) or a new application of an approved product, within 30 days of the first baseline evaluation.
7. Pregnant and/or breastfeeding women, or women who intend to become pregnant during the course of the study.
The Effect of Preoperative Aminophylline

Several clinical studies and case reports suggested that aminophylline antagonizes the effects of diazepam , barbiturates , sevoflurane ,morphineand propofol.However, the available results from uncontrolled clinical settings make it difficult to quantify the specific effects of aminophylline on hypnotics and anesthetics

Aminophylline, a theophylline derivative, exerts multiple pharmacological effects, either through phosphodiesterase inhibition (i.e., a potent bronchodilating action, which is often used for the treatment of bronchial asthma) or via adenosine receptor blockade .It is generally considered that the majority of actions ascribed to therapeutic doses of xanthines (caffeine and theophylline) are due to their action as adenosine receptor antagonists.

To the best of the investigator's knowledge this hypothesis was not reported in patients scheduled for major pelvi-abdominal surgeries under general anesthesia , and aminophylline was not given as premedication to test this hypothesis as it was previously administrated after the end of surgery ,also it was recommended by previous clinical studies to evaluate the effective dose of aminophylline that affect the extubation and recovery time.

Eligibility Criteria:
Inclusion Criteria:

* Patients age: 20-60 years
* Males and females patients
* American Society Of Anesthesiology (ASA) physical status I- II .

Exclusion Criteria:

* Patient refusal to participate in this study
* Patient with known sensitivity to aminophylline
* Patients with history of cardiac failure
* Patients with renal or hepatic dysfunction and in chronic alcoholism since clearance of aminophylline is decreased.
* Patients with peptic ulcer, hyperthyroidism, glaucoma,as these conditions may be exacerbated.
* Patients with opioid addiction
* Current treatment with B agonists, anticholinergic agents, tranquilizers, anticonvulsants ,or antidepressants.
* Pregnancy.
* Habitual coffee consumption exceeding 2 cups per day.