cyrilzakka/clinical-trials huggingface dataset:
24-Hour Glycemia: Rosiglitazone Versus Glimepiride In Type 2 Diabetes

A better glycemic control is associated with less complications (cardiac diseases, blindness, etcetera) for type 2 diabetic patients. The objective is to study if rosiglitazone may lead to a more regular glycemic pattern with less hyperglycemia and hypoglycemia episodes than with a sulphonylurea (glimepiride).


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 40 to 80 years
* Diagnosis of type 2 diabetes mellitus for at least 6 months
* Body mass index (BMI) ≥25kg/m2
* 7%≥HbA1c ≤ 9% at visit 2
* Treatment with metformin between 1.7g/day and 3g/day for at least 12 weeks prior to visit 1
* Female subjects must be non-pregnant, post-menopausal, surgically sterile or using effective contraceptive measures
* Written informed consent

Exclusion Criteria:

* Use of any oral antidiabetic drug other than metformin within 12 weeks prior to screening
* Significant hypersensitivity to thiazolidinediones and sulfonylureas or compounds with similar chemical structure
* Subjects who have required the use of insulin for glycaemic control at any time in the past or subject with a history of metabolic acidosis including diabetic ketoacidosis
* Subjects with clinically significant ongoing oedema or with a history of oedema in the 12 months prior to visit 1
* Subjects with a history of severe hypoglycaemia
* Anemia defined by haemoglobin concentration \<11.0g/dL for males or \<10.0g/dL for females
* Renal disease or renal dysfunction, e.g. as suggested by serum creatinine levels ≥135µmol/L in males and ≥110µmol/L in females
* Presence of clinically significant hepatic disease (i.e. ALT, AST, total bilirubin or alkaline phosphatase \>2.5 times the upper limit of the normal reference range)
* Congestive heart failure (NYHA class I to IV), unstable or severe angina, recent myocardial infarction
* Subjects with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids
* Female who are lactating, pregnant, or planning to become pregnant
* Any clinically significant abnormality identified at screening which in the judgement of the investigator makes the subject unsuitable for inclusion in the study (e.g. physical examination, laboratory test, ECG, ...)
* Use of any investigational agent within 30 days or 5 half-lives (whichever is longer) prior to enrolment in this study
* Active alcohol, drug or medication abuse within the last 6 months or any condition that would indicate the likelihood of poor subject compliance
* Subjects not willing to comply with the procedures described in this protocol.
HERO Study: Helping Evaluate Reduction in Obesity

A prospective, international, multi-center study of clinical outcomes and estimated healthcare resource expenditures associated with the treatment of obesity using the LAP-BAND AP® Adjustable Gastric Banding System.


Eligibility Criteria:
Inclusion Criteria:

* Patient and investigator have made a decision, independent of the study, to proceed with LAP-BAND AP® implantation.
* Male or female aged ≥ 18 years.
* BMI ≥ 40 or a BMI ≥ 35 with one or more severe co-morbid conditions, or those who are 45.5 Kg / 100 lbs or more over their estimated ideal weight.

Exclusion Criteria:

* Prior bariatric surgery.
* Type I diabetes patients.
* Participating in another ongoing clinical study with concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter patterns of care, use of medications or the outcomes under study.
PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation

This is a Phase 1 dose-escalation study of PRT3789, a SMARCA2 degrader, in participants with advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutation and/or deletion. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) of PRT3789 monotherapy and in combination with docetaxel, describe any dose limiting toxicities (DLTs), define the dosing schedule, and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) to be used in subsequent development of PRT3789.

This is an open-label, multi-center, dose-escalation, first in human, Phase 1 study of PRT3789 as monotherapy and in combination with docetaxel, a SMARCA2 degrader, evaluating participants with advanced or metastatic solid tumors with loss of SMARCA4 due to truncating mutation and/or deletion. The study will evaluate escalating doses of PRT3789 until the MTD or RP2D is determined. Taking into account pharmacokinetic and pharmacodynamic data from the preceding dose levels, the dose may be escalated until a dose limiting toxicity is identified. Approximately 186 participants will be enrolled in monotherapy, dose escalation, backfill, and combination cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures
* Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy with any mutation of SMARCA4 (dose escalation and combination cohorts) and loss of function mutation of SMARCA4 (backfill cohorts) by local testing that have either progress on or ineligible for standard of care therapy
* Must have measurable or non-measureable (but evaluable) disease per RECIST v1.1 for dose escalation and combination cohorts
* Must have measureable diseases per RECIST v1.1 for backfill cohort
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Willing to provide either archival or fresh tumor tissue sample
* Adequate organ function (hematology, renal, and hepatic)

Exclusion Criteria:

* Participants with solid tumors with known concomitant SMARCA2 mutation or loss of protein expression
* Clinically significant or uncontrolled cardiac disease, uncontrolled electrolyte disorders, uncontrolled or symptomatic central nervous system (CNS) metastases or leptomeningeal disease
* History of another malignancy within 3 years except for adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancies, or malignancies previously treated with curative intent and not on active therapy or expected to require treatment or recurrence during the study
* Concurrent treatment with strong or moderate CYP3A4 inhibitor or inducer
Deep Brain Stimulation in Severe Obsessive-compulsive Disorder

Deep brain stimulation is an established treatment for movement disorders. New indications for deep brain stimulation are under investigation, among them severe and treatment-resistant obsessive-compulsive disorder. Here, the investigators investigate clinical outcomes, safety and mechanism of action of DBS in the BNST in a series of 11 participants with severe therapy-refractory OCD.


Eligibility Criteria:
Inclusion Criteria:

* Severe OCD according to the Diagnostic and Statistical Manual of Mental Disorders: DSM-IV
* YBOCS score of at least 25/40
* Disease duration of ≥5 years with persistent disabling symptoms despite adequate trials with at least 3 different serotonergic acting antidepressants, augmentation with antipsychotics, and CBT
* Only patients between 18 and 65 years of age who could understand and comply with instructions and provide their own written consent.

Exclusion Criteria:

* Current psychotic or substance abuse disorder
* Clinically significant medical disorder, or previous brain surgery
A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding

This is a global prospective observational study of women with Fabry disease and their infants during pregnancy and/or breastfeeding. The study will evaluate outcomes of pregnancy and/or breastfeeding in women and infants exposed to migalastat.

This is a global prospective observational study of women with Fabry disease and their infants during pregnancy and/or breastfeeding. The study will evaluate outcomes of pregnancy and/or breastfeeding in women and infants exposed to migalastat. All pregnant women with Fabry disease are eligible to enroll, an unexposed cohort potentially can be used for comparisons.

Cases will be reported voluntarily to the Pregnancy Coordinating Center (PCC) from any country by Healthcare Providers (HCPs), by patients and secondary contacts. The PCC will follow patients throughout their pregnancies and/or breastfeeding and infant through 1 year of age.

There will be 2 cohorts enrolled in the study. Cohort 1 will be pregnant and/or breastfeeding patients who have Fabry Disease, and have been exposed to at least 1 dose of migalastat during pregnancy and/or breastfeeding. Cohort 2 will be pregnant and/or breastfeeding patients who have Fabry Disease, who were not exposed to migalastat during pregnancy and/or breastfeeding.

This is an observational study, it will enroll patients and collect data as described in this protocol for a minimum of 10 years.

Eligibility Criteria:
Inclusion Criteria:

Female patients meeting the following criteria will be eligible for study enrollment:

1. Patients with Fabry disease who are pregnant and/or breastfeeding, whether or not they are exposed to migalastat
2. Able and willing to provide informed consent or assent, if applicable.
3. Able and willing to provide HCP contact information.

Exclusion Criteria:

None
Xirtam H Combination In the Treatment of Hypertension Evaluation Study.

This is post-marketing observational study in which data on safety and effectiveness of Xirtam H will be collected from routine clinical practice. The study objectives are to investigate the effect of Xirtam-H on blood pressure and achievement of target blood pressure as well as safety and satisfaction of treatment. All hypertensive patients (Blood pressure \> 140/90 mmHg) where investigator feels that addition of Xirtam H would be beneficial to patients will be included in non interventional study. The routine investigation suggested by the attending physician will be done in patients of hypertension. No additional investigation will be done for the study purpose. The patient not controlled on existing treatment and prescribed Xirtam H will be included in study after taking the informed consent. The patient will be followed up for 2-follow up visit each after 6 weeks. The physical examination, routine investigation, blood pressure measures will be done and the data will be entered in the CRF as mentioned in CRF in each visit. The study is planned to be carried out in 9604 patients from around 300 - 350 trial sites in India.


Eligibility Criteria:
Inclusion Criteria:

* All Indian hypertensive patients (Blood pressure \> 140/90 mm Hg) where investigator feels that addition of Xirtam H would be beneficial to patients will be included in non interventional study.

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with corresponding product prescribing information
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain

Investigate the efficacy and safety of mirogabalin in Chinese participants with diabetic peripheral neuropathic pain in comparison to placebo.

The primary objective is to compare change from baseline in weekly Average Daily Pain Score (ADPS) at Week 14 in Chinese patients with Diabetic Peripheral Neuropathic Pain (DPNP) receiving mirogabalin versus placebo.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes mellitus at screening
* Painful distal symmetric polyneuropathy, diagnosed at least 6 months prior to screening (see Procedures manual for the Diagnosis of Diabetic Peripheral Neuropathy and Neurological Examination for details)

Exclusion Criteria:

* HbA1c (National Glycohemoglobin Standardization Program) \> 10.0% at screening
* Uncontrolled blood glucose within 1 month prior to screening, at screening or randomization
* Other severe pain at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP
* Neurologic disorders at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP
* Major psychiatric disorders at screening or randomization
* Creatinine clearance (using the Cockcroft-Gault equation) \< 60 mL/min at screening
Non-mesh Repair of Inguinal Hernia: Desarda Versus Darn

To compare the results of Desarda and Darn techniques in inguinal hernia repair in Assiut University Hospital.

Inguinal hernia is one of the most common types of abdominal hernias with a prevalence of 75% of all abdominal hernias. Inguinal hernia repair is one of the most encountered surgeries all over the world. The use of mesh for inguinal hernia repair is the most commonly applied technique. However, being a foreign body, mesh repair has its own disadvantages. These include Postoperative hematoma and seroma, foreign body reaction, infection, mesh rejection, mesh migration, and fistula formation. Moreover, the use of mesh in potentially contaminated operating field is not advisable. Infectious complication and their consequences have restricted the use of mesh in emergency settings. In addition, mesh repair is not available in every part of the world since it increases the cost of the operation. Therefore, the non-mesh repair of inguinal hernia has been recently revisited. Different techniques for non-mesh inguinal hernia repair are available including Bassini, Shouldice, Desarda and Darn. In 2001,Indian Surgeon Dr. Desarda, introduced a novel technique of a tissue- based hernia repair without mesh with almost zero recurrence rates in which an undetached strip of the external oblique aponeurosis is sutured to the inguinal ligament below and the muscle arch above, behind the cord, to form a new posterior wall. External oblique muscle gives additional strength to the weakened muscle arch to keep this strip physiologically dynamic. In 1948, Moloney described a suture inguinal herniorrhaphy in which two layers of continuous monofilament non-absorbable suture lines with no tension were inserted. The first suture line is between the lower edge of the internal oblique muscle/aponeurosis and the inguinal ligament. The second superficial layer is between the rectus sheath and the inguinal ligament. All sutures should be placed without tension but with no slack .

Literature are deficient in comparing Desarda technique and Darn technique in the repair of inguinal hernia.

Eligibility Criteria:
Inclusion Criteria:

* inguinal hernia
* Age more than 18
* Male patients

Exclusion Criteria:

• simultaneous performance of other surgical procedures
Effectiveness of Proprotein Convertase Subtilisin/kexin Type 9 (PCSK9) Inhibitor Initiation Before Percutaneous Coronary Intervention on Acute Myocardial Infarction Patients

The goal of this clinical trial is to learn if drug tafolecimab works to treat participants with acute myocardial infarction (AMI) scheduled for primary percutaneous coronary intervention (PCI). It will also learn about the safety of drug tafolecimab. The main questions it aims to answer are:

* Does drug tafolecimab lower the risk of 1-year major adverse cardiovascular events?
* Does drug tafolecimab improve the coronary microvascular dysfunction?
* What medical problems do participants have when administering drug tafolecimab by injection? Researchers will compare the results administering drug tafolecimab or not to see if drug tafolecimab works to treat AMI.

Participants will:

* Administer drug tafolecimab by injection or not every month for 12 months
* Receive the standard of care of AMI
* Complete the measurement of coronary angiography-derived microcirculation resistance index after PCI
* Complete cardiac magnetic resonance after PCI if available
* Visit the clinic at 1,6,12 months after the first administration for checkups and tests
* Report any discomfort, event or queries at any time


Eligibility Criteria:
Inclusion Criteria:

* Adults 18-75 years old
* AMI diagnosed according to the latest guidelines, including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI)

  * The requirement for STEMI was that primary PCI was scheduled within 12 hours of onset.
  * The requirement for NSTEMI was that coronary angiography was scheduled within 2 hours for very high-risk participants and within 24 hours for high-risk participants .
* Regardless of baseline LDL-C levels
* Participants voluntarily took part in this study and signed informed consent

Exclusion Criteria:

* Previous or ongoing treatment for any PCSK9i
* Allergy to PCSK9i, statins, or any of the drug ingredients used during the trial
* History of hemorrhagic cerebrovascular disease
* History of old myocardial infarction/chronic heart failure
* History of PCI or coronary artery bypass grafting (CABG) or preparation for CABG
* Above Killip level II
* Prolonged cardiopulmonary resuscitation (\>20min)
* Definite mechanical complications (including perforation of the interventricular septum, or rupture of the papillary tendon bundle or the left ventricular free wall)
* malignant arrhythmia
* Severe uncontrolled infection, bleeding disorder, end-stage renal disease, severe liver disease, endocrine dysfunction, or the expected less than 1 year survival of malignant tumors
* Pregnant or lactating women
* Participate in other clinical trials
TAP Block With Plain Bupivacaine Versus Wound Infiltration With Exparel for Postoperative Pain Management

In this randomized, controlled, observer-blinded study we plan to evaluate pain relief after ultrasound-guided transversus abdominis plane (TAP) block using bupivacaine and wound infiltration using liposomal bupivacaine in patients undergoing abdominal hysterectomy.

Patients undergoing open total abdominal hysterectomy at Parkland Hospital (n=60) will be randomized into one of two groups to receive either ultrasound-guided bilateral TAP block with bupivacaine (Group 1) or infiltration of the surgical wound with liposomal bupivacaine (Group 2) for postoperative pain management. The remaining aspect of perioperative care, including the general anesthetic technique, postoperative care will be standardized and will be similar for all patients. The duration of the involvement in the study will be until 48 hours postoperatively. The pre-anesthesia care unit personnel will identify patients during their preoperative clinic visit.

Patients in Group 1 will receive ultrasound-guided bilateral TAP block at the end of the surgery. Patients in Group 2 will receive Exparel prior to closing the incision which will be injected subfascially and subcutaneously. In the first 24-h postoperative period, patients in both Groups will receive acetaminophen 1000 mg every 6 h orally, ketorolac 30 mg, IV every 6 h, orally and morphine via an intravenous patient controlled analgesia (IV-PCA) system to maintain adequate pain control. In the 24-48 h study period, all patients will receive oral ibuprofen 800 mg and acetaminophen 1000 mg three times a day and a combination of hydrocodone/acetaminophen 5mg/ 325 mg 1-2 tablets, as needed.

The postoperative analgesia will be documented using the visual analog score (0=no pain, 10=worst pain). In addition, total opioid dose over the 48-h study period will be documented. Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. Rescue antiemetics will be given to any patient who complains of nausea and/or vomiting.

All variables will be assessed at 2, 6, 12, 24, and 48 hours, postoperatively by an investigator blinded to group allocation.

Eligibility Criteria:
Inclusion Criteria:

* Female
* ASA physical status 1-3
* Scheduled for open abdominal hysterectomy
* Age 18-80 years old
* Able to participate personally or by legal representative in informed consent in English or Spanish

Exclusion Criteria:

* History of relevant drug allergy
* Age less than 18 or greater than 80 years
* Chronic opioid use or drug abuse
* Significant psychiatric disturbance
* Inability to understand the study protocol
* Refusal to provide written consent
The Efficacy of Selective Laser Trabeculoplasty

Selective laser trabeculoplasty (SLT) is a new method to reduce intraocular pressure in eyes with open angle glaucoma or ocular hypertension. SLT may also be effective for cases with previously failed ALT procedures. We will study the efficacy and safety of the SLT procedure.

Selective laser trabeculoplasty (SLT) has been shown to be a safe, well tolerated, and effective intraocular pressure reduction therapy for several forms of open-angle glaucoma. SLT produces significantly less disturbance to the trabecular meshwork and is theoretically more repeatable than the ALT procedure. This retrospective research will begin with cases treated in 2001. It will evaluate whether SLT is effective for patients who have had prior treatment with ALT and it will determine whether the IOP lowering effect is sustainable over time. It will also assess the efficacy of repeated SLT procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary open angle glaucoma, ocular hypertension, pseudo exfoliative glaucoma, pigment dispersion glaucoma

Exclusion Criteria:

* History of prior invasive glaucoma surgery
Feasibility Study to Evaluate Safety and Device Performance of the Hospital Glucose Management System (HGMS)

The purpose of this study is to assess safety and device performance of the Medtronic Hospital Glucose Management System (HGMS) for up to 72-hours.

Assess safety and device performance of the Medtronic HGMS in the critically-ill setting and analyze the following:

1. Device Performance:

   * Functionality of HGMS
   * Alerts/Alarms Specificity and Sensitivity
   * System Workflow
2. Safety:

   * Descriptive statistics will be used to characterize safety events
   * Moderate and severe anticipated device and procedure related adverse events
   * All serious adverse events and unanticipated adverse device effects related events

Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years old
2. Subject is admitted to the ICU
3. Subject has a treatment regimen that includes a glucose target range of ≥140 mg/dl
4. Subject has a treatment regimen that includes an intended continuous intravenous insulin for at least 24 hours

   a. Including patients with no previous diagnosis of Diabetes Mellitus
5. Subject has anticipated life expectancy greater than 96 hours
6. Subject has recent platelet count greater than 30,000 per micro-liter

Exclusion Criteria:

1. Subject currently has a suspected or diagnosed medical condition that, in the opinion of the Investigator, warrants exclusion from the study or prevents the subject from completing the study
2. Subject is currently participating in another investigational drug or device study
3. Subject is pregnant, as determined by hospital admission
4. Subject is receiving treatment that includes Hydroxyurea.
Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery

Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary sleeve gastrectomy procedures will be studied.

Patients scheduled for primary laparoscopic sleeve gastrectomy for the treatment of morbid obesity will be assigned to receive tranexamic acid vs. placebo before surgery. Intraoperative bleeding will be scored, as well as postoperative bleeding and blood or blood-product requirements. POstoperative venous thromboembolic events will be recorded up to 2 months following surgery.

Eligibility Criteria:
Inclusion Criteria:

* Morbid obesity
* Approved and scheduled for laparoscopic sleeve gastrectomy

Exclusion Criteria:

* Previous bariatric surgery
* Platelet count under 100,000
* Concurrent anticoagulation treatment
* Previous venous/atrerial thromboembolic event
* Known allergy to tranexamic acid
* History of heparin induced thrombocytopenia
* Oral contraceptive use
* Female hormonal replacement therapy
* Active thromboembolic state
* Genetic hypercoagulable state