cyrilzakka/clinical-trials huggingface dataset:
Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension

A randomized, double-blind, placebo-controlled, dose-ranging, Phase II study to evaluate the safety, efficacy, and tolerability of MLS-101 in Subjects With Uncontrolled Hypertension


Eligibility Criteria:
Inclusion Criteria:

1. Male and nonpregnant, nonlactating female subjects ≥ 18 years of age.
2. Written informed consent Health Insurance Portability and Accountability Act authorization, and local patient privacy required documentation for this study have been obtained
3. Automated office blood pressure (AOBP) with SBP ≥ 130 mm Hg
4. Background antihypertensive treatment of ≥ 2 drugs
5. Serum cortisol ≥ 18 mcg/dL

Exclusion Criteria:

1. Concomitant use of epithelial sodium channel inhibitors or mineralocorticoid receptor antagonists

3. Subjects with hypokalemia

4. Subjects with hyperkalemia

5. Subjects with serum cortisol \< 3 mcg/dL

6. Subjects with serum sodium \< 135 mEq/L

7. Subjects with estimated glomerular filtration rate \< 60 mL/min/1.73m2

8. Subjects with type 1 or uncontrolled (hemoglobin A1c ≥ 9%) type 2 diabetes mellitus

9. Subjects with body mass index \> 40 kg/m2

10. Subjects with unstable angina

11. Subjects with SBP ≥ 175 mm Hg or DBP ≥ 100 mm Hg for Part 1 and SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg for Part 2 at Pre-Screening, Screening/Start of Placebo Run-in, or Randomization

12. Subjects with a decrease in SBP ≥ 20 mm Hg or DBP ≥ 10 mm Hg from sitting to standing position at screening

13. Subjects who, in the opinion of the investigator, have suspected nonadherence to antihypertensive treatment

14. Subjects who, in the opinion of the investigator, have any major medical illness or symptoms

15. Subjects who, in the opinion of the investigator, have any acute or chronic medical or psychiatric condition

16. Subjects undergoing treatment with any of the following medications:

1. Topical corticoids
2. Sympathomimetic decongestants
3. Theophylline
4. Phosphodiesterase type 5 inhibitors
5. NSAIDs
6. Intramuscular steroids
7. Estrogen
8. Cytochromes
9. Strong CYP3A and CYP3A4 inducers

   17. Subjects with known hypersensitivity to MLS-101 or any of the excipients

   18. Subjects who are night-shift workers
Diet in Elderly With Type 2 Diabetes

Sarcopenia is characterized by progressive and generalized loss of skeletal muscle mass which may affect performance. Diabetes can affect muscle cell function, making sarcopenia worse.

This is a prospective and interventional study on a elderly population affected by type 2 diabetes mellitus. All subjects, recruited will undergo tests for the diagnosis of sarcopenia according to the EWGSOP2 criteria. All subjects, both sarcopenic and non-sarcopenic, will be introduced to a targeted nutritional program aimed at improving the composition of the diet, in terms of both micro- and macro-nutrients.

The sample will consist of about 100 subjects (50 sarcopenic and 50 non-sarcopenic) who receive the nutritional program. Particular attention will be paid to the intake of an adequate protein intake for the elderly subject (1.1 g/kg/day). A food diary will be required to assess daily protein-calorie intake and questionnaires to assess daily physical activity and quality of life.

The primary objective is to assess the efficacy of nutritional intervention in elderly affected by type 2 diabetes mellitus and sarcopenia. The secondary objective is to identify the prevalence of sarcopenia in patients with type 2 diabetes mellitus compared to non-diabetic subjects and to verify the relationship between pharmacological therapy and the presence of sarcopenia as well as evaluate any changes in style and quality of life and of glycometabolic compensation.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* BMI \>20 kg/m2
* HbA1c ≥6.5% (48 mmol/mol) e ≤10% (86 mmol/mol)

Exclusion Criteria:

* T1DM or LADA
* Patients with serious primary diseases of heart, brain, liver, kidney and hematopoietic system
Effect of Different Irrigation Activating Techniques on Irrigant Penetration Depth and on Post-Operative Pain

Irrigation activation in endodontics is considered now a very important step for the success of root canal treatment. In this study, the investigator will examine the effect of two recent activation systems ( XP-endo Finisher file and the new sonic EDDY system) in comparison with the conventional needle irrigation on irrigant penetration depth into root canals using radiopaque contrast media and digital radiography and on the postoperative pain after single-visit endodontic treatment using a visual analog scale.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic vital/non vital teeth requiring root canal treatment.
* Teeth with sound periodontal apparatus.
* Teeth without pus or inflammatory exudates draining through the canal.
* Teeth without anatomic variations.
* Teeth with sinus tract.
* Teeth without history of trauma.
* Patients not on analgesics or sedative medication prior to root canal therapy

Exclusion Criteria:

* • Patients with any systemic diseases.

  * Pregnant or lactating patients.
  * Immunocompromised patients.
  * Apparently thin roots in which apical preparation with #40 file would be overzealous.
  * Patient allergic to anything used in this procedure especially rubber dam material and Iohexol (radiographic contrast media).
  * Teeth with calcified canals.
  * Patients with acute apical periodontitis, acute apical abscess, and weeping canals.
  * Necrotic painful teeth with the absence of sinus tract for drainage.
A PET Study of the Effects of p38 MAP Kinase Inhibitor, VX-745, on Amyloid Plaque Load in Alzheimer's Disease (AD)

This study will assess the effects of administration of VX-745 for 12 weeks on amyloid plaque burden in Alzheimer's disease (AD). Subjects who meet entry criteria will undergo 11C-PiB (Carbon-11-labeled Pittsburgh Compound B) positron emission tomography (PET) at baseline and after 45 days of dosing with VX-745. Cognitive testing will also be conducted at baseline and day 45.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent
* Diagnosis of mild cognitive impairment (MCI) due to probable AD or of mild AD
* MMSE range: 20 to 28
* Evidence of amyloid pathology by amyloid PET scan
* Participants may be taking medications for AD, provided that the dose of these medications has been stable for \>3 months
* Proficiency in Dutch and adequate visual and auditory abilities to be able to perform all aspects of the cognitive and functional tests
* Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.

Exclusion Criteria:

* Evidence of neurodegenerative disease other than AD
* Inability for any reason to undergo PET and fMRI scans (including notably: history of allergic reaction of any severity to 11C-PiB injection; pacemaker, vascular stent or stent graft)
* Psychiatric disorder that would compromise ability to comply with study requirements
* Significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder or metabolic/endocrine disorders or other disease that would preclude treatment with p38 MAP kinase inhibitor and/or assessment of drug safety and efficacy
* Recent (\<90 days) changes to AD medications prescribed for cognitive reasons or with the potential to impact cognition
* Participation in a study of an investigational drug less than 6 months or 5 half-lives of the investigational drug, whichever is longer, before enrollment in the study
* Male subjects with female partner of child-bearing potential who are unwilling or unable to adhere to contraception requirements
* Female subjects who have not reached menopause or have not had a hysterectomy or bilateral oophorectomy/salpingoophorectomy
* Positive urine or serum pregnancy test or plans desires to become pregnant during the course of the trial
* Any factor deemed by the investigator to be likely to interfere with study conduction
Il-17 Levels in Intrahepatic Cholestasis of Pregnancy

The aim of this study is to investigate maternal and fetal serum IL-17 levels in pregnant women with intrahepatic cholestasis of pregnancy and to find out if Th-17 cells have a role in progress of intrahepatic cholestasis of pregnancy.

Intrahepatic cholestasis of pregnancy (ICP) is the most prevalent pregnancy-specific liver disease. It occurs mainly in the second or third trimester of pregnancy. It typically resolves after delivery spontaneously but it is associated with an increased risk of adverse fetal outcomes.

The cause of ICP is heterogeneous, pathophysiology is poorly understood and therapies have been empiric. Genetic predispositions, environmental influences, dietary factors and hormonal influences have been studied and cited in the literature.

Comparing with placebo, ursodeoxycholic acid (UDCA) has been shown improvement in treatment of pruritus in previous studies. S-adenosylmethionine, guar gum, activated charcoal, dexamethasone, cholestyramine, etc. are not effective in the treatment of symptoms.

CD4+ T cells are an essential regulators of immune responses and inflammatory diseases. They are also called chief of orchestra cells of immune system. The balance between T helper-(Th)1, Th-2 and Th-17 cells and their cytokinergic interaction are crucial for the response of the organism. Th17 and its specific cytokine IL-17 are responsible for pathogenesis of autoimmune diseases as autoimmune uveitis, experimental autoimmune encephalomyelitis in animal models and potentially also in human autoimmune diseases such as multiple sclerosis, Crohn's disease, rheumatoid arthritis, psoriasis, primary biliary cirrhosis. Recently, IL-17 targeted therapies (secukinumab, ixekizumab and brodalumab) are being studied in Phase III clinical trials to evaluate their overall efficacy and safety for certain autoimmune diseases.

Th-17 levels have been investigated in normal and abnormal pregnancies and results were incompatible with each other. Some researchers have said that the level of IL-17 increased during pregnancy but the others not.

Low serum IL-17 is associated with premature birth. Up-regulation of the IL-17 is associated with preeclampsia.

K. Harada et all. (2009) demonstrated that IL-17-positive cells are associated with the chronic inflammation of bile ducts in primary biliary cirrhosis(PBC). Also, some authors demonstrated that Th-17-related cytokines were increased significantly in patients with PBC.

Maho Ichikawa et all. presented a case of male newborn infant who showed progressive severe cholestasis with selectively high Levels of Serum IL- 17.

Based on all this information, we decided to investigate maternal and fetal serum IL-17 levels of pregnants with ICP and the effects of UDCA therapy on it and find out if Th-17 cells have a role in progress of ICP.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of ICP

-

Exclusion Criteria:

multiple pregnancies known chronic illness
ARTERIAL EMBOLIZATION OF PERSISTENT GENICULATE ARTERIES FOR CHRONIC PAIN MANAGEMENT AFTER TOTAL KNEE-REPLACEMENT ARTHROPLASTY(KNEE EMBOLISATION)

Recent works in interventional radiology have shown interesting results in the treatment of musculoskeletal inflammatory sites by arterial embolization. Supra-selective arterial embolization has been successfully developed by Dr. Okuno (Japan) to manage moderate to severe knee osteoarthritis. Also, inflammation of the surgical site mediated via geniculate arteries is a major cause for persistent chronic post-operative gonalgia.

Hypothesis: Selective arterial embolization of persistent geniculate arteries could reduce chronic post-operative gonalgia after TKA with minimally invasive approach.

Objective: To evaluate the feasibility of selective arterial embolization of persistent geniculate arteries to reduce chronic post-operative gonalgia after TKA.

Material and methods: This study is a single-center, prospective, feasibility study. Patients will be recruited after rheumatology consultation for chronic post-operative gonalgia, more than 6 months after TKA for moderate to severe gonarthrosis. Eligible patients are adults with moderate to severe chronic post-operative gonalgia (Visual Analysis Scale (VAS) \> 50mm) and degraded life quality (assessed by SF36 score), despite at least 3 months of optimal medical treatment. Non-inclusion criteria are mainly other rheumatologic or orthopedic severe diseases, severe surgical complications. Under local anesthesia, with homolateral antegrade femoral access, patient will undergo selective arterial embolization of persistent and aberrant peri-prosthetic arteries using HydroPearl® 200µm Mircospheres. Follow-up consultations will be scheduled at D1, M1, M3, M6 and M12. For a significance level of α=0.05 and power of 80% we require a cohort of 24 patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (male or female) aged 18-85
* Suffering from moderate to severe chronic pain (EVA \> 50mm) more than 6 months after total prosthetic knee replacement surgery for severe gonarthrosis with impact on quality of life.
* And having followed for at least 3 months a well-conducted conservative medical treatment (anti-inflammatory, analgesic, masso-kinesiotherapy).
* The patient may initially have had a single or bilateral replacement. The period of 6 months must be respected for each side, between the intervention and the inclusion for homolateral pain.
* Patient willing to participate in the study and with signed informed consent.
* Patient willing to undergo post-operative monitoring for one year.

Exclusion Criteria:

Orthopaedic or rheumatological pathologies:

* Rheumatoid arthritis
* Psoriatic rheumatism
* Spondylarthropathies
* History of primary or secondary bone tumor, in remission or active.
* Myeloma
* Operational criteria:
* Infection of the surgical site
* Re-operation
* Severe bleeding
* Use of turnstile per-operative
* Wound of popliteal artery
* Diabetic patient
* Comorbidities:
* General condition responsible for objective hemostasis disorder (hemophilia, Willebrand disease, thrombocytopenia) and anticoagulant treatments.
* Pads 100 G/L
Dulaglutide Versus Liraglutide in Obese Type 2 Diabetic Adolescents Using Metformin

To compare the efficacy and effect on glycemic control of Dulaglutide versus Liraglutide in obese Type 2 diabetic adolescents using metformin

To observe the efficacy, effect on glycemic control, impact on BMI and incidence of adverse effects of Dulaglutide and to compare it to Liraglutide in individuals aged thirteen to eighteen who have Type 2 diabetes mellitus and are obese.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Obese
* Taking metformin
* Male or female

Exclusion Criteria:

* Non obese
* Not taking metformin
* Taking other injectable diabetic medications
Ultrasonographic Bladder Wall Thickness and Different Forms of Detrusor Overactivity

In the last decade, several authors proposed ultrasound measurement of Bladder wall thickness (BWT) for the screening of the voiding dysfunction and of the detrusor overactivity (DO). The aims of the investigator prospective study were:

* to compare the ultrasonographic measurement of BWT in women with DO vs women with other urodynamic diagnosis in a very large population.
* to verify whether the BWT in women with DO can be different in the clinically or urodinamically different forms of DO.


Eligibility Criteria:
Inclusion Criteria:

* All women referred to our Urogynecology Unit from January 2005 to December 2008 for symptoms of OAB, stress urinary incontinence or mixed incontinence and sottoposte a prove urodinamiche complete were included in this prospective study

Exclusion Criteria:

* The investigators excluded women with documented recurrent urinary tract infections
* Previous antimuscarinic treatment
* Previous pelvic surgery
* Neurological disease
* Vaginal prolapse \> I stage
* Symptoms or clinical and/or urodynamic signs of voiding dysfunction
* Patients included in other ongoing clinical trials during the same study period.
Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Cancer

The purpose is to assess the efficacy and toxicity of the study agent, enzastaurin, in participants with recurrent or persistent ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have recurrent or persistent epithelial ovarian or primary peritoneal carcinoma.
* All participants must have measurable disease.
* Participants must have at least one "target lesion" to be used to assess response on this protocol.
* Participants must not be eligible for a higher priority GOG protocol, if one exists.
* Participants who have received one prior regimen must have a GOG Performance Status of 0, 1, or 2. Participants who have received two prior regimens must have a GOG Performance Status of 0 or 1.
* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
* Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least four weeks prior to registration.
* Participants must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
* Participants must NOT have received any non-cytotoxic therapy for management of recurrent or persistent disease.
* Participants of child-bearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception (for example, intrauterine device \[IUD\], birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment.

Exclusion Criteria:

* Participants with previous enzastaurin treatment.
* Participants who have received radiation to more than 25% of marrow-bearing areas
* Participants with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
* Participants who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Participants who are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin (refer to Concomitant Medications for a discussion of enzyme inducing anti-epileptic drugs \[EIAEDs\]).
* Participants who are receiving concurrent administration of any other systemic anticancer therapy except for a biphosphonate if patient has bony metastases.
* Participants who have received prior therapy with non-cytotoxic agents (i.e. bevacizumab).
* Participants with serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study.
Use of One Kind of Controllable Tube Ileostomy in the Low Rectal Cancer

Most surgeons suggest the use of fecal diverting to address the high morbidity and mortality associated with anastomotic leakage (AL) in patients with high risk factors on AL who are undergoing low anterior resections(LAR). This exploratory study was conducted to evaluate the efficacy and safety of one kind of controllable tube ileostomy(CTI), which was designed to protect rectal anastomosis in patients with high risk factors on AL. Results of SCCI were compared to those of the loop ileostomy (LI) method.

In fact when we told the patients about the tube ileustomy's effect and risk, almost all the almost all of my patients like to choose tube ileustomy(I have study this method for long time and have good expeience, and my patients either choose tube ileostomy directly or let me do the choice.) So I gave all the patients who meet the requirenments all tube ileustomy and have no control group.

After low anterior resection(LAR), a double row of concentric purse-string sutures were placed in the ileum wall using 3-0 absorbable suture. The diameters of the purse-string rings were about 10 mm and 20 mm, respectively. The investigators then made a small incision within the inner purse-string and inserted the trachea cannula into the proximal end of the ileum. The inner purse-string suture then was tied, followed by the outer purse-string suture. The outer purse string should capsulate the inner purse string to prevent leakage. Normal saline was injected into the air bag until the ileum wall. The investigators will test the pressure of airbag, and control the pressure of airbag from 30-40cmHg. The investigators then pulled the cannula out through the abdominal wall. The incision site in the ileum was approximated to the inner abdominal wall and extraperitonized by fixing the mobilized ileum wall around the cannula to the inner abdominal wall. This was accomplished using 3-4 interrupted sutures.

In the CTI group, the tube will be removed after 3-4 weeks. If anastomotic leakage occurred, the investigators will test the airbag pressure and keep the pressure during 30-40cmHg. Because with time went on, the ileum will dilated , the airbag pressure will go down, then the feces may go through the airbag plane and flow into colon and the tube ileostomy will lose its defunctioning effect.When the investigators control the airbag pressure, we can control the defunctioning effect of tube stomy. So it is called controllable tube ileostomy. The investigators will keep the tube until the anastomotic leakage was cured.

Eligibility Criteria:
Inclusion Criteria:

* Rectal Tumor After Low Anterior Resection the Anastomosis Located extraperitoneal
* Patients Agreed to Undergo the tube ileostomy or loop ileostomy Procedure

Exclusion Criteria:

* Bowel Preparation is not Satisfied Before Operation
* Blood lose is more than 1500ml during operation
* Critical incident during operation
* The vagina or bladder is seriously damaged and the fix is not satisfied.
Research Study to Determine Sensitivity to Gentle Touch and Pressure During an Active Migraine Attack.

Cutaneous allodynia (pronounced q-tane-ee-us all-o-din-ee-a) is common in migraine. It is a heightened skin sensitivity during an active migraine attack. Migraine attacks in patients who experience allodynia are more difficult to treat. This study intends to collect and evaluate data on the phenomenon of allodynia in patients with episodic migraine during an actual attack. The results of this study may help clinicians better understand allodynia, thereby helping them diagnose and more effectively manage patients with migraine and allodynia.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18-65, inclusive
* Diagnosis of episodic migraine with or without aura.
* Ability to read and understand an informed consent form and study procedures

Exclusion Criteria:

* Patients with abnormal sensory findings on examination, or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc).
* Patients who suffer from headache (of any type) 15 or more days per month
* Patients who are cognitively impaired, as determined by investigator
* Patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators.
* Patients who had taken any acute pain medication (e.g. triptans, ergots, NSAIDs, opioids, butalbital, acetaminophen) for any indication within 12 hours prior to allodynia testing.
* Patients with skin diseases that may cause abnormal skin sensation.
* Patients who had been treated with a nerve block in the 4 week period prior to allodynia testing Patients who had been treated with Botulinum neurotoxin within the 4 month period prior to allodynia testing