cyrilzakka/clinical-trials huggingface dataset:
Efficacy of PENS of the Auricle as an Opioid Sparing Postoperative Analgesic Technique in Cancer Endometrium and Cancer Cervix Patients

Pain relief following laparotomy surgery requires a variety of techniques including invasive ones like epidural or nerve blocks along with different classes of drugs, out of which opioids are most predominant. Each of these drugs have with their own set of advantages and also side effects. An ideal common system of analgesia is not possible due to patient variability. And no drug is devoid of side effects. Hence the aim is to ensure effective analgesia using drugs or techniques which are minimally invasive with negligible side effects.

Efficient post operative pain relief is an essential part of comprehensive recovery of patients. Conventional method of pain management of laparotomy surgeries in CA endometrium and cervix patients involves invasive techniques like epidural or selective nerve block coupled with a varied choice of analgesics like opioids, NSAID or acetaminophen, wherein each drug is associated with its own set of contraindications and side effects. Despite advances in analgesic regimen including multimodal analgesic regimen, opioids have been observed to remain the mainstay postoperative analgesia in cancer patients despite its well-established side effects.

This double-blinded prospective interventional study is conducted to explore the alternative of percutaneous electrical nerve stimulation (PENS) devices for effective pain relief with minimal to no side-effects.

The device will have tiny needles and a battery system that will be placed on and behind the patient's ear when they are under anesthesia.

It acts by stimulating nerves around ear region by series of pain free impulse generation leading to centrally (brain) mediated response by altering certain chemical substances responsible for causing pain thereby providing relief for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 yrs
* Diagnosed with CA-endometrium OR CA -cervix of stage I/II and post RT CA cervix patients coming for hysterectomy
* Elective surgery
* Informed consent obtained
* ASA (American Society of Anaesthesiology) physical status 1-3

Exclusion Criteria:

* Patient refusal
* Cancer cervix other than the stages mentioned in inclusion criteria ASA PS \>3
* Emergency surgery, Laparoscopic and robotic procedures
* Unplanned postoperative ventilation
* Allergy/sensitivity to adhesive
* Active skin infection/lesion in the ear region
* H/O of seizure or cerebral disease
* H/O chronic pain and prolonged analgesic usage
* H/O opioid dependence
* H/O anxiety or psychiatric illness requiring treatment
* Pre-existing implantable/ electronic on demand device
* Patients who might require MRI in the study period
* Patients with transmissible diseases
* Patients with coagulopathies
* Absolute or relative contraindication to drugs used in the study
Diagnostic Values of Galectin-3, Soluble ST2 and BNP in Predicting the Clinical Outcome of ST-Segment Elevation Myocardial Infarction Patients

An acute ST-elevation myocardial infarction occurs due to occlusion of one or more coronary arteries, causing transmural myocardial ischemia which in turn results in myocardial injury or necrosis. Acute myocardial infarction (AMI) may lead to the development of heart failure (HF). Accessible diagnostic tools commonly used in HF such as natriuretic peptides and (NYHA) classiﬁcation reﬂect already overt clinical HF. Troponin and creatine kinase reﬂect myocardial damage, but their usefulness in predicting long-term LVR is limited. Recent guidelines on HF management stressed that HF onset may be delayed or prevented through certain Interventions, such as pharmacotherapy ,post infarction rehabilitation, or modiﬁcation of HF risk factors. Therefore, it is important to identify potential markers, which would be more informative of HF preclinical stages to recognize patients with an increased risk of HF onset, and to start treatment in advance (1) Gal-3 participates in inﬂammation and pro ﬁbrotic pathways, while sST2 is a biomarker of inﬂammation, cardiac mechanical strain, and tissue ﬁbrosis, both of which may predict LVR (2).

sST is a biomarker of inﬂammation, cardiac mechanical strain, and tissue ﬁbrosis(3).

B_type natriuretic peptide (BNP) is elevated in acute myocardial infarction and is a quantitative biochemical marker related to the extent of infarction and left ventricular systolic dysfunction(4).


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Hospital admission due to ﬁrst-time STEMI treated with pPCI.

Exclusion Criteria:

* History of previous acute coronary syndrome, Previously diagnosed HF or asymptomatic LV dysfunction with LVEF \<50% or previously diagnosed signiﬁcant valvular disease or any other previously diagnosed structural heart disease Severe renal dysfunction, Severe liver disease, Chronic inﬂammatory disease, Current neoplastic disease
Perspective Memory and Executive Functions in HIV+ Patients

The primary goal of this observational study is to evaluate prospective memory in HIV+ patients compared to healthy subjects. The secondary goal is to examine the relationship between prospective memory and Hot Cognition (mechanical cognitive abilities) and Cold Cognition (cognitive abilities supported by emotion and social perception). The main questions it aims to answer are:

* Do HIV+ patients have more impaired prospective memory than healthy subjects?
* Is there a greater influence of Hot Cognition on prospective memory than Cold Cognition? Participants will undergo a battery of neuropsychological tests: Memory for Intentions Screening Test (MIST), Montreal Cognitive Assessment (MOCA), Interpersonal Reactivity Index and Modified Five Point Test.


Eligibility Criteria:
Inclusion Criteria HIV+:

* consent to participate in the study
* diagnosis of HIV
* Current antiretroviral therapy
* age \>18 years
* native Italian speaker

Exclusion Criteria HIV+:

* age \<18 years
* presence of major psychiatric disorders within the past 6 months
* additional neurological conditions that may impair the performance of the tests (Alzheimer's disease, Outcomes of head-brain trauma, cerebrovascular episodes)
* Alcohol and drug addiction within the past 6 months
* Additional medical conditions that may impair neurocognitive profile and functional abilities (cerebrovascular damage, cardiac problems with functional impairment, severe liver disease)

Inclusion Criteria HIV- :

* consent to participate in the study
* Absence of HIV infection (HIV-RNA negative)
* age \>18 years
* native speaker of Italian

Exclusion Criteria HIV+ :

* age \<18 years
* presence of major psychiatric disorders within the past 6 months
* additional neurological conditions that may impair the performance of the tests (Alzheimer's disease, Outcomes of head-brain trauma, cerebrovascular episodes)
* Alcohol and drug addiction within the past 6 months
* additional medical conditions that may impair neurocognitive profile and functional abilities (cerebrovascular damage, heart problems with functional impairment, severe liver disease).
Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease

"RUN-CD" is an investigator initiated "Non interventional Trial" on biologics in Crohn´s Disease (CD) patients in Germany with a prospective documentation of effectiveness in induction and maintenance therapy of biologics, especially of Ustekinumab, with a special interest on predictors of long-term responses and favorable disease outcome and documentation of severe side effects caused by the therapy with biologics.

The effectiveness and safety of induction and maintenance therapy of Ustekinumab and other biologics will be assessed in different relevant subgroups of Crohn's Disease patients. To this end, different confounders have to be considered. Patients followed-up for several years will likely receive changing treatments. These changes have to be taken into account. Furthermore, the decision to prescribe, to stop or to continue a treatment depends on the availability of treatment options and experiences with these alternatives:

1. Confounding by indication will be taken into account
2. Patient characteristics which likely influence the risk of developing a particular endpoint will be taken into account
3. The possible influence of co-medication will be considered
4. Changing risks over time will be considered
5. Power considerations needs to be conducted prior to the comparison of incidence rates
6. Appropriate statistical methods will be applied to deal with these challenges

The principles described above will be followed in a similar manner for the analysis of effectiveness and safety endpoints. An appropriate power analysis will be performed before each sub-analysis.

Eligibility Criteria:
Inclusion Criteria:

CD-patients aged 18-80 years at enrollment written informed consent is given

Exclusion Criteria:

planned surgical intervention malignant disease in history lack of adequate documentation possibilities
Developing Of A New Incontinence Care Product

The aim of this randomized controlled clinical trial, prospective study is to developing a new incontinece care product for containing the fecal incontinence and to examine the effect of this new product on prevention of perineal dermatitis.

Urinary and faecal incontinence which affected the large number of people are common and embarrassing health problems. Urinary incontinence affects the life quality , and causes to isolation and depression. Faecal incontinence can cause to psychosocial problems such as loss of self-esteem, progressive isolation, social stigmatisation and reduces the life quality, also burden a high cost on the patients and the community . Both urinary and fecal incontinence may leads to incontinence-associated dermatitis (IAD), an inflamatory skin disease, which is a a clinical evolution of skin damage associated with moisture , as a result of chronic or repeated exposure of the skin to urine or fecal matter. In IAD shows as redness with or without blistering, erosion, or loss of the skin barrier function IAD which causes discomfort and stres for patients , is a serious and common problem in many health care setting and impacts patients' well-being. Health care professionals who are working in many health institutions struggled to giving the optimal care to keep incontinent patients' skin in a healthy condition. When IAD developed, the risk of infection, the length of hospitalization, and morbidity increases and those patients are at greater risk of developing a pressure ulser.

The research question was; are there differences in the incidence of IAD in patients with fecal incontinence by a new incontinece care versus adult diaper.

Eligibility Criteria:
Inclusion Criteria:

* bedridden patients who had fecal and urinary incontinence,
* had not diabetes mellitus,
* patients whose perineal and perianal skin is intact,
* had indwelling urethral catheter and
* patient who accepted to participate to the study

Exclusion Criteria:

* patients who had diabetes mellitus,
* patients whose had darkly pigmented area in the perineal and perianal area,
* patients had pressure ulcers or erithema
* who have not accepted to participate
Treatment of Adults With Growth Hormone Deficiency

The purpose of this study is to evaluate efficacy and safety profile of a new weekly administered growth hormone preparation compared with placebo in adults with growth hormone deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of at least 23 years and not more than 70 years of age
* GHD of either adult onset(AO)or Childhood onset(CO), either idiopathic or secondary to pituitary disease
* Confirmed diagnosis of GHD defined
* IGF-1 SDS ≤ -1 at screening
* No exposure to rhGH within the last 6 months
* Patients with adequate adrenal function, which is confirmed by ACTH stimulation test at screening; or Patients with known secondary hypoadrenalism on adequate glucocorticoid replacement therapy
* If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 3 months before study entry
* Women of child-bearing potential to be using a reliable method of contraception at the screening and be willing to use it throughout the study
* A negative serum pregnancy test is required at screening for females of child-bearing potential.

Exclusion Criteria:

* History of malignancy other than cranial tumor or leukemia causing GHD or fully treated basal cell carcinoma
* Evidence of active malignancy
* Evidence of growth of pituitary adenoma or other intracranial tumor within the last 12 months, or patients without MRI or CT data to confirm the tumor stability within the last 12 months
* Significant hepatic dysfunction
* Chronic renal impairment
* Clinically significant pulmonary, cardiac, hepatic, renal, or neuromuscular disease
* Prader-Willi syndrome
* Acute severe illness in the last 6 months
* Benign intracranial hypertension
* Active Cushing's syndrome within the last 12 months
* Uncontrolled hypertension
* Patients with overt diabetes mellitus or evidence of persistent impaired glucose tolerance
* Severe psychiatric disease or patients who cannot understand the objective and methods of the study or patients with current alcohol abuse
* Pregnancy or lactation
* Known hypersensitivity to any ingredient of the study drug
* Inability to undergo scanning by dual-energy X ray absorptiometry (DXA) due to a body weight more than 130 kg or in situ internal or external devices known to interfere with DXA scanning
* Weight reducing drugs or appetite suppressants
* Anabolic steroids other than gonadal steroid replacement therapy within 2 months before study entry
* Methylphenidate within 2 months before study entry
* Systemic corticosteroids other than in replacement doses within the 3 months before study entry.
* History of non-compliance with medications, un-cooperativeness or drug abuse
* Patients participating in another study parallel to, or within 6 months prior to study entry, or previous participation in this study
* Patients who are not able to comply with the study protocol for any reason.
A Real-World Registry Investigating TReprostInil sodiUM in Pulmonary Hypertension (Re-TRIUMPH)

A Real-World Registry investigate Treprostinil sodium used in patients with Pulmonary Hypertension (Re-TRIUMPH).

This study is a multicenter, prospective, single-arm, observational, real-world study conducted in China. Patients who are at least 18 years of age, have been diagnosed with pulmonary hypertension (PH), agree to participate and meet the eligibility requirement will be enrolled in 20 pulmonary vascular centers across the country for the medically reasonable use of intravenous (or subcutaneous) Treprostinil injections. In the event that eligible patients are enrolled in the study, all aspects will be carried out in an observational manner, and no additional methods or procedures will be necessary. The patient and the physician will jointly determine the clinical management of the patient, including the length of treatment. Patients will be followed up for an observation period of at least 1 year. As part of standard clinical practice, patient data will be collected at the first appointment and every three to six months thereafter. After one year of follow-up, data collection will cease.The main purpose is to evaluate the efficacy and adverse reactions of subcutaneous (intravenous) prostacyclin in the treatment of pulmonary hypertension under current clinical practice. The secondary objectives is to understand the drug treatment plan of treprostinil in clinical practice of patients with pulmonary arterial hypertension in China and to understand the efficacy and adverse reactions of treprostinil in the treatment of patients with different types of pulmonary hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pulmonary hypertension who consent to receiving Treprostinil injection;
* Patients who must be over the age of 18;
* The informed consent form must be signed.

Exclusion Criteria:

* Patients who have received Treprostinil Injection for less than two weeks;
* Patients who have used Treprostinil within the past three months;
* Any situation that the investigator believes could affect the interpretation of the study results or pose a risk to patients using Treprostinil.
Dose Escalation Study of AUY922 in Advanced Solid Malignancies in Japan

This study will characterize the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of AUY922 in adult patients with advanced solid malignancies in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced malignant solid tumors
* ECOG Performance Status of ≤ 2
* Patients must have the following laboratory values:
* Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Hemoglobin (Hgb) ≥ 8.5 g/dl, Platelets (plt) ≥ 100 x 109/L
* Potassium, Calcium, Magnesium, Phosphorus within normal limits or correctable with supplements
* AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN)
* Serum bilirubin ≤ 1.5 x ULN, Serum albumin \> 2.5g/dl, Serum creatinine≤ 1.5 x ULN or 24-hour clearance ≥ 50 ml/min
* Able to sign informed consent and to comply with the protocol

Exclusion Criteria:

* Patients with brain metastasis.
* Prior treatment with any HSP90 or HDAC inhibitor compound.
* Treatment with therapeutic doses of coumarin anticoagulants.
* Pregnant and lactating women.
* Severe and/or uncontrolled acute or chronic liver disease
* Severe and/or uncontrolled acute or chronic renal disease
* Chronically significant heart disease
* History (or family history) of long QT syndrome. QTc ≥ 450 msec on screening ECG, ischemic heart disease, heart fail, ECG abnormalities, atrial fibrillation, atrial flutter or ventricular arrhythmias including ventricular tachycardia or Torsades de Pointes.
* Patients who are currently receiving treatment with any medication which has a relative risk or prolonging the QTcF interval or inducing Torsades de Pointes
* Patients with known disorders due to a deficiency in bilirubin glucuronidation (e.g Gilbert's syndrome).

Other protocol-defined inclusion/exclusion criteria may apply
LAAM-HAART PET Imaging

The purpose of this study is to determine the effects of the antiretroviral drugs efavirenz and ritonavir on human brain LAAM disposition in vivo.


Eligibility Criteria:
Inclusion

Each subject must meet all of the following criteria:

1. Male or non-pregnant female volunteer, 18-50 yr old
2. Good general health with no known major medical conditions
3. BMI \< 33
4. Provide informed consent

Exclusion Criteria

Subjects will not be enrolled if any of the following criteria exist:

1. Known history of liver or kidney disease
2. History of major medical conditions
3. HIV seropositive
4. Fasting blood glucose \> 110 mg/dl (because HAART can cause glucose intolerance)
5. Family history of type 2 diabetes
6. Use of prescription or non prescription medications, herbals or foods known to be metabolized by or altering P-glycoprotein or CYP3A (hormonal birth control medications are acceptable if alternative means of contraception are used)
7. Females who are pregnant or nursing
8. Females taking hormonal contraceptives who are unwilling to use alternative means of contraception
9. Contraindications to MRI (e.g., metal implants or splinters in the body; a worn or implanted medical device, such as a pacemaker or drug pump; inability to lie flat for up to one hour; claustrophobia) or contraindications to PET scanning (e.g., inability to lie flat for up to one hour, claustrophobia, current
10. Current or recent (within 12 months prior to screening) participation in research studies involving radiation exposure such that the total research-related radiation dose to the subject in any given year would exceed the limits set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1))
Open-label Study to Evaluate the Safety of Various Dosing Regimens of MuSK-CAART for MuSK Myasthenia Gravis

Muscle-specific tyrosine kinase (MuSK) myasthenia gravis (MG) is a rare but potentially severe disease, in which patients develop pathogenic autoantibodies that specifically target the MuSK protein in the neuromuscular junction. This phase 1 study is being conducted to evaluate the safety of various dosing regimens of an investigational cell therapy, MuSK-CAART, that can be given to patients with anti-MuSK antibody positive Myasthenia Gravis (MuSK MG), who have active disease. Various dosing regimens of MuSK-CAART alone, in combination with cyclophosphamide (CY), and in combination with CY and fludarabine (FLU) will be evaluated. Treatment with MuSK-CAART may potentially lead to complete and durable remission of disease.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of MuSK-type MG with at least 1 prior positive anti-MuSK antibody test.
* History of a negative anti-AChR (acetylcholine receptor) antibody test.
* Positive anti-MuSK antibody test at screening
* MG severity Class I to IVa on the MGFA (Myasthenia Gravis Foundation of America) Clinical Classification

Exclusion Criteria:

* Rituximab in the last 12 months.
* Prednisone \> 0.25mg/kg/day \[in Part A\]
* Other autoimmune disorder requiring immunosuppressive therapies.
* Investigational treatment for MG in the past 12 weeks.
* Absolute lymphocyte count \< 500/µL at screening.
Open Versus Laparoscopic Assisted Pancreaticoduodenectomy

Compare open and laparoscopic assisted pancreaticoduodenectomy regarding intraoprative blood loss, organ injury, completion of planned laparoscopic steps, duration and early post operative course of pain, hem stability, oral feeding, leakage(pancreatic, billary and intestinal). ,bleeding, mortality, lymph nodes and safety margins .

Pancreaticoduodenectomy is the only option curative intended in the treatment of resectable pancreatic ductal adenocarcinomas, duodenal carcinoma, ampullary carcinoma, lower common bile duct cholangiocarcinoma,. It is still associated with very high morbidity and mortality. \[1\]. Pancreatic cancer ranks as the seventh leading cause of cancer-related death worldwide, and the fourth among other cancers\[2,3\]. In recent years, the minimally invasive techniques has considered revolution in surgeries of pancreatic cancers \[4,5\]. Laparoscopic assisted pancreaticoduodenectomy is a hybrid procedure combining laparoscopic resection and reconstruction through a small incision.it companies laparoscopic mobilization and dissection due to magnification compared with open pancreaticoduodenectomy\[6\]. Several studies have shown that laparoscopic assisted pancreaticoduodenectomy could result in less blood loss less, pain ,less wound infection and shorter hospital stay compared to open pancreaticoduodenectomy\[7,8\]. Limited literature described the safety and efficacy of laparoscopic assisted pancraticododenostomy .Also such comparative studies deficient in evaluation of outcomes of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.So the interest of our study is to compare between the feasibility and safety of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.

Eligibility Criteria:
Inclusion Criteria:

1. age less than 70 years.
2. resectable tumour,
3. fit for surgery

Exclusion Criteria:

1. patients with jaundice with serum bilirubin above 200mml/dl.
2. patients with bleeding tendency until corrected.
3. patients with advanced and metastatic malignancy.
4. patients with cardiopulmonary diseases.