cyrilzakka/clinical-trials huggingface dataset:
Intravenous Tapentadol in Post-Bunionectomy Pain

The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo primary unilateral first metatarsal bunionectomy
* Female patients must be postmenopausal, surgically sterile, or practicing an effective method of birth control if they are sexually active
* Qualifying pain intensity (within a maximum of 5 hours after the last surgical stitch) and Baseline pain intensity (last pain score measured within 10 minutes before dosing) 5 on an 11-point (0 to 10) pain intensity numerical rating scale (NRS).

Exclusion Criteria:

* History of malignancy within the past 2 years
* Current or history of alcohol or drug abuse.
* Clinically relevant pulmonary, gastrointestinal, endocrine, metabolic, neurological, psychiatric disorders (resulting in disorientation, memory impairment or inability to report accurately
* History of seizure disorder, epilepsy, or any condition that would put the subject at risk of seizures
* Severely impaired renal function
* Moderately or severely impaired hepatic function
* Contraindications, or a history of allergy or hypersensitivity, to tapentadol, ibuprofen, or excipients
* Use of prohibited concomitant medication, or not allowed use of restricted concomitant medication
Role of Routine on-Table Cholangiography in Laparoscopic Cholecystectomy

The purpose of this study is to assess whether routine imaging of the biliary system during routine gallbladder surgery alters clinical outcome


Eligibility Criteria:
Inclusion Criteria:

* all patients over the age of 18 with biliary colic or cholecystitis

Exclusion Criteria:

* any history of allergic reaction to contrast material
* patients with abnormal liver function test results
* any clinical history of jaundice
* patients with a history of pancreatitis
* patients with a history of previous ERCP
* patients whose ultrasound showed common bile duct or intra-hepatic duct dilation
* all patients with previous major upper abdominal surgery
* all patients with acalculous cholecystitis or gallbladder polyps
Effect of Enteral Docosahexaenoic Acid Administration in Children With Acute Lymphoblastic Leukemia

The purpose of this study is to evaluate if enteral docosahexaenoic acid (DHA) administration during the first three months of treatment reduces the deterioration of nutritional status, treatment toxicity and early mortality in children with acute lymphoblastic leukemia.

Cancer is often associated with malnutrition.The most of children with cancer loss weight, and 50-80% of patients with cancer experience morbidity and mortality as a result of progressive wasting.

As a consequence of malnutrition, patients with cancer may have a poorer outcome, reduced effectiveness of chemotherapy and increased risk of chemotherapy-induced toxicity compared to those who are well nourished at diagnosis. On the other hand, in the recent years, there has been increased focus on the role of long chain polyunsaturated fatty acids and their effect on prevention and treatment of several diseases. The results of animal studies and adults with cancer have demonstrated that the consumption of long chain polyunsaturated fatty acids can slow the growth of cancer, increase the efficacy of chemotherapy and reduce loss weight and the side effects of the chemotherapy.

Beneficial effects of enteral long chain polyunsaturated fatty acids has been reported in adults with cancer. However, in children with cancer the scientific reports are scarce; therefore, is necessary to evaluate if the long chain polyunsaturated fatty acids administration in children with acute lymphoblastic leukemia has the same effects on clinical and nutritional outcomes that have been previously showed by different studies in adults with cancer.

Eligibility Criteria:
Inclusion Criteria:

* Children with acute lymphoblastic leukemia diagnosis
* Authorization from both parents or legal guardian for recruiting of the child into the study with consent signed form after the purpose and procedures have been explained
* Must be able to swallow capsules of DHA or placebo
* Malnutrition

Exclusion Criteria:

* Patients had received radiotherapy or chemotherapy
* Parents who decide to decline of the study
Oral NSAI Versus Acetaminophen or Placebo as a Discharge Treatment of Non Complicated Renal Colics

Treatment with NSAI in renal colics has not been well investigated and there is no clear recommendations regarding this subject.

The aim of this study is to determine if an oral NSAI treatment is beneficial in patients discharged for the emergency department after the first line treatment of a renal colic investigating the reccurence of pain, the reconsultation rates and the admissions.

Renal colic (RC) are a frequent cause of consultation in the emergency departement (ED). It counts for approximatively 20 % of patients presenting to the ED with severe acute onset abdominal pain.

The first line treatment of renal colics is based on NSAI drugs associated with antalgics and is further investigated in the NSAI vs Morphine study (NCT02156596) But there is no clear recommendations regarding the outpatient treatment of renal colics. Oral NSAI are still widely used as a second line medicine for this condition and variety of molecules were tried with non solid scientific arguments.

Piroxicam, a non-selective COX inhibitor drug appared to the oxicam class of NSAI, is widely used to treat rhumatoid and inflammatory disesases, and often prescribed in Tunisia as a second line treatment of RC.

In this study, the investigators aimed to investigate the efficiency and safety of the use of oral NSAI drugs (piroxicam) compared to Acetaminophen or placebo as a second line treatment of renal colics

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Consenting to participate in the study
* Patients treated in the ED for RC
* No contraindications of NSAI or paracetamol treatment

Exclusion Criteria:

* Contraindication of NSAI treatment
* Patients non reachable by telephone call
* Patients that did not receive or use the treatment
Oxaliplatin Combined With Fluorouracil and Leucovorin in Treating Patients With Recurrent or Metastatic Cancer of the Esophagus or Stomach

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with fluorouracil and leucovorin in treating patients who have recurrent or metastatic cancer of the esophagus or stomach.

OBJECTIVES: I. Determine the response rate in patients with recurrent or metastatic carcinoma of the esophagus or gastric cardia receiving the combination of oxaliplatin, fluorouracil, and leucovorin calcium. II. Determine the duration of response and overall survival of this patient population receiving this regimen. III. Determine the toxicity, including neurotoxicity, of this regimen in this patient population.

OUTLINE: This is an open-label, multicenter study. Patients receive oxaliplatin IV over 2 hours on day 1, then leucovorin calcium IV over 2 hours with fluorouracil IV bolus, followed by fluorouracil IV over 22 hours on days 1 and 2. Treatment continues every 2 weeks for a minimum of 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive at least 3 additional courses of therapy. Patients are followed for a minimum of 2 years or until death.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study over 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed carcinoma of the esophagus or gastric cardia Stage IV or recurrent Bidimensionally measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin normal SGOT less than 2 times upper limit of normal (ULN) Renal: BUN less than 1.5 times ULN Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No congestive heart failure No unstable angina pectoris No myocardial infarction within the past 6 months Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 6 months after study No allergy to platinum compounds or antiemetics appropriate for study No uncontrolled concurrent illness No active infection No clinical evidence of peripheral neuropathy by physical exam or history

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony-stimulating factors during the first course of study Chemotherapy: More than 4 weeks since prior chemotherapy No more than 1 prior chemotherapy regimen for carcinoma of the esophagus or gastric cardia No prior fluorouracil Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents No concurrent antiretroviral therapy in HIV-positive patients No other concurrent anticancer agents
Acellular Dermal Matrix Allograft Versus Free Gingival Graft

The present split-mouth controlled randomized clinical trial aimed to evaluate clinical and histological results of acellular dermal matrix allograft (ADM) compared to autogenous free gingival graft (FGG)


Eligibility Criteria:
Inclusion Criteria:

* absence or deficiency of keratinized tissue (\< 1mm) in two homologous contralateral sites of inferior premolars
* Miller Class I or II gingival recession
* Absence of radiographic bone loss
* Vital tooth or with adequate endodontic treatment
* Root surfaces without caries
* Good oral hygiene (plaque index \< 20%)

Exclusion Criteria:

* Allergic to penicillin
* Presenting systemic disease that impede surgical procedure
* Smokers
* Pregnancy
* Intake of calcium channel blockers that cause gingival augmentation
Preeclampsia and Contact Activation

Preeclampsia (PE) affects approximately 5% of all pregnancies with 2,500 cases registered annually in Denmark. PE is characterized by incomplete modelling of the spiral arteries of the uterus, hypertension, inflammation, hypercoagulability and proteinuria. Neonatal complications and increased cardiovascular risk are common features of the syndrome.

PE shares pathophysiologic features with recognized protein misfolding disorders and misfolded proteins are present in urine from women with PE. Misfolded proteins are potent activators of the contact system (CAS) which is involved in inflammation, coagulation and fibrinolysis.

Plasminogen activator inhibitor 2 (PAI-2) regulates important fibrinolytic processes in the placenta. The oxidative milieu characterizing PE may trigger misfolding of PAI-2 which then loose inhibitory capacity, but gain CAS-activating capacity. Thus, misfolding of PAI-2 may affect the fibrinolytic system in the placenta and compromise the modelling of the spiral arteries. Moreover, misfolded PAI-2 may contribute to the hypercoagulability and the inflammatory conditions characterizing women with PE.

The aim of the present study is i) to characterize CAS in women with PE, ii) to study the CAS-activating capacity of misfolded PAI-2 and iii) to develop and apply immunochemical methods for determination of native and misfolded PAI-2 in plasma.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women developing preeclampsia

Exclusion Criteria:

* Healthy pregnant women
Adapted ERAS in Gynecologic Oncology Surgery

Background: In recent decades, the new concept of Enhanced Recovery After Surgery (ERAS) program has been well accepted in the fields of gynecologic surgery. Many studies have shown the effectiveness of ERAS protocol in reducing hospital's length of stay, patient's morbidity, and rate of postoperative complications while cutting back on health care cost. Thus, standard guidelines such as ACOG has strongly recommended ERAS protocol implementation into each institution. However, institutions have self-limitations on adapting the standard ERAS pathway published from ERAS society due to the demand in resources. The concept of partial implementation of ERAS protocol has been raised and was mentioned in guidelines that ERAS implementation should be individualized to each institution. Nevertheless, the effectiveness of adapted ERAS protocol itself has not been well researched.

Objectives: To examine the effect of partial implementation of ERAS protocol adapted to our institution on patient's recovery (based on hospital length of stay, pain score, time to flatulence, postoperative complications, and re-visits) compared to standard routine care in women diagnosed with gynecologic malignancy (cervix, endometrium, and ovary) undergoing elective open surgery.

Design: A randomized controlled trial in gynecologic cancers (cervix, endometrium, and ovary) women, age 18-75 years, undergoing elective open gynecologic oncology surgery at Faculty of Medicine, Chiang Mai University hospital. The participants will be randomly assigned into one of two study groups: intervention (adapted ERAS protocol) and control (standard routine care).

For the intervention group, each woman will be brought through the adapted ERAS protocol step by step starting from preoperative counseling and preparation, intraoperative management, and postoperative management standard according to the adapted ERAS protocol. For the control group, each woman will be cared for using routine standard care.

The primary outcome is length of hospital stay.

1.3 Proposed duration 24 Months


Eligibility Criteria:
Inclusion Criteria:

* 18 - 75 years old
* Diagnosed with gynecologic malignancy of cervix, endometrium, or ovary
* Elective laparotomy surgery

Exclusion Criteria:

* Intraoperative accidental injury to urinary or GI organs
* Retain endotracheal intubation after surgery
* Peritoneal drainage for monitoring of bleeding/infection
* Unable to follow oral instructions
* Severe neuromuscular disease
* Preoperative hyperalimentation
* Neoadjuvant chemotherapy within 3 weeks prior to the procedure
* Previous abdominal/pelvic radiation
* Bowel obstruction
* Emergency operation
Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917

This study will compare glucose lowering with CS-917 compared to placebo after 3 months of treatment


Eligibility Criteria:
Inclusion Criteria:

* Drug naive or newly diagnosed type 2 diabetic subjects:
* Never received oral antihyperglycemic or insulin therapy or
* No oral antihyperglycemic or insulin therapy for more than 6 months since original diagnosis and
* No insulin therapy within one year of screening, with the exception of use during hospitalization or for use in gestational diabetes and
* No antihyperglycemic therapy for more than three consecutive days, or a total of of seven non-consecutive days, during the 8 weeks prior to screening.
* HbA1C\>6.7% and \< or = to 10% at screening

Exclusion Criteria:

* Current insulin therapy
* Symptoms of poorly controlled diabetes
* History of diabetic ketoacidosis or hyperosmolar, nonketonic coma within one year of screening
* Serum bicarbonate \< or = to 19 meq/L
* Serum creatinine (Scr) \> 1.4 mg/dL (females) or 1.5 mg/dL (males)
* Contraindication to metformin
Conventional Spinal Anaesthesia Versus Fractional Spinal Anaesthesia on Hemodynamics

compare the systemic haemodynamic response to fractional spinal anaesthesia versus conventional spinal anaesthesia , in a group of elderly and comorbid patients with hip fracture.

Spinal anaesthesia affects sympathetic chain activity, leading to a reduction in vasomotor tone.It was found that the incidence of hypotension following single-shot spinal anaesthesia, has previously been described as being 28-69%. As a matter of fact, autonomic nervous system function plays a key role in the development of haemodynamic instability and intraoperative hypotension . Haemodynamic stability should be considered as a primary intraoperative target, since several findings suggest avoiding systemic pressure drops . It was found that hypotension is primarily related to the overall dose injected ; however, several other variables, including the volume, the type of the anaesthetics injected, different adjuvant agents, and pre- and intraoperative factors, may impact the haemodynamic effect of the SA.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hip fractures.
* Patients age \>60 years old.
* ASA ≤ 3.

Exclusion Criteria:

* Patients on anticoagulant medication.
* Planned for general anaesthesia .
* Patients had atrial fibrillation.
Posaconazole vs Itraconazole in Preventing IFD Post-HSCT

Invasive Fungal Disease (IFD) after haematopoietic stem cell transplantation (HSCT) remain a clinical challenge.The studay aims to compare the efficacy and safety of posaconazole oral suspension vs itraconazole oral solution in preventing IFD post-HSCT.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent Aged ≥13 years Patients undergoing hematopoietic stem cell transplantation. Cardiac: Left ventricular ejection fraction ≥ 50% Adequate renal and hepatic function Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

* Pregnant or lactating females Any co-morbidity precluding the administration ofposaconazole or itraconazole
Intensive Medical Treatment for Nephropathy Caused by Type 2 Diabetes With Hypertension

To observe the effect of intensive medical treatment for type 2 diabetic patients with hypertension: to discover whether or not intensive medical treatment improves proteinuria, and the difference between the clinical meaning of responder and non-responder (criteria: 50% reduced proteinuria continuing 6 months or more during the observation period.)

It is reported that the risk of a cardiovascular event occurring is 1.78 times higher in patients with diabetic nephropathy (DN) than in patients without DN. It is also reported that angiotensin II receptor blockade (ARB) prevents the progression of DN in diabetic patients with early phase nephropathy beyond its blood pressure lowering effect. The guidelines by the Japanese Society of Hypertension 2004 recommended that it was necessary to control blood pressure (BP) below 130/80 mmHg in all diabetic patients. This has become the universal target BP for the prevention of cardiovascular events in hypertensive patients. On the study of intensive medical treatment \[including angiotensin-converting enzyme inhibitor (ACEI)\], it is reported that ACEI not only prevents the progression of DN in microalbuminuria but also decreases proteinuria \<1 g/day in the nephrotic syndrome. Therefore, ACEI is thought to be effective for DN. However, it is not clear whether or not intensive medical treatment (including ACEI) improves nephropathy with proteinuria \>1 g/day.

Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetic patients with hypertension, with all 5 of the criteria listed below:

1. Age 20 years and above
2. Blood pressure \>125/75 mmHg
3. Urinary protein creatinine ratio 1g/g・cr or Urinary protein \>1 g/day
4. Presence of diabetic retinopathy
5. Already performing dietary management

   * There were no limitations on serum creatinine.
   * BP was recorded 3 times while the patient was seated and averaged.
   * The subjects in this study were outpatients with written informed consent.

Exclusion Criteria:

1. Another definable renal disease other than DN
2. Collagenosis
3. Malignant hypertension with emergent treatment
4. Severe hypertension (diastolic BP \>120 mmHg)
5. Severe chronic heart failure or acute myocardial infarction in the past 6 months
6. Atrial fibrillation or severe arrhythmia
7. Anamnesis of cerebrovascular disease with neuropathy
8. Anamnesis of anaphylaxis or chronic dermatopathy
9. Severe hepatic disease
10. Pregnancy
11. Anamnesis of anaphylaxis from angiotensin II receptor blocker
12. Patients are judged to be inapposite by the attending physician
The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy

Study about the effect of ethanol extract physalis angulate in scleroderma patients with standard therapy to reduce skin fibrosis based on modified Rodnan Skin Score, reduce inflammation, immunological response and fibrosis: A Randomized Clinical Placebo ControlledTrial with a prospective cohort study on scleroderma outpatient clinic in Cipto Mangunkusumo Hospital in Jakarta and Hasan Sadikin Hospital in Bandung, from January 2016 to July 2017

Background.

Scleroderma is a systemic autoimmune disease that can not be cured, the progression of the disease still difficult to prevent and lead to increased morbidity and mortality. Disease-modifying anti-rheumatic drugs (DMARDs) as standard immunosuppressant drugs to reduce, eliminate, inhibit inflammation and fibrosis in scleroderma patient is still less effective.

Objectives.

To evaluate the effect of ethanol extract of Physalis angulate Linn to reduce skin fibrosis based on MRSS, ESR, BAFF, sCD40L, and P1NP in scleroderma patients with standard therapy

Methods.

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial on scleroderma patients with standard therapy, who admitted to Cipto Mangunkusumo Hospital Jakarta and Hasan Sadikin Hospital Bandung, from January 2016 to July 2017.

Patients must be controlled every month until three months for follow up. Subjects were divided into two parallel group, one of intervention group, and one of placebo group

Eligibility Criteria:
Inclusion Criteria:

1. Patients who meet the criteria of the type of limited scleroderma diagnosis / limited or diffuse type.
2. Patients who routine control in rheumatology outpatient clinics in Ciptomangunkusumo hospital Jakarta and Hasan Sadikin hospital Bandung RSHS who received standard therapy for scleroderma with a stable dose over the past 3 months.
3. The research subjects aged 15 to 60 years.
4. Subjects with modified Rodnan Skin score ≥ 5.
5. Disease duration ≥ 1 year

Exclusion Criteria:

1. Impaired liver function with cirrhosis
2. Chronic Renal dysfunction (chronic kidney disease stages 4-5). Or creatinine levels\> 2 mg / dL in the last 1 month prior to randomization.
3. Other autoimmune disease/overlap syndrome.
4. Received a steroid/prednisone \>10 mg/day in the last 1 month.
5. Patients who are pregnant or breastfeeding.
6. Patients with active tuberculosis and or are being treated with anti-tuberculosis medicines.
7. Severe heart disease. (Heart Disease with impaired function according to the New York Heart Association Class III or IV)
8. History of allergies to herbal Ciplukan / Physalis angulate Linn. or a history of hypersensitivity to certain drugs.
9. Hypotension (BP \<90/60 mmHg)
10. Hypoglycemia (Glucose level \<70 mg / dL)
11. Do not want to participate in the study
Chronic Pain After Inguinal Herniorrhaphy

The purpose of this study is to determine whether laparoscopic inguinal hernia repair leads to a lower incidence of chronic pain compared to open herniorrhaphy.


Eligibility Criteria:
Inclusion Criteria:

* Primary inguinal hernia

Exclusion Criteria:

* History of severe mental illness or chronic pain elsewhere