cyrilzakka/clinical-trials huggingface dataset:
Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib

The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with placebo on overall survival in subjects with advanced hepatocellular carcinoma who have received prior sorafenib.


Eligibility Criteria:
Select Inclusion Criteria:

1. Histological or cytological diagnosis of HCC.
2. The subject has disease that is not amenable to a curative treatment approach.
3. Received prior sorafenib.
4. Progression following at least 1 prior systemic treatment for HCC.
5. Recovery to from toxicities related to any prior treatments.
6. ECOG performance status of 0 or 1.
7. Adequate hematologic and renal function, based upon meeting protocol defined laboratory criteria within 7 days before randomization.
8. Child-Pugh Score of A.
9. Antiviral therapy per local standard of care if active hepatitis B (HBV) infection.
10. Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment.
11. Female subjects of childbearing potential must not be pregnant at screening.

Select Exclusion Criteria:

1. Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
2. Receipt of more than 2 prior systemic therapies for advanced HCC.
3. Any type of anticancer agent (including investigational) within 2 weeks before randomization.
4. Radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) or radionuclide treatment within 6 weeks of randomization.
5. Prior cabozantinib treatment.
6. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.
7. Concomitant anticoagulation, at therapeutic doses, with anticoagulants.
8. Serious illness other than cancer that would preclude safe participation in the study.
9. Subjects with untreated or incompletely treated varices with bleeding or high risk for bleeding.
10. Moderate or severe ascites.
11. Pregnant or lactating females.
12. Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low-grade tumors.
Does Preoperative Vaginal Preparation With Povidone-iodine Before Cesarean Delivery Reduce the Risk of Endometritis?

Cesarean delivery rates are increasing in Turkey and a major component of this increase is cesarean on demand. Although data on the rate of cesarean delivery in Turkey is limited, a national study reported a rate of 23.8%. Infectious morbidity, consisting primarily of endomyometritis and wound infection, remains a leading cause of postoperative complications. Estimates of postcesarean infection rates range from 7% to 20%, depending on demographic and obstetric variables. Infection following cesarean delivery results in not only increased hospital stay but also increases the cost of care. Strategies to minimize postoperative infectious and other morbidities have included modifications of surgical technique, changing of gloves, methods of placental delivery, cervical dilatation during cesarean delivery, and altering the uterine position during repair of the uterine incision. Despite these interventions, endometritis is still major problem after cesarean delivery.

Endometritis appears to result from ascending vaginal flora bacteria, with anaerobes playing an important role. The microbes endogenous to the vagina change throughout the course of pregnancy and parturition. Larsen and Galask noted that anaerobic species located in the vagina increase dramatically by the third postpartum day. In many cases, the surgeon's hand, reaching below the infant's head or presenting part, is in direct contact with the vagina. Vaginal bacterial flora have been cultured from the delivering surgeon's glove in 79% (95% confidence interval \[CI\] 58%, 100%) of cesareans that follow labor. In these cases, vaginal flora are delivered directly to the uterus, abdominal cavity, and the abdominal incision. Vaginal preparation has been shown to decrease the quantitative load of vaginal microorganisms as well as to remove certain species of bacteria.


Eligibility Criteria:
Inclusion Criteria:

* Women older than 38 weeks estimated gestational age and required cesarean section.

Exclusion Criteria:

* Highly emergent cesarean
* Allergy to povidone iodine
* Chorioamnionitis on admission
* Fever on admission
Agreement Between Arterial, Central Venous, and Peripheral Venous Lactate in the Intensive Care Unit

The main objective of this study is to examine the agreement between arterial, central venous, and peripheral venous lactate values in a population of medical Intensive Care Unit (ICU) patients.

This study is a single-center, prospective trial to assess the agreement between arterial, central venous, and peripheral venous lactate measurements. When an arterial lactate is deemed to be necessary as part of ICU management, a central venous and peripheral venous sample will also obtained within 5 minutes. All of the samples will be analyzed using the same analyzer as quickly as possible. A maximum of 10 paired arterial and venous lactate samples will be obtained per patient to prevent a single patient from dominating the data set. Additional data collected on a standardized data collection form will include primary diagnosis, intubation status, use of inotropic agents, hypotension (defined as a systolic blood pressure \< 90 mm Hg), ICU length of stay and mortality. The Bland-Altman method will be used to assess agreement between arterial (A), central venous(CV), and peripheral venous (PV) lactate measurements. Approximately 50 patients will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 years or older
* Admitted to the Intensive Care Unit (ICU)
* Determined by their treating clinicians to require both a central venous line and arterial line

Exclusion Criteria:

* None
Effect of Probiotic on Constipation in Patients With Parkinson's Disease

The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis ®duo) effect on constipation and on neuropsychological performance

The aim of the study is to collect data for the assessment of the Lactobacillus casei DG (Enterolactis® duo) effect on overall abdominal pain, bowel movements and other abdominal symptoms and on neuropsychological performance in patients with Parkinson's Disease. The investigators suppose that, due to the immunomodulatory action of probiotics, overall neuropsychological function will improve as well as due also to prebiotic abdominal symptoms will decrease following consumption of Lactobacillus casei DG (Enterolactis® duo).

Eligibility Criteria:
Inclusion Criteria:

* A positive diagnosis of functional constipation or Irritable Bowel Syndrome -subtype constipation according to Rome IV criteria.
* Negative for colon cancer screening
* Negative relevant additional screening or consultation whenever appropriate.
* Ability of conforming to the study protocol.
* Stable treatment for Parkinson's disease

Exclusion Criteria:

* Presence of any other relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant on the basis of predefined values a part from Parkinson's disease
* Ascertained intestinal organic diseases, including ascertained celiac disease or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
* Previous major abdominal surgeries.
* Inability to conform with protocol.
* Recent history or suspicion of alcohol abuse or drug addiction.
* Previous participation in this study.
Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer

Traditionally cancer pain is treated with long acting opioids such as morphine around the clock. However, there is no evidence that all patients have a stable pain requiring around the clock medication. So far opioids for self-administration with a rapid onset of action have not been available. Recently a nasal formulation of fentanyl (an opioid similar to morphine) was released in Europe for treatment of breakthrough pain, i.e. an unpredictable pain with short duration that breaks through the otherwise stable pain controlled with the around the clock medication. The basic idea is that this formulation may open for patient controlled analgesia of chronic cancer pain, due to the ultra rapid onset of action of nasally delivered fentanyl. This means that the patient only takes medication when in pain. This single center feasibility / safety study is the first part of a study to investigate this alternative cancer pain treatment approach.


Eligibility Criteria:
Inclusion Criteria:

1. Cancer patients with metastatic disease
2. Adult (older than 18 years)
3. Life expectancy of \> 3 months
4. Cancer-related pain \> 3 on an 11 point Numerical Rating Scale (NRS)
5. In the need of opioids (step II or III)
6. Able to use nasal drugs.
7. Women of child bearing potential using adequate contraception
8. Informed consent given according to applicable requirements before any trial-related activities. Trial-related activities are any procedure that would not have been performed during the routine management of the patient

Exclusion Criteria:

1. History of substance abuse
2. Cognitive impairment which makes the patient unable to complete questionnaires or not able to comply with the study procedures
3. Treated with MAO inhibitor within the last 14 days
4. Known hypersensitivity to study drug or specific contraindications to the study drug
5. Nasopharyngeal device such as gastric tube
6. Concomitant participation in any other trials dealing with pain with an investigational drug or device apart from cancer treatment within 14 days prior to inclusion in this trial
7. Pathological conditions of the nasal cavity as contraindication to nasal fentanyl
8. Sleep apnoea syndrome
9. Pregnant or breastfeeding women
10. Psychiatric disease
Vascular No-React Graft Against Infection

This study seeks to demonstrate the effectiveness and safety of the Non-valved Conduit for CE marking on the basis of infection. The rationale for infection resistance with the conduit is that BioIntegral Surgical No-React® treated products have a well-documented history of infection resistance in hybrid vascular settings.


Eligibility Criteria:
Inclusion Criteria:

* Infected prosthetic graft and/or bifurcation
* High risk of infection at graft implantation
* Mycotic aneurysm
* No alternative available

Exclusion Criteria:

* Below-knee procedure
* AV access
Characterization of the Essure System Tubal Sterilization Using Ultrasound and X-Ray

Tubal sterilization is the most prevalent form of contraception in the United States and the world. Currently, approximately half of these are performed with a laparoscope and half through a mini-laparotomy after delivery. Micro-insert hysteroscopic sterilization system received FDA approval for elective sterilization in 2003. Compared to other forms of female sterilization, this procedure is minimally invasive and does not require entering the abdominal cavity. In addition, it is at least as effective in preventing pregnancy as other forms of tubal occlusion. Given the distinct advantages of this method, it could become the preferred method of tubal sterilization for physicians and their patients. Currently, there is no published data concerning the appearance of the micro-inserts system using other imaging modalities that are commonly used in gynecologic practice. As the use of this device becomes more widespread it will be more commonly encountered in radiographic imaging performed as part of routine patient care. The main objective of this study is to provide important descriptive data concerning the ultrasonographic and x-ray appearance of the micro-insert hysteroscopic sterilization device. An additional objective of this study is to identify characteristics on plain film and ultrasound (US) that correlate with tubal occlusion or patency.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients requesting sterilization

Exclusion Criteria:

* Unsuccessful placement of the hysteroscopic sterilization system in one or both fallopian tubes. In addition, a patient will not be offered the opportunity to participate in the study if there are any conditions that would preclude attempted placement of the hysteroscopic sterilization system. These include hypersensitivity to nickel-titanium or contrast media, current or recent pregnancy (within the previous six weeks), active genital tract infection, prior tubal ligation, or known congenital uterine malformation.
Vaginal Misodel® in Comparison With Orally Administrated Misoprostol (Cytotec®) at Induction of Labour

The study will compare orally administrated solution of Misoprostol (Cytotec®) with vaginal slow release (7ug/h) Misoprostol (Misodel®) regarding efficacy and safety during labour.

To compare orally administrated solution of misoprostol (Cytotec®) with vaginal slow release misoprostol (Misodel®) regarding efficacy and safety during labour Design: Randomised controlled trial (RCT)

Settings:

Obstetric departments of Sodersjukhuset, Stockholm Obstetric departments of Women's clinic, Karlstad.

Eligibility Criteria:
Inclusion Criteria:

Primipara BS ≤ 4p Gestational week \>37

Exclusion Criteria:

Multipara Multiples Gestational week \<37 BS \>4 IUFD Previous uterine surgery
Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Having a Tonsillectomy

Patients scheduled for a tonsillectomy need postoperative pain treatment. Some of the most widely used postoperative analgetics (NSAIDs) sometimes cause rebleeding in the postoperative period, and another often used analgetic, morphine, causes nausea and vomiting. The researchers therefore will investigate new combinations of postoperative analgesics in hopes of improving pain and the need for opioids during the postoperative period.

We will investigate the effect of paracetamol versus paracetamol combined with pregabalin versus paracetamol combined with pregabalin and dexamethasone on pain and morphine requirements in the first 24 hours postoperatively. Outcomes include amount of morphine and ketobemidone used, and pain measured on a VAS scale. Side-effects, e.g., PONV, dizziness and sedation are also measured.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for benign tonsillectomy
* Between the ages of 18 and 50 years old
* ASA 1-2 and a surgical technique without the need for local anaesthetics or electrical scissors

Exclusion Criteria:

* Malignancy
* Patients who are unable to cooperate
* Does not speak Danish
* Has allergy for drugs used in the trial
* Has abused drugs and/or medicine
* Epilepsy
* Diabetes treated with medicine
* Treatment with systemic steroids 4 weeks prior to the operation
* Daily use of antacids
* Daily use of analgesics
* Use of antidepressives
* Known kidney disease
* Pregnancy
Comparison of Combination Antibiotics Eyedrop to Artificial Tear in Hordeolum After Incision and Curettage

To compare the effectiveness of combined antibiotic ophthalmic solution (neomycin sulfate, polymyxin B sulfate and gramicidin) with placebo (artificial tear) in the treatment of hordeolum after incision and curettage

Hordeolum is a common eyelid disease. In case of mass, I\&C is required but role of antibiotic after I\&C is not clear. It may not need in post drainage period.

Eligibility Criteria:
Inclusion Criteria:

* at least 5-millimeters hordeolum
* the onset within 7 days

Exclusion Criteria:

* previous incision and curettage of the same site within 1 month or more than 3 times
* lesions in the adjacent areas suggesting of complications associated with hordeolum such as preseptal cellulitis or blepharitis
* The patients with immunodeficiency, history of bleeding tendency
* allergy to aminoglycoside, polymyxin B, gramicidin, xylocaine and povidone iodine
Local Infiltration Analgesia vs Adductor Canal Block for Analgesia After Anterior Cruciate Ligament Reconstruction

Early rehabilitation after anterior cruciate ligament reconstruction is of paramount importance and requires optimal pain control based on a multimodal concept, including injection of local anaesthetics. Regarding this latter, different options have emerged recently such as the adductor canal block, performed before the surgery by the anaesthesiologist or the infiltration of the articulation performed by the surgeon at the of the intervention. No trial has compared these two approaches. As practice of medicine should be based on evidence, we decided to undertake this randomised controlled trial where we compared the adductor canal block with the local infiltration analgesia technique in terms of pain and functional outcomes

Patients scheduled to undergo anterior cruciate ligament reconstruction under general anaesthesia will be randomly allocated to two groups: local infiltration analgesia or adductor canal block.

The local infiltration analgesia will be performed by the surgeon at the end of surgery with 20 mLs of ropivacaine 0.5%. The adductor canal block will be performed by the anaesthesiologist under ultrasound guidance after the surgery, before awaking the patient, using the same solution (20 mLs ropivacaine 0.5%)

Postoperative analgesia will include intravenous patient-controlled analgesia of morphine (settings 1 mg/ml, 2 ml/10 minutes, 40 mg/4 hours), ibuprofen (3x400 mg) and acetaminophen (4x1000 mg).

A research assistant and a physiotherapist, both blinded to the group allocation, will collect pain and rehabilitation data, respectively.

Eligibility Criteria:
Inclusion Criteria:

* patients from 18 to 50 years old scheduled to undergo anterior cruciate ligament reconstruction

Exclusion Criteria:

* peripheral neuropathy
* pre-existing femoral neuropathy
* diabetes mellitus
* alcoholism
* drug addiction
* cancer with chemotherapy
* chronic pain state
Evaluation of Serum Prostatic Specific Antigen (PSA) After Cyproterone Compound Treatment Compared With Oral Contraceptives Pill in Hirsute Polycystic Ovary Syndrome Patients

The purpose of this study is to evaluate the effect of oral contraceptive on the serum free prostatic specific antigen (PSA)in women with polycystic ovary syndrome(PCOD)compared with cyproterone compound.

The purpose of this study is to evaluate the effect of oral contraceptive on the serum free prostatic specific antigen (PSA)in women with polycystic ovary syndrome(PCOD)compared with cyproterone compound.

This randomized clinical trial included 60 polycystic ovary syndrome patients with hirsutism who were referred to infertility and reproductive health research center and governmental public educational hospital from Feb2007 till Dec 2007. Polycystic ovary syndrome was defined as the diagnostic criteria of 2003 census Rotterdam. Hirsutism was defined as the presence of excessive hair in body and Ferriman -Gallway scores more than 7. Women who received hormone therapy during the last 3 months, on a diet or herbal treatment were excluded from the study. The other exclusion criterion's consisted of Hyperprolactinemia, thyroid disorders, ovarian tumors and Cushing disease. Hirsutism was determined by the Ferriman-Gallway score and recorded for every patient. Blood samples for serum PSA, and the hormonal profile including free testosterone, dehydroepiandrostenedione sulfate(DHEAS) and 17-hydroxyprogesterone(17-OHP) were taken at baseline and at the end of the treatment at the early follicular phase between 3th to 5th days of menstrual cycle at 8 AM. Patients were divided randomly in two treatment groups according to the computer based table. one group received oral contraceptive pills and the other one received cyproterone acetate combined ethinyl-estradiol(Diane) for 3 months. Hirsutism score was evaluated after treatment again. The blood samples were taken during the early follicular phase after 3 months of treatment to avoid pharmacological effect of treatment and serum PSA, free testosterone, DHEAS,17-OHP were measured again. The university ethics committee approved the study and the informed consent was obtained from patients.

Eligibility Criteria:
Inclusion Criteria:

* PCOS patients

Exclusion Criteria:

* Women who received hormone therapy during the last 3 months,
* On a diet
* Herbal treatment
* Hyperprolactinemia
* Thyroid disorders
* Ovarian tumors
* Cushing disease.
Study Evaluating the Efficacy of DVS-233 in Fibromyalgia

The purpose of this study is to determine if DVS-233 is safe and effective in the treatment of pain and other symptoms of fibromyalgia syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia according to 1990 American College of Rheumatology (ACR) criteria

Exclusion Criteria:

* Other painful conditions that may make results difficult to interpret.
* Treatment with other drugs for fibromyalgia with 14 days of study start or during the study.
Acute Pain Trajectories and Persistent Pain After Breast Cancer Surgery

Persistent pain after breast cancer surgery (PPBCS) is a significant clinical problem, affecting between 25 and 50% of patients. Several factors are associated with the development of PPBCS, including acute postoperative pain. The analysis of pain trajectories through mixed model modeling is an alternative to static pain measures, improving precision and providing information on the time course of pain resolution. Our aim was to investigate if the characteristics of pain trajectories during the first postoperative week are correlated with the persistence of pain 3 months after breast cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for breast cancer surgery
* General anesthesia

Exclusion Criteria:

* Previous breast surgery
* Reconstructive surgery scheduled during follow-up
* Day-surgery patients
* Inability to understand the questionnaires