cyrilzakka/clinical-trials huggingface dataset:
This is a Safety and Tolerability Study Evaluating a New Treatment for Subjects With Mild to Moderate Alzheimer's Disease

This is a long term extension study to evaluate safety and tolerability of subjects who complete study M10-985 which is evaluating a new treatment for subjects with mild to moderate Alzheimer's disease.

This is a Phase 2, open-label, multicenter, 28 week extension study to evaluate the long-term safety and tolerability of ABT-126 in subjects who complete dosing through Week 24 of Study M10-985. Up to 410 subjects may participate at approximately 30 sites in several countries.

Eligibility Criteria:
Inclusion Criteria:

- The subject and caregiver must voluntarily sign and date an informed consent. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject. - The subject was randomized into Study M10-985 and completed dosing through Week 24 in that study. - With the exception of a diagnosis of mild to moderate AD and the presence of stable medical conditions, the subject is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG. - If male, the subject is surgically sterile (vasectomy, is sexually inactive, or is using a barrier method of birth control (condom) with spermicidal foam/gel/film/cream/suppository for the duration of the study and for 30 days following the last dose of study drug. However, if the male subject's partner has been postmenopausal for at least 2 years or is surgically sterile, then use of a barrier method of birth control is not required. - The subject has an identified, reliable caregiver who will provide support and ensure compliance with the study medication and procedures, and provide accurate information about the subject's status during the study. - The subject and caregiver must have sufficient visual, hearing and graphomotor skills to complete the study procedures.

Exclusion Criteria:

- Experienced an adverse event or abnormal finding in physical examination, vital signs, laboratory profile and/or ECG measurements in Study M10-985 that indicates the subject could become medically unstable during the current study. - The subject is currently taking or is expected to be prescribed any excluded medications (including acetylcholinesterase inhibitors or memantine), without the approval of Abbott medical monitor. - The subject anticipates a move outside the geographic area of the investigative site or is planning extended travel inconsistent with the recommended visit intervals. - The subject is currently enrolled in, or plans to participate in, another experimental study during the course of this trial. - The subject developed any significant medical or psychiatric condition that, in the opinion of the investigator, renders the subject an unsuitable candidate to participate in this study. - For any other reason the investigator considers the subject to be an unsuitable candidate to receive ABT-126 or to participate in this study.
Perifosine With Temsirolimus for Recurrent Pediatric Solid Tumors

The purpose of this study is to test the safety and effectiveness of 2 drugs, perifosine in combination with temsirolimus in children with solid tumors. Neither drug is currently part of the standard treatment of solid tumors in children. Both drugs have been tested alone to treat solid tumors in children with little success. There is now new insight that if given together, perifosine and temsirolimus may work together to stop the growth of solid tumors and may also make them shrink. The doctor wants to find out what effects; good and/or bad, perifosine in combination with temsirolimus has on the patient and the cancer. The doctors are testing four different dose schedules of perifosine with temsirolimus and the patient will be asked to partake in one of the dose schedules. The dose schedule will be lower for those enrolled early in the study.


Eligibility Criteria:
Inclusion Criteria:

* Any solid tumor that has failed standard therapy
* Patient must have evidence of tumor by CT, MRI, MIBG scan, serum markers, or tissue sampling.
* Age ≤ 21 years (age ≤ 35 years for biopsy proven medulloblastoma or neuroblastoma)
* Karnofsky/Lansky performance status ≥ 50% (Karnofsky score for age\> 16 years and Lansky score for age ≤ 16 years)
* ANC≥ 1000 at least 24 hours off GCSF
* Platelets ≥ 100K at least one week off platelet transfusions
* Hg≥ 8g/dL at least one week off PRBC transfusion
* AST ≤ 2 x the upper limit of normal
* ALT ≤ 2 x the upper limit of normal
* Total bilirubin ≤ 2.0 mg/dl
* Patients must have cholesterol level \< 350 mg/dl and triglycerides level \< 400 mg/dl because temsirolimus can induce hyperlipidemia.
* Serum creatinine ≤ 1.5 x the upper limit of normal for age, or calculated creatinine clearance or nuclear GFR ≥ 70 ml/min/1.73 m2.
* ≥ 3 weeks since last non-nitrosourea chemotherapy
* ≥ 6 weeks since last nitrosoureas
* ≥ 4 weeks since last RT
* Patients must agree to practice adequate contraception. Females of childbearing potential must have a negative serum B-HCG pregnancy test documented within 14 days prior to registration. Females must not be breast feeding.
* Patients must be able to swallow tablets whole
* Patients that participated in the phase I single agent perifosine study for recurrent pediatric solid tumors and did not experience a DLT are eligible to participate in this study and can start ≥ 2 weeks since last dose of perifosine
* Patients that have been previously treated with an mTOR inhibitor can still enroll in this trial as long as they did not experience a DLT in the single agent mTOR inhibitor trial

Exclusion Criteria:

* Pregnancy
* Patients must not have an uncontrolled active infection.
* HIV-Positive patients receiving combination anti-retroviral therapy are excluded from the study due to possible retro-viral drug interactions. HIV testing not required.
* Patients must not be taking EIAEDs. If patients were previously on EIAEDs that have been discontinued, patients must have been off the agent for at least 2 weeks prior to registration.
* History of or known pulmonary hypertension or history of or known pneumonitis.
The Influence of Short-term Starvation on Hepatitis B Virus Load

Hepatitis B virus is a small DNA virus that affects 400 million people worldwide. The virus infects the liver and previous studies, done in tissue culture and in animals, have shown that viral replication is affected by metabolic changes occurring in the liver. Specifically, starvation induces HBV gene expression and replication, in parallel to the activation of the gluconeogenesis response, and feeding attenuates viral activity. In this study we are going to recruit HBV patients with detectable viremia and analyze their viral load after an over night starvation versus after a morning meal. Our hypothesis is that following an over-night starvation viral load will be higher than that in the fed state.


Eligibility Criteria:
Inclusion Criteria:

* Hepatitis B virus patients with detectable viremia
* \>18 years old
* signed a consent form

Exclusion Criteria:

* patients with malignancy
* Patients with diabetes mellitus
* Alcohol consumption of more than 140grams a week
* Advanced liver disease
* HCV or HIV infection
* Pregnancy
* Mental retardation or unable to understand basic explanation about the study -
Pletaal SR Post Marketing Observational Study

This is a Post Marketing Observational Study of cilostazol (Pletaal® SR capsule). As this study is observational in nature to collect the safety data after administrating the Pletaal SR capsule, from baseline to 16 weeks.

This study will be conducted in a prospective, single-arm, multi-center format. As this study is observational in nature, the patient's follow-up is not prescriptive in nature and must be left up to the judgment of the physician (investigator), within the period of observation set forth in the protocol.

Eligibility Criteria:
Inclusion Criteria:

- Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study : 1. Patients who are prescribed Pletaal® SR capsule treatment as per investigator's medical judgment for adults aged 19 and over.

2. Patients who gave written authorization to use their personal and health data Physician (Investigator) will refer to the product market authorization (package insert) for inclusion criteria.

Exclusion Criteria:

* Patients presenting with any of the following will not be included in the study 1. Patients with hemorrhage 2. Patients with congestive heart failure 3. Patients with known hypersensitivity to Cilostazole or any ingredients of Pletaal® 4. Women who are pregnant or may possibly become pregnant 5. Patients who is not eligible to participate this study as investigator's medical judgment Physician (Investigator) will refer to the product market authorization (package insert) for exclusion criteria.
Investigating the Effect of Normal Frequency-band and Infra-low Frequency Neurofeedback on Functional Brain Connectome

In this basic research project a novel form of neurofeedback is investigated, in which in addition to the use of 1) normal frequency bands (1-35 Hertz), 2) very slow signals (low frequency; \< 0.1 Hertz) are used, which correspond more to the basic excitability of the brain. Because of the slow signal characteristics, this method is called infra-low frequency neurofeedback (ILF-NFB for short). Although this method has been successfully applied in clinical settings since the 1980s, the mechanisms underlying the effect are largely unexplored. For that purpose, a project consistiong of three studies will be conducted in order to investigate the neurophysiological effects of both signal elements on healthy participants:

* Study 1 examines the effects of normal frequency band training alone.
* Study 2 examines the effects of low frequency training.
* Study 3 examines the effects of the combination of normal frequency band and low frequency training

For each study, a total of 40 clean data sets are to be collected, resulting in a minimum amount of 120 participants for all three studies.

All three studies investigate the effects of the neurofeedback on brain connectivity patterns by means of functional magnetic resonance imaging (fMRI), accompanied by measurements of the autonomic nervous system (ANS) and behavior.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Written informed consent after participants' information
* Fluent in German language (required for an adequate answering of the questionnaires)
* No previous experience with neurofeedback treatments

Exclusion Criteria:

* Alcohol, drug and analgesics consumption within the last 24 hours
* Pre-existing neurological and/or psychiatric conditions
* History of brain injuries
* Alcohol and drug abuse
* Chronic diseases that require permanent medication
* Exclusion criteria met based on the screening questionnaire
* General contraindications for MR-testings (e.g. claustrophobia, pace maker, cochlear implant, insulin pump)
* Hypersensitivity to loud noises
* Incapable of lying still during a longer period of time
Intraoperative Clonidine for Postoperative Pain Management in Patients Undergoing Surgical Treatment for Endometriosis

The role of a single dose of intraoperative clonidine on postoperative opioid requirements, pain intensity and opioid-related side effects in patients undergoing surgical treatment for endometriosis remains scarcely explored. A prospective double-blind, randomised controlled trial investigating the effect of a single-dose of intraoperative clonidine in patients undergoing surgical treatment for endometriosis is therefore conducted.

Background with aim: Acute postoperative pain is a major and common concern for the large number of patients who undergo surgery each year. Despite advances in pain management strategies, many patients continue to suffer from moderate-to-severe pain during the early postoperative period. This is concerning as unrelieved pain can result in decreased patient satisfaction, increased morbidity, prolonged hospital length-of-stay and increased risk of persistent pain. Effective treatment of acute postoperative pain should therefore be prioritized. Opioid analgesics remain the mainstay treatment for postoperative pain. The potential benefits of opioid therapy for acute pain are short-term pain control. However, there are several potential harms associated with opioid use which may outweigh the benefits including sedation, nausea, vomiting, constipation and risk of long-term use. In this respect, a single dose of clonidine could provide stable analgesia and potentially reduce the need for shorter-acting opioids. Therefore, the investigators decided to carry out the present study with the aim to examine the analgesic efficacy and safety of intraoperatively administered intravenous clonidine in patients undergoing surgical treatment for endometriosis on postoperative opioid consumption, pain intensity and opioid-related side effects.

Method: 120 patients undergoing surgical treatment for endometriosis will be included in this prospective, randomized, double-blind, controlled trial with two arms: an intervention arm (clonidine 150 microgram) and a control arm (isotonic saline). The study will be GCP-monitored, and is approved by the Danish Medicines Agency (2022064017) and the National Committee on Health Research Ethics (2209269).

Hypothesis: The investigators hypothesize that a single dose of intraoperatively administered intravenous clonidine will be effective in reducing postoperative opioid requirements, pain intensity and opioid-related side effects.

Eligibility Criteria:
Inclusion Criteria:

• Patients scheduled for surgical laparoscopic treatment of endometriosis at Aarhus University Hospital

Exclusion Criteria:

* Age \< 18 years
* American Society of Anesthesiologists (ASA) physical status IV or V
* Allergy to clonidine
* Inability to provide informed consent
* Known severe renal insufficiency
* Known severe bradyarrhythmia
* Pregnancy, lactation:
* Daily opioid consumption the last 7 days before surgery
* Pain intensity \>5 on more than half of the days during the last month
The Clinical Significance of Sentinel Lymph Node Imaging Combined With Imaging Examination in Pelvic and Peritoneal Lymphadenectomy for Endometrial Carcinoma

The aim of this prospective cohort study is to explore the clinical significance of sentinel lymph node imaging combined imaging examination evaluation in pelvic and peritoneal lymphadenectomy for endometrial carcinoma management.

The clinical data including surgical procedure, the situation of sentinel lymph node imaging and pathological results of patients with endometrial carcinoma treated in our hospitals between April 2019 and April 2021 will be analyzed in this study to clarify the homogeneity of imaging evaluation, sentinel lymph node development evaluation and pathological results.

Eligibility Criteria:
Inclusion Criteria:

1. Females who are diagnosed with endometrial carcinoma;
2. Patients who are willing to receive primary non-reserved fertility function surgery to treat their disease;
3. Patients who are agreed to participated in this prospective cohort study.

Exclusion Criteria:

1. Patients who still have the will to have pregnancy;
2. Patients who have other diseases or heavy injuries that will interfere with the results;
3. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
Effect of CVP and IOH on AKI and AKD

This study was aimed to explore the effect of intraoperative venous congestion and intraoperative hypotension (IOH) on acute adverse kidney events, defined as acute kidney injury (AKI) and acute kidney disease (AKD), after cardiac surgery

Venous congestion and IOH were primary exposures and quantified as area under the curve (AUC) of central venous pressure ≥12, 16 or 20 mmHg or mean arterial pressure ≤55, 65, 75 mmHg. The primary outcome was AKI or AKD defined as renal dysfunction persisting \> 7 days after surgery. Multivariable logistic regression and Cox proportional hazard models were used to determine the association between intraoperative venous congestion/hypotension and postoperative acute adverse kidney events, respectively, adjusted for relevant confounding factors and multiple comparisons.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older,
* Patients underwent cardiac surgery (coronary artery bypass grafting, heart valve surgery, heart transplant or surgical excision of intracardiac myxoma)
* Patients receiving invasive intraoperative BP monitoring during surgery
* Patients underwent cardiopulmonary bypass (CPB) during surgery

Exclusion Criteria:

* Pre-existing renal insufficiency defined by presence of abnormal preoperative serum creatinine ≥ 133 μmol/L and/or preoperative diagnosis of renal insufficiency within 6 months'preoperative period.
* Patients with preoperative dialysis dependence within 60 days before the index surgical procedure,
* Surgical duration less than 30 minutes
* Surgery on the aorta
* Insufficient hemodynamic and laboratory data for outcomes and/or exposure ascertainment
Use of Pessary in Case of Cervical Insufficiency and Short Cervix

Prematurity is the most important cause of obstetric morbidity and mortality. Health centers and obstetricians are trying to reduce the preterm birth rate by taking into account the permanent effects of premature birth on human life in the early and long term.

The most effective solution of preterm delivery is to determine the patients entering the risk group and to prevent preterm labor by putting the correct diagnosis at the right time. Recently, there have been studies on the efficacy of pessary practice in preventing preterm birth, but with the positive results of these studies, there has been hope for early birth prevention as well as other treatments.

The aim of this study is; To assess the effectiveness of pessary use in patients with high risk for preterm labor and prophylactic cervical length less than 25 mm below 25 weeks and with a history of cervical insufficiency.

The aim of this study is; To assess the effectiveness of pessary use in patients with high risk for preterm labor and prophylactic cervical length less than 25 mm below 25 weeks and with a history of cervical insufficiency.

100 pregnant women with a preterm delivery history and / or a cervical length of less than 25 mm will be included among the pregnancies between 16 and 24 weeks of gestation referred to obstetric and perinatology clinics. Information will be given about the success of treatment in the prevention of early birth of the pessary and the use of the disease pessary. Urine culture and cervical culture samples will be taken from both groups of patients. In the presence of infection, the patient's treatment will be planned and out of work. If no infection is detected and the patient agrees to use the pessary, the pessary will be used to prevent premature birth.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a cervical length of 25 mm\> and a preterm labor history in the previous pregnancy

Exclusion Criteria:

* Patients with vaginal bleeding, with congenital anomalies, chorioamnionitis
Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With DLBCL: a Phase II Multicenter Study of the FIL

The purpose of the study is to evaluate feasibility and efficacy of rituximab-bendamustine (R-B)combination in elderly patients affected by diffuse large B-cell lymphoma and defined as frail according to CGA.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven CD20 positive diffuse large B-cell non-Hodgkin's lymphoma
* Age \> 70 years
* No previous treatment
* FRAIL patients defined as follows (see Appendices B-E) Age \> 80 years with UNFIT profile, i.e.

  * ADL \> 5 residual functions
  * IADL \> 6 residual functions
  * CIRS 5-8 co-morbidities of grade 2

or Age \< 80 years with

* ADL \< 4 residual functions, or
* IADL \< 5 residual functions, or
* CIRS : 1 co-morbidity of grade 3-4, or \> 8 co-morbidities of grade 2

  * Life expectancy \> 6 months
  * Written informed consent
  * Accessibility of patient for treatment and follow up

Exclusion Criteria:

* History of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
* Previous exposure to cytotoxic agents
* Suspect or clinical evidence of CNS involvement by lymphoma
* HBsAg, HCV or HIV positivity; HBcAb positivity is accepted only with concomitant treatment with Lamivudine
* AST /ALT \> twice upper the normal range; bilirubin \> twice upper the normal range; serum creatinine \> 2.5 mg /dl
* Evidence of any severe active acute or chronic infection
* Concurrent co-morbid medical condition which might exclude administration of full dose chemotherapy
* Senile dementia
* Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
The Prone to Supine Breast MRI Trial

The purpose of this study is to determine whether a supine MRI obtained immediately after a standard diagnostic prone MRI exam, without a second injection of gadolinium (Gd) contrast material, would be of sufficient quality to allow the Radiologist to define the tumor edges ("segment" the tumor) so that a 3-D image of the tumor can be generated to form a BCL.

The purpose of this study is to find out whether additional MRI images taken with patients in a different position after completing a standard MRI are of sufficient quality to allow a radiologist to identify the edges of the tumor.

These additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.The information gathered in this study will make it more feasible to use a new device called the "breast cancer locator" to help surgeons more accurately remove breast cancers.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Female gender.
* Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ
* Tumor size at least 1 cm in diameter as visualized on mammogram or US.
* A diagnostic breast MRI is considered to be clinically indicated.
* Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.

Exclusion Criteria:

* Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes.
* Severe claustrophobia.
* Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (eGFR \< 30 ml/min/1.73m2).
* History of median sternotomy.
* Pregnancy. Patient attestation that they are not pregnant will be acceptable.
* Patients who have received neoadjuvant chemotherapy.