cyrilzakka/clinical-trials huggingface dataset:
Granulocyte Colony Stimulating Factor (G-CSF) After Salvage Chemotherapy in Refractory AML

Granulocyte Colony Stimulating Factor (G-CSF, filgrastim) is now widely used after chemotherapy which complicates hematological toxicity involving neutropenia. As prolonged neutropenia leads to neutropenic fever due to bacteremia or fungal infection, the use of G-CSF prevents severe infectious complication in various cancer patients.

In acute myeloid leukemia (AML), leukemic blasts have been expected to have G-CSF receptor which may be stimulated by G-CSF, and refractory patients were not treated with G-CSF in salvage chemotherapy in Catholic blood and marrow transplantation (BMT) Center for a long time. This strategy induced prolonged neutropenia and a lot of infectious complications some of which led to deaths.

Although there are some data which remind us G-CSF may proliferate leukemic blasts, the investigators also identified several reports which suggested that subgroup with G-CSF use showed acceptable CR rate and improved survival outcomes compared to a subgroup without G-CSF use.

Therefore investigators are now trying to identify the effects of G-CSF for refractory AML patients in salvage chemotherapy setting regarding the duration of neutropenia and admission, incidence of infectious complications and the duration of antibiotics application. Furthermore, overall response rate (CR+CRi) after salvage chemotherapy and survival outcomes will be calculated according to G-CSF use.

Also, investigators will detect G-CSF receptor using cluster of differentiation 114 (CD114), and analyze the clinical outcomes according to the subgroups with or without using G-CSF during neutropenic period.

Patients will be treated with mitoxantrone and etoposide and cytarabine. Patients will be randomly divided according to the usage of G-CSF.

Subgroup with G-CSF will be treated with G-CSF after 7\~10 days post-chemotherapy, when blasts will disappear from peripheral blood.

Subgroup without G-CSF will be observed until 25\~28 days post-chemotherapy. If blood counts are nor recovered, the investigators can perform bone marrow biopsy to identify the status of the bone marrow.

After then, G-CSF can be applied if blasts are not observed in both peripheral blood and bone marrow.

When absolute neutrophil counts are recovered and there are no evidence of infectious complications, patients will discharge safely from hospital.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0\~2
* AML with remission failure after standard chemotherapy
* Stable liver and renal function (=\< Upper normal limit (UNL) x 2.5)
* Stable heart and lung function (Ejection Fraction (EF) \> 45%, Forced expiratory volume at one second (FEV1) \> 40%)

Exclusion Criteria:

* Acute promyelocytic leukemia
* Central nervous system (CNS) involvement
* Uncontrolled bleeding
* Uncontrolled infectious complication
* Pregnancy, Breast feeding
* Significant cardiovascular disease within 6 months
* Significant organ failure (\> UNL x 2.5)
Korean Version of the "Quality of Recovery 15" After General Anesthesia

The aim of this study is to test the Korean version of QoR-15 for its validity and clinical acceptability and feasibility.

Quality of recovery (QoR) after anesthesia is an important measure of the early postoperative health status of patients. The QoR-40 is a widely-used questionnaire for postoperative patients and the short-form version of it (QoR-15) was developed in 2013. The validation of QoR-15 has been reported in the version of English, Portuguese, Danish, Chinese and Swedish. However, the study to validate the Korean version of QoR-15 has not been demonstrated.

Patients undergoing surgery and general anesthesia are asked by the investigators to complete the QoR-15 questionnaire and Korean 36-Item Short Form Health Survey (SF-36) a day before surgery. They are then asked to repeat the QoR-15 questionnaire 24 h postoperatively and also rate their overall postoperative pain score using 11-point numeric rating scale (NRS).

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo elective general surgery, thoracic surgery and gynecological surgery under general anesthesia
* Age between 18 and 80 years
* Willingness and ability to sign an informed consent document
* Ability to understand the contents of questionnaires

Exclusion Criteria:

* Age under 18 or over 80.
* Do not understand our study
* Medical or psychological disease that can affect the treatment response
FOAM: Functional Outcome After Ventral Mesh Rectopexy

Rectal prolapse is a protrusion of rectal wall through the anus. A surgical technique called Ventral mesh rectopexy has become a standard procedure for this condition in many centers.

The goal of this trial is to investigate functional outcome, recurrence rates and complications after ventral mesh rectopexy. The main question it aims to answer is:

- Do bowel function, quality of life and sexual function improve after Ventral mesh rectopexy?

Participants will:

* be asked to fill in questionaires before surgery, 3-6 months after surgery and 12 months after surgery.
* be examined by a surgeon 3-6 months, 12 months and 3 years after surgery.

Several different procedures have been described for surgical treatment of rectal prolapse and a consensus has not yet been reached. Over the past 20 years, the use of Ventral mesh rectopexy to treat external rectal prolapse has gained increasing worldwide acceptance. Ventral mesh rectopexy has become a standard procedure in many centers based on low recurrence rates, limited complications and good functional results but the use and type of mesh have been debated. Concerns have also been expressed regarding the choice of surgical technique, which differs between centers, and the lack of high-level evidence.

There are few prospective trials and the use of LVMR in a Swedish setting has not yet been evaluated. FOAM (Functional Outcome After ventral Mesh rectopexy) therefore aims to investigate bowel function, quality of life, sexual function, recurrence rates and complications after ventral mesh rectopexy.

A prospective cohort study on patients undergoing ventral mesh rectopexy for external rectal prolapse in Sweden will be conducted. Approximately 70 patients will be included at a maximum of 10 hospitals in Sweden.

Eligibility Criteria:
Inclusion Criteria:

* full-thickness rectal prolapse
* the surgeon agrees that ventral mesh rectopexy is needed for the condition
* capable of participating in follow-up visits and answering questionnaires
* informed consent

Exclusion Criteria:

* patient below 18 years of age
* ongoing pregnancy
* inability to understand the Swedish language
* dementia or other cognitive disorder that unables informed consent
Analgesia in Knee Arthroscopic Surgery

Pain relief in knee Arthroscopic Surgery is essential for rapid recovery of function.

Intra-articular analgesia is useful in reducing patients' postoperative disability. It anticipates and prevents the onset of pain, and helps avoid the need for additional drugs. Usually it is possible to reach good analgesia in the immediate postoperative period by the administration of analgesic drugs. Recently, intra-articular administration of different anaesthetic substances with a local action (e.g. bupivacaine) has been introduced in clinical practice. The aim of the administration of these substances should not be the reduction of postoperative pain, but its prevention.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for knee arthroscopy under spinal anaesthesia

Exclusion Criteria:

* Diabetes Mellitus
* Contraindication to spinal anesthesia
* Patient refusal
A Study of Perfusion of Colorectal Anastomosis Using FLuorescence AnGiography (FLAG-trial)

This is a randomized, controlled, parallel study to determine the difference in post-operative anastomotic leak rate of colorectal anastomosis where colon and rectal tissue perfusion is evaluated using fluorescence angiography with indocyanine green and without this method.

The design involves random allocation of eligible patients to operation with colorectal anastomosis and intraoperative fluorescence angiography with indocyanine green and operation alone. After surgery on 7-8 POD patients are examined to two sides X-Ray proctography performed by introducing 100 ml of water-soluble liquid contrast material through the anus over the anastomotic line by a Foley catheter for diagnosis of anastomotic leakage.

Eligibility Criteria:
Inclusion Criteria:

* Have a planned circular stapled colorectal anastomosis
* Have signed an approved informed consent form for the study

Exclusion Criteria:

* Has known allergy or history of adverse reaction to indocianyne green, iodine or iodine dyes.
Efficacy and Safety of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes

This mechanistic study is designed to investigate the effect of vildagliptin on the sensitivity of the a-cell to glucose under hypoglycemic conditions in patients with type 2 diabetes (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* Patients with T2DM, diagnosed at least 6 weeks prior to visit 1, who have had no treatment with oral antidiabetic agents for at least 12 weeks prior to study entry (visit 1) and no treatment with oral antidiabetic agents at any time in the past for \> 3 consecutive months
* \>/= 18 years
* Body mass index in the range of 22-35 kg/m2
* HbA1c \</=7.5%

Exclusion Criteria:

* Type 1 diabetes
* Acute metabolic diabetic complications
* Evidence of significant diabetic complications
* Insulin treatment within the past 6 months

Other protocol-defined inclusion/exclusion criteria may apply
Priority to Cryopreservation Strategy (PCS) in IVF-ICSI Cycles

This multicentre randomized controlled trial will be done to evaluate a new strategy in IVF-ICSI practice that gives that priority to freeze for the embryos and goes to fresh embryo transfer only if at least one set of same quality embryos is available for cryopreservation.

This study will be a non-blind, prospective, double-armed, randomized clinical trial. The study will be conducted at five centers, the Educational Hospital Fertility Unit of Tanta University, the fertility center of Cairo University, the fertility center of Assiut University, the Egyptian Consultants Fertility Center in Tanta, and MRC fertility center in Cairo from May 1st 2019 till the end of the objected number. The study will be conducted in accordance with the Declaration of Helsinki, and all participants should sign a written informed consent before inclusion in the study.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for IVF/ICSI
* Presence of good number of embryos \> 5

Exclusion Criteria:

* Low quality embryos
* Low ovarian reserve
* Low number of embryos
Feasibility of a Stress Reduction Intervention Study in Sickle Cell Disease

Stress is known to trigger acute pain crisis of sickle cell disease (SCD). SCD is an inherited blood disorder that afflicts about 100,000 people in the United States, and is among the most common lethal genetic diseases in the United States. Though worldwide in distribution, in the US it is most commonly found in African Americans. Its best known complication is severe, recurrent relentless pain, often known as pain crisis. Non-drug treatment for SCD pain such as cognitive coping interventions have been shown to be effective for reducing SCD pain intensity, but they are complicated, multifaceted, and time-consuming. A simple and cost-effective alternative such as guided imagery (GI) could reduce the effect of stress on SCD pain. GI is an intervention where patients listen to and view audio-visual recordings while being directed to visualize themselves being immersed in that scene or scenario. There are no published studies on the use of GI as a simple stress coping intervention or tracking stress in a systematic manner as a trigger for SCD pain.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older,
* Diagnosis of SCD,
* Self-reported pain of at least 3 on a 0-10 scale related to SCD,
* Spoke and read English, and
* Self-identified as being of African or Hispanic descent.

Exclusion Criteria:

* Legally blind or physically unable to complete procedures.
Immunological Change and the Single Nucleotide Polymorphism (SNP) in Children With Irritable Bowel Syndrome (IBS)

Currently, the pathophysiology of Irritable bowel syndrome( IBS) remains unclear . The purpose of this study is want to investigate the immunological changes in the children with IBS.

Irritable bowel syndrome (IBS) is a highly prevalent functional gastrointestinal disorder.Many children suffered from this disease and had impact on their daily life. However, the underlying pathophysiologic mechanisms remain to be elucidate. Dysregulation of the gut immune system is considered an important pathophysiology. We want to investigate the immunological changes in the IBS children.

Eligibility Criteria:
Inclusion Criteria:

* (5-18y/o) with IBS,
* All patients had chronic or relapsing symptoms of IBS consistent with the ROME II criteria

Exclusion Criteria:

* A history of psychologic disorders, probiotics, anti-inflammatory, analgesic, or immunosuppressive medication (nonsteroidal anti-inflammatory drugs, steroids) within the past 3 months were excluded
AB Gait Estim Neurophysiology

This study is being done to answer the question: What are the effects of electrical stimulation and stepping practice on connections between the brain and muscles? The long-term goal of this project is to develop novel, effective, and personalized rehabilitation protocols founded on an understanding of neurobiological mechanisms that combine electrical stimulation with gait training to improve gait performance in older adults and stroke survivors.

The rationale of this project is to explore and generate preliminary data regarding how electrical stimulation-based strategies modulate cortical and spinal circuits in able-bodied individuals.

The researchers will evaluate the effects of short treadmill walking bouts or single gait training sessions with and without electrical stimulation on somatosensory, spinal-reflex, corticospinal circuit neurophysiology, and/or gait performance.

The study will provide important preliminary and normative data that can explain how brain circuits change with stimulation or stepping practice and inform future rehabilitation studies on patients. The study population is able-bodied individuals.

This study is being done to determine the effects of electrical stimulation and walking practice on connections between the brain and muscles.

This study consists of 1-5 study visits lasting up to 5 hours each. Participants will complete stepping training with or without electrical stimulation delivered to their leg muscles; noninvasive stimulation will be delivered to the participants' brain or nerves in the leg to measure the strength of connections within their brain and between their brain / spinal cord and their muscles.

The number of sessions for each participant will depend on whether the same participant completes only 1 or more than 1 study aim.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* Able-bodied (healthy without any physical disability, neurological, orthopedic, or other medical disorder affecting walking or study protocol participation)
* Ability to walk \>10m overground and for 1 minute on a treadmill
* Ability to follow 3-stage commands and provide informed consent.

Exclusion Criteria:

* Self-reported history or evidence of orthopedic or physical disability
* History or evidence of neurological pathology
* Pregnancy (female)
* Uncontrolled hypertension
* Cardiac pacemaker or other implanted electronic system
* Presence of skin conditions preventing electrical stimulation setup
* Impaired sensation in the left upper limb.
* Bruises or cuts at the stimulation electrode placement site
* Concurrent enrollment in rehabilitation or another investigational study.
* History or evidence of orthopedic or physical disability interfering with study procedures
* History or evidence of neurological pathology or disorder
* Severe uncontrolled medical problems (e.g., hypertension, cardiovascular disease, rheumatoid arthritis, active cancer or renal disease, epilepsy) that may interfere with study procedures
* Contraindications to TMS such as metal implants, medications that can increase cortical excitability, unexplained dizziness in the past 6 months
Unilateral TAP Block vs Trocar Insertion Sites Infiltration Anesthesia in Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is a commonly performed operation in general surgery practice. Peripheral nerve block methods commonly used for analgesia after this operation are: transversus abdominis plane block (TAP) and trocar insertion sites local anesthetic infiltration anesthesia In this study, we aimed to compare these methods in terms of postoperative analgesia, nausea-vomiting and patient satisfaction

Patients will be randomly allocated by a computer generated random numbers list into three groups. After general anesthesia induction and intubation patients will receive analgesia according to group allocation. In group TAP (Group T) the transversus abdominis plane block will be commenced with ultrasound guidance while the patients is in the supine position with a subcostal approach using 20 mL 0.25% bupivacaine and 21 G block needle. In group infiltration anesthesia (Group I) the trocar insertion sites will be infiltrated with 20 mL 0.25% bupivacaine: 7 mL for the 10 mm trocar insertion sites and 3 mL for the 5 mm trocar insertion sites. The control group (Group C) will not receive any local anesthetic. All patients will receive rescue analgesia with intravenous patient controlled analgesia with tramadol (20 mg bolus dose and 20 minutes lockout time)

Postoperative pain will be assessed during resting and coughing with a Numeric Pain Scale (NRS) and nausea and vomiting with a Postoperative Nausea Vomiting Score at the postoperative 1, 3, 6, 12. and 24 hours. The amount of tramadol consumed in the postoperative period will be recorded. Patient satisfaction will be assessed with the Likert scale at postoperative 24 hours.

Eligibility Criteria:
Inclusion Criteria:

• Clinical diagnosis of biliary disease

Exclusion Criteria:

* Uncooperative patients
* Blood coagulation disorders
* Laparatomy
* Obesity: body mass index \>35
* Renal failure
* Hepatic failure
* Emergency surgery
* Pregnancy
Prospective Study of BK Virus Disease After Allogeneic Hematopoietic-cell Transplantation: Defining BK Disease's Natural History, Clinical Spectrum, Immunology, and Outcomes

This research study is evaluating the reactivation of BK virus in patients who have undergone allogeneic hematopoietic-cell transplantation.

Every year, more than 25,000 patients worldwide receive lifesaving bone marrow transplantations with hematopoietic-cells from another person. It is estimated that over 75% of these patients will develop an infectious complication, of which approximately one third can be life-threatening. A significant proportion of these infections are caused by opportunistic viruses, such as BK virus.

This virus establishes latent infection in most individuals, but does not normally cause disease. It can reactivate after hematopoietic-cell transplantation and represents the second most common viral infection in this patient population. BK virus is associated with kidney failure and a decreased chance of survival after hematopoietic-cell transplantation. There are no effective antiviral treatments for this disease.

Despite being the second most common cause of clinical disease hematopoietic-cell transplantation, very little is known about this virus. To address this knowledge gap, the investigators aim to study patients with confirmed BK virus disease post allogeneic hematopoietic-cell transplantation.

As part of this study, regular urine and blood tests will be done to understand how the virus behaves over time and which organs it affects. Blood and urine samples will also be obtained to study how the immune system rebuilds itself after hematopoietic-cell transplantation. Finally, an ultrasound of the kidneys and the bladder will be done to evaluate for any presence of disease in these organs.

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥18 years old
* All adult patients who undergo allo-HCT will be eligible for the study, regardless of age, underlying disease, conditioning regimen, or GVHD prophylaxis regimen

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Glucose Tolerance in Healthy Overweight Adults

The primary objective is to compare the postprandial glycemic response of healthy overweight adults after consuming an amino acid drink mix versus a control drink.


Eligibility Criteria:
Inclusion Criteria:

1. Fasting blood glucose level of ≥ 70mg/dL and ≤ 125 mg/dL.
2. Subject states that he/she does not have type 1 or 2 diabetes.
3. Subject is overweight as defined as waist circumference ≥ 101 cm (40 inches) male; ≥ 88 cm (35 inches) female.
4. Subject's BMI is ≥ 25 kg/m2.
5. Subject's blood pressure is \< 140 mm Hg systolic and \< 90 mm Hg diastolic.
6. Subject is between 20 and 45 years of age, inclusive.
7. Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
8. If female is of childbearing potential, is practicing birth control
9. If subject is on a chronic medication such as a thyroid medication or hormone therapy, has been on constant dosage for at least two months prior to screening visit.

Exclusion Criteria:

1. Subject is eating a low carbohydrate diet such as Atkins, Zone, or South Beach diet plan.
2. Subject states that he/she has current infection, has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
3. Subject states that he/she has an active malignancy.
4. Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
5. Subject states that he/she has end-stage organ failure or is status post organ transplant.
6. Subject states that he/she has a history of renal disease.
7. Subject states that he/she has current hepatic disease.
8. Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
9. Subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit that could profoundly affect blood glucose.
10. Subject has taken/is currently taking any herbals, dietary supplements, or medications during the past four weeks prior to screening visit to control hypertension or cholesterol.
11. Subject states that he/she has clotting or bleeding disorders.