cyrilzakka/clinical-trials huggingface dataset:
Trial of Prophylactic Versus Empirical Vancomycin for the Prevention of Streptococcal Sepsis After Hematopoietic Cell Transplantation

This is a randomized 2-arm study to compare two different times of giving the drug vancomycin. Half of the patients will begin vancomycin two days before a bone marrow transplant. The other half will get it as soon as they have the first fever.

Streptococci are bacteria that live in one's mouth and gut. These bacteria can escape into the blood when the lining of the mouth and gut weakens from cancer therapy. This can make the person who is undergoing a bone marrow transplant very sick. All patients who get this infection are treated with antibiotics. Vancomycin is one drug that is used to treat this bloodstream infection once it is diagnosed. Studies have shown that giving vancomycin before a bone marrow transplant seems to prevent this infection. However, giving vancomycin too soon may increase the chance that the kidneys will be irritated. It may also increase the chance that other bacteria will become resistant to this drug. We, the investigators at Memorial Sloan-Kettering Cancer Center, do not know if waiting to start vancomycin until the patient has a first fever can also prevent this infection.

The primary objective of this study is as follows:

* To compare prophylactic with empirical vancomycin administration for reducing early viridans streptococcal bacteremia in allogeneic hematopoietic stem cell transplant (HSCT) patients.

The secondary objectives of the study are:

* To examine the safety and tolerability for each vancomycin administration approach.
* To measure the incidence of vancomycin-resistant enterococcal (VRE) infections for patients managed with each of the two vancomycin administration approaches.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing allogeneic HSCT for hematologic malignancies or other disorders
* Conditioning regimen that includes high-dose total body irradiation (TBI) (\>1200 cGy)
* The ability to understand and the willingness to sign the Institutional Review Board (IRB)-approved Informed Consent, including the Research Authorization component of the Informed Consent form.

Exclusion Criteria:

* Non-TBI conditioning regimen
* Prior history of hypersensitivity to vancomycin (excluding history of "Red Man Syndrome")
* Fever or infection that requires intravenous vancomycin or oral/intravenous linezolid between day-7 and day-3 before hematopoietic stem cell transplant
Oldpain2go®: an Exploratory (Pre-Feasibility) Study.

Research question: Is there any evidence to suggest that the oldpain2go® intervention merits scientific investigation?

Aims:

1. To collect data to:

   1. give an indication of the potential effect size, of any effects, from the oldpain2go® intervention, in people with persistent low back pain.
   2. to explore the eligibility criteria, recruitment methods and materials proposed here, for potential use in a future Feasibility study, of the oldpain2go® intervention.
2. To compare demographic characteristics, medical history and outcome measure data of:

   1. people for whom Oldpain2go® is indicated (at the Oldpain2go® screening session), with those for whom it is not,
   2. people for whom the Oldpain2go® intervention works, after one treatment, with those for whom it does not, and
   3. people for whom the Oldpain2go® intervention works, after one, or two, treatments, with those for whom it does not work after two treatments.

Eligibility Criteria:
Inclusion Criteria:

* Currently suffering from persistent, non-specific, low back pain
* Aged over 18 years
* For whom Oldpain2go® is indicated as a treatment option after the standard clinical screening process for the Oldpain2go® treatment

Exclusion Criteria:

* Any Red Flags,
* Any causative (or potentially causative) structural abnormality, or pathology detected or suspected
* Any concurrent pathology, or condition that would limit options for Physiotherapy treatment,
* Lack of (or any reason to doubt presence of) Mental Capacity to give Informed Consent
Is Reflexology Applied to Children With Cerebral Palsy an Effective Method?

Objectives: This study was planned to investigate the influence of reflexology applied to children with cerebral palsy together with physical therapy program involving neurodevelopmental approaches.

Methods: The study involved 40 children aged,16 girls and 24 boys between 3 and 15 years and divided into two groups. While the children in Group 1 were given twice a week for eight weeks neurodevelopmental treatment, reflexology was applied to those in Group 2 together with neurodevelopmental treatment. Drooling Severity and Frequency Scale, Pediatric Sleep Questionnaire and the Children's Health Questionnaire was used to assess the drooling, status of sleep and quality of life in children.

The study involved a total of 40 children aged between three and 15 diagnosed with CP by a pediatric neurologist. Children at levels 3/4/5 of the GMFCS who did not have any open wounds on the foot, where the application was to be performed, and whose parents consented to the child's participation were accepted in the study. However, those children were excluded who were treated with botulinum toxin in the last six months, underwent surgery, were treated with reflexology or any other alternative medicine method and who had refractory epilepsy.

Eligibility Criteria:
Inclusion Criteria:

* Children at levels 3/4/5 of the GMFCS who did not have any open wounds on the foot, where the application was to be performed, and whose parents consented to the child's participation were accepted in the study.

Exclusion Criteria:

* who were treated with botulinum toxin in the last six months, underwent surgery, were treated with reflexology or any other alternative medicine method and who had refractory epilepsy.
Does IV Magnesium Improve Quality of Recovery With ERAS Protocols in Laparoscopic Colorectal Surgery?

This study is a randomized, double blind controlled trial examining the impact of incorporating a single intraoperative intravenous magnesium bolus and infusion into a preexisting Enhanced Recovery After Surgery (ERAS) protocol for colorectal surgery in place of preoperative oral pregabalin. These protocols are pathways designed with the goal of achieving early surgical recovery by utilizing a constellation of perioperative care techniques that include the use of opioid-sparing pain medications, minimally invasive approaches, and prevention of post-operative nausea and vomiting, among others. Intravenous magnesium has shown to be an effective non-opioid analgesic in abdominal surgeries that decreases total opioid consumption, pain, and improves recovery. The purpose of this study is to evaluate whether or not the addition of intravenous magnesium to our institutional ERAS protocol will improve specific outcome measures, and provide additional benefits when compared to oral preoperative pregabalin. The primary outcome is the patient's quality of recovery based on the "Quality of Recovery - 40 Questionnaire" (QOR 40), and secondary outcomes will be opioid consumption, pain, shivering, sedation scores, acute kidney injury, gastrointestinal function, respiratory function, and hospital length of stay.


Eligibility Criteria:
Inclusion Criteria:

* Elective Laparoscopic Colorectal Surgery
* Age 18-75
* ASA (American Society of Anesthesiologists) Physical Status Classification 1-3

Exclusion Criteria:

* Current use of Buprenorphine/Suboxone or Methadone maintenance treatment
* Known history of substance abuse
* Use of intra- and/or postoperative Ketamine or Lidocaine infusion
* Pre- or postoperative placement of Epidural catheter
* Inability to speak English or communicate verbally
* Chronic Kidney Disease (CKD) Stage 3
* Hepatic Cirrhosis
* Neuromuscular disease
* Heart block on EKG
* Uncontrolled diabetes with Hba1c \> 8%
* Known allergies to study drugs
Plasmapheresis for Nephrogenic Fibrosing Dermopathy (NFD)/Nephrogenic Systemic Fibrosis (NSF)

The purpose of this study is to evaluate the pathophysiology of nephrogenic fibrosing dermopathy (NFD)/nephrogenic systemic fibrosis (NSF).


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with NFD/NSF following a kidney transplant
* diagnosed with NFD/NSF following a liver transplant
* NFD/NSF and who have not had a kidney or liver transplant
* diagnosed with NFD/NSF and who have not had a kidney or liver transplant
Dynamic Changes of Sera Immunoglobulin G4 and Interleukin-10 in the Patients of Pancreatic Cancer After Chemotherapy

Investigators have previously found that the infiltration of immunoglobulin G4(IgG4) positive plasma cells in tumor tissue predicts a poor prognosis of pancreatic cancer after curative resection. Investigators further attempt to explore the possible roles of IgG4 and the inducer of IgG4, interleukin-10(IL-10), in the chemotherapy of pancreatic cancer. In this primary study, investigators plan to observe the dynamic changes of sera IgG4 and IL-10 in peripheral blood after gemcitabine-based chemotherapy and analyze the correlations of IgG4 and IL-10 with the response of gemcitabine and overall survival of pancreatic cancer.

Human immunoglobulin G(IgG) is a family consisting of four members, IgG1, IgG2, IgG3 and IgG4.IgG4 is regarded as an inhibitory IgG which can inhibit the activation of immune responses\[1\]. Recently it was reported that IgG4 could weaken the activation of macrophages to promote cancer progression\[2\]. Autoimmune pancreatitis(AIP) is the most common clinical manifestation of IgG4-related sclerosing diseases(IRSD) which is characterized by abundant infiltration of IgG4 positive plasma cells\[3\].Although there are abundant infiltrations of IgG4 positive plasma cells in pancreatic lesion of AIP, the correlation of IgG4 positive plasma cells with pancreatic cancer has never been reported.Investigators have previously found that higher level of infiltration of IgG4 positive plasma cells in tumor tissue predicts a poor prognosis of pancreatic cancer after curative resection(not published).Investigators further attempt to explore the possible roles of IgG4 and the inducer of IgG4, IL-10, in the chemotherapy of pancreatic cancer.Since gemcitabine is the first line chemotherapeutic drug for pancreatic cancer, in this primary study,investigators plan to observe the dynamic changes of sera IgG4 and IL-10 in peripheral blood after gemcitabine-based chemotherapy and analyze the correlations of IgG4 and IL-10 with the response of gemcitabine and overall survival of pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Age ranging from 18 to 75-year old;
2. Pathological verified pancreatic cancer including adenocarcinoma and cancerogenesis of intraductal papillary mucinous neoplasm (IPMN);
3. Pancreatic cancer patients receiving adjuvant chemotherapy after curative resection; pancreatic cancer patients with recurrent lesions receiving chemotherapy after curative resection; pancreatic cancer patients with unresectable tumor receiving chemotherapy;
4. Patients have good physical status to receive chemotherapy;
5. No history of chemotherapy and the current regimen contains gemcitabine;
6. No medical history of IgG4 related diseases and other connective tissue diseases;
7. Written consent is available.

Exclusion Criteria:

1. Patient younger than 18-year old;
2. Patient has chemotherapy before;
3. The physical status is too poor to receive chemotherapy;
4. The patient has history of IgG4 related diseases and some other connective diseases;
5. Written consent is not available.
The Promus Element Rewards Study

This study is being done to study stent deformation on persons with de novo coronary lesions to determine how much deformation takes place and how often. The information gathered from the group that receives the Promus element stent will be compared to other groups that receive other contemporary drug eluting stents.


Eligibility Criteria:
Inclusion Criteria:

* Patients, male or female, 18 years or older;
* Patients with de-novo coronary lesions and slated to receive a Promus Element stent;
* Patients who are slated to undergo IVUS after stent deployment during implantation procedure

Exclusion Criteria:

* Patients receiving more than one drug-eluting stent within the same lesion during implantation procedure;
* Patients with in-stent restenosis;
* Patients who had IVUS imaging attained with manual pullback.
Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes

This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age at Visit 1
* Drug naïve patients with T2DM diagnosed at least 2 months prior to Visit 1
* HbA1c ≥ 7.0 % and ≤ 10.0% at Visit 1
* Body Mass Index (BMI) in the range of 22-45 kg/m2 at Visit 1

Exclusion Criteria:

* Pregnant or lactating female
* FPG ≥ 270 mg/dL (≥15 mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply
Preoperative Embolization in Surgical Treatment of Spinal Metastases.

The main purpose of this study is to assess the efficacy of preoperative embolization in decreasing operative blood loss, decreasing the need for intraoperative transfusion and facilitate surgical resection in metastatic spine surgery. Furthermore the study aims at describing the vascularity in a series of spinal metastasis, and to correlate this with perioperative blood loss.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for decompression and posterior thoracic and/or lumbar instrumented spinal fusion because of spinal metastasis/metastases.
* Informed signed consent.

Exclusion Criteria:

* Contrast fluid allergy.
* Clotting disorders.
* Renal failure.
* Not suitable for arterial access.
* Pregnancy.
Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial

Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).

Anemia is the commonest hematological disorder that occurs in pregnancy. According to the recent standard laid down by 'WHO', anemia is present when the Hemoglobin (Hb) concentration in the peripheral blood is 11 gm/dl or less. The most common cause of anemia in pregnancy is lack of iron. This study is done to compare the efficacy and tolerability of iron amino acid chelate and that of iron salts (ferrous fumarat).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at 14 -18 weeks of gestation calculated from the first day of their last menstrual period and confirmed or modified by ultrasound
* Hemoglobin level 8-10.5 g/dL
* Serum ferritin\<15µg/L

Exclusion Criteria:

* The presence of anemia from causes other than iron deficiency(e.g: Folat deficiency anemia,Vitamin B12 deficiency, ect...).
* Multiple gestations
* The presence of clinical and/or laboratory evidence of hepatic, renal, hematological or cardiovascular disease
* Patients with known gastritis
* History of mal-absorption syndrome
* Those with known hypersensitivity to iron preparations
* Those under current iron supplementation
A Study of MK0431 in Patients WIth Hepatic Insufficiency (0431-017)(COMPLETED)

A study to compare the plasma concentrations of MK0431 at different times in patients with hepatic insufficiency vs healthy control subjects.


Eligibility Criteria:
Inclusion Criteria:

* If female, non pregnant, BMI less than 40 kg/m2
* Patient has chronic, stable hepatic insufficiency

Exclusion Criteria:

* Patient unwilling to refrain from alcohol and grapefruit juice prior to and shortly after study drug administration
* Patient has diabetes, had a heart attack or stroke, or uncontrolled congestive heart failure during the past 6 months
* Patient has a history of drug or alcohol abuse
* Patient smokes \> 10 cigarettes per day
* Patient consumes more that 6 cups of caffeinated beverages per day
* Patient has had surgery, donated blood or participated in another clinical trial within the past 4 weeks
Impact of Microphone Positioning on Auditory Performance in Cochlear Implant Users

The construction of our auditory space requires several prerequisites, including localization abilities in 3D (azimuth, elevation and distance). These abilities rely on the proper development and functionality of the auditory system to extract various acoustic cues from our environment. Extraction and analysis of these auditory cues are based on the synchronous use of ears, called binaurality. Other natural behaviours are useful to precisely determine the location of a sound source: visual information and head movements.

The slightest anatomical-functional change (e.g. unilateral hearing loss, malformation of the pinna) can disturb spatial hearing abilities. Many patients with hearing loss are fitted with a hearing aid (HA) or a cochlear implant (CI) to ensure the best speech understanding. However, this auditory rehabilitation remains insufficient to restore a good perception of spatial hearing. One of the key point to improve sound localization seems to be microphone positioning on hearing aids. Several questions remain on the optimal microphone positioning.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 75 inclusive
* Regular follow-up in the Ear Nose and Throat department of the Edouard Herriot hospital in Lyon
* Post-lingual deafness
* Fitted with two Advanced Bionics (AB) cochlear implants (Naïda Q70 or Naïda Q90 processor) Or fitted with one AB cochlear implant and a contralateral hearing aid
* Fitted with the latest implant for more than 1 year
* Normal or corrected vision
* Able to understand experimental instructions
* Affiliated with a social security scheme

Exclusion Criteria:

* Oculomotor disorder
* Bilateral vestibular areflexia
* Adult subject to a legal protection measure (guardianship, curatorship)
Laparoscopic Total Left-sided Surgical Approach Versus Traditional Bilateral Surgical Approach for Hiatal Hernia

Background: In China, guidelines for the treatment of hiatal hernia (HH) are lacking. Furthermore, efficacy and safety assessments of surgical approaches for HH and for the protection of the vagus nerve and organ function are needed. Therefore, the present clinical trial is being conducted to establish the normative treatment for HH. Methods: The current trial is an ongoing, single-center, randomized controlled trial of patients with HH. The total sample size required for the trial (July 2020-December 2023) is approximately 114 patients.

Patients will be randomly assigned to either an experimental group (total left-sided surgical approach; TLSA) or a control group (traditional bilateral surgical approach; TBSA) at a ratio of 1:1 using the block randomization method. We will use case report forms (CRFs) and electronic data capture (EDC) systems to obtain demographic information, preoperative laboratory tests, auxiliary examination results, operation information, and postoperative condition. The patients will be followed up for 3 years after surgery. The primary endpoint is the gastrointestinal quality-of-life index (GIQLI) at 1 year. The secondary endpoints include an efficacy evaluation index \[consisting of the incidence of gallstones and gastric emptying disorders, gastrointestinal function recovery time, visual analog scale (VAS) scores, objective evaluation of postoperative indices, and surgical information\] and a safety evaluation index (consisting of the incidence of postoperative complications, the 30-day postoperative mortality rate, and the HH recurrence rate at 1 and 3 years after surgery). Discussion: TLSA can protect the normal physiological function of organs to a certain extent by protecting the vagus nerve from injury, and has satisfactory short- and long-term efficacy. There is no significant difference in the incidence of postoperative complications and surgical safety between TLSA and TBSA. Our findings will facilitate clinical decision-making for HH and improve the life quality of patients.

Trial registration: Chinese Clinical Trial Registry, ChiCTR2000034028 (registration date: June 21, 2020). Keywords: Hiatal hernia (HH); surgical approach; efficacy; safety; randomized controlled trial


Eligibility Criteria:
Inclusion Criteria:

* (I) HH (type II/III/IV) diagnosed by gastroscopy, high-resolution esophageal manometry, and 24-hour esophageal pH monitoring.

(II) Aged 18-65 years, with no sex restrictions. (III) Eastern Cooperative Oncology Group score of ≤2 points and an American Society of Anesthesiologists score of ≤2 points.

Exclusion Criteria:

- (I) patients with cerebrovascular injury that occurred within the 6 months prior, unstable angina, or myocardial infarction; (II) patients with a history of uncontrolled epilepsy, central nervous system disease, or malignant tumor, or those with impaired judgment or mental illness who cannot cooperate with the research (III) patients with a history of digestive system tumors, or thoracic or abdominal surgery
Effect of AQW051 in Patients With Memory Impairment

This study will investigate AQW051 in patients with either mild Alzheimer's disease or amnestic mild cognitive impairment. The effect on cognitive impairment will be measure using validated computerized tests which measure cognitive function. This study will also explore the safety and tolerability of AQW051 in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give written informed consent
* Meet the diagnostic criteria for either amnestic mild cognitive impairment (amnestic MCI) or mild Alzheimer's Disease (AD).
* Structural brain scan within the last 6 months prior to randomization that indicates no other underlying disease, in particular no evidence for vascular pathology except for normal age-related white matter/incidental white matter changes which is normal for this age group.
* Daily contact with a primary caregiver/partner

Exclusion Criteria:

* Immune therapy targeting Alzheimer beta amyloid within the last 12 months
* Institutionalized
* Disability that may prevent completion of all study requirements (e.g., blindness, deafness, or communication difficulty)
* Reported use of tobacco products in the previous 3 months or have a urine cotinine level greater than 500 ng/ml
* Past medical history of clinically significant electrocardiogram (ECG) abnormalities or a family history (grandparents, parents, and siblings) of prolonged QT-interval syndrome
* History or current diagnosis of conditions specified in the protocol.

Other protocol-defined inclusion/exclusion criteria may apply.