cyrilzakka/clinical-trials huggingface dataset:
Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients

Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold before apheresis, and if transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).

An open label, multi-center, phase 2 study was conducted in patients with MM or NHL who were to be treated with peripheral blood stem cells (PBSC) autologous transplantation. The only change to the standard of care was the addition of plerixafor to a mobilization regimen of chemotherapy and G-CSF. Patients were first given a mobilizing regimen of chemotherapy as per local practice guidelines and G-CSF (at customary doses) and apheresis was performed. After the first apheresis, plerixafor was given at 10PM, 10-11 hours before the second apheresis the next day or in the morning of the second day, 6 hours before the second apheresis. The change in the patient's peripheral CD34+ cell count between the plerixafor dose and the start of apheresis was measured. The apheresis yields on Day 1 and Day 2 were compared.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria (Abbreviated List):

* MM in first partial response/complete response, first relapse, or second partial/complete response
* NHL in first or second partial or complete remission
* NHL patients who do not have bone marrow involvement and \< 10% for follicular involvement
* MM patients who have stable disease with \< 40% bone marrow involvement
* No more than three prior regimens of chemotherapy (thalidomide and Decadron are not considered chemotherapy)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* White blood cell count (WBC) \>3.0 x 10\^9/L
* Absolute neutrophil count \>1.5 x 10\^9/L
* Platelet count \>100 x 10\^9/L

Exclusion Criteria (Abbreviated List):

* Brain metastases or carcinomatous meningitis
* Hypercalcaemia \[\>1 mg/dl above the upper limit of normal (ULN)\]
* Cardiovascular disease that includes proven or predisposition to ventricular arrhythmias
* Acute Infection
Glucosamine Sulphate, Ginger, Ginger-Avocado-Soya and Ginger-Ibuprofen for Chronic Back Pain

The main purpose of this study is to investigate the ability of some dietary supplement products to affect general joint health and life quality in a selected population with back pain.

The study is randomized and double - blind, with parallel groups receiving treatment for a duration of 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Chronic back pain daily or almost daily for at least 3 months prior to inclusion
* Patient classified as I or II according to Quebec Task Force
* No intake of glucosamine sulphate, ginger, or avocado-soya extract during last 3 months
* Fertile women should, at start, have a negative pregnancy test and during test use acceptable prevention methods (p-pills, intrauterine device \[IUD\], depot gestagen, subdermal implant, hormonal vaginal ring or transdermal depot plaster).
* Anxiolytics, muscle relaxants, physiotherapy, chiropractic treatment, or training should not have been used during last 3 months.

Exclusion Criteria:

* Serious disease (eg. heart disease, cancer (within past 5 years), kidney disease, blood diseases, inflammatory diseases (eg. chronic rheumatoid arthritis, fibromyalgia)
* Suspicion that back pain is caused by osteoporosis, other arthritic condition than osteoarthritis, cancer, infection, pain from organ disease or psychosomatic cancer disease.
* Uncontrolled elevated blood pressure, defined as systolic ≥ 160 mm Hg or diastolic ≥ 90 mm Hg.
* VAS measurement at inclusion less than ved 30 mm or over 90 mm.
* Prehistory of ulcer, stomach surgery, or inflammatory bowel disease
* Pain relief medication besides must not be taken during study.
* Patients in need of non-steroidal anti-inflammatory drugs (NSAIDs), morphine, or similar medication are not eligible. Same is also valid for patients in need of injections or acupuncture.
* Back surgery within 6 months before inclusion or earlier surgery without effect
* "Heart" aspirin (low dose), ulcer medication, or blood thinning medication
* Alcohol abuse
* Depression
* Pregnancy or breastfeeding
* Allergy to crustaceans or known intolerance for glucosamine sulphate, ginger, avocado, soy, or ibuprofen
* Allergy or asthma released by salicylic acid or other arthritis medication (NSAIDs)
* Patient who is seeking pension due to back pain or has other economical interests connected to his/her back pain
Effects of Time-Restricted Fasting on the Postprandial Glycemic Responses

The goal of this clinical trial is to investigate whether fasting timing has a significant effect on postprandial glycemic responses in healthy adults. The main questions it aims to answer are:

1. Whether fasting timing has a significant effect on postprandial insulin actions and plasma glucose concentration.
2. Whether fasting timing could modulate the glycemic metabolome and circadian rhythms in healthy individuals.

Participants will get the two interventions:

No-dinner: breakfast at 7.30 a.m., lunch at 1.00 p.m. and no dinner; No-breakfast: no breakfast, lunch at 1.00 p.m. and dinner at 8.00 p.m.

A randomized, crossover study design is used with 2 intervention days and a 6-day washout period, to evaluate the effects of early and late fasting on postprandial glucose responses in healthy adults. Randomization was performed by the Fudan staff with a block size of 2 using a balanced design using computer-executed software. The primary endpoint is the fasting and postprandial blood glucose, insulin, and continuous glucose monitoring after fasting. Secondary endpoints include postprandial blood lipids, clock gene expressions in peripheral blood cells, and non-targeted postprandial plasma metabolome. The 2 intervention days include a no-breakfast day and a no-dinner day. The diets before, during, and after the intervention day was designed according to Dietary Guidelines for Chinese Residents (2022), and the energy distribution of three meals is 1:1:1, with the energy percentage of carbohydrate, protein, and fat being 55%, 15%, and 30%, respectively. The time of breakfast, lunch, and dinner is 7.30 a.m., 1.00 p.m., and 8.00 p.m., respectively. All participants are instructed to follow their natural dietary plans in the wash-out period, and the food intakes and sleep circle were recorded by a modified food frequency questionnaire (FFQ).

Eligibility Criteria:
Inclusion Criteria:

1. Both men and women are eligible.
2. Age: 18-40 years old.
3. Healthy adults: no history of diabetes mellitus, no use of hypoglycemic drugs, no insulin injection.
4. All participants have a good sleep circle, with no somnipathy.

Exclusion Criteria:

1. Severe mental illness or other major medical comorbidities and autoimmune diseases (e.g., chronic renal failure, cardiovascular diseases, or cancer)
2. Skipping breakfast or dinner more than 10 times within 6 months.
3. Following a special diet, currently on weight loss medication, using sleeping medications.
4. Pregnancy or to be pregnant.
Study of Choroid Plexus Cauterization in Patients With Hydrocephalus

The purpose of this study is to determine whether endoscopic choroid plexus coagulation is safe in adult patients with communicating hydrocephalus and risk factors for complications from the standard surgical treatment. It may also help determine whether the endoscopic choroid plexus coagulation is effective in treating your communicating hydrocephalus. The Investigators hope that this research will allow us to place fewer shunts in patients with conditions similar to yours, avoiding complications.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age 18 or older) with communicating hydrocephalus, who have risk factors for complications following shunt surgery. Risk factors include loculated hydrocephalus (i.e., imaging evidence that the ventricles of the brain do not communicate with each other, in the setting of known communicating hydrocephalus); prior episodes of ventriculitis and/or shunt infection; subdural hematoma associated with shunt placement; inability to place a distal catheter in the peritoneal cavity due to scarring or prior infection; and multiple prior episodes of shunt failure.
* In patients with communicating hydrocephalus who have significantly increased lateral and third ventricular size and normal fourth ventricular size, an endoscopic third ventriculostomy will be performed in conjunction with the choroid plexus cauterization, provided that communicating hydrocephalus is thought to be present, based on either the history (for example, past meningitis or other infectious or inflammatory disease, or history of communicating hydrocephalus without disproportion of the ventricles in the past; or imaging findings, such as patency of the foramina of Magendie and Luschka).

Exclusion Criteria:

* Exclusion criteria include patients who have non-communicating hydrocephalus; patients who are undergoing emergency surgery because of rapid decline in neurologic condition; and patients with medical conditions such as coagulopathy or severe cardiac conditions, that preclude neurosurgical intervention.
* In the case of adults unable to consent, informed consent will be obtained from appointed health care proxies. Minors, pregnant women, and prisoners will be excluded from the study.
Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)

Intraoperative intravenous fluid management practice varies greatly between anesthesiologists. Postoperative fluid based weight gain is associated with major morbidity. Postoperative respiratory complications are associated with increased morbidity, mortality and hospital costs. The literature shows conflicting data regarding intraoperative fluid resuscitation volume. No large-scale studies have focused on intraoperative fluid management and postoperative respiratory dysfunction.

Hypotheses:

Primary - Liberal intraoperative fluid resuscitation is associated with an increased risk of 30 day mortality Secondary - Liberal intraoperative fluid resuscitation is associated with increased likelihood of postoperative respiratory failure, pulmonary edema, reintubation, atelectasis, acute kidney injury and peri-extubation oxygen desaturation.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 upwards
* Tracheally intubated at the beginning of the procedure and extubated at the end of the procedure

Exclusion Criteria:

* Cases where the subject had additional surgeries within the previous four weeks
* Ages under 18
The Effect of Gastric Bypass Surgery on the Glucose Metabolism Seen in Patients With Type 2 Diabetes

Gastric bypass surgery has in many studies shown total remission of type 2 diabetes as early as 1 - 2 days after surgery and this is before any real weight loss has occurred. This suggest that the remission of the diabetes is due to the direct effect of the operation more that the secondary effect of the weight loss. The reason for the major effect on the glucose metabolism after gastric bypass surgery is still unaccounted for.

This PhD. project will try to unveil some of the mechanisms that could explain the effect of gastric bypass surgery on the glucose metabolism seen in patients with type 2 diabetes.

The hypothesis of the study is that a factor "X" will course the remission of the diabetes. This factor "X" is related to the anatomic changes of the gastro intestinal tract, by eliminating the foods passage through the distal part of the ventricle and the duodenum, in combination with the Roux- en-Y sling.

The PhD. project will consist of clinical trails on patients that will undergo gastric bypass surgery. The studies will take place before and within the 1. week after surgery. The investigators will measure different hormones and adipokines in fast and the postprandial state. To discover possible new proteins the investigators will run proteomic on some samples. All the results will be compared to the same parameter on patients undergoing gastric banding, where the anatomy of the intestine hasn't been changed.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria in Denmark for undergoing gastric bypass and see the above study and cohort description.
* Well treated hypertension \< 145/85. HbA1C \<8,5 % and c-peptid\> 700pmol/l

Exclusion Criteria:

* In treatment with antidepressive, DPP-4 inhibitors and intreatment for thyroid problems.
* Patients treated with insulin.
RheOx Registry Study in Europe

Post-market clinical study (registry study) to collect post-market safety and clinical utility data in European patients with chronic bronchitis treated with RheOx.

RheOx is a device-based, energy delivery system that delivers high frequency short duration energy to the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.

Two sessions of treatment will be delivered one month apart. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session (approximately one month after the right side is treated). Treatment will be delivered by a respiratory physician (interventional pulmonologist) in a tertiary teaching hospital during a bronchoscopic procedure. The bronchoscopy will be delivered during general anaesthesia. It is anticipated that the bronchoscopic procedure will last less than 60 minutes in total. Treatment will be deemed to have been delivered following the successful treatment during the two bronchoscopies.

Subjects will be required to submit to several tests and questionnaires during the study including respiratory function tests.

Eligibility Criteria:
Inclusion Criteria:

* Patient has moderate to severe Chronic Bronchitis

Exclusion Criteria:

* Patient has an implantable cardioverter defibrillator, pacemaker, or any other implantable electronic device.
* Patient has history of ventricular tachyarrhythmia or any clinically significant atrial tachyarrhythmia (i.e., abnormality with vital signs) and/or history of type II second or third degree AV block.
* Patient has airway stent(s), valves, coils, or other lung implant/prosthesis.
Flow Proportional Pressure Support in Volunteers

Flow proportional pressure support (FPPS) is a new mode of spontaneous breathing assistance. In patients with increased respiratory resistance the role of FPPS in comparison with the pressure support assist breathing mode is still unclear. In this study the investigators evaluate objective and subjective measured data in healthy volunteers with artificial increased resistance and FPPS breathing assistance.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* ASA I and II

Exclusion Criteria:

* refusal of written informed consent
* chronic respiratory or cardiac diseases
Support for COVID19 Patients at Home

The rapid spread and increase of acute respiratory infection cases caused by the novel SARS-CoV-2 coronavirus represent a major challenge for healthcare systems around the world. The shortage of facilities and medical personnel is a major problem in the face of a serious epidemic. The Lombardy Region, and in particular the territories of Milan, Bergamo and Brescia, was the most affected due to the rapid increase in cases and limited medical resources during the initial phase of the epidemic.

The collaboration between hospital and territory with integrated communication systems and the monitoring of patients with appropriate technological tools that include telemedicine, are fundamental to ensure the continuity of care and the sustainability of the health system, also significantly reducing the risk of contagion for health professionals.

The MIRATO Project wants to test the remote health surveillance services and a telemonitoring program for patients discharged after a period of hospitalization for COVID19 caused by the new coronavirus SARS-CoV-2 and their comorbidities if present.

Patients discharged from hospitals still present in many cases breathing difficulties, bed rest symptoms and other disabilities related to the acute event. In addition, some patients are seeing rekindling of symptoms such as fever, dry cough, difficulty respiratory and blood desaturation into oxygen. These problems underline the need for procedures that allow us to safely discharge patients to be able to better follow their convalescence but also to be able to intervene quickly in the event of symptoms returning.

The purpose of the home health surveillance intervention will be:

* Monitor the evolution of the state of health with standardized tools based on scientific evidence
* Provide counselling support to help recovery
* Have certain and early identification of signs and symptoms related to a possible resumption of the COVID19 pathology and or to comorbidities
* Compare outcome results with case-control design three months after hospital discharge

Eligibility Criteria:
Inclusion Criteria:

* Hospitalisation for COVID19
* Patients discharged at home

Exclusion Criteria:

* Patient refusal
* Patients discharged at a nursing home
Clinical Evaluation of Insect Repellent and Insecticide Treated Nets in Lao PDR

Rural communities involved in agriculture are often at highest risk of insect-borne diseases in Southeast (SE) Asia.

Skin-applied insect repellents may prove a useful means of reducing mosquito-borne diseases for those people working outdoors in high risk areas.

This trial is evaluating the use of insect repellent (20% diethyltoluamide) to reduce incidence of malaria, Japanese Encephalitis and Dengue. The investigators will recruit up to 1000 households from 100 villages in rural Laos. In each house the investigators shall recruit up to 5 individuals. Half of households will be randomised to repellent, half to a placebo. All individuals will be provided with insecticide treated bed nets for use at night. All household occupants will be followed for 7 months to record malaria cases by Rapid Diagnostic Test every month. Blood spots will be collected at start and end of study to measure Japanese Encephalitis and Dengue. All positive cases will be promptly treated. Outcome will be reduction in number of malaria cases (primary outcome) and Dengue/Japanese Encephalitis (secondary outcomes).


Eligibility Criteria:
Inclusion Criteria:

* working in agriculture
* available for monthly follow-up

Exclusion Criteria:

* allergy to repellent
* pregnant / breastfeeding
Effectiveness of Lung Sono in One-lung Ventilation

To observe the effectiveness of ultrasound-guided alveolar recruitment in thoracic surgery with one-lung ventilation(OLV).

One-lung ventilation(OLV) is essential in thoracic surgery for patient safety and better surgical view. However, pulmonary complications such as hypoxemia may be caused by OLV which might be preventable with adequate alveolar recruitment and positive end-expiratory pressure(PEEP). Alveolar recruitment has been performed with conventional methods without diagnostic tools in clinical setting.

Ultrasound is a non-invasive, radiation-free device with high accuracy for the diagnosis of lung atelectasis. There are a few reports regarding the usefulness of lung ultrasound in other surgeries, but not in thoracic surgeries with OLV.

Thus, investigators designed a study to observe the effectiveness of ultrasound-guided alveolar recruitment in thoracic surgery with OLV.

Eligibility Criteria:
Inclusion Criteria:

* Elective thoracic surgery which requires one-lung ventilation with lateral decubitus position

Exclusion Criteria:

* Patients who refuse to agree
* Previous lung surgical history
* History of pneumothorax or bullae
* Severe cardiopulmonary disease, COPD
* Operation time \< 1hr
Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance

This 12-week controlled diet and weight intervention study seeks to define the molecular pathways that link excess body weight to the development of insulin resistance (IR). Blood, adipose and stool are sampled at three timepoints; baseline, peak weight (4 weeks) and post weight loss to monitor changes in cellular processes. Additionally, direct insulin sensitivity testing, and radiological measurement of visceral fat and intrahepatic fat content is measured at three timepoints to correlate clinical indices with cellular changes.

Obesity has become an epidemic worldwide. Metabolic/cardiovascular complications of obesity are likely related to the fact that obese individuals tend to be insulin resistant (IR). While insulin- mediated glucose uptake (IMGU) correlates with adipose tissue mass, not all obese individuals are IR, and metabolic and cardiovascular profiles of those who are IR vs insulin sensitive (IS) differ significantly. Why one individual who reaches a BMI of 30 kg/m2 will develop IR and another with similar BMI and activity level remains IS is unclear. Furthermore, while insulin sensitivity improves with weight loss, this response varies as well. Given that fat mass per se does not fully explain the obesity contribution to IMGU, itis likely that differential adipocyte function plays a role. With this study, our purpose is to employ an integrated omics strategy to identify analyte/pathway signatures in blood and adipose tissue that characterize IR versus IS states and expand our biological knowledge of the mechanisms underlying IR.

Eligibility Criteria:
Inclusion Criteria:

* Age 35-65
* BMI 25-35 kg/m2
* Stable body weight
* Nondiabetic

Exclusion Criteria:

Patients with;

* diabetes
* major organ disease
* history of liposuction or bariatric surgery
* active eating or psychiatric disorder
* pregnancy or lactation, heavy alcohol use
* recent change in weight (over the past 12 weeks)
* use of weight loss medication, statins, or oral steroids

Clinical screening exclusions;

* hematocrit \< 33%
* fasting glucose \>/= 126 mg/dL
* blood pressure \>160/100 mmHg
Database Maintenance for Bariatric Procedures

Bariatric surgery registry for quality control and investigational purposes.


Eligibility Criteria:
Inclusion Criteria:

* morbid obesity

Exclusion Criteria:

* unfit for surgery