cyrilzakka/clinical-trials huggingface dataset:
Concurrent Pemetrexed/Cisplatin With Pleural Intensity Modulated Radiation Therapy for Patients With Unresectable Malignant Pleural Mesothelioma

The purpose of this study is to evaluate the safety of combining chemotherapy at different doses with a specific type of radiation therapy delivered to the entire lining of the lung to find out what effects, if any, it has on people. This radiation technique is called pleural intensity modulated radiation therapy (IMRT). IMRT specifically targets the lining of the lung (pleura) where the cancer is and reduces the risk of damaging the lung itself. When given after chemotherapy, pleural IMRT has demonstrated promising results with respect to keeping mesothelioma under control longer. However, the investigators want to determine if giving pleural IMRT at the same time as chemotherapy is safe. If safe, further studies will be done to see if chemotherapy and pleural IMRT given at the same time keeps the tumor under control for a longer period of time than chemotherapy followed by pleural IMRT.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of malignant pleural mesothelioma at MSKCC
* No plans for surgical resection
* Stage T1-4, N0-3, M0
* No prior radiation therapy to the chest, breast or supraclavicular fossa that would limit radiation delivery to the full prescription dose
* Prior chemotherapy regimens ≤1
* Age ≥18 years
* Karnofsky performance status ≥ 80%
* Pulmonary function tests as follows: DLCO\>50% predicted
* Adequate hematologic, hepatic, and renal function as indicated by the following laboratory values

  * Absolute neutrophil count ≥ 1,500/mcL
  * Platelets ≥ 100,000/mcL
  * Calculated creatinine clearance (CrCl) ≥ 45mL/min (using Cockcroft \& Gault method)
  * Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless known Gilbert's disease)
  * AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN

Exclusion Criteria:

* Pregnant or lactating women, or men or women not using effective contraception
* Patients with an active infection that requires systemic antibiotics, antiviral, or antifungal treatments
* Patients with a concurrent active malignancy (with the exception of skin cancer)
* Patients with serious unstable medical illness
* Patients with idiopathic pulmonary fibrosis
* Patients with NYHA heart failure class \>2
* Patients with only one kidney that is ipsilateral to the mesothelioma
* Implanted pacemaker and/or defibrillator ipsilateral to the mesothelioma if it cannot be moved
* Patients meeting the following exclusion criteria will be excluded from the MRI portion only:
* Metallic implant, e.g. pacemaker, defibrillator
* Unmanageable claustrophobia
* High risk for nephrogenic systemic fibrosis
Effects of BBT Versus Diaphragmatic Breathing on Exercise Capacity and Quality of Life in Patients With COPD

Group A will be treated with manual chest physical therapy and Buteyko breathing technique Group-B will be treated with manual chest physical therapy and Diaphragmatic breathing technique. Patients will perform the technique 5 times a weeks for 8weeks and treatment evaluation will be done after 8 weeks

A randomized clinical trial will be conducted at Gulab Devi Hospital, Lahore through convenience sampling technique on 48 patients which will be allocated through simple random sampling through sealed enveloped into group A and group B. Pre-treatment values of patients exercise capacity will be recorded by 6MWT/6MWD- 6 minute walk test/ 6 minutes' walk distance and patients quality of life through St George respiratory questionnaire as primary outcomes while oxygen saturation, heart rate will be measured by pulse oximtery during 6MWT as secondary outcomes. Group A will be treated with manual chest physical therapy and Buteyko breathing technique Group-B will be treated with manual chest physical therapy and Diaphragmatic breathing technique. Patients will perform the technique 5 times a weeks for 8weeks and treatment evaluation will be done after 8 weeks.

Data will be analyzed using SPSS software version 25.After assessing normality of data by Shapiro-Wilk test , it will be decidedeither parametric or non-parametric test will be used.

Eligibility Criteria:
Inclusion Criteria:

* Age group : 40-65 years
* Both males and females
* Clinical diagnosis of COPD confirmed by smoking history and PFT airflow
* Patients taking their regular medications e.g bronchodilator

Exclusion Criteria:

* Restrictive lung disease
* Pneumothorax
* Resting O2 saturation \<90% with room air breathing
* Recent exacerbations
* Patients with active viral or bacterial infection
* Abdominal or thoracic surgery (\<3months ago)
* Cardiologic conditions (\<6months ago e.g Myocardial infarction or unstable angina
* Intubated Patients
* Orthopedic or urogenital conditions
* Neurological disorders limiting cognition \& mobility
Evaluation Study for the Programme DiaNe for People With Diabetic Nephropathy

This study is designated to evaluate the effect of a patients' educational program called DiaNe® for consultation and support people with diabetic kidney disease in an early stage. The aim of the study is to examine if the program is suitable to stop deterioration of kidney function and to maintain or improve glycemic control. The consultation and support program DiaNe® substantially contributes to a better understanding of the affected clients for this complex clinical picture, allows them for specific interventions and creates the rationale for an active therapeutic relationship.

According to statistics diabetes mellitus is considered to be the leading cause for end stage renal disease in Germany, approximately 35% of the patients starting on dialysis are affected by diabetes-induced nephropathy. This can be seen in countries all over the world. This situation has been known for years. To date, neither structured intervention methods nor educational programs have been designed for and targeting those affected, which would consequently allow for structured, multifactorial intervention at an early stage of diabetic nephropathy. Multifactorial interventions, as published in the Steno-2 trial, appear to be highly effective with regard to long-term complications of diabetes. In order to realize this approach for the affected as well as the medical staff caring for patients with diabetes-induced nephropathy we developed DiaNe®, a consultation and support program, which is designed to give detailed information to the affected in order to induce behavioral changes. We were able to show a clinically significant reduction of microalbuminuria within a first monocenter evaluation trial. We wanted to verify this effect by means of a prospective multicenter randomized cohort trial according to GCP-ICH guidelines.

Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus
* proven diabetic nephropathy by histological/lab findings and/or discretion of nephrologist
* ability to understand the German language

Exclusion Criteria:

* end stage renal disease and/or dialysis
* unable or unwilling to follow the protocol
* pregnant women
* discretion of nephrologist
Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy

The purpose of this study is to determine whether the AmnioFix dehydrated human amniotic membrane is effective in protecting nerves in men receiving robotic assisted laparoscopic prostatectomies.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 45-70
2. Clinically localized prostate cancer with Gleason score 6 or 7
3. SHIM Score greater than or equal to 16 in the absence of medication
4. Feasibility to perform unilateral or bilateral nerve sparing RALP

Exclusion Criteria:

1. Clinically locally advanced cancer and/or with Gleason score 8 or 9.
2. Difficulty performing nerve sparing RALP.
3. Prior surgery at the site.
4. Site exhibits clinical signs and symptoms of infection.
5. SHIM score at screening \<16.
6. Current use of anticoagulant medication including Coumadin, Plavix, etc.
7. Has had "salvage prostatectomy" - patients who failed prior therapies including external radiation therapy, cryotherapy, etc.
8. Has prior radiation therapy treatment at the site.
9. Prior hormonal therapy such as Lupron or oral anti-androgens.
10. Non-mobile, i.e. not ambulatory or bed ridden.
11. The presence of comorbidities that can be confused with or can exacerbate the condition including:

    1. diabetes
    2. advanced atherosclerotic vascular disease
12. Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
13. Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
14. Unable to comply with penile rehabilitation.
15. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
16. Patients who are unable to understand the aims and objectives of the trial.
17. Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
18. Currently taking medications which could affect graft incorporation (supervising physician's discretion).
19. Allergic to gentamicin and/or streptomycin.
20. Damage to neurovascular bundles during surgery.
Inflammatory Response to Opioid Versus Opioid Free Anesthesia

Anesthetic agents, including opioids can modulate the altered immune function in patients with obesity through mechanisms that involve the expression and release of cytokines. For this reason, anesthetic care in patients with obesity remains controversial. Therefore, the aim of the study was to compare the effect of opioid-containing anesthesia vs opioid-free anesthesia using the Cortínez-Sepúlveda model on serum levels of IL-6, IL-1β and TNF-α before and after surgery in obese patients undergoing bypass surgery.

Methods: A randomized cross-sectional study of 40 unrelated obese adults was performed in the Anesthesiology and Bariatric Surgery Service at the Civil Hospital of Guadalajara "Dr. Juan I. Menchaca". Before undergoing laparoscopic Roux-en-Y gastric bypass, patients were randomly assigned to two anesthesia groups: opiod-containing (n=20) or opioid-free (n=20). The opioid used in the opioid-containing anesthesia group was fentanyl. To characterize the disposition of intravenous propofol for the target-controlled infusion technique in obese patients, the Cortínez-Sepúlveda pharmacokinetic model was used. Body mass was determined to the nearest 0.05kg using a balance scale (Seca 703; Seca, Hamburg, Germany). Blood samples were taken before and immediately after surgery and cytokine serum levels were determined with ELISA kits. Statistical analyses were performed using the IBM Statistical Package for the Social Sciences software package version 20.0 (IBM Corp., Armonk, NY, USA).


Eligibility Criteria:
Inclusion Criteria:

* Who were scheduled for bypass surgery at the Service of Anesthesiology and Bariatric Surgery of the Civil Hospital of Guadalajara "Dr. Juan I Menchaca", Jalisco, Mexico, were recruited.

Exclusion Criteria:

* Patients with a history of ischemic heart disease, history of drug abuse, and with any known allergy to any of the drugs used during anesthesia. Elimination criteria were: patients who withdrew their consent or with insufficient and poor quality blood samples (coagulated) or other reasons that did not allow sample processing.
Gambro AK200 ULTRA Hemodiafiltration Study

This study is designed to assess the safety, efficacy and dialytic capabilities of hemodiafiltration with on-line prepared substitution fluid using the AK200 ULTRA in comparison to conventional hemodialysis.

The AK200 ULTRA is a new device in the United States, but has been used for several years in Europe. The AK200 ULTRA is a single unit which is preprogrammed to provide standard hemodialysis as well as hemofiltration and hemodiafiltration with on-line preparation of the substitution fluid The AK200 ULTRA hemofiltration and hemodiafiltration is performed using a high flux membrane with high ultrafiltration rates compensated by volumetrically controlled infusion of on-line prepared substitution fluid. The AK200 ULTRA is, therefore, capable of providing dialysis treatments which can improve the removal of medium to high weight molecules without the difficulties associated with the manual measurement and administration of external substitution fluid.

This study is designed to assess the safety, efficacy and dialytic capabilities of hemodiafiltration with on-line prepared substitution fluid using the AK200 ULTRA in comparison to conventional hemodialysis. This study is motivated by the need for a commercially available product capable of administering hemofiltration and hemodiafiltration in a clinical setting. The ultimate goal of this study is to improve morbidity and mortality in the ESRD patient population in the United States.

Eligibility Criteria:
Inclusion Criteria:

1. Subject received chronic dialysis therapy
2. Subject was stable on three dialysis sessions per week
3. Subject was able to understand and sign the informed consent

Exclusion Criteria:

) On chronic renal replacement therapy for less than three (3) months 2) Hospitalization for reasons other than vascular access complications in the past three (3) months 3) HIV + 4) Hepatitis B+ 5) Pregnancy, verified by pregnancy test for women of child bearing potential 6) Access recirculation \> 10% 7) Hematocrit less than 26% 8) History of non compliance 9) Pediatric patients, defined as less than 18 years old
Exploring Multiple Self-Help Interventions to Promote Self-Efficacy and Overcome Disability

EMPOWER-IBD aims to identify behavioral interventions to strengthen patients' self-efficacy for self-management as a mechanism to reduce IBD-related disability. This multisite, randomized controlled trial with 16 arms will randomize adults with moderate-to-severe IBD-related disability to a combination of four multimodal behavioral interventions to test their clinical effectiveness in reducing IBD-related disability and improving self-efficacy. The interventions are four existing, publicly available disease-specific self-help resources offered at no cost to the participants: a book, smart app, help center, and peer mentor. Participants will complete online surveys and may engage in virtual focus groups. Participants may receive an honorarium (e-gift card) and/or be entered into a lottery for a giftcards post-survey completion and focus group participation.


Eligibility Criteria:
Inclusion Criteria:

1. Adults (age ≥ 18 years) with IBD and moderate-to-severe IBD-related (IBD) Disability Index score \> 35 26,27)
2. Able to consent, complete surveys, and participate in focus groups in English.

Exclusion Criteria:

1. No/low disability (IBD-DI \< 35) on the baseline survey
2. Inability or unwillingness to participate in the interventions
3. Inability to download apps from the Apple AppStore or Google Play store (necessary to engage with the smartapp intervention)
4. Limited English proficiency (necessary because some interventions are currently only offered in English)
Is Our Microbiome a Predictor of Cardiac Risk

The purpose of this study is to determine a relationship between a person's flora/bacteria in their gut (the intestinal microbiome) and their risk of cardiovascular disease. Investigators will look at inflammatory markers in the blood and also look at the genome of the bacteria in the gut.

Investigators will look at inflammatory markers in the blood and also look at the genome of the bacteria in the gut. This research is being done because Investigators believe that there is a connection between the way food is digested by a person's gut bacteria and the development of atherosclerosis (hardening of the arteries) and cardiovascular disease. The ultimate goal of this research is to eventually determine if changes to the gut bacteria can prevent cardiovascular disease or disease progression.

Eligibility Criteria:
Inclusion Criteria:

Anyone undergoing cardiac catheterization for suspected coronary artery disease over age 18.

Exclusion Criteria:

1. Patients currently on long-term antibiotics who cannot stop them for at least 2 weeks prior to providing a stool sample.
2. Patients on chronic laxatives who cannot stop for at least 2 weeks prior to stool collection.
3. Patients on probiotics and cannot stop for 2 weeks prior to giving a stool sample (yogurt is ok).
4. Patients who are unable to provide a stool sample to Mayo Clinic within 24 hours of collection utilizing Fed Ex overnight mail (i.e. people overseas who are unable to provide a sample before leaving the USA.)
Patient Experience and Technical Success of Community Sleep Studies

This study looks at the quality of the common mechanisms used to diagnose obstructive sleep apnoea (OSA) by patients in their own homes. These are pulse oximetry as a stand alone measurement and multi-channel respiratory studies that measure oximetry but also record some combination of signals including airflow at the mouth and or nose, chest and abdominal expansion, body position and snoring. This study will examine the patient acceptability of these methods and the proportion of studies that achieve various levels of technical quality ranging from a full night with all data available to a completely failed study and categories in between.

There is a study underway to develop a non-contact detector of breathing (SafeScan) as a new method of diagnosing obstructive sleep apnoea (OSA). There are a number of different methods already available to achieve this end but one proposed advantage of the new SafeScan device is that it will not affect sleep quality and because there are no measuring devices attached to the patient it is less likely that the signal will be lost in the night due to the normal movements of sleep. However there are no data available that quantify these factors as an issue for the current techniques and devices.

The proving study for SafeScan is a comparison of the ability of the device to measure sleep apnoea compared to full in-hospital polysomnography (PSG) and one outcome will be the proportion of studies that have lost data. However the future use of the SafeScan device will be in the community. The common diagnostics used by patients in their own homes are pulse oximetry as a stand alone measurement and multi-channel respiratory studies that measure oximetry but also record some combination of signals including airflow at the mouth and or nose, chest and abdominal expansion, body position and snoring. We propose a study to examine the patient acceptability of these methods and the proportion of studies that achieve various levels of technical quality ranging from a full night with all data available to a completely failed study and categories in between. In addition there will be an analysis of the results to explore whether there are features of the patients such as age and obesity that make technical success or failure of the studies more likely.

Eligibility Criteria:
Inclusion Criteria:

Patient able to provide assent by completion of the Research Questionnaire Adult patients (≥ 18 years of age) Patients undergoing a home sleep study

Exclusion Criteria:

Patients unable to complete questionnaires due to language or other barriers
Non-Invasive Reduction of Fat in the Inner Thighs

Evaluate the safety and efficacy of non-invasive fat reduction in the inner thighs with the ZELTIQ CoolSculpting System.

The Zeltiq CoolSculpting System, which reduces subcutaneous fat in specific areas of the body, will be studied for safety and efficacy when used in the inner thigh.

Eligibility Criteria:
Inclusion Criteria

1. Male or female subjects \> 18 years of age and \< 65 years of age.
2. Subject has clearly visible fat on the inner thighs and in the investigator's opinion, may benefit from the treatment.
3. Subject has not had weight change exceeding 10 pounds in the preceding month.
4. Subject with body mass index (BMI) up to 30. \[BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.\]
5. Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in his/her diet or lifestyle during the course of the study.
6. Subject has read and signed a written informed consent form.

Exclusion Criteria

1. Subject has had a surgical procedure(s) in the area of intended treatment.
2. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment.
3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
4. Subject needs to administer, or has a known history of, subcutaneous injections (e.g., heparin, insulin) into the area of intended treatment within the past month.
5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
6. Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
7. Subject has a history of a bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
8. Subject is taking or has taken diet pills or supplements within the past month.
9. Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
10. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
11. Subject is pregnant or intends to become pregnant in the next 8 months.
12. Subject is lactating or has been lactating in the past 6 months.
13. Subject is unable or unwilling to comply with the study requirements.
14. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
15. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data, or would pose an unacceptable risk to the subject.