cyrilzakka/clinical-trials huggingface dataset:
Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

Currently there are no approved therapies for lung transplant recipients in the United States (US). Treatment with CIS following lung transplantation has previously been demonstrated to result in a clinically meaningful improvement in survival and chronic rejection-free survival compared to placebo, but additional data supporting its use is needed prior to Food and Drug Administration (FDA) approval. This treatment use protocol is a mechanism for providing eligible lung transplant recipients early access to CIS in advance of FDA approval.


Eligibility Criteria:
Inclusion Criteria:

* Single-or double-lung transplant recipients who have a high risk for developing chronic rejection
* Single or double-lung transplant recipients who have developed chronic rejection
* Single or double-lung transplant recipients who have serious or life-threatening complications of systemic immunosuppressive therapy

Exclusion Criteria:

* Known hypersensitivity to cyclosporine or propylene glycol (PG)
* Females who are pregnant or are considering becoming pregnant
* Females who are breast feeding a child.
5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial

To compare 2 different models for prescribing opioid pain medication to provide better pain control to participants with an abdominal cancer who are having surgery.

Primary Objectives:

The co-primary objectives of this study are as follows:

1. To determine differences in the initial OME prescribed upon discharge between each algorithm/model.

1. To determine OME usage by day 14 after hospital discharge.

Secondary Objectives:

Secondary objectives are as follows:

1. To determine rates of patients with zero OME upon discharge.
2. To determine rates of OME refill requests and completions at 15- and 30-days post-operation.
3. To determine number of unused or leftover pills at 15- and 30-days post- operation
4. To determine persistent opioid use at 30-days, 3-months, and 6-months post-operation
5. To elucidate patient, prescriber, and oncologic factors predictive of persistent opioid use
6. To assess quality of life using patient-reported outcomes at 30-days, 3-months, and 6-months post-operation.
7. To determine patient satisfaction with either prescribing model.

Eligibility Criteria:
Inclusion Criteria:

* Participants ≥18 years of age
* Participants undergoing any of the following abdominal surgeries on an elective basis at MD Anderson Cancer Center:
* Open pancreatectomy
* Open hepatectomy
* Open resection of retroperitoneal sarcoma
* Open nephrectomy
* Open cytoreductive surgery (in ovarian cancer)
* Participants with a planned inpatient admission of at least 48 hours after surgery
* Opioid-naive patients who use less than or equal to 7.5 mg OME per day (on average) during the 30 days prior to consent
* Participants able to understand and willing to sign an informed consent document
* English and non-English-speaking participants

Exclusion Criteria:

* Participants requiring non-elective (emergent or urgent) surgery will be excluded
* Participants with a current or previous history of substance abuse disorder, including alcohol or drugs
* Participants prescribed long-acting chronic pain medications
* Participants using hydromorphone or fentanyl or under the care of a chronic pain specialist
* Participants unable or unwilling to participate in follow-up study requirements (e.g., QOL surveys, opioid log)
* Participants discharged on palliative or hospice care
* Participants with a history of allergic reactions to opioids
* Participants enrolled in any other opioid discharge protocol
* Participants who are pregnant
* Participants who are cognitively impaired
Prediction and Prevention of Preeclampsia by First Trimester Ultrasound

The purpose of this study is to determine whether the Fetal Medicine Foundation algorithm for individual risk calculation for preeclampsia (PE) and pregnancy induced hypertension (PIH) is suitable to identify women in high risk of developing these diseases in a Norwegian population.

It has been shown that low dose acetylsalicylic acid (ASA) in pregnancy reduces adverse outcome of pregnancy in women that have high risk of developing preeclampsia (PE). It is a challenge for the clinician to identify the high risk women. Doppler blood flow measurements in uterine arteries in second trimester have been shown useful to predict the development of the disease but prophylactic treatment with ASA from this point in pregnancy has not been proven effective. Fetal Medical Foundation has developed an algorithm that calculates individual risks for PE/ PIH based on Doppler blood flow measurements and anamnestic information.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Nulliparous
* Para 1+ with previous preeclampsia or gestational hypertension
* last menstrual period (LMP) pregnancy length at inclusion \< 13 weeks
* Residence in Trondheim + 8 surrounding municipalities

Exclusion Criteria:

* Pregnancy length \> 13+6 weeks (CRL \> 85 mm)
* Twins
* Missed abortion
* Fetal anomaly
A Safety Study of LY2886721 Multiple Doses in Healthy Subjects

This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of LY2886721 multiple doses, how the body handles the drug, and the drug's effect on the body.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and non-childbearing potential women
* Body mass index between 18.0-32.0 kilograms per square meter (kg/m\^2)
* Are reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures and research unit policies

Exclusion Criteria:

* Taking over-the-counter or prescription medication with the exception of vitamins or minerals
* Smoke more than 10 cigarettes per day
* Drink more than 5 cups of caffeine containing beverages (for example, coffee, tea) per day
Collecting Tissue Samples From Patients With Leukemia or Other Blood Disorders Planning to Enroll in an ECOG Leukemia Treatment Clinical Trial

RATIONALE: Collecting and storing samples of blood and bone marrow from patients with cancer to study in the laboratory may help doctors learn more about diagnosing cancer and determine a patient's eligibility for a treatment clinical trial. It may also help the study of cancer in the future.

PURPOSE: This laboratory study is collecting tissue samples from patients with leukemia or other blood disorders who are planning to enroll in an ECOG leukemia treatment clinical trial.

OBJECTIVES:

* To provide a mechanism for sample collection and submission for diagnostic review to determine eligibility of patients with suspected leukemia or related hematologic disorders for enrollment on ECOG leukemia clinical trials.
* To obtain baseline samples for correlative studies outlined in parent clinical trials.

OUTLINE: This is a cohort, multicenter study.

Patients submit bone marrow and/or blood samples. The samples are studied to determine patients' eligibility for ECOG leukemia treatment clinical trials. Samples may be stored for future correlative studies related to ECOG treatment clinical trials.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Candidate for enrollment on an ECOG treatment clinical trial for acute or chronic leukemia

  * Suspected clinical diagnosis and protocol ID number of the treatment clinical trial under consideration must be submitted to ECOG's Leukemia Translational Studies Laboratory to ensure that the required antibody panels are used and functional assays are performed
* Chosen ECOG treatment clinical trial must be active and accruing

  * Patient must not have begun treatment on the ECOG treatment clinical trial
* Patient may be concurrently enrolled on this laboratory study and a treatment clinical trial if immediate treatment is medically necessary

  * If subsequent diagnostic review alters the original diagnosis, the patient will be removed from the treatment clinical trial

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Comparison of Sirolimus and Azathioprine in Lung Transplantation

The purpose of this study is to compare the safety and effectiveness of two different anti-rejection drug regimens.

This multicenter prospective, randomized controlled clinical trial compared the open label use of sirolimus with that of azathioprine in a tacrolimus-based immunosuppression regimen. Eligible patients were identified during a 90-day screening period immediately after transplantation and randomized via a computer-generated scheme. Patient randomization was stratified according to center and rejection status in the first 90 days after transplantation. All patients received IL-2 receptor antagonist induction therapy, tacrolimus, azathioprine, and corticosteroids until 90 days after transplantation. At 90 days after transplantation, patients were randomized at a 1:1 ratio to either continue azathioprine or change from azathioprine to sirolimus.

The dosing and levels of immunosuppressive medications were standardized for all patients included in this study. Tacrolimus was dosed at 0.04 mg/kg twice daily with target trough levels between 5 and 15 ng/ml, azathioprine was administered at 2 mg/kg daily with dose adjustments for leukopenia, sirolimus was initially dosed at 2 mg/day with target trough levels between 5 and 15 ng/ml, and prednisone was tapered to not more than 10 mg/day by 3 months after transplantation. All patients received induction therapy with either daclizumab or basiliximab as per the product package insert.

In addition, prophylactic antimicrobials were standardized among the participating sites. All patients with either donor and/or recipient cytomegalovirus (CMV)-positive serostatus received either intravenous ganciclovir or oral valganciclovir for a total of 90 days. Lung transplant recipients who were negative for both donor and recipient CMV serostatus received valacyclovir for 90 days. Antifungal prophylaxis was determined by each site. Pneumocystis jiroveci prophylaxis was continued throughout the study. Lipid-lowering medications were recommended according to the National Cholesterol Education Program guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Lung transplant recipients between the age of 18 and 65 years of age.
* Females who are capable of becoming pregnant must have a negative pregnancy test prior to consent. (Females of childbearing potential must be using a medically acceptable method of birth control for the duration of the study.)
* All patients must be able to give written informed consent.

Exclusion Criteria:

* White blood cell count (WBC) \< 4.0/mm3
* Platelet count \< 100,000/mm3
* Severe hypercholesterolemia (\> 350 mg/dl) or hypertriglyceridemia (\> 500 mg/dl)
* Uncontrolled systemic infection at the time of consent.
* Previous organ transplant
* Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry or for the duration of the study (3 years).
* Use of maintenance immunosuppression other than daclizumab, tacrolimus, azathioprine, or prednisone prior to randomization.
JSP191 Antibody Conditioning Regimen in MDS/AML Subjects Undergoing Allogenic Hematopoietic Stem Cell Transplantation

This is a Phase 1a/b study to evaluate the safety and tolerability of an antibody conditioning regimen known as JSP191, in combination with low dose radiation and fludarabine, in subjects with Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) undergoing allogenic blood stem cell transplantation.

This is a Phase 1a/b study to evaluate the safety and tolerability of an antibody conditioning regimen known as JSP191, in combination with low dose radiation and fludarabine in subjects with Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) undergoing allogenic blood stem cell transplantation.

Blood Stem Cell transplantation offers the only potentially curative therapy for many forms of Acute Myeloid Leukemia (AML) and for Myelodysplastic Syndrome (MDS). While standard of care conditioning regimens given prior to blood Stem Cell transplantation, such as standard TBI/Flu conditioning are well tolerated, they are associated with increased rates of relapse due to persistence of disease causing Hematopoietic Stem Cells and insufficient graft versus leukemia effect.

The biological conditioning regimen JSP191 is an antibody that binds to CD117. CD117 is the receptor for Stem Cell Factor on blood forming cells. CD117 binding to Stem Cell Factor is critical for survival and maintenance of blood forming stem cells.

The binding of JSP191 to CD117 blocks CD117 from binding to Stem Cell Factor on blood forming stem cells. In the absence of CD117/Stem Cell Factor binding, hematopoietic stem cells that are currently occupying the bone marrow niches in MDS/AML patients are depleted.

This study will investigate the safety and tolerability of adding JSP191 (an anti-CD117 monoclonal antibody therapy) to standard TBI/Flu conditioning regimen in adults with AML and MDS undergoing hematopoietic stem cell transplant.

Eligibility Criteria:
Key Inclusion Criteria:

* AML/MDS as defined by specific criteria, including but not limited to the following subtypes:

  1. AML in CR
  2. MDS \< 5% BM blasts
  3. MDS 5 - 10% BM blasts
  4. AML not in CR or MDS \> 10% BM blasts
* Patients with human leukocyte antigen (HLA) matched related or unrelated donors
* Adequate end organ function as defined in study protocol

Key Exclusion Criteria:

* Patients with any acute or uncontrolled infections
* Patients receiving any other investigational agents
* Patients with active non-hematologic malignancy
* Prior allogeneic hematologic cell transplantation
ABX-EGF in Combination With Paclitaxel and Carboplatin for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)

Rationale: Overexpression of epidermal growth factor receptor (EGFR) has been observed in kidney, prostate, colon, lung, breast, and other cancers, and is often associated with a poor prognosis. TGFa and EGF, the ligands for EGFR, are also overexpressed in some of these tumor types, suggesting a self-propagating stimulus that may be responsible for rapid tumor growth. Blocking this stimulus by blocking activation of EGFR with ABX-EGF, a fully human monoclonal antibody against EGFR, may prevent tumor growth and perhaps shrink tumors. Purpose: This is a Phase 2 clinical trial to evaluate the safety and efficacy of ABX-EGF in combination with paclitaxel and carboplatin in the treatment of advanced NSCLC.


Eligibility Criteria:
For complete inclusion and exclusion criteria, please refer to the investigator. Inclusion Criteria: - 18 years of age or older. - Pathological diagnosis of NSCLC. - Bidimensionally measurable disease. - Tumor tissue available for immunohistochemistry studies. - Tumor over-expressing EGFR as ascertained by immunohistochemistry. - Disease stage IIIB with pericardial or pleural effusion, or stage IV. - Life expectancy of at least 12 weeks. - Adequate hematology function - Adequate renal function - Adequate hepatic function - ECOG score of less than 2. - Brain metastases, if present; must be controlled and asymptomatic. Exclusion Criteria: - Calcium \> ULN (treatment for hypercalcemia allowed). - Use of any investigational therapy within 30 days of ABX-EGF infusion. - Any cancer therapy for NSCLC other than radiation therapy, surgery, or steroids. - Radiation therapy within 2 weeks before ABX-EGF infusion. - LVEF less than 45% as measured by MUGA. - Symptomatic ventricular arrhythmia or symptomatic conduction abnormality. - Myocardial infarction within 1 year before first dose of study drug. - History of cancer that has required treatment or been active within past 5 years, other than NSCLC, basal cell carcinoma, or cervical carcinoma in situ. - Women (e.g., of childbearing potential, who are post-menopausal for less than six months, not surgically sterilized or not abstinent) who are not willing to use an oral or implanted contraceptive, double barrier birth control, or an IUD during the course of the study and for 6 months following treatment. - Men not willing to use contraception upon enrollment into this study and for 1 month following treatment. - Women who are breast-feeding or have a positive pregnancy test within 72 hours of first study drug administration. - Known to be HIV positive. - Any patient who's best medical interests would not be met by entry in the study in the opinion of the Investigators.
Analysis of Volatile Organic Compounds in Patients With Type 1 Diabetes in Induced Hypoglycaemia With a Breath Analyser

The breath analysis (BreathSpec® device) data of all participants that were included into the VAARA study (NCT05771090) will be analysed, this includes data from up to 40 breath samples from each of the 10 participants who underwent 2 insulin-induced hypoglycaemic episodes during two visits. The primary objective is to find a possible association between volatile organic compounds (VOCs) measured by the BreathSpec® device and blood glucose. For this we will use descriptive statistics, correlation coefficients, as well as a Principal Component Analysis and a partial least squares discriminant analysis. Furthermore, the time lag between hypoglycaemia onset and change in VOCs will be quantified.


Eligibility Criteria:
(as in VAARA study, NCT05771090)

Inclusion Criteria:

* Written informed consent.
* Type 1 Diabetes with Multiple daily insulin injection (MDI) or Continuous subcutaneous insulin infusion therapy (CSII) \>1 year
* Age 18 - 50 (inclusive)
* Caucasian ethnicity
* BMI between 18.5 and 24.9 kg/m2 (inclusive)
* Usage of a continuous glucose monitoring (CGM)

Exclusion Criteria:

* Pregnancy or lactation period
* History of cardiovascular diseases
* Diabetes-related comorbidities
* HbA1c \>9 %
* Epilepsy
* Smoking (last cigarette within past 6 months)
* Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome.
* Known sensitivity to Latex.
* Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation.
Sitagliptin in Non-Diabetic Patients Undergoing General Surgery

The purpose of this study is to compare sitagliptin with a placebo for the prevention of high glucose after general surgery.

Approximately 30-40% of hospitalized patients will develop stress hyperglycemia (high glucose in response to surgery or illness). High glucose is linked to an increased risk of hospital complications including wound infection, kidney failure and death. Patients with high glucose are treated with insulin given through an arm vein or by frequent insulin injections under the skin. Recent studies have found that inpatient therapy with oral dipeptidyl peptidase-4 inhibitor (DPP4-I) is an effective alternative to insulin in improving glycemic control with low risk of hypoglycemia in general medicine and surgical patients.

Sitagliptin is an oral medication approved by the Food and Drug Administration (FDA) to treat patients with diabetes. The aim of this study is to determine whether treatment with sitagliptin once daily can prevent the development of stress hyperglycemia during the postoperative period in non-diabetic patients undergoing general surgery.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing non-cardiac surgery
* No previous history of diabetes or hyperglycemia
* Fasting blood glucose level of \<126 mg/dl
* Blood glucose \<126mg/dl at the time of randomization (could occur at any time of the day)

Exclusion Criteria:

* History of hyperglycemia (blood glucose equal to or above 126 mg/dl or HbA1C greater than 6.5%) or previous treatment with oral antidiabetic agents or insulin
* Patients undergoing cardiac surgery
* Patients anticipated to require ICU care following surgery
* Severely impaired renal function (GFR \< 30 ml/min) or clinically significant hepatic failure
* Moribund patients and those at imminent risk of death (brain death or cardiac standstill)
* Patients with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction
* Patients with clinically relevant pancreatic or gallbladder disease
* Treatment with oral (\> 5 mg/day) or injectable corticosteroid
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Pregnancy or breast-feeding at time of enrollment
Difference Between Pressing and Vacuum Techniques in Fabrication of Orthodontic Aligners in Cases With Spacing: A Cross-sectional Study

This cross sectional study is aiming to compare 2 techniques of clear aligners fabrication identifying which is better.


Eligibility Criteria:
Inclusion Criteria:

* Maxillary arch with moderate spacing.
* Full permenant dentition.

Exclusion Criteria:

* Missing teeth.
* Any restorations.
Clinical Study Comparing Two Implant Surface Finishes in Patients Undergoing Cementless Total Hip Replacement

Prospective, randomized study of Summit Porocoat versus Summit DuoFix HA in total hip arthroplasty

Hydroxyapatite (HA) is a bioactive ceramic that resembles the natural inorganic mineral content of bone, and as such is a highly osteoconductive material. The purpose of this study is to compare an HA coated and uncoated prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* Primary total hip replacement
* Patient age less than or equal to 75
* Sufficient bone stock to support prosthesis

Exclusion Criteria:

* Previous hip replacement
* Significant angular/bony deformity
* Active joint sepsis
* Metal allergy
* Renal transplant
* Psychosocial disease
* Neurological disease/musculoskeletal disease that may affect weight-bearing
Osteopathic Treatment in Patients With Low Back Pain: Stabilometry

Determine the improvement in nonspecific low back pain patients with osteopathic techniques (Body Adjustment Protocol) and know changes in stabilometric measures analyzed with a stabilometric platform (Footscan®).

Fifty patients participate in this study (25 experimental group with body adjustment protocol of osteopathy and 25 control group). For a first objective of this study, all the patients determine if the osteopathic approach to the body adjustment approach will improve low back pain (Oswestry Questionnaire). For the second aim, the investigators want to know if there are changes in the distribution of body weight in lower limbs in group experimental and control group, analyzed with a stabilometric platform (Footscan®).

The experimental group is treated with osteopathy, three sessions (20 minutes/session) and a frequency one session/week. The treatment osteopathic is the body adjustment protocol. In the other hand, the control group made 2 stretching global postures once a week (10 minutes for each posture) for three weeks: the first was for the anterior muscular chain and the second posture to stretch the posterior muscle chain. Before treatment, immediately after the last session and a month later, are measured stabilometric parameters, height and Oswestry.

The analysis will be made with Statistical Package for the Social Sciences (SPSS Statistics) 22.0

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65 years.
* Patients with non-specific low back pain.
* Patients with alteration in the distribution of loads in a podiatric platform.

Exclusion Criteria:

* Specific low back pain diagnosed.
* Pregnancy.
* Recent surgery in the last year.
* Acute musculoskeletal disorders out of the lumbar region.
* Patients with vestibular and instability problems.
* Meniere syndrome.
* Oncologic patients.
* Patients with manual therapy treatment during the study.