cyrilzakka/clinical-trials huggingface dataset:
Comparison of NODAT in Kidney Transplant Patients Receiving Belatacept Versus Standard Immunosuppression

This study is being conducted to determine if belatacept is an appropriate alternative immunosuppressive medication (reducing the immune system's effect) when a kidney transplant patient develops new onset diabetes after transplant (NODAT). Patients who are diagnosed with NODAT will be approached with the opportunity to participate in this study. If they agree to participate, they will be randomized one-to-one (like a coin flip) to the study arm (belatacept) or the control arm (their current medication regimen). If a patient is randomized to the study arm, they will be tapered off of their current regimen when they have started receiving their monthly belatacept infusions. The control arm will mean the patient will continue their current, standard of care medications, but following the tacrolimus trough levels indicated within the study protocol. Different laboratory tests (i.e. fasting blood glucose) will be measured during the study to monitor the progression of NODAT in all patients.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be given by patient.
* Adult patients between age 18 and 65
* Thymoglobulin induction at the time of transplant
* Patient must be Epstein-Barr Virus seropositive

Exclusion Criteria:

* Patient who received an blood type incompatible transplant, or with T-cell or B-cell positive crossmatch
* Patients with Hepatitis B, Hepatitis C, HIV or a clinically significant systemic infection within 30 days prior to transplant
* History of stroke, severe cardiac disease or cardiac failure
OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study

A Single Dose PK Study of OxyNorm® immediate-release capsules 5, 10, and 20mg, and a multiple-dose PK Study of OxyNorm® immediate-release capsules 10mg in Chinese patients with pain.It will be a single center, open label, randomized, oral administration study.

Single dose: The subjects will be randomized to receive a single dose of OxyNorm® immediate-release capsules 5, 10, and 20mg.

Multiple dose: The subjects will take 3 days OxyNorm® capsule 10mg, once every 6 hours, 10mg per dose. In the morning of the 4th day, the subjects will take single dose of OxyNorm® capsule 10mg. On the 5th day, all the subjects complete the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pain, Multiple dose group should enroll the Patients with cancer pain;
* Patients aged \>≥30 to ≤ 60 years;
* Body weight ≥ 45kg, and BMI range ≥19, \<24;
* Karnofsky score ≥ 70;
* The results of liver function and kidney tests must meet the following criteria: ALT、AST is within the upper limit of normal value ranges by a factor 2, and TB、BUN、Cr is within the upper limit of normal value ranges by a factor 1.25;
* The electrocardiogram examination results are normal;
* Patients must have given a written informed consent prior to this trial, and have the capability to complete every required test.

Exclusion Criteria:

* Have hypersensitivity history to any opioids;
* Have known hypersensitivity to any of compositions of the study drugs;
* Patients who are likely to have paralytic ileus or acute abdomen or to perform an operation on abdominal region；
* Patients with respiratory depression, cor pulmonale, or chronic bronchial asthma;
* Patients who are unable to stop taking monoamine oxidase inhibitor during this trial period or time lapses less than 2 weeks since drug withdrawal;
* Patients with hypercarbia;
* Patients with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency;
* Patients with alcoholism or drug abuse history;
* Positive anti-HIV or syphilis antibody test result;
* Patients who are pregnant, or lactating;
* Urine screening before study is positive for opioids, barbiturates, amphetamines, cocaine metabolites, methadone, diazepam and cannabinoids;
* Donated 400 mL or more of blood or blood products within 3 months prior to the start of the study, or donated 200 mL or more of blood or blood products within one month prior to the start of the study;
* Subjects who participated in a clinical research study within one month of study entry;
* Patients who are currently taking opioids.
Postoperative Analgesia After Shoulder Replacement

A comparison was made regarding opioid analgesic usage immediately after elective shoulder replacement and for seven days at home between patients randomly given either 0.5% or 0.75% ropivacaine via interscalene block prior to surgery.

It is hypothesized that no significant difference will exist between both groups with respect to pain medication used in the hospital and for a 7-day period at home.

After IRB approval, 46 patients undergoing elective shoulder replacement surgery were recruited at Methodist Hospital (Philadelphia) for this single blind, randomized pilot study. Consented patients spent 48 hours in-house. They were randomly given either 0.5% or 0.75% ropivacaine via interscalene block (ISB) prior to surgery. After the operation, patients were transferred to the post anesthesia care unit (PACU) and placed on a patient controlled analgesia (PCA) morphine pump: basal rate of 0 mg; bolus of 1 mg; lock-out period of 10 min (maximum dose of 6 mg/hr). If the PCA did not provide adequate analgesia, subjects could also receive a bolus of morphine, 2 to 4 mg i.v., every fifteen minutes for several doses p.r.n. In addition, parameters of the PCA could also be modified in order to allow for increased delivery of morphine (e.g., lock-out of 6 min w/max dose of 10 mg/hr) for patient analgesia. PCA morphine therapy was continued after patient was transferred from the PACU to the patient's recovery room. PCA morphine therapy was discontinued the day after surgery and patients were given oral Percocet tablets for pain management. . Thirty-nine patients successfully completed this part of the study. There was no significant difference (p\>0.05) between groups in amount of post-operative medications consumed (PCA morphine and oral analgesics) or post-operative pain.

Upon release, patients were given pain and medication diaries to complete for seven successive days. All patients recorded the total amount of Percocet tablets taken at home each day in addition to pain scores (0-10) in the morning, afternoon and evening. Twenty-seven patients successfully completed this part of the study. There was no significant difference (p\>0.05)between groups in regard to pain; however, patients in the higher 0.75% group unexpectedly took more tablets (p\<0.05).

Conclusion: The 0.5% ISB dose of ropivacaine was found to be equally efficacious as 0.75%; since this lower concentration would also reduce the risk of serious systemic toxicity, it is recommended for ISB prior to elective shoulder replacement.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing total shoulder replacement surgery
* 18 years of age or older
* expected length of stay of at least 24 hours
* able to report pain levels
* able to request medications as needed
* American Society of Anesthesiologist (ASA) physical status classification of P1 or P2

Exclusion Criteria:

* liver disease
* kidney disease
* antidepressant therapy (e.g., for clinical depression and/ or chronic pain syndrome)
* ASA physical status classification of P3 or higher
* pregnancy
* allergy to any medications used to treat patient
Predictors of Bone Mineral Density in Lupus Nephritis Activity

Our aim in this study is Correlation of histopathology of renal biopsy in SLE with lupus nephritis patients versus predictors of bone mineral density in active and inactive lupus nephritis

Systemic lupus erythematosus (SLE) is an autoimmune disorder characterized by multisystem damage, leading to significant health issues \[1\]. There is growing concern over the adverse effects of medications used to treat SLE and the potential long-term complications \[2\]. Lupus nephritis (LN) is a severe and frequently manifestation of SLE, associated with significant morbidity and mortality \[3-5\]. Research indicates that female patients with SLE are at a higher risk of developing reduced bone mineral density (BMD) \[6-9\]. Moreover, women exhibit a high prevalence of osteoporosis and osteoporotic fractures \[10\]. Osteoporosis is a common and serious complication of SLE, contributing to increased morbidity and mortality rates \[11, 12\]. there is a notable gap in the literature regarding osteoporosis prevalence among LN patients. Risk factors such as glucocorticoid therapy, early menopause, and low calcium and vitamin D intake are known to contribute to bone loss \[13-16\], yet the specific risk factors associated with osteoporosis in LN patients vary by country, indicating a need for further research in this area. The pathophysiology of bone mineral density (BMD) reduction in Systemic Lupus Erythematosus (SLE), particularly in relation to lupus nephritis (LN) activity, is multifactorial and complex. The mechanisms behind this association involve immune system dysregulation, chronic inflammation, steroid use, kidney dysfunction, and alterations in mineral metabolism (17)

Eligibility Criteria:
Inclusion Criteria:

The patients with lupus nephritis based on KDIGO over 18 years and less than 60 years The patient diagnosed as SLE with lupus nephritis and in active form. The patient diagnosed as SLE with lupus nephritis and without active criteria The patient consent.

Exclusion Criteria:

Patients with SLE and also diagnosed as end stage renal disease on regular hemodialysis

* Association of another autoimmune as rheumatoid arthritis
* Association of HCV, HBV
* Association of diabetes mellitus or malignancy
* Patient had history of vitamin D supplementation
Study of Management of Appendicular Abscess

This study aims to detect indications of surgical drainage after failure Ultrasound guided percutaneous drainage This study will include any male and female above 18 years old that presented with appendicular abscess Patients with appendicular abscess above the age of 18 years old All patients with generalized peritonitis or immunocompromised patients will be excluded from the study

Prospective randomized study we will collect 30 patients diagnosed with appendicular abscess and they all will undergo Ultrasound guided percutaneous drainage of abscess and the group who will fail to insert the pigtail will undergo surgical drainage we will record the time of operation, number of cases with intraoperative complications and then follow up these patients during time of hospital stay for post operative pain and paralytic ileus

Study outcomes:

Primary outcomes:

1. Incidence of intra operative complications
2. Length of operations
3. Post operative pain
4. Incidence of intraoperative complications as injury of important structures
5. Lenght of hospital stay
6. Incidence of post operative complications related to surgery as wound infection, recurrence, intestinal obstruction

Secondary outcomes:

1. Cosmotic outcomes
2. Incidence of recurrence of pathology
3. Patient satisfaction

Eligibility Criteria:
Inclusion Criteria:

* Patients with appendicular abscess above the age of 18 years old

Exclusion Criteria:

* Generalized peritonitis and patients with signs of spreading infection, toxemia and septicemia Multi-locular appendicular abscess Immunocompromised patients, hepatic dysfunction, renal impairment, uncontrolled patients and cardiac disease
Dose Escalation Study of SH U04722 in Solid Tumors

This study will evaluate the safety and tolerability of SH U04722 in patients with solid tumor cancers. In addition, this study will identify the recommended dose and administration schedule of SH U04722 for phase II development in Japanese cancer patients, evaluate the pharmacokinetic profile of SH U04722 and gather preliminary data on the effectiveness of SH U04722 in patients with solid tumors.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:-Refractory to conventional antineoplastic treatment or no standard therapy option available-ECOG Performance Status score of \< 2-Agreement not to take vitamin E products such as Juvela (except for over-the-counter \[OTC\] and diet supplements). Exclusion Criteria:- Patients treated with other unapproved drugs/investigational drugs, chemotherapy, biological response modifiers, immunotherapy or endocrinotherapy within 4 weeks prior to entry in this study or nitrosoureas within 6 weeks before initial dosing of SH U04722 -Patients on concurrent therapy with warfarin or coumarin derivatives.-Patients who had radiation therapy within 2 weeks prior to entry into this study. -Patients with a history of serious hypersensitivity to taxanes.-Patients with current peripheral neuropathy (? Common Terminology Criteria for Adverse Events \[CTCAE\] Grade 2)
AntibaCterial presCribing & OraL Health Practice

A study by Allied Health Professionals to explore the experience of patients undergoing tooth extraction at Leeds Dental Institute in relation to antibiotic medication, dental anxiety and oral health practices

Consented patients attending the Leeds Dental Institute for tooth extraction will be asked to complete 3 questionnaires in order for the researchers to understand more about the background of patients who have teeth extracted at the centre. The study will focus on the patient's previous experience of dentistry such as whether they have had antibiotics prescribed for toothache, whether they suffer from dental anxiety and how they regularly look after their oral health.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing extraction of one or more teet
* Parents/Guardians of children aged 5-12 years old undergoing extraction of one or more teeth
* Patients aged 13-15 undergoing extraction of one or more teeth
* Patients and Parents/Guardians who are willing to give informed consent or assent to complete questionnaires

Exclusion Criteria:

* Patients, parents/guardians unable or unwilling to provide informed consent
* Parents/Guardians of patients aged less than 5 years old
* Patients or parents who are unable to communicate directly with the health person carrying out the treatment
Usual Care Intervention Research Evaluating the Impact of a Personalized Pharmaceutical Plan on the Duration of Opioid Treatment in Non-cancerous Pain

Many treatments with WHO grade III opioids are being introduced in the rheumatology department for non-cancerous pain. The duration of this treatment prescribed at discharge is often uncontrolled and sometimes leads to significant addiction.

The team at the local pain center recommends an average duration of 28 days for this type of pain. There is a full-time pharmacy intern in the rheumatology department.

The aim of this work is to evaluate the impact of a targeted pharmaceutical interview on the duration of the morphine treatment initiated during hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and \< 75 years old when entering the rheumatology department
* Hospitalization in the rheumatology department
* Patient with acute non-traumatic musculoskeletal disease
* Patient not taking grade III opioid treatment
* Patient affiliated to a social security scheme
* Patient having read and understood the information letter and signed the consent form
* Patient present on a day which the pharmacy intern is present

Exclusion Criteria:

* Presence of cancer, fibromyalgia, already diagnosed at inclusion
* Patient does not understand French
* Patient with Current or past opioid addiction
* Person deprived of liberty by administrative or judicial decision
The Randomized OPTIMAL-ACT Trial

The purpose of this study is to find the ideal range of the activated clotting time (ACT) during percutaneous coronary intervention (PCI) that is associated with lowering the rate of undesirable medical outcomes


Eligibility Criteria:
Inclusion Criteria:

* Age\>18
* Referred for coronary angiography with possible coronary revascularization or adjunctive invasive diagnostic testing (IVUS/OCT, FFR, or iFR)

Exclusion Criteria:

* Receipt of LMWH at treatment dose (not DVT prophylaxis dose) within 6 hours of coronary angiography
* Prior GP IIb/IIIa use within the previous 72 hours
* Use of warfarin (vitamin K antagonist) or direct oral anticoagulant
* Patients on LMWH bridging strategy
* PCI within prior 30 days
* Planned use of bivalirudin as the procedural anticoagulant
* Rotational atherectomy
* Excimer laser coronary angioplasty
* Chronic total occlusions
* Patients with active bleeding disorders or bleeding diathesis
* Patients with ST-segment elevation myocardial infarction
* Patient with clinical evidence of cardiogenic shock (defined as SBP\<90 mmHg for ≥30 min OR support to maintain SBP ≥90 mmHg AND evidence of end-organ hypoperfusion (urine output \<30 mL/h or cool extremities)
* Chronic kidney disease stage 4/5 (GFR 30 mL/min)
Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy

Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as alternative colonoscopy techniques have been documented to decrease patient discomfort during and after the procedure.

This prospective, randomized, single-center trial was designed to evaluate whether the combination of water immersion during insertion and CO2 insufflation during withdrawal (Water/CO2)for minimal sedation colonoscopy (2 mg of midazolam i.v.)is superior to the other colonoscopy methods (Water/Air, CO2/CO2, Air/Air).


Eligibility Criteria:
Inclusion Criteria:

* men and women older than 18 years referred for diagnostic outpatient colonoscopy
* provided written consent

Exclusion Criteria:

* history of colorectal surgery
* known diagnosis of inflammatory bowel disease
* chronic benzodiazepine use
* refusal of minimal sedation
The Transversus Abdominis Plane Block: A Prospective Randomized Clinical Trial Using EXPAREL.

The purpose of the study is to evaluate the effectiveness of EXPAREL in a transversus abdominis plane block by assessing the demand of postoperative narcotic, length of hospital stay and incidence of postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

1. Patients over the age of 18 years w
2. Elective laparoscopic colorectal resection.

Exclusion Criteria:

1. Patients under 18 years.
2. Patients unable to provide informed consent
3. Patients undergoing emergency surgery.
4. Pregnant women
5. Severe liver or kidney disease (GFR 15-29 ml/min)
Study to Evaluate the Effect of Six Cycles of Treatment With a Combined Oral Contraceptive (EE 0.30 mg/DRSP 3 mg) on Quality of Life.

The purpose of this study is to evaluate the effects on the quality of life and BMI of new contraceptives.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Female requiring contraceptives.
* Aged 18 to 35 if a non-smoker, aged 18 to 30 if a smoker.
* Regular menstrual cycle (defined as duration of 28 +/- 5 days).

Exclusion Criteria:

* No Contraindication for OC use
Study To Determine The Effect Of Food And Strong CYP3A4 Enzyme Inhibitor On PF-04449913 Drug Levels

The study aims to determine what effect a high fat meal will have on the drug exposure of PF-04449913. The study also aims to determine the effect of a strong enzyme (CYP3A4) inhibitor on drug exposure of PF-04449913.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between the ages of 18 and 55 years (inclusive):Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen
* 12-lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility. Subjects with one of the following currently in the past 6 months: myocardial infarction, congenital long QT syndrome, torsades de pointes or clinically significant ventricular arrhythmias.
* Pregnant or nursing females and females of childbearing potential including those with tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory FSH test results at Screening.
Migraine and Neuropathic Pain in Osteoarthritis

The goal of this observational study is to estimate the frequency of neuropathic pain and migraines in a group of patients with osteoarthritis of the knees, hips, hands, spine or other joints. In addition to their usual care for osteoarthritis, participants will complete questionnaires to define migraine and neuropathic pain.

This study will be proposed to patients with osteoarthritis who come for their routine consultation. If the patient has no abjection to taking part in the study, the doctor will give them the questionnaires to fill in. The questionnaires are about: perception of pain , depression and anxiety, how patients manage their disease emotionally, migraine, neuropathic pain, functional ability, osteoarthritis assessment.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years old
* patients with articular or/and spinal osteoarthritis
* affiliation to a social security system.
* able to read and understand french

Exclusion Criteria:

* patients who refuse to participate in the study
* patients unable to complete self-questionnaires
* minors or adults under the protection of the law or under the protection of justice