cyrilzakka/clinical-trials huggingface dataset:
Conversion From Sirolimus to Everolimus in the Maintenance Treatment of Liver Transplant Recipients

This study aims to determine the safety and efficacy of conversion of sirolimus to everolimus in the maintenance treatment of LT recipients. Patients will be monitored every 12 weeks after the switch of treatment for 48 weeks. The laboratory tests including hematological, renal, hepatic, and metabolic parameters will be performed at each visit. Twenty-four-hour urine creatinine clearance and proteinuria will be determined from a 24-hour urine collection at baseline and week 48.

Everolimus (EVL) and sirolimus (SRL), an antagonist of mammalian target of rapamycin, has been introduced into solid organ transplantation to either replace or reduce the dose of potentially nephrotoxic calcineurin inhibitors. Although not approved for liver transplantation (LT), SRL has still been used in several LT centers. After EVL was approved by FDA and the Ministry of Health in Turkey for use in LT recipients, SRL was converted to EVL in our institution. This study aims to determine the safety and efficacy of conversion of SRL to EVL in the maintenance treatment of LT recipients.

Patients who switch from SRL to EVL will be monitored every 12 weeks after the switch of treatment for 48 weeks.

Efficacy measure will be included any observation in terms of biopsy-proven acute/chronic rejection and graft or patient loss due to rejection.

Safety evaluations will be included discontinuation of EVL and analyses of adverse events and grading laboratory abnormalities.

Laboratory evaluations will be included hematological (CBC), renal (serum creatinine, estimated glomerular filtration rate \[eGFR; Modification of Diet in Renal Disease (MDRD) and Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI)\], and electrolytes), hepatic (serum transaminases, alkaline phosphatase, γ-glutamyl transferase, bilirubin, and albumin), and metabolic parameters (fasting glucose, cholesterol, and triglyceride) at each visit. Twenty-four-hour urine creatinine clearance and proteinuria will be determined from a 24-hour urine collection at baseline and week 48.

For patients who were on additional immunosuppressive treatments, those medications will also be continued.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Liver transplant recipients who switch from sirolimus to everolimus

Exclusion Criteria:

* Patients who refuse the everolimus switching
Effect of Soy on Cognition and Hot Flashes in Men With Prostate Cancer Undergoing Testosterone Suppression Therapy

This study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are being treated with testosterone suppression therapy. Hypothesis: Treating men who have prostate CA with daily Revival will result in at least a 50% reduction in hot flashes compared to placebo.

This research study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are undergoing (ADT) androgen deprivation therapy. Participants will be given either placebo or Revival. Participants will be asked to take their supplement once/day for 14 weeks.Blood will be drawn to check on liver, kidney, thyroid, cholesterol,and prostate health. Urine will be collected to check on bone markers. Patients will be asked to complete questionnaires to test memory, attention span, and vocabulary.Possible benefits may include increase in memory, decrease in hot flashes, and a general increase in quality of life.

Eligibility Criteria:
Inclusion Criteria:

* men \> or =21 with prostate CA and hypogonadism for at least 3 months

Exclusion Criteria:

* on growth promoting agents
* on appetite stimulating agents
* on Prednisone and others
First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks

The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.


Eligibility Criteria:
Inclusion criteria:

* Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
* Severity of psoriasis disease meeting all of the following three criteria:

Psoriasis Area and Severity Index (PASI) score of 12 or greater, Investigator's Global Assessment (IGA) score of 3 or greater, Total body surface area (BSA) affected of 10% or greater.

-Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.

Exclusion criteria:

* Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
* Current drug-induced psoriasis.
* Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
* Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
* Hematological abnormalities.
* History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
* History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
* Pregnant or nursing (lactating) women. Other protocol-defined inclusion/exclusion criteria may apply
Immunomodulation, IL-1 Inhibition, and Postoperative Incisional Pain

The investigators hypothesize that perioperative administration of anakinra will reduce incisional pain by lowering the concentration of inflammatory mediators in surgical wounds. This knowledge is important because it suggests a new, previously unexplored pharmacological target for the control of postoperative incisional pain.

This study will test whether administration of anakinra, an IL-1 receptor antagonist, will decrease pain and improve wound healing in patients undergoing vascular or orthopedic surgical procedures. The investigators will administer two doses of Anakinra via an injection under the skin, one dose one hour before surgery and a second dose on the first postoperative day (24 hours after surgery). The investigators will remove fluid from the surgical incisions using a small plastic catheter placed under skin during surgery and measure the amounts of pain- causing inflammatory mediators. The investigators will also measure the amount of pain the participant is experiencing using questions about pain intensity and by gently touching the incision to determine sensitivity of the incision site.

Eligibility Criteria:
Inclusion Criteria:

-Patients 18 years of age and older presenting to the Stanford Preoperative Evaluation Clinic prior to elective orthopedic surgical procedures or elective vascular surgical procedures not involving the abdominal aorta or carotid arteries.

Exclusion Criteria:

Patients will be excluded from participation if they have one or more of the following conditions:

1. Evidence of active local or systemic infection as demonstrated by fever, leukocytosis (white blood cell count \> 11,000/ul), productive cough, new infiltrate on chest x-ray, or purulent drainage from any source
2. End-stage renal disease
3. A history of diabetic neuropathy
4. A malignancy other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the previous 5 years
5. Leukopenia (white blood cell count \< 2,000/ul)
6. Thrombocytopenia (platelet count \< 100,000/ul)
7. Abnormal liver function test result (aspartate aminotransferase or alanine aminotransferase level ≥1.5-fold the upper limit of normal)
8. A history or infection with tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
9. Pregnant or breastfeeding
Factors Affecting PrEP Adherence

The purpose of this study is to test a new way to take a questionnaire that asks about adherence (whether the person is taking the medicine correctly). This new questionnaire is called Interactive Questionnaire System (iQS). In this study, the iQS will be tested on HIV-negative young men who have sex with men (YMSM) who are taking PrEP as part of another study, either ATN 110 or ATN 113.

Among Men who have Sex with Men (MSM) in the U.S., Human Immunodeficiency Virus (HIV) incidence has remained highest in those less than 30 years of age, demonstrating the need for new ways to prevent HIV in Young Men who have Sex with Men (YMSM). Pre-exposure Prophylaxis or PrEP is the use of a daily medication to prevent HIV infection. In order for PrEP to work the pills must be taken, so adherence is a very important part of PrEP. Efforts to accurately assess adherence to PrEP have been hindered because participants do not always accurately report adherence and the flawed methods that have been used to measure adherence. In previous studies it has been shown that participants over-report adherence when compared to drug concentration levels in blood. Although drug-levels can be used to monitor adherence, the cost can be prohibitive and specimens may be difficult to collect in real-time. This means that better and more accurate assessments of PrEP adherence from self-reports are needed in order for PrEP to achieve wide-spread use.

This longitudinal pilot sub-study of ATN 110 and ATN 113 (Project PrEPare - An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among Young Men Who Have Sex With Men (YMSM) in the United States) aims to assess how structural (physical settings) and partnership factors affect adherence of YMSM to PrEP. This study will compare levels of adherence reported in the Interactive Questionnaire System (iQS) to those collected in ATN 110 or ATN 113 by Audio Computer Assisted Self Interview (ACASI), Wisepill, and drug concentration levels in blood and hair. The iQS will be administered at study entry and week 24 visits. PrEP, Emtricitabine/Tenofovir disoproxil fumarate (Truvada®), will be administered as part of the ATN 110 and ATN 113 protocols. Study drug will not be administered as part of this study, ATN 123.

Eligibility Criteria:
Inclusion Criteria:

* Concurrent enrollment in ATN 110 or ATN 113 and prescribed FTC/TDF (Emtricitabine/Tenofovir disoproxil fumarate (Truvada®)) for PrEP;
* Ability to understand written and spoken English; and
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Appears visibly distraught or presence of active serious psychiatric symptoms (e.g., active hallucinations, suicidal, homicidal, or exhibiting violent behavior) at the time of consent; and
* Intoxicated or under the influence of alcohol or other substances at the time of consent.
Tumour Registry Colorectal Cancer

To describe treatment reality of patients with colorectal cancer treated by office-based and clinic-based medical oncologists in Germany.

The TKK is a prospective, longitudinal, nation wide cohort study with the purpose to record information on the antineoplastic treatment of colorectal cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

The impact of nutrition (CoNut) and physical activity (CoNut) on the course of the adjuvant disease will be examined, as well as long-term effects of adjuvant treatment (CoTox) and the final phase of the palliative process (CoLife). Based on the available data a prognostic score will be developed.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer
* 18 years and older
* Antineoplastic treatment

Exclusion Criteria:

* No colorectal cancer
* Below 18 years
* No antineoplastic treatment
Tailored Egoscue Exercises in Patients With Lumbar Radiculopathy

Lumbar radiculopathy (LR), commonly sciatica, is characterized by inflammation of the lower back's nerve roots. It is typically caused by sensory disruptions that arise from the lumbar spine and extend downward below the knee. LR is marked by alterations in motor and sensory functions, such as Radicular discomfort,functional performance paresthesia, or tingling in the lower limb.

This research aims to explore the Effects of Tailored Egoscue Exercises on Pain, Functional Performance and Sleep Quality in Patients with Lumbar Radiculopathy

The study was a randomized controlled trial, total 54 patients were recruited from Rayan Medical Center, Gujrat by using probability convenience sampling technique and assigned into two equal groups .27 patients in Group A (Experimental group) did Egoscue exercises while Group B (Control group) was provided with routine rehabilitation. In this study, age group between 45 to 65 pre-diagnosed with lumbar radiculopathy by a neurophysician was included. Lasègue's test , Bragard's test and Slump test was performed as a screening tool in the study. Exercises was performed for 40 minutes per day on 3 alternate days per week for 6 weeks.Group A (Experimental Group) included 10 minutes of heat therapy and 30 minutes of Egoscue training while at Group B (Control Group) 10 minutes of heat therapy, gentle stretches \& core stabilization exercises for 30 minutes was performed. Patients was assessed at three levels pre (at baseline), mid (after 3 weeks) and post level(after 6 weeks) . Assessment tool was a Numerical pain rating Scale, Rolland-Morris Disability Questionnaire \& Insomnia Severity Index (ISI) to assess the outcome variable

Eligibility Criteria:
Inclusion Criteria:

* Age 45-65 years
* Both male and female
* Lumbar disc herniation /lumbar radiculopathy secondary to L4/L5 and L5/S1
* Patients diagnosed with lumbar radiculopathy by neuro physician
* Positive Lasègue's test(SLRT): Positive if pain occurs when the hip is flexed at 30 and 60 or 70 degrees from horizontal.
* Positive Bragrd's sign: Applying ankle dorsiflexion after the straight leg raise (SLR) with the knee extended causes pain.
* Positive Slump test: positive if symptoms are increased in the slumped position and decreased as the patient moves out of neck flexion

Exclusion Criteria:

* Received treatment for LBP in the past 6 months
* Practiced any kind of exercise or sports activity during the last 6 months
* spinal tumors
* infections
* pregnancy
* neoplasm
Effect of Quadratus Lumborum Block on Perioperative Analgesia and Inflammatory Responses in Laparoscopic Nephrectomy

Quadratus lumborum (QL) block can reduce intraoperative opioid consumption, decrease inflammation responses of IL-6, and reduce acute pain intensity in comparison with non-receiving QL block as the control group.

Quadratus lumborum block had been studied as an effective postoperative analgesia in lower abdominal surgery, due to its spread to the thoracic paravertebral space and thoracolumbar fascia nerve. The effect of preincisional ultrasound (US)-guided QL block as "preemptive analgesia" on patient underwent laparoscopic living donor nephrectomy has never been evaluated. As preemptive analgesia, quadratus lumborum block could provide analgesics before and after surgery. Both groups immediately received basic postoperative analgesia regimen paracetamol 1 gr IV 8th hourly.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 30 kg/m2
* ASA 1 or 2

Exclusion Criteria:

* refused to participate
* chronic use of analgesics or anti-inflammatory drugs
* allergy to local anaesthetic
* duration of surgery \<4 or \> 6 hours
* duration of anaesthesia \<5 or \> 7 hours
* neuropathy
Short Term Effects and Risks of Physical Exercise in Subjects With Hypohidrotic Ectodermal Dysplasia

Because of their lack of sweat glands individuals with hypohidrotic ectodermal dysplasia (HED) are at particular risk of life-threatening hyperthermia during exercise in a warm environment. In this study, the effects of physical exercise are investigated in boys and male adolescents with X-chromosomally inherited HED as well as age-matched controls, who undergo standardized exertion on a bicycle ergometer at ambient temperatures of 25°C and 30°C. Body core temperature during and after ergometry, heart rate, performance, and serum lactate as a marker of metabolic stress are measured. Subjects with HED are expected to show an endangering rise of body temperature in connection with physical exercise. To clarify, whether novel cooling devices may reduce the likelihood of overheating, the effects of such devices are evaluated at 30°C.


Eligibility Criteria:
Inclusion Criteria:

* for patients: hypohidrotic ectodermal dysplasia caused by EDA gene mutations
* regular fluid intake prior to the investigation
* written informed consent

Exclusion Criteria:

* acute febrile illness
* acute or chronic heart disease
* arterial hypertension
* gastrointestinal disorders
* implantable electronic devices
* MRI investigation scheduled for the 5 days subsequent to the study
* clinical signs or diagnostic findings of dehydration
Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE.

To compare the complete healing of erosive esophagitis(EE) after 3 weeks of treatment with Secretol 80/80 versus Nexium 40 mg daily.

We hypothesize that Secretol 80/80 daily will demonstrate better efficacy than Nexium 40 mg daily in healing erosive esophagitis(EE)and controlling gastroesophageal reflux disease(GERD)related symptoms after 3 weeks of treatment.In addition, Secretol 80/80 daily will have a faster effect on the aforementioned clinical parameters but a similar safety profile.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Ages 18-75
* EE Los Angeles grades C or D
* Heartburn and/or regurgitation at least 3 times a week during the 7 day run- in period prior to randomization.
* Able to read, understand, and complete study questionnaires and record
* Able to understand the study procedures and sign informed consent
* Able to comply with all study requirements

Exclusion Criteria:

* Subjects with Barrett's esophagus, non-erosive reflux disease,EE grades A or B, or peptic stricture on endoscopy
* Subjects with previous upper gastrointestinal surgery
* Subjects with clinically significant underlying comorbidity
* Helicobacter pylori positive
* Clinically significant GI bleed within the last 3 months
* Esophagitis not related to acid reflux
* Bleeding disorder
* Zollinger-Ellison, achalasia,esophageal varices, duodenal/gastric ulcer, upper gastrointestinal malignancy
* Women pregnant or lactating
* History of allergic reaction to any Proton Pump Inhibitor (PPI)
* Patients can't be treated concurrently with warfarin or other anticoagulants,salicylates,steroids,NSAIDS \> 3 times/week
* Any medication dependant on gastric acid for optimal absorption
Study of Doxorubicin in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer

This was a randomized, multi centre, open label, two treatment, two period, two sequence, single dose, crossover study, with at least 28 days washout between doses, conducted under fed (normal breakfast) conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
2. Patients with metastatic breast cancer/advanced ovarian cancer having age within the range of between 18-55 years.
3. Subjects who had no evidence of underlying disease
4. Subjects who had signed written consent form

Exclusion Criteria:

1. Females who were pregnant, breastfeeding, or are likely to become pregnant
2. Subjects who had any medical condition (except metastatic breast cancer/advanced ovarian cancer) that could jeopardize their health or prejudice the results
3. Subjects deemed uncooperative or noncompliant
4. Smoking or consumption of any nicotine products
Oral Testosterone for the Treatment of Hypogonadism in Males

Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.

The purpose of this study is to evaluate the pharmacokinetic (PK) parameters of testosterone after administration of TSX-002 (easy to swallow testosterone capsules) to hypogonadal men. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the PK parameters of the testosterone metabolite, dihydrotestosterone (DHT), as well as the safety and tolerability of TSX-002. The study consists of three (3) periods, for which TSX-002 will be taken orally at various doses. Study duration is approximately 9 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic hypogonadal male subjects (Testosterone \> 100 and \<300 ng/dL, two separate 10 am samples one week apart),
* 18-70 years old,
* Willing and able to provide informed consent and to participate in all 3 periods of the study.
* BMI \< 35 kg/m2.

Exclusion Criteria:

* Malabsorption conditions (e.g. history of cholecystectomy, Inflammatory Bowel Disease, Pancreatitis, Celiac disease, Sprue, Dumping syndrome, Bariatric surgery; Short bowel syndrome, Lactose intolerance);
* Alcoholics or substance abuse;
* Gastroparesis; IPSS (International Prostate Symptom score) \> 19; PSA (prostate-specific antigen)\> 4 ng/ml;
* Congestive Heart Failure, uncontrolled (NYHC \>1);
* Uncontrolled sleep apnea;
* Topical or injectable testosterone replacement therapy (any kind including dehydroepiandrosterone (DHEA) and nutritional supplements) within past 4 weeks;
* Testopel excluded if within 2 years;
* Aveed excluded if within past 6 months;
* Hematocrit \> 50.