cyrilzakka/clinical-trials huggingface dataset:
Testosterone and Pain Sensitivity

This research is being done to see whether testosterone replacement in men who take opioid-based pain medications and have low testosterone levels will show improvement in pain tolerance, pain perception and quality of life.

Some men who take opioid-based medications (narcotics) for pain develop low testosterone levels. Research has shown that low testosterone levels may make a person more sensitive to pain. This means that if a person with a painful condition develops low testosterone level as a result of his pain medications, he might become more sensitive to pain and so may need higher doses of pain medications for pain control.

Testosterone is a male hormone that is important for sperm production and the development of male characteristics such as muscle mass and strength, fat distribution, bone mass and sex drive. Testosterone hormone replacement therapy has been used for decades to treat men with low testosterone levels (male hypogonadism). Testosterone replacement therapies are available in the form of an injection into the muscle, implants under the skin, oral capsules taken by mouth, topical gels applied to the skin, and skin patches.

This study will use Fortesta®, a topical testosterone gel (T-gel) absorbed into the skin. Fortesta® is currently on the market as an FDA-approved treatment of male hypogonadism (low testosterone levels).

Men with non-cancer related pain who take opioid-based medications for pain and have low testosterone levels may join this study. (A low testosterone level is defined as early morning (before noon) blood testosterone level of 300 ng/dl or less, or a free testosterone of 50 ng/dl or less)).


Eligibility Criteria:
Inclusion Criteria:

* Men
* 18 Years of Age and Older
* Serum total testosterone level \<300 ng/dl or free testosterone \< 50 pg/ml
* Consumption of at least 10 mg of hydrocodone (or analgesic equivalent of another opioid) for at least 4 weeks
* Absence of hospitalization in past 2 months
* No acute illness in past 2 months
* No prior history of any form of hypogonadism
* No current anabolic therapy (growth hormone, DHEA, etc)
* No current use or consumption in past 2 months of glucocorticoids and melatonin
* Normal digital rectal examination
* Normal PSA level

Exclusion Criteria:

* Liver enzymes \>3 times upper limit of normal
* Serum creatinine \> 2 times upper limit of normal
* Neurological disease
* Active psychiatric illness
* Any addictive and/or illicit drug use
* Alcoholism (\>10 drinks/week)
* Patients currently receiving glucocorticoids, melatonin or anabolic agents
* Hospitalization in past 2 months
* Acute illness in past 2 months
* Consumption of \< 20 mg of hydrocodone (or analgesic equivalent of another opioid)
* Severe BPH
* PSA \>4.0 ng/ml
* Prostate cancer
* Breast cancer
* Any cancer or cancer related pain
* History of alcohol abuse
* Known peripheral neuropathy (any etiology) or peripheral vascular disease (including Raynaud's disease), which may interfere with pain testing
* Concurrent warfarin treatment
Diet and Physical Activity Program in Colorectal Cancer Survivor: a Randomized Controlled Trial

Colorectal cancers (CRC) represent the 1st digestive cancer and the 3rd cancer in the world. The World Cancer Research Fund summarized evidence from observational studies and concluded that low dietary fiber, and high red and processed meat (RPM) intakes were associated with higher risk of (CRC), whilst physical activity (PA) protected against developing colon cancer.

Post-treatment management is essential for improving the health and quality of life of colorectal cancer (CRC) survivors. The number of cancer survivors is continually increasing, which is causing a corresponding growth in the need for effective post- treatment management programs. To date, there is insufficient information available from the published literature as to the most effective way in promoting lifestyle changes in CRC survivors. Moreover, none of these interventions have been conducted in an African population. We aim to assess whether the proposed program may effectively modify the targeted behaviors, to evaluate whether the dietary and PA interventions of the "Moving Bright, Eating Smart" program are effective in reducing the consumption of red and processed meat (RPM) and refined grain (RG), increasing the physical activity (PA) levels in north African (Libyan and Tunisian) adult colorectal cancer (CRC) survivors and to assess the efficacy of behavioral interventions on cancer outcomes (overall survival, disease free survival).


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven colorectal adenocarcinoma patients above the age of 18 years within one year of completion of main cancer treatment who are able to provide informed consent.

Exclusion Criteria:

* Colorectal cancer patients who have persistent or recurrent disease at the time of the recruitment, are receiving cancer treatment, have known contraindication to physical activity, have psychiatric disease.
3 Tesla (3T) Stroke Medical Radiologic Technology (MRT) for Examining Mismatch in 1000+

The purpose of this study is to compare clinical and economic parameters of stroke patients who have received acute MRI imaging (test group) to patients who have received routine CT imaging (control group) in the clinical setting of acute stroke.

The primary objective:

* Prospective validation of infarct development in ischemic stroke and transitory ischemic attacks on the basis of all patients given a preliminary diagnosis of stroke or TIA in the emergency ward of the Benjamin Franklin Campus of Charité-Universitätsmedizin Berlin.

Secondary objectives:

* Determination of the spontaneous reperfusion rate in patients with an initial mismatch in the correlation between the time from onset of symptoms to the time of first imaging and NIHSS score severity
* Characterization of metabolic changes in ischemic tissue in cases of minor subcortical infarct using high resolution diffusion weighted MRI (DWI) and perfusion MRI with 2nd pass corrected CBF cards
* Proof of the principle that stroke MRI can improve patient care / shorten the period in which patients are bedridden
* Measurement of the diffusion tensor in acute ischemic stroke (Hamburg DTI study)
* Proof of structural damage and investigation of pathogenesis in patients suffering from clinical transitory ischemic attacks (TIA)
* Investigation of the correlation of clinical symptoms and lesion site as well as of changes in cortical plasticity in patients with solitary thalamus infarct
* Brain plasticity and motor learning in cases of a purely cortical infarct
* Characterization of gender specific damage patterns in stroke
* Morphologic and pathophysiological typing of the cryptic and cardial embolic infarct in correlation to incidence of arrhythmia
* Characterization of localization and morphology of infarcts in patients presenting in the emergency ward with central vestibular nerve syndrome / recording frequency of cerebral sessions in patients presenting with a primary diagnosis of central vestibular nerve lesion
* Clinical characterization of cerebellar and brain stem infarcts which are accompanied by vertigo symptoms and their correlation to infarct location

Eligibility Criteria:
Inclusion Criteria:

* Suspected stroke or TIA within 24 hours from symptom onset

Exclusion Criteria:

* MRI contraindication
Efficacy Study of Zinc Supplementation on Anemia, Oxidative Stress and Inflammation in Hemodialysis Patients

The purpose of the study is to evaluate the effect of Zinc supplementation on health status of hemodialysis patients through measurement of the following before and after Zinc administration: Inflammatory markers, Oxidative stress markers and Anemia markers. Also, Evaluation of quality of life of hemodialysis patients before and after Zinc administration using Fatigue severity scale questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Under regular hemodialysis for at least 6 months.
* Clinically stable condition as outpatients.
* Zinc-deficient patients (plasma Zinc concentrations less than 80 mcg/dl).

Exclusion Criteria:

* Patients taking any antioxidant supplements including vitamin E, Omega-3 fatty acids, green tea preparations or immunosuppressive medications within 2 months prior to enrollment in the study.
* Patients receiving Al hydroxide phosphate binders.
* Hospitalization in the previous month before the onset of the trial, or having active infection.
* Patients with malabsorption diseases (e.g, Crohn's disease), liver diseases, cancers, mental retardation, dementia or psychiatric illness.
Nimotuzumab in Combination With Chemoradiation for Esophageal Cancer

Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The phase I study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemo-radiotherapy in patients with locally advanced esophageal cancer tumours.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent form signed before performing any of the study's specific procedures.
* ECOG performance status 0-2.
* Age \> 18 and \< 75.
* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan and MRI or greater than or equal to 2 cm by other ordinary radiographic technique.
* Histologically confirmed diagnosis of locally advanced esophageal.
* Life expectancy of more than 3 months.
* Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.
* No serious blood producing,abnormal function of heart,lung, liver, or kidney or immuno-deficiency
* Neutrophils ≥3×109/L, platelet count≥100×109/L and haemoglobin≥9g/dL ,Creatinine ≤ 1.5 x NUL

Exclusion Criteria:

* Previous radiotherapy or chemotherapy
* Pregnant or breast-feeding women
* Drug abuse, unhealthy drug/alcohol addiction,or virus (HIV) infection
* Evidence of distant metastasis
* Participation in other clinical trials
* Patients with aphthosis, complete obstruction, fistula or deep peptic ulcer in the esophagus, or haematemesis
* Uncontrolled psychiatric disease or seizure
* Patients not fit for the clinical trial judged by the investigators
Effect of Vitamin D Deficiency and Vitamin D Supplementation on Glucose Metabolism

This study was intended to evaluate the effect of vitamin D supplementation on insulin sensitivity and pancreatic islet beta-cell function. Our hypothesis was that vitamin D supplementation to normal levels in patients with impaired fasting glucose will result in improved insulin sensitivity and improved beta cell function.

A modified frequently sampled intravenous glucose tolerance (mFSIGT) test was used. On day 0, baseline 22 time point mFSIGT was performed. Subjects were then treated with cholecalciferol (vitamin D3) supplementation - 10,000 IU/day - for 28 consecutive days. mFSIGT was then repeated measuring glucose, insulin and c-peptide at all time points. 25-OH vitamin D, PTH, and calcium were also measured at time point 0 pre and post vitamin D supplementation. Data was analyzed using the Bergman/Boston minimal model for insulin homeostasis with MinMod Millennium software.

Eligibility Criteria:
Inclusion Criteria:

* Impaired fasting glucose
* Adult, age between 18 and 65
* Serum vitamin D level below 30 ng/mL

Exclusion Criteria:

* History of nephrolithiasis
* Any medications that can effect insulin sensitivity or beta cell function (i.e. antipsychotics, metformin)
* Pregnancy
* Liver disease
* Renal disease
Effects of tDCS on Maximal Isometric Strength and Endurance Test of Trunk Extensors.

Improving trunk muscle strength and endurance is one of the many goals to be achieved in rehabilitation protocols for a variety of health conditions. Cerebral electrical stimulations techniques, such as transcranial direct current stimulation (tDCS) can modulate motor brain areas involved in motor functions. However, their effects on trunk function are lacking.

This study aims to investigate the effects of transcranial direct current stimulation (tDCS) on trunk muscle strength and endurance in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with no complaints of pain, discomfort in the musculoskeletal system.

Exclusion Criteria:

* Musculoskeletal or neurological disorder
* Under medication
The Effect of Ice, Green Tea and Arnica Montana Application on Post-Operative Intubation Related Sore Throat and Hoarseness

The study was planned to determine the effect of arnica montana, green tea mouthwash and ice particles impregnation on postoperative sore throat and hoarseness.

Research Hypotheses Hl: Gargling with green tea after surgery reduces sore throat. H2: Impregnation of postoperative ice particles reduces sore throat. H3: Post-operative gargling with arnico montana reduces sore throat. H4: Gargling with green tea after surgery reduces hoarseness. H5: Impregnation of postoperative ice particles reduces hoarseness. H6: Postoperative mouthwash with arnico montana reduces hoarseness.

Research Question

1. Do ice particles impregnation, gargling with green tea and gargling with arnico montana reduce intubation-related sore throat in patients undergoing general anesthesia?
2. Do ice particles impregnation, gargling with green tea and gargling with arnico montana reduce hoarseness due to intubation in patients undergoing general anesthesia?

Eligibility Criteria:
Inclusion Criteria:

* To agree to participate in the research,
* To be 18 years or older,
* To know how to read and write,
* No hearing problem,
* Not having difficulty in understanding,
* To live before the operation,
* Having experience before surgery,
* The duration of the operation is 30 minutes or more,7
* No nasogastric catheter

Exclusion Criteria:

* Having a sore throat before surgery,
* Having hoarseness before surgery,
* To have oral and neck surgery,
* Having a history of allergy,
* Having a nasogastric catheter,
* The duration of the operation is less than 30 minutes,
A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis

A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have an established diagnosis of UC for ≥3 months
* Have confirmed diagnosis of moderately for severely active UC
* Have current bowel urgency
* Have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic/Janus Kinase (JAK) inhibitor/sphingosine-1-phosphate (S1P) receptor modulator therapy for UC.

Exclusion Criteria:

* Have Crohn's disease (CD)
* Have inflammatory bowel disease-unclassified, formerly known as indeterminate colitis, or
* Have ulcerative proctitis, disease limited to the rectum, that is, distal to the recto-sigmoid junction, which lies approximately 10 to 15 centimeter (cm) from anal verge.
* Have an inherited immunodeficiency syndrome or a monogenic cause of UC-like colonic inflammation
* Have any history or current evidence of cancer of the gastrointestinal tract
* Have active tuberculosis
* Have HIV infection.
Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID

A proof of concept (POC) study will be conducted in 44 volunteers that have been fully vaccinated against hepatitis B in the past (at least 5 years ago) to assess the safety and immunogenicity of intradermal vaccination with hepatitis B surface vaccine antigen using a newly developed intradermal injection device VAX-ID, compared to intramuscular and intradermal (Mantoux technique) injection.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults, checked anamnestically (based on medical history) at entry of the study
* 18-35 years
* vaccination status: fully vaccinated against hepatitis B at least 5 years ago, with proof of vaccine response (to avoid non-response among the subjects). Subjects has to ask for a document of this proof at the service occupational medicine of the University of Antwerp.
* capable of understanding, reading and writing Dutch

Exclusion Criteria:

* other vaccination(s) 4 weeks before study onset
* pregnancy and lactation (women will be questioned during anamnesis)
* plan to have other vaccination during the study period
Prospective Collection of Biological Data of Prognostic Relevance in Patients With B-Cell Chronic Lymphocytic Leukemia

The purpose of the present study is to develop a biological prognostic index in patients with Binet stage A Chronic Lymphocytic Leukemia (CLL) who do not necessitate therapy according to NCI guidelines and to prospectively validate the proposed score system based on the absence/presence of 1, 2 or 3 unfavorable prognostic markers such as cluster of differentiation 38 (CD38) expression, Zap-70 expression and immunoglobulin heavy chain variable region (IgVH) configuration.

Clinical data including information on disease localization and laboratory parameters will be collected at study entry, during follow up and at disease progression (or after 36 months after registration) Biological markers will be evaluated at centralized laboratory, at study entry and at time of disease progression (or after 24 months of follow-up for non progressed patients) Using the scoring system, patients can be separated into 3 risk groups: low-risk (score 0), intermediate-risk (score 1) and high-risk (score 2-3), with significantly different clinical courses.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of B-CLL by NCI criteria, performed by local haematologist. (Diagnosis will be confirmed by the biological review committee according to flow cytometry analysis (positive clusters of differentiation antigen 5 (CD5), 19 (CD19),23 (CD23)).
* Age \> 18 years and \< 70 years.
* Eastern Cooperative Oncology Group (ECOG)\<=2.
* Binet stage A.
* Diagnosis performed within 12 months before inclusion in the study.
* Patients who do not necessitate therapy by NCI guidelines (watch and wait policy).
* Shipment of peripheral blood sample to centralized laboratory for biological assessment.
* Clinical data including baseline information on disease localization and laboratory parameters at staging and assurance of follow up updating for at least 3 years are requested.
* Written informed consent.

Exclusion Criteria:

* Patients with CLL whose diagnosis exceed 12 months before registration.
* Patients with leukemic phase of lymphoproliferative disorders of B origin CD5- and/or CD23- according to flow cytometry analysis.
* Clinical Binet stage B or C.
* Patients who necessitate therapy according to NCI guide-lines (no watch and wait policy).
* Age \> 70 years.
* Without a written informed consent.
Evaluation of a Preoperative Education in Total Knee Arthroplasty

The benefit of preoperative rehabilitation treatment combining physiotherapy and targeted education for patient undergoing Total Knee replacement (TKR) is now well known. Thus, there is lack of validated booklet containing evidence based informations.

Our aim is to assess the impact of an evidence based education pre-operative booklet on patient's knowledge and beliefs. The secondary objectives are to assess the impact of the booklet on patient's satisfaction on the information received, the length of stay in orthopedic surgery and the transfer rate to rehabilitation wards.

To show a difference of 2 points on the knowledge score (range 0-10) between the two groups, with a = 0.05 and a power of 90%, we considered that 44 patients are needed. The evaluations will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge and beliefs scores at each visit and on a satisfaction score on the last one. Quantitative data will be compared between groups by the Kruskal-Wallis and qualitative parameters via Fisher exact test.

The study protocol was approved by the local Ethic Committee.

The benefit of preoperative rehabilitation treatment combining physiotherapy and targeted education for patient undergoing Total Knee replacement (TKR) is now well known. Thus, there is lack of validated booklet containing evidence based informations.

Our aim is to assess the impact of an evidence based education pre-operative booklet on patient's knowledge and beliefs. The secondary objectives are to assess the impact of the booklet on patient's satisfaction on the information received, the length of stay in orthopedic surgery and the transfer rate to rehabilitation wards.

To show a difference of 2 points on the knowledge score (range 0-10) between the two groups, with a = 0.05 and a power of 90%, we considered that 44 patients are needed. The evaluations will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge and beliefs scores at each visit and on a satisfaction score on the last one. Quantitative data will be compared between groups by the Kruskal-Wallis and qualitative parameters via Fisher exact test.

The study protocol was approved by the local Ethic Committee.

Eligibility Criteria:
Inclusion Criteria:

* Age ranging from 55 to 75 Planned total knee arthroplasty

Exclusion Criteria:

* Age under 55 or above 75 Patients institutionalized Patients who have received a total knee arthroplasty of the ipsilateral knee Patient not affiliated to a social security scheme (beneficiary or assignee) Patients with chronic inflammatory rheumatism Cognitive and behavioral issues Disorders of understanding and expression of the French language TKR on complex knee