cyrilzakka/clinical-trials huggingface dataset:
Pilot Study to Detect SARS-CoV-2 Virus in Sperm

This is a prospective study involving 50 patients, with acute SARS-CoV-2 infection and a positive RNA detection. Men will give semen, saliva, urine and blood specimens following RT-PCR diagnosis and 15, 30, 60 and 90 days after. SARS-CoV-2 RNA will be detected in seminal plasma, native semen cells and processed spermatozoa.

The purpose of this study is to seek the presence of SARS-CoV-2 in semen, to determine its localization and infectiousness and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa.

Since the end of 2019, an epidemic of SARS-CoV-2 infections (COVID-19) began in China and is now a global pandemic affecting more than 3 millions of people. Droplets and close contact are the most common routes of transmission of SARS-CoV-2 and aerosol transmission may be another route. Researchers have detected SARS-CoV-2 in samples of respiratory tract, saliva, stool, gastrointestinal tract, urine, tears and conjunctival secretions of COVID-19 patients.

Vertical transmission from mother to infant has been suspected, but not confirmed to date. Information about localization of SARS-CoV-2 in the genital tract or shedding is poorly documented and the results of these studies were discrepant. One of two studies have reported SARS-CoV-2 RNA in semen from six infected patients. However, there is no data on the duration of the seminal excretion of the virus, its viral load and infectiousness and on its localization in semen compartments (cells, seminal plasma, spermatozoa).

The purpose of this study is to seek the presence of SARS-CoV-2 in semen, to determine its localization and infectiousness and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa.

This is a prospective study involving 50 patients, with acute SARS-CoV-2 infection and a positive RNA detection. Men will give semen, saliva, urine and blood specimens following RT-PCR diagnosis and 15, 30, 60 and 90 days after. SARS-CoV-2 RNA will be detected in seminal plasma, native semen cells and processed spermatozoa.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 to 50, male.
* Patient in acute phase of infection with SARS-CoV-2 and whose RT-PCR shows the viral genome in the nasopharyngeal or salivary sample or in any other sample.
* Patient who can come to the laboratory for samples
* Patient having given his free and informed consent and having signed the consent
* Patient affiliated to a social security scheme or equivalent

Exclusion Criteria:

* Patient having previously consulted for male infertility or having previously carried out a semen examination which was abnormal (WHO standard)
* Patient with ejaculation disorder or unable to take a semen sample or with an abnormal semen volume (\<1.5 mL).
* Patient who would present serious clinical signs that would not allow him to travel to the investigating center to take samples.
* Patient under a protection regime for adults (including guardianship, curatorship or safeguard of justice.
Study of Urinary Angiotensinogen as a Marker to Warn the Deterioration of Renal Function in CKD Patients Early.

Chronic kidney disease (CKD) that results in end-stage renal disease (ESRD) is a major international health problem. Many clinical markers such as urine protein or eGFR(evaluated glomerular filtration rate),can estimate the renal function, but not sensitive. As well-known, the crucial role of angiotensin II (AngII), the major effector of the renin-angiotensin system (RAS), in the development of renal fibrosis that results in ESRD is widely recognized.Abundant researches find that intrarenal RAS takes an important role on the progression of CKD. At present, no clinical marker is available to evaluate intrarenal AngII activity because it is difficult to measure it directly in patients. So find and establish a bio-marker of local renal RAS activation maybe a breakthrough in early detection and treatment of CKD. Angiotensinogen(AGT) is the only known substrate for renin and the level of AGT in humans is close to Km value for renin. Thus , changes in AGT levels can control the activity of the RAS, and its up-regulation may lead to activity of Ang levels. Then we hypothesis that the AGT is a early bio-marker of local renal RAS activation as well as CKD.

1. Screening: Select CKD(3-4) patients from outpatients, Urine routine examination and Renal B-mode ultrasonography and so on.
2. Confirm: Sign consent with the patients who meet the inclusion criteria, then these patients are included in the study.
3. Create patients records and complete related-inspections.
4. Clinical follow-up: Follow-up once every six months, and we will record every patient's disease progress every time. Each follow-up, the patient needs to leave 5 ml blood samples and 20 ml of urine samples, used for the following study.
5. Detection, Observation and Evaluation: Patients are divided into two groups according to AGT levels: higher than the normal group and the normal group. Observe the changes in eGFR of different group. Statistics judge whether AGT can be as a early warning indicators of renal function decline.

Eligibility Criteria:
Inclusion Criteria:

* CKD, in the stage of 3 or 4, and kidney biopsy is preferred selection;
* Signed the informed consent;

Exclusion Criteria:

* Kidney cancer patients;
* Kidney transplantation;
* Hereditary kidney disease;
* Secondary renal disease(diabetic nephropathy and hypertensive nephropathy are excluded)
Immune Benefits of Consumption of Dairy Yogurt in Elderly

To investigate the impact of consuming dairy yogurt on immun function including natural killer (NK) cell activity, circulating levels of cytokines, and immunoglobulin (Ig) in elderly.

A randomized, open-labelled, placebo-controlled study was conducted on 200 nondiabetic, nonobese and elderly (≥60 years) subjects. Over a twelve-week period, the test group consumed one bottle (120 mL) of dairy yogurt each day, whereas the placebo group consumed same volume of low fat milk daily. NK cell activity (%) was measured based on the ratios of effector cells (E; peripheral blood mononuclear cells, PBMCs) from each participant to target cells (T; K562 cells) at E:T= 10:1, 5:1, 2.5:1, 1.25:1 or 0.625:1. In addition, cytokines and immunoglobulin levels measured using commercial kits as manufacturer's instruction.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* Over 60 years old without any health problems
* The levels of white blood cells within range 4x10\^3/μL\~10x10\^3/μL

Exclusion Criteria:

* Individuals who get a cold
* Diabetes
* Hypersensitivity or disease history for milk protein
* Epilepsy, neurological, or psychological disease
* Alcoholism or drug addiction
* Liver disease or severe kidney failure disease
* Inflammation-related disease
* Consumption of other test products or drugs within 1 month prior to screening
* Regular consumption of immune-related functional foods including yogurt or milk within 1 month prior to screening
* History of inflammation-related disease or taking medication to treat inflammation-related disease within 1 month prior to screening
* History of cancer within 5 years
* Any inappropriate condition
International Severe Asthma Registry: Canadian Cohort

The International Severe Asthma Registry is a global initiative looking to ensure that the care of people with severe asthma will continue to improve by collecting detailed information about the health and treatment of as many people with the disease as possible. The study will gather anonymized longitudinal real-life data for participants with severe asthma for five years. The purpose of the registry is to track the progress of participants and determine how well they are responding to treatment. Medical research using data from the registry will give the investigators a better understanding of severe asthma and help the investigators develop and improve the care and treatment for severe asthma participants. The Canadian cohort of the registry will collect information from Canadian participants with severe asthma across seven different sites.

Study staff will collect medical information through reviewing participant medical charts and interviewing participants about their health/asthma. The information collected includes birth date, gender, ethnicity, height/weight, body mass index, medical history (smoking history and exacerbation history), current and past asthma related medications, and any recent test results available pertaining to blood work, lung function, allergen skin prick, and imaging. This information will be collected at the baseline visit, and then once a year at a follow up visit, for five years (total of five visits).

Participants will be assigned a unique study number to protect the confidentiality of their personal health care information. All study data will be de-identified and then stored in a secure information management system, hosted at the study sponsor, Optimum Patient Care Global Limited in Cambridge, United Kingdom. Participant identities will always be kept confidential and will not be included in any research that is published. Data collected across the Canadian sites will be used to find ways to improve asthma treatments in Canada, to report on current patterns of managing severe asthma in Canada, to identify different sub-groups of severe asthma, and to carry out various medical research to understand asthma better and develop new treatments.

Research records and health or other source records may be inspected in the presence of the Principal Investigator or by representatives of the University of British Columbia's Clinical Research Ethics Board for the purpose of monitoring the research. No information or records that disclose participants' identities will be published without subject consent, nor will any information or records that disclose participants' identities be removed or released without subject consent unless required by law.

Eligibility Criteria:
Inclusion Criteria:

* Participants 18 years or older
* Participants receiving treatment according to GINA Step 5 or uncontrolled in GINA Step 4 (uncontrolled is defined as having severe asthma symptoms or frequent exacerbations)

Exclusion Criteria:

-Participants with mild to moderate asthma
Chronic Non-bacterial Osteomyelitis Treated With Pamidronate

In a randomized double blind placebo controlled trial to investigate the effect of pamidronate in treatment of chronic non bacterial osteomyelitis.

Main objective:

1. Reduction of the inflammatory activity in the bone lesions measured by whole body MRI after 36 weeks.
2. Healing of the inflammatory activity in the bone lesions measured by whole body MRI after 36 weeks.

Secondary objectives:

1. Changes in bone lesions in whole body MRI between baseline and week 12 and between week 12 and week 36
2. Changes in bone lesions of anterior chest-wall (adults) evaluated by CT scan between baseline and week 36.
3. Changes in patient self reported outcome measures
4. Changes in inflammatory markers and bone markers.

Chronic non-bacterial osteomyelitis is a multifocal inflammatory bone disorder. The pathogenesis is unknown. The disease is mainly diagnosed in childhood. There is a strong association with inflammatory disorders of the skin, mainly psoriasis. The disease is characterized by recurrent episodes of pain and disability. It is unclear if SAPHO syndrome (synovitis, acne, pustulosis, hyperostosis, osteitis) might be the adult version of chronic non-bacterial osteomyelitis. The disease can persist in adulthood and course chronic bone deformations.

Wholebody MRI is the most sensitive imaging for diagnosing and monitoring the non bacterial osteitis.

The treatment of chronic non-bacterial osteomyelitis is largely empiric. First line treatment is NSAID (Non Steroidal Anti-Inflammatory Drug). When NSAID is inadequate the bisphosphonate pamidronate has been described relief pain in small cohorts in retrospective studies.

In this research protocol, investigators seek to investigate if it is beneficial to use pamidronate in the treatment of chronic non bacterial osteomyelitis and the osteitis component in SAPHO syndrome. Primary outcome is whole body MRI. Secondary outcome is CT scan, patient measure reported outcome and biomarkers. A biobank may help us to understand the pathogenesis and future treatment targets of chronic non bacterial osteomyelitis.

Eligibility Criteria:
Inclusion Criteria:

* Age: 9-65 years (inclusive)
* Fulfilling the diagnostic criteria for chronic non bacterial osteomyelitis:

  1. Mono-, oligo- or multifocal inflammatory bone lesions (osteomyelitis, osteitis, osteosclerosis)
  2. Diagnostic score according to A. Jansson criteria (2009) \> 39 or malignancy and infection excluded by biopsy
  3. Symptoms \> 6 weeks
* Volunteer, signed written informed content

Exclusion Criteria:

* Age older than 65 years
* Age younger than 9 years
* Pregnant women or nursing (breastfeeding) mothers
* Hypersensitivity to pamidronate, bisphosphonate og additives in pamidronate
* Known history or current lymphoproliferative disease
* History of surgery on glandula thyroidea
* Known alcohol/medical abuse
* Poor dental status
* Low Vitamin D- status
* Liver/ kidney disease
* Abnormal laboratory screening for comorbidity
Infusional C-myb ASODN in Advanced Hematologic Malignancies

The purpose of this study is to evaluate whether C-myb Antisense (AS) Oligonucleotides (ODNs)is a possible treatment modality for advanced hematologic malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have one of the following: acute myeloid or lymphoid leukemia; or Myeloproliferative disorder(MPD) including Chronic Myelogenous Leukemia (CML); or Myelodysplastic Syndrome (MDS); or Non-Hodgkin's Lymphoma (including CLL); or Multiple Myeloma
* Patients with acute leukemia must meet one of the following conditions:

  \*have disease which is refractory to a course of standard induction chemotherapy \*have relapsed diseased after documentation of previous clinical remission or \*have untreated disease and not be a candidate for conventional first line treatment
* Patients with CML or other MPD must have evidence of accelerated phase or blast crisis
* Patients having clinical features of CML in transformation but who are negative for Philadelphia chromosome may be entered provided there is a prior definable chronic phase
* Patients with Philadelphia chromosome positive CML must have failed treated with Gleevec (Imatinib) in order to be eligible for study
* Patients with myelodysplastic syndrome (MDS) must have \> 5% blasts in the peripheral blood or bone marrow and have at diagnosis as IPSS score of \>= 1
* Patients with CLL must have relapsed or refractory disease after at least three courses of conventional therapy and have been determined to no longer be a candidate for conventional therapy
* Patients with non-Hodgkin's lymphoma (other than CLL) must have relapsed or refractory disease after at least two courses of chemotherapy and have been determined not to be a candidate for further conventional therapies
* Patients with multiple myeloma must have failed at least 3 prior therapies
* Performance Status 0, 1 or 2
* Serum creatinine \< 2.0 mg/dl; serum bilirubin \< 2 mg/dl and AST/ALT \< 3.0 x upper limit of normal
* PTT within normal range
* Age \> 18
* Patients must have an indwelling central venous catheter

Exclusion Criteria:

* Significant cardiac disease which requires active therapy
* Intercurrent organ damage or medical problems that will jeopardize outcome of therapy
* Pregnant or lactating females
* Received prior c-myb AS ODN therapy
* Patients with suitable HLA identical sibling donor who are deemed to be appropriate and willing candidates for allogeneic bone marrow transplantation
* Patients requiring anticoagulation with unfractionated heparin.
Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban

The study will address the impact of genetical variation of a protein involved in the intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.

The study will address the impact of genetical variation of a protein involved in the intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants
* Aged between 18-35 years inclusive
* Male
* Caucasian
* Body mass index (BMI) between 18 and 27 kg per m² inclusive.
A Coordinated Return to Work Program

The aim of the study is to investigate the possibility that a diagnostic evaluation by a multidisciplinary team reduces the length of sick leave.

Workers on sick leave due to back, neck or shoulder pain are randomized into 2 groups. Individuals in the intervention group are offered an extra multidisciplinary diagnostic evaluation. The multidisciplinary team consists of an occupational physician, a physiotherapist, a chiropractor, a psychologist and a social worker. The result is a coordinated evaluation of the individuals problems with suggestions as to further actions. The focus is on evaluating, if and when the individual can return to work. No treatment is given.

Verbatim exemption from the local medical ethics board:

"February 19, 2004 Journal no. VF 20040030 JK/csf Re: research project: A Coordinated Return to Work Program (KIA) The The Medical Ethics Committee of Vejle and Funen Counties has reviewed this research project at its meeting on February 9, 2004.

The entire committee decided that this project is an HTA (Health Technology Assessment) study and not a biomedical research project.

Therefore the committee decided that the project is not within the committee's legal competence areas, and is exempt from approval by a medical ethics committee before being carried out.

The committee has no further comments to this case. on behalf of the committee Sincerely Erik Laier Jette Krarup

__________________________________________________________________________________________________________________________________________________

Odense University Hospital direct telephone: +45 6541 3425 Kløvervaenget 10, 2.sal e-mail: Vejle-fynkomiteen@ouh.fyns-amt.dk 5000 Odense C fax: +45 6619 4392 Denmark"

Eligibility Criteria:
Inclusion Criteria:

* On sick leave due to back,
* Shoulder or neck pain

Exclusion Criteria:

* Pregnant,
* Other causes of sick leave
Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes

The aim of this study and the primary outcome is to clinically evaluate effect of laparoscopic duodenal-jejunal bypass on non-obese type 2 diabetes. Secondary outcomes will evaluate CCK, FFA, Cholesterol Ghrelin, C-peptide, and HbA1c levels. Patients will be followed closely to ensure the desired results are sustained in long term


Eligibility Criteria:
Inclusion Criteria:

* Adults age 20-65 years
* Clinical diagnosis of type II diabetes buy on of the following three criteria (American Diabetes Association)

  1. A normal or high C-peptide level (to exclude type 1 diabetes) (\>.9ng/ml)
  2. A random plasma glucose of 200mg/dl or more with typical symptom of diabetes
  3. A fasting plasma glucose of 126mg/dl or more on more than one occasion
* BMI 22-34 KG/m2
* Patients on oral hypoglycemic medications or insulin to control T2DM
* Inadequate control of diabetes as defined as HbA1c\>7.5
* No contraindication for surgery or General Anesthesia as determined by multidisciplinary surgical team
* Ability to understand and describe the mechanism of action of ricks and benefits of the operation

Exclusion Criteria:

* Patients who meet any of the following exclusion criteria will be exclusion criteria will be excluded from enrollment into the study
* Enrolled in another clinical study which involves and investigational drug
* Diagnosis type 1 diabetes
* Pregnancy (all female patients will have beta HCG) or planned pregnancy within 2 years of entry into the study or unwilling to use reliable contraceptive method
* Previous gastric or esophageal surgery
* Immunosuppressive drugs including corticosteroids
* Coagulopathy (INR\>1.5 or platelets\<50,000/ul)
* Anemia (Hgb\<10.0g/dl)
Glenohumeral Internal Rotation Deficit (GIRD)

A loss of mobility in the shoulder in direction of internal rotation is associated with shoulder tendon pathology. Cause-effect relationship between these two is still not clear. It is suspected that this loss of mobility reduces the size of the tunnel in which this shoulder tendon is lying, namely the subacromial space. Overhead athletes frequently show glenohumeral internal rotation deficit (GIRD) while being healthy and free of shoulder pain. This makes this population interesting to investigate. This study wants to look at shoulders of overhead athletes with GIRD and measure the size of the subacromial space. After this, the athletes will be instructed to perform a home stretching program and at the end the effect of this on mobility and the size of the subacromial space will be measured.60 athletes will be recruited and randomly allocated to the control group and the stretching group. Before they start stretching, subacromial space size will be measured by use of ultrasound. This is a safe and non-invasive measuring tool. Mobility will be measured by use of a digital inclinometer. This also is safe and non-invasive. Patients will be instructed a stretching exercise, which they will be performing at home once a day during 6 weeks. At the end all outcome measures will be reassessed.


Eligibility Criteria:
Inclusion Criteria:

* overhead athletes: at least 3 hours/week training
* male and female
* 18-30 years of age
* No shoulder pain during last 3 months for which a doctor was consulted
* No shoulder surgery
* No neck diseases

Exclusion Criteria:

-
TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB

Primary Objectives:

1) To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin.

Secondary Objectives:

1. To determine risk factors for abnormal pharmacokinetic parameters for isoniazid and rifabutin.
2. To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy.
3. To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy.
4. To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.

This study will seek to enroll every eligible patient enrolled in TBTC Study 23. Consenting patients will be asked to undergo measurements of isoniazid (if receiving), rifabutin and 25-OH desacetyl rifabutin levels at a time point in the study when steady state rifabutin levels are expected to have been achieved (at least two weeks following the start of rifabutin).

Eligibility Criteria:
Inclusion:

1. Patient enrolled in TBTC Study 23
2. Informed consent

Exclusion:

1. Severe anemia (Hct \<25%)