cyrilzakka/clinical-trials huggingface dataset:
Testosterone Replacement Therapy in Advanced Chronic Kidney Disease

Muscle wasting is common in advanced chronic kidney disease (CKD) and adversely affects morbidity and mortality. In 2/3 of males with advanced CKD serum testosterone (TT) levels are reduced, and likely contributes to the wasting. As TT in relatively safe physiologic replacement doses, increases muscle mass in otherwise normal TT deficient subjects, we hypothesize that physiologic TT replacement will be effective in preventing and treating the loss of muscle mass and function in CKD patients, will improve quality of life and may reduce some cardiovascular disease (CVD) risk factors.

All subjects will undergo baseline testing that will consist of functional capacity tests, blood tests and muscle biopsies (described in detail below). Subjects will then receive testosterone gel which will be applied daily to the skin of the abdomen or thighs every morning at the same time for 16 weeks. Two days after the hormone treatment is started, the blood testosterone (TT) level will be measured 6 hours after administration. Our goal will be the attainment of serum total TT levels in the mid- to upper normal young adult range. If the serum TT is not at goal, the dose of gel will be increased or decreased repeat testing will be performed within one week. All subjects will be tested for serum TT levels every 4 weeks to assure that the serum total TT remains at goal level. Measurements will be repeated at 8 and 16 weeks.

Eligibility Criteria:
Inclusion Criteria: Inclusion criteria: CKD subjects; males with calculated GFR (MRDR equation) between 15 and 40 ml/min/1.73m2 and stable or slowly progressive renal failure (decline in function of \<1ml/min/month) including those patients requiring hemodialysis and serum testosterone levels of \<300 ng/ml and capable of safely performing required exercise testing and serum testosterone levels of \<300ng/ml and capable of safely performing required exercise testing.

Exclusion Criteria: Exclusion criteria: applicable to both CKD and control subjects. Any unstable chronic medical condition, previous kidney transplant. Uncontrolled diabetes mellitus, active vasculitis, active autoimmune disease, malignancy(\<5 yrs), obesity (BMI \> 35), alcoholism or other recreational drug use, active heart disease, angina, uncontrolled arrhythmias or myocardial infarct within past 3 months, peripheral vascular disease with claudication, active lung, liver or GI disease, sleep apnea, medically unstable subjects and subjects who received anabolic, catabolic or cytotoxic medications during the prior 3 months. History of prostate CA, PSA \>4g/ml, or advanced BPH (AUA symptom score \> 21) and abnormal prostate on digital rectal examination. Bone or joint abnormalities that would preclude exercise testing.
Clinical Evaluation of the Aptima® Combo 2® Assay Using the Panther® System in Female Urine Samples

The objective of this study is to evaluate the performance characteristics of the AC2 assay on the Panther system using female urine specimens.


Eligibility Criteria:
Inclusion Criteria:

* The subject is ≥14 years of age at the time of enrollment and is currently sexually active (eg, has had penile/vaginal intercourse within the past 6 months).
* For subjects under 18 years old, assent of the subject and/or parental/legal guardian permission has been obtained if required by the institutional review board (IRB).
* The subject and/or legally authorized representative is willing and able to undergo the informed consent process prior to study participation, and:
* reports symptoms consistent with a suspected STI (eg, abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort); or
* is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI; or
* is asymptomatic and undergoing screening evaluation for possible STIs; or
* is asymptomatic and undergoing a routine pelvic examination.

Exclusion Criteria:

* The subject took antibiotic medications within the last 21 days prior to collection.
* The subject already participated in the study.
* The subject has a history of illness that the PI or designee considers could interfere with or affect the conduct, results, and/or completion of the study.
Curcumin Biomarker Trial in Head and Neck Cancer

There is considerable evidence that turmeric consumption may have a protective effect against cancer progression. The purpose of this study is to examine the short-term effects of supplementation with a turmeric extract, Curcumin C3 Complex®, on biomarkers of head and neck squamous cell carcinoma (HNSCC).

This is an open label, exploratory biomarker trial of the food substances Curcumin C3 Complex® in subjects with newly diagnosed HNSCC. Curcumin, a novel safe nutritional interventional agent has exciting potential usage as a preventive/adjuvant agent, and prevents tumor formation by inhibiting an important molecular pathway that is shown to cause cancer progression, which we will test as a tumor marker in this clinical trial.

The primary objective is to evaluate biomarker response of HNSCC patients to the food substances Curcumin C3 Complex®. This will be done by comparing post-intervention values to baseline values. In addition, we will determine the levels of curcumin and its metabolites in tumor and adjacent tissue.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with newly diagnosed head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx and have at least one accessible tumor
* Subjects willing to undergo tumor biopsies
* Subjects willing to refrain from nonsteroidal anti-inflammatory drugs (NSAIDS)
* Eastern Co-operative Oncology Group (ECOG) status of 0-3
* Absolute Neutrophil Count ≥ 1500/mm³, Hgb ≥ 10g/dl and Platelet count ≥ 150,000 mm3
* Adequate Renal Function: serum creatinine ≤ 1.5 × upper limit of normal (ULN). Adequate hepatic function: total bilirubin ≤ 1.5 × ULN, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.0 × ULN
* Signed and dated institutional review board approved informed consent form before any protocol specific procedures are performed
* Willingness of subjects who are not surgically sterile or postmenopausal to use reliable methods of birth control for the duration of the study and for 2 weeks after last dose of study drug
* No consumption of curcumin-rich foods to subject's knowledge within the previous 48 hours
* Age ≥ 18 years to ≤ 90 years

Exclusion Criteria:

* Subjects receiving anticoagulation therapy
* Known hypersensitivity to curry or black pepper
* Prior cancer therapy in the last 30 day
* Concurrent chemotherapy or radiation
* Severely immunocompromised subjects
* Subjects known to be HIV positive
* any major illness that, in the investigator's judgment, will substantially increase the risk asociated with the subject's participation in the study
* Pregnant or nursing women
* Unwillingness or inability to comply with required study visits and procedures in this protocol
A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches

To study the effect of Rozerem, a high affinity MT1 and MT2, low affinity 5-HT2B receptor agonist used for insomnia, as a migraine prophylactic agent.

In a recent, large study of migraineurs, over half reported difficulties with sleep initiation or maintenance. Those who had shorter average sleep times reported more severe headaches. Poor sleep has been associated with increased frequency and severity of migraines. The improvement of migraine frequency with improved sleep hygiene has been documented.

PET imaging has shown increased regional cerebral blood flow to neural structures involved in the sleep wake cycle during migraine headaches. Polysomnography has shown specific headache types to occur in specific sleep stages.

Melatonin has been effective primarily in headache due to delayed sleep phase syndrome. Recent studies support the efficacy of melatonin in treating migraine. The purpose of this study is to examine the efficacy of Rozerem as a prophylactic migraine medication. If effective, the benefits of the drug as a prophylactic agent for migraine include the tolerability of the drug and the possible secondary benefit of improvement in sleep.

Hypothesis: Rozerem will decrease migraine frequency due to the improvement in sleep and possibly due to the shared neurophysiology of sleep and migraine affected by melatonin.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* 3-8 Migraine headaches/month
* Able to understand and comply with the study

Exclusion Criteria:

* Currently on migraine prophylaxis
* Currently on sleep medication \> 4days/month
* Currently on Fluvoxamine
* Untreated psychiatric or sleep disorders
* MRI abnormalities other than those attributable to migraine headaches
* Abnormalities on neurological exam other than known neurological disorders unassociated with migraine or sleep
* Known disorders of prolactin
* Bipolar disorder
* Hepatic disease
* Pregnancy
Effect of Addition of Steroids on Duration of Analgesia

The purpose of the study is to investigate the differences in post-procedural pain scores and narcotic use among patients who receive a Superior Hypogastric Nerve Block (SHNB) with and without corticosteroid performed as part of the Uterine Artery Embolization (UAE) procedure.

Investigators will enroll a total of 28 women undergoing the UAE procedure with 14 subjects in each study arm. This investigation is a single blind randomized control trial investigating the post-procedural analgesic effect of adding a corticosteroid (Triamcinolone) as an adjuvant to a SHNB that contains bupivacaine for patients undergoing UAE, compared to patients undergoing nerve block for pain control following UAE with local anesthetic only. Before and after the procedure, patients will be asked to complete online surveys in order to record their pain score (measured on the Visual Analog Pain Scale), opioid and other pain medication use, and other symptoms, such as nausea.

Eligibility Criteria:
Inclusion Criteria:

* females
* aged between 30 and 60 years
* diagnosed with symptomatic uterine fibroids and/or adenomyosis and scheduled to undergo UAE procedure

Exclusion Criteria:

* Contraindications to UAE
* SHNB is deemed unsafe for the patient
* Allergies to local anesthetic or steroid agent
* History of inflammatory bowel disease or ulcerative colitis
* Uncorrectable abnormal coagulation profile
* Diabetes mellitus
Femtosecond Laser-assisted Astigmatism Treatment

The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure including arcuate incisions (AI) correcting astigmatism, also referred to as arcuate keratotomy (AK). The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery and additionally perform arcuate keratotomy in individuals with more than 1.0 Diopter (dpt) of astigmatism. Cataract surgery will be performed in subjects who have signed an informed consent form.

Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: postoperative refraction, visual acuity, slitlamp examination, and corneal topography


Eligibility Criteria:
Inclusion Criteria:

* Age-related cataract necessitating lens extraction and posterior IOL implantation
* Regular corneal astigmatism between 1.0 and 2.5 DPT
* Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)

Exclusion Criteria:

* Corneal abnormality
* Preceding ocular surgery or trauma
* Uncontrolled glaucoma
* Proliferative diabetic retinopathy
* Iris neovascularization
* History of uveitis/iritis
* Microphthalmus
* Recurrent intraocular inflammation of unknown etiology
* Blind fellow eye
* Uncontrolled systemic or ocular disease
Influence of Culture Media on Clinical Outcomes in Poor Responders or Severe Male Infertility

In this study the suitability of two -sequential and single step- commercially available culture media from the same brand was compared. The aim of such study is to verify whether is possible to improve the efficiency of infertility treatments in those couples who usually have a high cycle cancellation rate, such as poor responder patients and severe male infertility. The study population is composed of couples attending the fertility clinic: to this purpose all those couples approaching IVF treatments with a diagnosis of OAT, cryptozoospermia, advanced maternal age and women with a "poor responder" diagnosis were recruited. IVF treatments were randomly set to be cultured either with two-step sequential media or with one-step media to acquire data concerning the ongoing embryo culture development and clinical outcomes.

The final goal in the field of Assisted Reproductive Technology is to obtain a single healthy newborn. For that purpose, a lot of factors are strictly interconnected each other's and have to be carefully evaluated. The choice of embryo culture system and of embryo selection strategy plays a crucial role in obtain and identify the embryo with the highest implantation potential. One really important key factor is the choice of the culture media. Currently, there are numerous commercially available culture media showing very different compositions. Essentially two strategies have been applied for the design of culture media: 1) "Back to nature" for sequential media, based on the physiology of the embryo and the measured concentration of substances present in its natural environment and 2) "Let the embryo choose" for single step media, where none a priori assumption of the concentration of a component is made. In the literature, there are a lot of studies analyzing the effect of culture media on human preimplantation embryos development and comparing biological and clinical outcomes among different media compositions. Several studies performed a comparison about the development of human zygotes in either a one-step or two-step culture system. Usually there were no significant differences between the two culture media systems regarding biological or clinical outcomes. Anyway, a greater number of blastocysts were generally obtained by the continuous single medium culture if compared with sequential culture media, even if the implantation and clinical pregnancy rates are comparable.

Eligibility Criteria:
Inclusion Criteria:

* advanced maternal age,
* poor responder women (\<=4 oocytes),
* cryptozoospermia,
* testicular retrieval of spermatozoa

Exclusion Criteria:

* any other
Management of Patients With Hepatitis C in a Public Health Care Setting: The Punjab Model

Background and Aims: The prevalence of hepatitis C virus infection (HCV) infection in Punjab, India is 3.29%, with an estimated burden of around 650,000 viremic chronic HCV (CHC) patients. The Mukh Mantri Punjab Hepatitis C Relief Fund (MMPHCRF) was launched in June 2016 to provide free treatment to all CHC aiming to eliminate HCV from Punjab. The study assessed the feasibility of decentralized care and efficacy and safety of 12 or 24 weeks of sofosbuvir (SOF) + ledipasvir (LDV) or SOF + daclatasvir (DCV) ± ribavirin (RBV) in the treatment of CHC patients in a public health care setting.

An algorithm was developed using SOF-based regimens to treat all patients (RKD). Genotyping is not recommended for patients without cirrhosis of liver and they are being treated with SOF+DCV for 12-weeks, while genotyping is recommended for patients with cirrhosis of liver (Figure 1). Patients with liver cirrhosis and genotype 3 are being treated with SOF+DCV+RBV for 24 weeks, while non-genotype 3 patients are being treated with SOF+LDV+RBV for 12-weeks or with SOF+LDV for 24-weeks (in RBV intolerant patients). SVR-12 is mandatory in all patients. Methods: Decentralized care: All patients are being evaluated and treated at 3 Government Medical Colleges and 22 District Hospitals; they were followed up to 12 weeks post-treatment to look for sustained viral response (SVR-12). Health care worker capacity building: 90 medical specialists were trained in a 4-hr predefined course, followed by online continued medical education sessions by regular Extension for Community Healthcare Outcomes (ECHO) Clinic are being conducted fortnightly. 50 pharmacists, 2 from each of the 25 centres, dispense medicine as per specialist prescription. Data Management: 25 trained data entry operators and Clinton Health Access Initiative (CHAI) are managing epidemiological data on CHC hotspots, high-risk groups, local service providers, etc. Monitoring: Medical alerts are being used for compliance monitoring. Study design: A cost-effective algorithm has been developed using SOF-based regimens to treat all patients. The diagnosis of cirrhosis is based on clinical evidence including Aspartate Transaminase (AST)-to-platelet ratio index (APRI ≥ 2.0) and FIB-4 score (\>3.25) or on liver stiffness measurement (LSM) ≥12.5 kilopascal (kPa) on fibroscan. The study aims to validate the efficacy and safety of generic all oral Direct Acting Antiviral (DAA) regimens in a decentralized algorithm based public health model in Punjab, India regardless of genotype/presence of cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Hepatitis C
* Age: \>18 years

Exclusion Criteria:

* Chronic liver disease of a non-HCV etiology
* Serum Creatinine \>1.5 mg/dl
* Evidence of hepatocellular carcinoma or other malignancy
* Significant cardiovascular, pulmonary, or neurological disease
* History of solid organ or bone marrow transplantation.
Immunogenicity and Persistence of Hepatitis B Vaccination in HIV-Infected Patients

At present, HIV-Infected Patients of Hepatitis B Vaccination in are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal.

This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in HIV-Infected Patients

Participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis B vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis B vaccine group at months 0, 1, 2, and 6. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) at enrollment
* Sign informed consent, willing to participate in this study

Exclusion Criteria:

* Being pregnant
* Intolerance or allergy to any component of the vaccine
* Any vaccination during the month preceding enrollment
* CD4 cell count ≤ 200 cells/µL
* Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
* The use of immunosuppressive agents in patients with nearly three months
Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi

This is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ) (IPT-SPAQ). Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, anemia, cognitive function and educational testing, as well as infection prevalence and disease incidence in young children sleeping student's households to assess the impact on transmission.

Students attending primary school in rural Blantyre District, Malawi will be offered enrollment in this study. The intervention will be conducted every 6-weeks during the school terms which coincide with peak malaria transmission. Students in the IPT-DP arm will be treated with with dihydroartemisinin-piperaquine (DP) (females less than 13 years old and all males) or chloroquine (females 13 years old or older). Students in the IPT-SPAQ arm will be treated with sulfadoxine-pyrimethamine plus amodiaquine (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older). Students in the all arms will receive routine malaria education.

Eligibility Criteria:
Student Inclusion Criteria:

* Currently enrolled in the study school
* Plan to attend the study school for the remainder of the school year
* Parent/guardian available to provide written informed consent

Student Exclusion Criteria:

* Current evidence of severe malaria or danger signs
* Known adverse reaction to the study drugs
* History of cardiac problems or fainting
* Taking medications known to prolong QT
* Family history of prolonged QT
* History of epilepsy or psoriasis
* Taking cotrimoxazole for long-term prophylaxis

Younger child Inclusion Criteria

* Slept in the household for most nights in the last month
* Age 6-59 months
* Parent/guardian available to provide written informed consent

Younger child Exclusion Criteria

- Current evidence of severe malaria or danger signs