cyrilzakka/clinical-trials huggingface dataset:
Swiss Study of the Impact of Mayzent on SPMS Patients in a Long-term Non-interventional Study

This study is a national, prospective, multicenter, non-interventional (observational) study with the aim to describe the impact of Siponimod treatment in a real-world SPMS population in Switzerland who are treated with Siponimod as per Swiss label.

Primary data will be collected during an observational period of three years of Siponimod treatment. Additionally, medical history of participants will be collected including EDSS, MRI outcomes, relapses and previous medication to allow the estimation of Siponimod treatment effects on an individual basis. It is planned to include an optional blood draw for a later biomarker analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Adult patients with a documented diagnosis of SPMS with inflammatory disease activity who are going to be treated with Siponimod under routine medical care and in accordance with the Swiss label
3. Patient willing and able to complete the questionnaires

Exclusion Criteria:

1. Patients treated outside of the approved Swiss label for Siponimod
2. Prior treatment or already ongoing treatment with Siponimod
3. Use of investigational drugs during the study, OR within 3 months before enrollment, OR within 5 half-lives of investigational drug before enrollment, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer
4. Subjects who are not able to provide consent due to incapable judgement
ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects

This is a Phase 1, open-label, single center, non-randomized study to evaluate the absorption, distribution, metabolism and excretion (ADME) of an oral solution of radiolabeled Ibrexafungerp following repeat administration in healthy male subjects. All subjects will undergo preliminary screening procedures, will remain the clinical unit for approximately 26 days and will receive radiolabeled Ibrexafungerp, orally for 3 days.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males aged 30 to 65 years willing and able to sign and informed consent.

Exclusion Criteria:

* Clinically significant medical history or concurrent medical conditions included but not limited to infections, liver or kidney disease
* Use of certain concomitant medications
* History of smoking or alcohol abuse
Comparing Skills Acquisition on Different Laparoscopy Software

Simulation based training is a standard part of surgical training. Over the years virtual reality simulator have been more and more integrated into the surgical curriculum for surgical novices.

Evidence shows that practicing using proficiency-based training programs significantly reduces the operation time and complication rates for during intial operations for young doctors.

The aim of this trial is to examine if skills obtained on a newer software version is transferable to the original software.


Eligibility Criteria:
Inclusion Criteria:

* Medical students without any prior laparoscopy experience in both a clinical or simulated setting

Exclusion Criteria:

* Prior experience with simulation based laparoscopy or clinical experience with laparoscopy
Safety and Efficacy of Doravirine, Tenofovir, Lamivudine (MK-1439A) in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030)

The primary objectives of this study are to evaluate the antiretroviral activity and the safety/tolerability of open-label doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF; MK-1439A; DELSTRIGO™) consisting of a single fixed-dose combination (FDC) tablet of DOR/3TC/TDF 100 mg/300 mg/300 mg in treatment-naïve HIV-1 infected participants with select non-nucleoside reverse transcriptase inhibitor (NNRTI) transmitted resistance-associated mutations.

This study had a Base Study (Day 1 to Week 96) and an optional Study Extension (Week 96 to Week 192).

Eligibility Criteria:
Inclusion Criteria:

* Is HIV-1 positive within 45 days prior to the treatment phase of this study, and have HIV treatment indicated based on physician assessment.
* Is naïve to antiretroviral therapy (ART) including investigational antiretroviral agents.
* Prior to screening, have had a genotype performed confirming the presence of only one of the following NNRTI mutations: K103N, Y181C, or G190A.
* Is considered clinically stable with no signs or symptoms of active infection at time of entry into the study (i.e. clinical status and all chronic medications should be unchanged for at least 2 weeks prior to the start of treatment in this study).
* Is highly unlikely to become pregnant or to impregnate a partner

Exclusion Criteria:

* Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
* Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1, including, but not limited to, adefovir, tenofovir, entecavir, emtricitabine, or lamivudine.
* Has documented or known resistance to study drugs (doravirine, lamivudine, and/or tenofovir)
* Has participated or anticipates participating in a study with an investigational compound/device within 30 days prior to signing informed consent
* Has any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other immunosuppressant drugs during the course of the trial.
* Requires or anticipates requiring any of the prohibited medications
* Has significant hypersensitivity or other contraindication to any of the components of the study drug
* Has a current (active) diagnosis of acute hepatitis due to any cause
* Has evidence of decompensated liver disease or has liver cirrhosis and a Child-Pugh Class C score or Pugh-Turcotte (CPT) score \> 9
* Is pregnant, breastfeeding, or expecting to conceive
* Is female and expecting to donate eggs, or is male and is expecting to donate sperm at any time during the study
Incidence of Oral Candidiasis, Prevalence of C. Dubliniensis in HIV Patients and In-vitro Azole Susceptibility

C. dubliniensis has been identified as pathogen in Oropharyngeal Candidiasis(OPC)particularly among HIV patients. Azole therapy is a cornerstone in OPC, but resistance within C. dubliniensis isolates to diflucan is common.This is a prospective collection of biological specimens from oropharyngeal cavity with the purpose of determining the prevalence of C. dubliniensis in HIV/AIDS patients at the Duval County Department of Health Comprehensive care Center. It is hereto proposed an estimation of azole-resistance in these isolates.

This is a study to try to establish the prevalence of C. dubliniensis as a causative organism of OPC in HIV and/or AIDS patients. We will aim to establish the resistance pattern for azoles but also for Flucytosine and amphotericin of these isolates.

This study will serve as a support to previously published articles that have suggested intrinsic azole-resistance within this particular species of candida and we will try to postulate its possible correlation with clinical failure.

Eligibility Criteria:
Inclusion Criteria:

* Any patient 18 years old or older with a documented diagnosis of HIV infection with or without AIDS-defining illnesses at the time of assessment, who is presenting with clinical symptoms and physical findings compatible with oropharyngeal candidiasis (as defined by the IDSA Guidelines for the Treatment and Management of HIV and HIV- related complications.

Exclusion Criteria:

* Any prior diagnosis or established treatment for oropharyngeal, mucocutaneous or esophageal candidiasis documented in the patient's chart or any proven diagnosis based on reviews of physically available medical records and or history provided by patients that can be subject to later confirmation pertaining to the use of parenteral antifungals within 6 months prior to enrollment (azoles, echinocandins, amphotericin B, Flucytosine, etc).
Effect of Magnesium Supplementation on Polycystic Ovary Syndrome

This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the sample size calculated 70 persons (35 persons for control group and 35 persons for patient group). Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 8 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including sex hormone levels, metabolic and inflammatory profiles will be measured at the beginning and end of the study as well as anthropetric measurements.


Eligibility Criteria:
Inclusion Criteria:

* Having PCOS according to the Rotterdam criteria,
* Age between 20-45 years,
* Lack of pregnancy and lactation,
* Not having certain regime during last 3 months,
* Non-smoking,
* Not having diseases, including: diabetes, cardiovascular , hepatic, renal and thyroid,
* Not taking supplements,
* Being overweight (Kg / m 25 ≤ BMI)

Exclusion Criteria:

* Hormone Therapy,
* Pregnancy and lactation during the study,
* Severe weight loss (more than 2.5 kg per month) during the study
Myocardial Protection With Adenosine During Primary Percutaneous Coronary Intervention in Pts With STEMI

OBJECTIVE: to evaluate the safety and efficacy of a brief intracoronary infusion of ADO applied at the time of reperfusion to limit infarct size and LV remodelling in patients with ACSST submitted to primary ACTP.

DESIGN: Multicentric, prospective, randomised, parallel, placebo-controlled double-blind study.

PATIENTS: 200 patients older than 18 with ACSST and without prior myocardial infarction receiving primary PTCA within 6 hours after symptom onset.

The main mechanism responsible for the sanitary impact of ischemic heart disease is cardiomyocyte cell death associated to acute coronary syndrome with ST segment elevation (ACSST). In most of these patients, performing PTCA or thrombolysis as soon as possible does not prevent the occurrence of myocardial necrosis involving a substantial portion of the area at risk. Intracoronary adenosine (ADO) at the time of reperfusion limits infarct size in animals, and preliminary clinical studies indicate that may be also protective in patients with ACSST receiving early reperfusion therapy. OBJECTIVE: to evaluate the safety and efficacy of a brief intracoronary infusion of ADO applied at the time of reperfusion to limit infarct size and LV remodelling in patients with ACSST submitted to primary ACTP. DESIGN: Multicentric, prospective, randomised, parallel, placebo-controlled double-blind study. PATIENTS: 200 patients older than 18 with ACSST and without prior myocardial infarction receiving primary PTCA within 6 hours after symptom onset. PROTOCOL: Intracoronary ADO (4mg) or placebo (saline) infusion distal to the culprit lesion immediately before stent deployment, NMR between 6 and 14 days and after 6 months. END-POINTS: Major: infarct size as measured by NMR, Secondary: changes in LV volumes and EF, and major cardiac events during the follow-up.

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years.
* patients with acute coronary syndrome with ST segment elevation within six hours of the onset of symptoms.

Exclusion Criteria:

* patients younger than 18 years and pregnant women.
* patients with previous transmural infarction.
* patients with clinical evidence of bronchospastic lung disease or prior bronchodilator therapy.
* patients with pacemakers.
* patients with TIMI flow higher than 1 and lower than 3.
Achilles Tendon Rupture - Intervention With Electrical Stimulation

Acute Achilles tendon rupture (ATR) is an injury that is commonly associated with complications, such as blood clotting, muscle loss and tendon lengthening, all of which affect the long-term outcome and return to sports. These complication are related to the treatment of ATR with lower leg immobilization in a boot.

The investigators aim to demonstrate that an intervention with calf neuromuscular electrical stimulation (C-NMES) during leg immobilization after ATR can 1) reduce blood clots, 2) lower the degree of muscle loss, 3) decrease tendon lengthening and 4) improve long-term outcome.

The participants will be divided by chance into two separate groups that compare standard treatment (control group) with C-NMES in addition to standard treatment (intervention group).

A total of 220 patients with diagnosed ATR will be included. The control group will be treated according to the standard regimen with a lower leg immobilization in a stable orthosis during eight weeks. The intervention group will during the eight weeks lower limb immobilization receive an additional intervention with C-NMES underneath the orthosis.

The total number of blood clots, venous thromboembolism incidence, up to mobilization, is defined as deep venous thrombosis (leg blood clots) assessed by screening duplex ultrasound, or pulmonary embolism (lung blood clots). Calf muscle loss, tendon length, and weight-bearing, will be studied at two and eight weeks. At six weeks and 12 months, validated self-reported function (ATRS) and self-reported health, return to sports, calf muscle function, and tendon length will be recorded for comparison between the two treatment groups. Secondary outcomes are coagulation factors, healing biomarkers and cardiovascular biomarkers.

The results of this study should contribute to an improved treatment regimen after ATR that allows for a safer and quicker return to activity and sports. Adjuvant NMES can readily be implemented in daily healthcare to lower complication risks, improve healing, reduce healthcare costs and improve return to sports.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with acute unilateral Achilles tendon rupture
* Included within 10 days after injury.

Exclusion Criteria:

* Inability to give consent to participate,
* ongoing treatment with anticoagulants,
* known allergy to contrast agents,
* planned follow-up at another hospital,
* inability to follow instructions,
* known renal failure,
* heart failure with pitting edema,
* thrombophlebitis,
* thromboembolic disease within the last 3 months,
* previous surgery of the tendon,
* known malignancy,
* hemophilia,
* pregnancy,
* treatment with high doses of acetylsalicylic acid.
Analysis of Trends Over Time of Hepatitis Related Incidence in Panama

The purpose of this study is to analyze the incidence of baseline hepatitis related outcomes (viral hepatitis A and unspecified viral hepatitis) together with the current frequency of the same outcome after introduction of Havrix™ in Panama.

In this study, systematic review of the databases of epidemiologic surveillance system (Ministry of Health), for hepatitis related outcomes will be performed. The analysis will be performed by age group, years and country region.

Eligibility Criteria:
Inclusion Criteria:

* Hepatitis related outcomes occurred during the period analyzed and registered in the Epidemiologic Surveillance System of the Ministry of Health, will be collected for the study

Exclusion Criteria:

* Not applicable
Culturally Adapted Motivational Interviewing With CBT and Mindfulness Based Relapse Prevention for Substance Use Disorder in Pakistan (CAMIAB)

The study has both quantitative and qualitative components. The aim of study is to:

1. Culturally adapt and integrate the existing Motivational Interviewing with Cognitive Behavioral Therapy(MICBT) and Mindfulness based Relapse Prevention (MBRP) for people with Substance Use Disorder (SUD) in Pakistan
2. Test the feasibility and acceptability of the integrated intervention called CAMIAB ('CAMIAB' means success in Urdu) in a randomized control trial (RCT).

This study aims to culturally adapt the existing Motivational Interviewing with CBT (MICBT) and integrate this with Mindfulness-Based Relapse Prevention (MBRP) intervention for people with SUD and to test the feasibility, and acceptability of the intervention in a randomized control trial (RCT). First phase will be cultural adaptation of intervention through focus groups and individual interviews with key stakeholders . Phase two will be to test integrated MICBT and MBRP on a small group of participants N=12.

Third phase will be a feasibility factorial randomized control trial with 260 participants with SUD (n=65). Participants will be recruited from primary care hospitals and drug rehabilitation centers in Karachi, Lahore, Rawalpindi, Hyderabad, and Peshawar Pakistan. Intervention will take place weekly over a period of 12 weeks. The intervention will consist of individual as well as group sessions. Assessments will be completed at baseline, after completion of intervention (12th week) and 24th week post randomization. All assessments will be administered by masked research assistants (RAs), not involved in delivering intervention sessions. The therapists delivering the intervention will be trained and will be provided ongoing supervisions by a senior therapist.

Eligibility Criteria:
Inclusion Criteria

* Participants with substance use disorder
* Meeting DSM-V criteria for substance use disorder
* Age 18 years and above
* Being able to understand spoken or written Urdu
* Have undergone through the process of detoxification before study intervention

Exclusion Criteria

• Any evidence of organic brain disease, clinically significant cooccurring medical illness or mental illness to the extent that can impede their ability to provide informed consent or engagement in the intervention.
Sphenopalatine Ganglion Block for Post-Dural Puncture Headache

The investigators are attempting to determine a less invasive method of treatment for postdural puncture headaches that can occur after regional anesthesia. The investigators will be evaluating the relief of headache with those subjects receiving treatment with a sphenopalatine ganglion block with bupivacaine versus placebo, evaluating the incidence of epidural blood patch, pain score of headache at 1 hour, then 24, 48, and 72 hours lower with post study treatment versus placebo, and potential side effects of those patients receiving study therapy as well as epidural blood patch.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists assigned class I-III
* age \>/= 18 years
* experiencing a postdural puncture headache within 7 days of neuraxial analgesia rated \>3/10 pain score

Exclusion Criteria:

* allergy to study medications \<18 years of age pain score on presentation \</=3/10 for headache
Post-marketing Surveillance of Children With Chronic Hepatitis C Treated With Intron A (Vial or Pen) and Rebetol (Study P04397)(TERMINATED)

The objective of the study is to assess the safety and efficacy of Intron A (3 Mio I.E./m2, 3 times per week) and Rebetol (15 mg/kg/day) in children aged 3 to 17, treated in common medical practice at 10 sites in Germany. The primary objective is to determine if there are any new severe adverse events observed with this recently approved dosing regimen. The study will also evaluate the rates of eradication of the HCV virus.

This study was terminated due to low enrollment. At the time of termination, 3 participants had enrolled. Therefore, these 3 participants transferred into study P04538 (NCT00727077) and will be included in the P04538 (NCT00727077) data reporting.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic hepatitis C (serum HCV-RNA-positive)
* Age 3 to 17 years
* Treatment-naïve
* Platelets \>= 100,000/mm\^3
* Neutrophil counts \>= 1,500/ mm\^3
* TSH must be within normal limits
* Hemoglobin \>=12 g/dL (females); \>=13 g/dL (males)
* Women of childbearing potential must have a routine pregnancy test performed monthly during treatment and for 7 months thereafter. Sexually active female subjects of childbearing potential must be practicing adequate contraception (intrauterine device, oral contraceptives, implanted contraceptives, surgical sterilization, barrier method, or monogamous relationship with a male partner who has had a vasectomy or is using a condom (+ spermicide) during the treatment period and for 7 months after stopping treatment.
* Sexually active male subjects must be practicing acceptable methods of contraception (vasectomy, use of condom + spermicide, monogamous relationship with a female partner who practices an acceptable method of contraception) during the treatment period and for 7 months after stopping treatment.

Exclusion Criteria:

* Contraindications according to the SPC and European approval
* Pretreatment of chronic hepatitis C
* Liver decompensation
* Hypersensitivity to the active substance or to any interferons or to any of the excipients
* Pregnant woman
* Woman who are breast feeding
* Existence of or history of psychiatric condition, in particular depression, suicidal ideation or suicide attempt
* A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
* Severe debilitating medical conditions, including patients with chronic renal failure or creatinine clearance \< 50 mlLmin
* Autoimmune hepatitis or history of autoimmune disease
* Severe hepatic dysfunction or decompensated cirrhosis of the liver
* Pre- existing thyroid disease unless it can be controlled with conventional therapy
* Epilepsy and/or compromised central nervous system function
* Individual decision of physician if patient suitable for treatment (e.g., disturbance of growth)
Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate in Healthy Adults

The purpose of this study is to determine the digestibility of serum-derived bovine immunoglobulin protein isolate in healthy adults. The information generated may help elucidate SBI's mechanism of action.

This study is evaluating the safety and absorption of serum-derived bovine immunoglobulin protein isolate (SBI) in healthy adults using 5, 10, and 20 g doses of SBI and placebo equivalents in a double blind crossover study and SBI affects over 14 days. Additionally, plasma amino acid response and IgG concentrations in both stool and plasma will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index of 18-32
* Medically normal with no significant abnormal findings at screening

Exclusion Criteria:

* Allergy or intolerance to beef
* Participated in another investigational study within 30 days
* Seropostive for HIV, hepatitis B surface antigen, hepatitis C virus
Effect of β-alanine Supplementation on Muscle Carnosine

Carnosine is a natural acid buffering substance of muscle. The primary objective of this study is to test whether a nutritional supplement of beta-alanine enhances carnosine content in muscle.

Volunteers will be randomized to receiving 3 nutritional supplements. Two supplements contain beta-alanine at different doses, the third supplement is a placebo.

Eligibility Criteria:
Inclusion Criteria:

* Stable health as evaluated by medical evaluation
* Body mass index higher than 18 kg/m2
* Body mass index lower than 25 kg/m2, unless body fat is less than 20%

Exclusion Criteria:

* intolerance to β-alanine,
* allergy to soy, fish and crustacean
* participation in another intervention study
* consumer of dietary supplement susceptible to contain beta-alanine
* determined to have very high baseline muscle carnosine concentration