cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients

The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care


Eligibility Criteria:
Key Inclusion Criteria:

* Patients chronically infected with hepatitis C virus (HCV) genotype 1
* HCV RNA viral load ≥10\*5\* IU/mL at screening
* Naïve or nonresponsive to the current standard of care

Key Exclusion Criteria:

* Cirrhosis
* Hepatocellular carcinoma
* Coinfection with hepatitis B virus, HIV-1 or HIV-2
Rifaximin Treatment of Papulopustular Rosacea

The purpose of this study is to determine the effects of rifaximin on skin symptoms in patients with rosacea by double-blinded, placebo-controlled, crossover study.

100 patients will be randomized into two groups.

Group A will receive one rifaximin 550 mg tablet three times a day (1650 mg/day) for 14 days, and after a 4-week washout period, receive one placebo tablet three times a day for 14 days.

Group B will receive placebo first, and then rifaximin with the same dosage schedule to Group A.

Assessments will be performed before application and 4 weeks after the last dosage, for both of rifaximin and placebo.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* \> 18 years of age with rosacea defined as:
* 3-40 papules/pustules and \< 2 nodules,
* A score of 2-4 on the Investigator Global Assessment

Exclusion Criteria:

* Untreated pancreatic insufficiency
* Crohn's disease
* Ulcerative colitis
* Active celiac disease by clinical history
* End stage renal failure
* Less than 18 years old
* Pregnancy or positive pregnancy test
* Rosacea subtype 1 (no papules )
* Topical or oral antibiotics within 4 weeks
* Acne treatments within 4 weeks prior to randomization
* Systemic retinoids within 90 days
* Topical or systemic corticosteroids 4 weeks prior to randomization
Pre-Approval Access to JNJ-53718678 for the Treatment of Respiratory Syncytial Virus (RSV) Infection in (a) Immunocompromised Adult and Pediatric Participants

The purpose of this pre-approval access program is to provide treatment to immunocompromised participants with serious/life-threatening diseases or conditions (Respiratory Syncytial Virus \[RSV\] infection) and to collect the safety data to understand the safety profile of JNJ-53718678.


Eligibility Criteria:
NOR-SYS: The Norwegian Stroke in the Young Study

NOR-SYS is a clinical research program about young ischemic stroke patients from 15 to 60 years. Patients, partners and the couple´s adult children who are at least 18 years old, are all invited to ultrasound examinations due to a standardized protocol.

Parents of patients and partners are invited to return their answers of standardized questionnaires about clinical ischemic events such as stroke, angina or myocardial infarction or peripheral artery disease.

Study inclusion time of patients and their families is 5 years. A biobank is build from samples from patients, partners and adult children. Clinical follow-ups for patients and partners are planned after 5, 10 and 15 years. Clinical follow-ups for adult children are planned after 10 and 20 years.

Hypotheses:

What do patients know about their parents clinical ischemic events? How much established pathology in arteries do we find by a standardized ultrasound protocol at the time of ischemic stroke at a young age? Differences concerning risk factors and ultrasound findings between patients and partners? Differences between children from families with several ischemic events among parents and grandparents vs. children from families without ischemic events? Biochemical markers related to ultrasound findings and artery disease.

Equal examinations for patients, partners and adult children are:

* Standardized questionnaires
* Extracranial duplexsonography
* Duplexsonography of the abdominal aorta
* Duplexsonography of femoral arteries
* Duplexsonography of epicardial, intrabdominal and subcutaneous fat
* Peripheral ultrasound, Ankle-arm index
* ECG
* Blood pressure measurement
* BMI and Waist-hip ratio
* Blood samples

Eligibility Criteria:
Inclusion Criteria:

* Documented ischemic stroke at age from 15 up to 60 years

Exclusion Criteria:

* Stroke as end-of-life event among patients with cancer or other life-threatening disease
* Stroke caused by trauma
Comparison of Everolimus- and Biolimus-Eluting Stents With Everolimus-Eluting Bioresorbable Vascular Scaffold Stents

The purpose of this study is to compare the efficacy and safety of everolimus- and biolimus-bluting stents with everolimus-eluting bioresorbable vascular scaffold stents.

The null hypothesis to be rejected is that there is no significant difference with regard to lumen late loss at 9 months and a clinical end point of death, myocardial infarction and TVR at 12 months between everolimus-eluting and biolimus-eluting stents and everolimus-eluting bioresorbable vascular scaffold stents.


Eligibility Criteria:
Inclusion Criteria:

* elective PCI
* ability and willingness to provide written informed consent

Exclusion Criteria:

* ST-elevation myocardial infarction in the previous 48 hours
* moderate to severe renal failure (defined as creatinine clearance of 30-60 ml/min and \<30ml/min respectively)
* known or presumed hypersensitivity to heparin, antiplatelet drugs and hypersensitivity to contrast dye incontrollable with premedication
High-frequency vs. Low-frequency vs. Sham DMPFC-rTMS for Major Depression

This trial will compare the efficacy and tolerability of 20 Hz vs. 1 Hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered twice daily over 15 days, in patients with a diagnosis of major depressive disorder. The trial will include structural and functional MRI, EEG, and behavioral measures obtained before, during, and after treatment.


Eligibility Criteria:
Inclusion Criteria (Patient):

* Voluntary and competent to consent to treatment
* MINI confirmed diagnosis of MDD
* Outpatient
* Between the ages of 18-65
* Failed to achieve a clinical response to at least one pharmacotherapy or behavioral treatment in the current episode.
* Have had no increase or initiation of any psychotropic medication in the last 4 weeks prior to screening
* Must adhere to study assessment and intervention schedule.
* Pass the TMS Safety Screening Questionnaire.

Exclusion Criteria (Patient):

* Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medical pump
* Have active suicidal intent
* Are pregnant
* Have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms have a MINI diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than MDD
* Have received rTMS for any previous indication due to the potential compromise of subject blinding.
Artificial Shrinkage for Human Blastocyst Prior Vitrification

Investigators aim to investigate the effect of elimination of blastocoelic fluid by creating a large hole in the zona pellucida at the cellular junction of the trophectoderm cells located far away from the inner cell mass with a laser pulse before vitrification.

Human blastocyst formation begins about 5 days after injecting a single sperm into an oocyte in ICSI cycle or incubation of them in IVF cycle. Human blastocyst consists of cells forming an outer layer called trophotoderm that will form the placenta in case of successful implantation, an inner cell mass which become the fetus, a fluid-filled blastocoel cavity in the center, and a surrounding zone pellucida from which the embryo hatches to implant in the uterus. Human blastocyst contains a large amount of liquid in the blastocoel, which alters the infiltration of vitrification solution during the vitrification procedures leading to ice crystal formation. Therefore, investigators need to compare blastocyst survival, clinical pregnancy and implantation rates between vitrified untreated expanded blastocysts and vitrified blastocysts with artificially eliminated blastocoels by a laser pulse prior to vitrification

Eligibility Criteria:
Inclusion Criteria:

* BMI of ≤ 32

Exclusion Criteria:

* Non-expanded blastocysts.
* Women who had uterine pathology or abnormality.
Efficacy and Safety of Lenalidomide Combined With Azacitidine vs Azacitidine in the Treatment of MDS-RS

At present, the main therapies for myelodysplastic syndromes with ring sideroblasts (MDS-RS) are red blood cell and platelet transfusion, erythropoietin (EPO), androgen, and iron chelation therapy. Lenalidomide is an immunomodulator with multiple mechanisms, including direct targeting of MDS clones, immunomodulation, erythropoiesis restoration, and angiogenesis inhibition. A Phase III, randomized, placebo-controlled trial of oral azacitidine (AZA) in lower-risk MDS reported higher rates of hemoglobin and platelet hematological improvement in patients with AZA monotherapy. Therefore, this study intended to investigate the efficacy and safety of lenalidomide and sequential AZA in the treatment of refractory MDS-RS versus azacitidine monotherapy.

Myelodysplastic neoplasms (MDS) are heterogeneous clonal disorders of stem cells that result in peripheral blood cytopenia and ineffective hematopoiesis, with the potential risk of the development of acute myeloid leukemia (AML). Most patients with myelodysplastic syndromes with ring sideroblasts (MDS-RS) are stratified into lower-risk groups by the revised International Prognostic Scoring System (IPSS). At present, the main therapies for MDS-RS are red blood cell and platelet transfusion, erythropoietin (EPO), androgen, and iron chelation therapy. Lenalidomide is an immunomodulator with multiple mechanisms, including direct targeting of MDS clones, immunomodulation, erythropoiesis restoration, and angiogenesis inhibition. Hypomethylating agents (HMA) like azacytidine (AZA) and decitabine (DEC), have been shown to improve survival or delay disease progression in high-risk MDS. A Phase III, randomized, placebo-controlled trial of oral AZA in lower-risk MDS reported higher rates of hemoglobin and platelet hematological improvement in patients with AZA monotherapy (24.3% vs 6.5%). Therefore, this study intended to investigate the efficacy and safety of lenalidomide and sequential azacitidine in the treatment of refractory MDS-RS versus azacitidine monotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years old.
2. Patients with a definite diagnosis of MDS-RS and stratified as lower-risk according to IPSS-R.
3. After at least 3 months of rhEPO treatment, with hemoglobin\<90g/L, absolute neutrophil count≥1.0× 109 /L, and platelet≥30× 109 /L
4. Unconditional hematopoietic stem cell transplantation
5. Adequate hepatic functions with alanine transaminase (ALT)/aspartate. transaminase (AST) levels within 2 times of the normal upper limit and total bilirubin levels within 2 times of the normal upper limit.

5. No active infection; Not pregnant or breastfeeding 6. ECOG≦2 with an expected life span of more than 6 months 7. Documented patient consent.

Exclusion Criteria:

1. Proliferative (white blood cell count ≥12× 109 /L) chronic myelomonocytic leukemia.
2. Complicated with active or uncontrolled infections.
3. Complicated with other malignancies.
4. Creatinine/transaminase ≥ 2 normal upper limit.
5. Complicated with myelofibrosis.
Study of Subcutaneous (Injected Under the Skin) Risankizumab to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Plaque Psoriasis With Palmoplantar Involvement

Plaque Psoriasis is a chronic inflammatory disease in which skin cells build up and develop scaly red and white patches on the skin. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. Palmoplantar (non-pustular) plaque psoriasis (PPPsO) represents a localized form of psoriasis in palms and soles. This study will evaluate how safe risankizumab is for the treatment of plaque psoriasis with palmoplantar involvement and to assess change in disease symptoms.

Risankizumab is an approved drug for the treatment of psoriasis. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo in Period A. In Period B, all the participants will receive risankizumab. Around 168 adult participants with a moderate to severe plaque psoriasis will be enrolled in approximately 55 sites across the world.

Participants will receive single subcutaneous (administered under the skin) risankizumab or placebo in period A (16 weeks). In period B (36 weeks), all participants will receive subcutaneous risankizumab once every 12 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic palmoplantar plaque psoriasis (PPPsO) (with or without psoriatic arthritis) for at least 6 months before Baseline and a Palmoplantar Investigator's Global Assessment (ppIGA) of moderate or severe, at Screening and Baseline.
* Must have at Screening and Baseline a plaque psoriasis (PsO) body surface area (BSA) involvement of greater than or equal to one percent, an Static Physician's Global Assessment (sPGA) score of moderate to severe (greater than or equal to three), a PPASI moderate to severe (greater than or equal to eight), at least one additional PsO plaque outside of the palms and soles.
* Must be a candidate for systemic therapy as assessed by the investigator.
* Previously had inadequately controlled disease by topicals, phototherapy and/or systemic treatments.

Exclusion Criteria:

* History of PsO other than chronic plaque type PsO
* History of current drug-induced PsO or a drug-induced exacerbation of pre-existing psoriasis.
* Ongoing inflammatory skin diseases other than PsO and psoriatic arthritis that could interfere with PsO assessments.
* Evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV), Active tuberculosis, Active systemic infection/clinically important infections in the last two weeks prior to Baseline.
* Prior exposure to risankizumab.
Effects of Shroom Tech Sport Supplementation and Concurrent Training

This study will examine how the supplement Shroom Tech Sport (STS) affects body composition and different performance and health measures over the course of 12 weeks. The supplement will be combined with a concurrent training regime consisting of resistance and high intensity interval training. Subjects will be tested for percent body fat to determine body composition. Further, they will also be tested for maximal strength (squat and bench), maximal power output and fatigue, lactate threshold and maximal oxygen volume consumption (VO2max). And finally, subjects will be tested for health and hormone markers in the blood. All of these measures will be compared against a placebo group participating in the same exercise intervention.


Eligibility Criteria:
Inclusion Criteria:

1. participate in the 3-4 week supplement wash out prior to beginning the experiment (except for basic protein supplements and multivitamins)
2. have at least 1 year of recreational exercise with a minimum of three times a week

Exclusion Criteria:

1. Prior steroid use
2. History of tumors
3. Pre-existing musculoskeletal disorders
The VIGORous Physical Activity for Glycaemic Control in Type 1 Diabetes (VIGOR) Trial

Background/Justification: Regular physical activity (PA) has substantial health benefits in persons with type 1 diabetes (T1D), including reduced risk of complications and cardiovascular mortality. Despite these benefits, individuals with T1D remain significantly less active than their peers without diabetes. Two major factors likely explain the low rates of PA in young people with T1D: (1) fear of post-exercise hypoglycaemia, particularly nocturnal hypoglycaemia, and (2) a lack of empirical evidence for the efficacy of PA for achieving optimal glycaemic control. A number of acute exercise trials recently demonstrated that the inclusion of vigorous intensity PA in conventional moderate intensity (i.e. walking) PA sessions may overcome these limitations. No studies have tested the efficacy of high intensity PA for reducing the risk of exercise-related hypoglycaemia or glycaemic variability in a randomized controlled trial (RCT).

Study Hypotheses: In persons 15-35 years of age living with T1D, this study will test the hypotheses that (1) the addition of intermittent vigorous intensity PA to a moderate intensity intervention will reduce the time spent in hypoglycaemia in the 12 hour period following exercise and (2) the addition of intermittent vigorous intensity PA to a moderate intensity PA intervention will elicit significant improvements in glycemic excursions, as measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour period following exercise.We are also exploring the hypothesis that reducing the risk of hypoglycemia will lead to a sustained increase in physical activity one year after randomization.


Eligibility Criteria:
Inclusion Criteria:

* Age: 15-45 years old
* Have lived with type 1 diabetes for at least 2 years
* HbA1c \<9.9%
* Currently physically inactive (\<150 minutes of self-reported structured physical activity per week)
* Undergone a resting ECG to screen for left ventricular hypertrophy, arrhythmias or signs or coronary artery disease that may be exacerbated with vigorous intensity exercise

Exclusion Criteria:

* Have frequent and unpredictable hypoglycaemia
* Had a change in insulin management strategy, including adoption of a pump, within 2 months of enrolment
* Are currently participating in structured activity or sport-related activities
* Are women who are pregnant or planning to get pregnant within the 12 months of the trial and those who are breastfeeding
* Have conditions that would render physical activity contraindicated including: uncontrolled hypertension (BP\>150mmHg systolic or \>95mmHg diastolic in a sitting position); severe peripheral neuropathy; history of cardiovascular disease
* Have a cognitive deficit resulting in an inability to provide informed consent
* Currently taking beta blockers
* Currently taking atypical antipsychotics or corticosteroids
A Study of Nonoxynol-9 (N-9) and HIV Infection

The purpose of this study is to see if nonoxynol-9 (N-9) gel used in the vagina can prevent the spread of HIV.

Most of the people with HIV in the world today live in southern Africa. Because this population is not likely to use condoms, an HIV-prevention method that women can control is needed. N-9 used in the vagina may help prevent the spread of HIV and other sexually transmitted diseases.

Intravaginal application of N-9 may help protect women from HIV and other STD infection. Low rates of condom use in sub-Saharan African populations, which constitute the majority of HIV infections, dictate the need for prophylactic methods women can control.

This trial will be conducted in Zimbabwe and Malawi. The Phase III trial is preceded by a 2-week safety and acceptability pilot study to determine the extent of genital irritation caused by N-9 and the placebo. Following the pilot study and prior to screening for enrollment in the Phase III trial, potential volunteers will participate in a 2-month behavioral counseling program that will encourage the use of condoms. Only participants who decide they cannot or will not be consistent condom users are enrolled in the main study. Study participants are given N-9 gel or placebo to use each time they have vaginal sexual intercourse for 18 to 36 months. Participants have a follow-up evaluation once a month; a pelvic exam and blood tests are performed every third month.

Eligibility Criteria:
Inclusion Criteria

Volunteers may be eligible if they:

* Are HIV-negative.
* Are sexually active and expect to have vaginal intercourse at least twice a week during the study.
* Are willing to keep a diary of their sexual behavior and N-9 use.
* Are willing to have regular clinic visits including pelvic exams.
* Are at least 18 years old.
* Are female.

Exclusion Criteria

Volunteers will not be eligible if they:

* Have had a child or an abortion in the past 42 days.
* Are allergic to latex or N-9.
* Have genital sores.
* Have syphilis, chlamydia, gonorrhea, or trichomoniasis.
* Are enrolled in another study for a product like N-9.
* Expect to use another vaginal product other than N-9 during the study.
* Are pregnant.
Vitamin D and Serum Calcium Level Insufficiency and Early Dental Implant Failure

In this study there is a trial to investigate whether there is a correlation between early implant failure and low serum levels of vitamin D.

Osseointegration is a complex phenomenon and depends on many factors; some are related to the implant (material, macroscopic design, and implant surface), others to the surgical-prosthetic protocol (surgical technique, loading conditions, and time), and others to the patient (quantity/quality of bone at the receiving site and the host response)

All these observations would suggest the existence of specific patient-related risk factors such as vitamin D deficiency in the blood, could play an important role in the occurrence of early dental implant failures (EDIFs), but unfortunately are neglected by the dental literature.

In this study there is a trial to investigate whether there is a correlation between early implant failure and low serum levels of vitamin D. Therefore we are including patients with early implant failure during the year 2020 using the same implant (material, macroscopic design, and implant surface), surgical-prosthetic protocol (surgical technique, loading conditions, and time)

The study will be performed into 15 male and 15 female participants that had dental implant placement in the last 3 months. An informed consent will be signed with the patient with full detail on the study.

The situation of the implant will be categorized into either successful or failed dental implant.

Medical history and lifestyle information will be obtained by questionnaire. Levels of serum vitamin D will be collected from participants

Statistical analysis will correlate between vitamin D and early implant failure.

Eligibility Criteria:
Inclusion Criteria:

* Missing single tooth
* Systemically free
* Average body mass index

Exclusion Criteria:

* Systemic conditions
* Bad oral hygiene