cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease

This study will examine the individual and combined effects of Coreg CR and lisinopril, on cardiovascular health as measured by Rasmussen Disease Score (RDS) in a blinded, placebo controlled comparison over a 9-month study period. Patients to be randomized will have pre-hypertensive blood pressures that do not require anti-hypertensive therapy and at least one additional cardiovascular risk factor.

* This study will compare the effect of Coreg CR and lisinopril, separately and together, on Rasmussen Disease Score in a controlled study with an inactive substance (placebo).
* Study patients will have pre-hypertensive (slightly elevated) blood pressures not requiring therapy.
* Lisinopril is an angiotensin converting enzyme (ACE) inhibitor. Angiotensin is a chemical that is made by the body continuously. Angiotensin narrows blood vessels and thereby maintains (elevates) blood pressure. When the enzyme is blocked by lisinopril, angiotensin cannot be converted into its active form. As a result, blood pressure is lowered. Lisinopril is a drug that has been approved for use by the U.S. Food and Drug Administration (FDA) and health authorities for the treatment of high blood pressure and heart failure.
* Coreg CR is a once-a-day heart medication that is part of a class of drugs known as beta-blockers. Beta-blockers prevent beta-adrenergic substances such as adrenaline from activating parts of the nervous system, including the heart. Beta-blockers therefore relieve stress on the heart by slowing heart beat, decreasing the force of heart muscle contractions, and reducing blood pressure. Coreg has also been approved by the FDA for the treatment of hypertension and various other cardiovascular conditions.
* It is possible that the beta blocker could increase the benefits of the ACE inhibitor by inhibiting renin production, which is an important step in angiotensin production. These two drugs may act together to provide even more protection to blood vessels and the heart.

Eligibility Criteria:
Inclusion Criteria:

* Males and females \> 18 years old with pre-hypertensive or borderline blood pressures (systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg) deemed not to need antihypertensive therapy. Subjects must also have one additional risk factor for cardiovascular disease, including:
* LDL \> 130 and \< 160 mg/dL
* HDL \< 40 mg/dL
* Fasting blood sugar \>100 and \< 126 mg/dL
* Body mass index ≥ 30
* Smoker
* Family history of premature heart disease or hypertension

Exclusion Criteria:

* Patients with a history of cardiac, cerebral or other vascular events within the previous 6 months will be excluded. Other exclusions include background therapy with a beta blocker or ACE inhibitor therapy, known or suspected intolerance to beta blockers or ACE inhibitors, angiotensin receptor blocker therapy, or diabetes. Pregnant or lactating women, and women of child-bearing age who are not using an acceptable form of contraception are also excluded from this study.
Treatment of Bacterial Vaginosis With Oral Tinidazole

The purpose of this study is to confirm the safety and efficacy of oral tinidazole for the treatment of bacterial vaginosis.

Tinidazole is a second-generation nitroimidazole i.e. an updated form of the standard drug used to treat bacterial vaginosis (metronidazole). Two dosing regimens are being compared to placebo to treat bacterial vaginosis, one of the most common vaginal infections.

Eligibility Criteria:
Inclusion Criteria:

Clinical and microbiological diagnosis of bacterial vaginosis -

Exclusion Criteria:

Other sexually transmitted disease

-
Study to Assess the Efficacy, Safety and Tolerability of Secukinumab in Japanese Subjects With Generalized Pustular Psoriasis (GPP)

The purpose of this study was to assess efficacy and safety data of secukinumab in Japanese subjects with generalized pustular psoriasis (GPP). This study was expected to support the filing of secukinumab in the indication of pustular psoriasis in Japan.


Eligibility Criteria:
Inclusion Criteria:

* At baseline, presence of GPP classified on the basis of the criteria for diagnosis of GPP by Japanese Dermatological Association (JDA)
* At baseline, erythema area with pustule ≥ 10%

Exclusion Criteria:

* Erythrodermic, guttate psoriasis, or subcorneal pustular dermatosis at screening.
* At baseline, : total score of JDA severity index for GPP ≥ 14
* Drug-induced psoriasis
* Ongoing use of prohibited psoriasis treatments.
Rewarding Feedback in Motor Learning and Rehabilitation

The effect of rewarding vs. non-rewarding feedback on acquisition of a motor skill is investigated in a single blinded parallel group design. Reward consists of performance dependent monetary reward, or of knowledge of performance in selected (above average) trials.

The investigators hypothesize improved motor skill learning and higher involvement of the dopaminsrgic system under rewarding vs. non-rewarding conditions.


Eligibility Criteria:
Inclusion Criteria:

* neurologically healthy
* right handed

Exclusion Criteria:

* Contraindications against magnetic resonance imaging
* pregnancy
Study to Evaluate Imatinib in Desmoid Tumors

The objective of the present study is to evaluate the activity and safety of imatinib in patients with aggressive fibromatosis who, after receiving the standard therapy, show an inoperable recurrent tumor or disease not readily controllable by surgery or radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histological confirmed aggressive fibromatosis (desmoid tumor)
* Measurable disease according to the RECIST criteria
* Evidence of relapse or disease progression within the last 6 months (based on RECIST criteria) in computed tomography or magnetic resonance imaging
* No possibility of complete surgical resection or cases in which surgical therapy leaving a large tissue defect, functional deficit or disfigurement would be required
* No possibility of curative radiotherapy with acceptable toxicity and/or late morbidity
* Previous treatment of the tumor region by surgical intervention and/or radiotherapy and/or antihormonal therapy possible
* Age \> or = 18 years
* WHO PS \< or = 1
* Effective contraception during study medication
* Signed informed consent form

Exclusion Criteria:

* Surgical intervention \< 4 weeks
* Prior therapy with imatinib
* Pregnancy or lactation
* Severe hepatic dysfunction
* Known allergic reaction to imatinib or one of its components
* The following laboratory values: Absolute neutrophil count \< 1.5 x 103/mm3, Platelets \< 100,000/mm3, Serum creatinine \> or = 2.5 mg/dl, SGOT and/or SGPT \> 2.5 x ULN (upper limit of normal), Total bilirubin \> 1.5 x ULN
* Participation in another study (four weeks before and during the study)
* Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix
Evaluation of Medium Chain Triglycerides in a Mixed Racial Population of Patients: a Feasibility Study

The study team will investigate the racial differences in the metabolic and clinical responses to Medium chain triglycerides (MCT) between African American and Caucasian American subjects.

It is generally accepted that type 2 diabetes (T2D) arises from the progression of insulin resistance (IR), with hyperinsulinemia (HI) as a compensatory response. The possibility that HI can precede and contribute to insulin resistance (IR) and metabolic syndrome (MS) has been suggested but not tested in humans. While IR and HI are closely associated, demonstrating a primary role for HI in T2D is key to the development of new treatment strategies for this disease. One group in which HI could play a bigger role in T2D is African Americans (AA) who are known to be more hyperinsulinemic than Caucasian Americans (CA). Racial disparities in T2D treatment outcomes adversely affect AA. Our main hypothesis is that suppression of HI will contribute to the prevention and treatment of T2D, especially among AA. Our goal in this pilot study is to show that consumption of medium chain triglycerides (MCT) in the diet will decrease basal insulin secretion and HI, and will lead to improvement in the insulin sensitivity index (Si). 24 subjects (12 AA, 12 CA) will participate in a clinical trial in which they will receive MCT for 6 weeks. Insulin secretion dynamics and insulin sensitivity will be assessed by use of the frequently sampled intravenous glucose tolerance test (FSIVGTT) and Bergman's minimal model analysis.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Males and female ambulatory subjects
* Self-identify as Caucasian/White or Black/African American
* Body Mass Index \<=45

Exclusion Criteria:

* Diagnosis of type 2 diabetes or hemoglobin A1c \>6.5
* Use of insulin, oral hypoglycemic, agents, or insulin-sensitizing agents
* Daily use of oral steroids
* Unstable weight within 3 months prior to baseline (e.g., weight gain or loss of \>3%)
* Use of any weight loss medications or sex hormone therapy
* Daily use of psychotropic medications (for schizophrenia, bipolar disorder, obsessive compulsive disorder, posttraumatic stress disorder, psychotic disorder, mania)
* Chronic kidney disease, on dialysis or history of renal transplant
* Poorly controlled cardiovascular disease or congestive heart failure
* Severe peripheral vascular disease or severe liver disease
* Cancer
* A condition requiring use of oxygen such as severe chronic obstructive pulmonary disease
* Women who are pregnant, lactating, or actively trying to become pregnant
* Any cognitive or other disorders that may interfere with participation or ability to follow restrictions
* Abnormal TSH levels (\<0.01 or \>1.5x the upper limit)
* Weight \>450 lb (205 kg) or height \> 6'6"
* Severe claustrophobia
* Has had or is preparing for bariatric surgery (pre- or post-bariatric)
* Medically required use of anticoagulant therapies
* Current use of MCT oil
* Anemia (hemoglobin and/or hematocrit outside sex-specific normal ranges)
Application of LARS Ligament in Bone Prosthesis Replacement

This is a single-center, prospective, real-world observational study designed to enroll all patients eligible for enrollment. Basic data, treatment methods, postoperative complications and limb function were collected. The differences in postoperative complications, postoperative limb function and so on between patients who underwent LARS ligament implantation and bone prosthesis replacement (ligament group) and patients who underwent bone prosthesis replacement (control group) were compared.

This is a single-center prospective real-world observational study of 100 eligible patients with bone tumors who are scheduled to undergo LARS ligament implantation and/or bone prosthesis replacement in Henan Cancer Hospital in the next 10 years. Basic data, treatment methods, postoperative complications and limb function were collected. The differences in postoperative complications, postoperative limb function and so on between patients who underwent LARS ligament implantation and bone prosthesis replacement (ligament group) and patients who underwent bone prosthesis replacement (control group) were compared.

Eligibility Criteria:
Inclusion Criteria:

Men and women of all ages are welcome.

Pathologically confirmed in our hospital as a subtype of malignant tumor.

He received LARS ligament and bone prosthesis replacement at our hospital.

Exclusion Criteria:

Not Applicable.
Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis

The aim of the study is to evaluate the efficacy of a therapeutic regimen which decreases glucocorticoid exposure compared with standard therapy in patients with proliferative lupus nephritis during remission induction by evaluating the histological and clinical remission.

After an initial screening phase during which a first kidney biopsy is performed, all patients that meet the inclusion criteria will be randomized to one of the treatment arms:

* EUROLUPUS regimen: 3 daily pulses of 750 mg of intravenous Methylprednisolone, followed by oral corticosteroid therapy starting with a dose of 0.5 mg / kg / day for 4 weeks, then decreased by 2.5 mg of Prednisolone / day each 2 weeks. A low dose of glucocorticoid (5-7.5 mg / day) is maintained until 24 months after enrollment. All patients will receive Cyclophosphamide intravenously starting day 1, 6 pulses at a fixed dose of 500 mg given at 2 weeks. After 3 months, Azathioprine (2 mg / kg / day) is initiated 2 weeks after the last administration of Cyclophosphamide and maintained for the next 21 months.
* RITUXILUP regimen: 2 doses of Rituximab 1 g and Methylprednisolone 500 mg on days 1 and 15. Patients will receive Mycophenolate Mofetil, initially 500 mg twice daily, titrated to a maximum of 1.5 g twice daily, depending on leukocyte count and digestive tolerance, which will be maintained 24 months.

Second kidney biopsy will be performed 6 months after the start of the treatment phase.

Eligibility Criteria:
Inclusion Criteria:

* Age of the patient between 18 and 80 years,
* Patients diagnosed with systemic lupus erythematosus according to ACR 1997 or SLICC-2012 criteria
* Diagnosis of proliferative lupus nephritis class III, IV +/- V (confirmed by renal biopsy and classified according to ISN / RPS);
* Estimated glomerular filtration rate by CKD-EPI\> 30 ml / min / 1.73 sqm
* Estimated glomerular filtration rate by CKD-EPI \<30 ml / min / 1.73 sqm but\> 15 ml / min / 1.73 sqm with chronicity index (according to NIH score) \<6
* Absence of contraindications to the use of Methylprednisolone, Mycophenolate mofetil, oral corticosteroids or Rituximab
* Ability to provide informed consent

Exclusion Criteria:

* The patient's age under 18 years
* Patients with life-threatening complications (e.g. Cerebritis)
* Estimated glomerular filtration rate by CKD-EPI \<30 ml / min / 1.73 sqm
* Estimated glomerular filtration rate by CKD-EPI \<30 ml / min / 1.73 sqm but\> 15 ml / min / 1.73 sqm with chronicity index (according to NIH score)\> 6
* Presence of pregnancy / lactation
* Patients who have received more than 2 g of Methylprednisolone intravenously in the last 4 weeks
* Use in the last 3 months of biological therapy
* Use of intravenous immunoglobulins / plasmapheresis in the last 6 months
* The presence of an active infection
* History of neoplasia
* Comorbidities requiring systemic corticosteroid therapy
* Non-adhesion
The Study of Pegylated Liposomal Doxorubicin Contrast Epirubicin for the Treatment of Diffuse Large B-cell Lymphoma

270 untreated patients, age between 18 and 65 years , with diffuse large B-cell lymphoma (B-DLCL) were treated with a pegylated liposomal doxorubicin (PL-doxorubicin) modiﬁed CHOP-rituximab regimen. PL-doxorubicin 35-40 mg/m(2)and epirubicin 70mg/m(2) were given in combination with standard dosage of prednisone, vincristine, cyclophosphamide, rituximab (according to CHOP-R regimen) every 21 days for six courses.

PL-doxorubicin 35-40 mg/m(2) and epirubicin 70mg/m(2) were given on day 1 in combination with standard dosage of prednisone, vincristine, cyclophosphamide (according to CHOP regimen) every 21days for six courses. The choice to adopt the dosage of 30 mg/m2(instead of 50 mg/m2 of conventionaldoxorubicin) was based on pharmacokinetic data and on the results of previous studies in lymphoma.Rituximab 375 mg/m2 was given on day 0 in subsequent courses of therapy. Granulocyte colony-stimulating factor was given in the presence of grade 4 neutropenia or febrile neutropenia until hematological recovery. Treatment was stopped if lymphoma progressed, the patient refused further participation,or if there was any other intercurrent clinical condition or adverse event.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* Diagnosis of previously-untreated DLBCL(patients with a transformed untreated low-grade lymphoproliferative disease were accepted)
* ECOG performance status \< 3 (and higher if due to lym-phoma)
* No symptomatic cardiac arrythmias or heart failure
* Acceptable renal, hepatic and pulmonary function
* Standard laboratory and radiological staging procedures and left ventricular ejection fraction analysis by echocardiography or scintigraphy were required before therapy in all cases
* The protocol was approved by the ethics review committee of each partici- pating center
* All patients gave informed written consent.

Exclusion Criteria:

* Patients with a previous history of cardiac disease;
* HIV-HBsAg-HCV positivity, central nervous system involvement or any other major clinicalcondition;
* Other than lymphoma, which might have precluded a regular therapeutic course, were excluded from the study.
Bioequivalence Study of Tansulosine 0,4 mg Capsule in Health Subjects -Fed State

The purpose of this study is to compare the bioavailability (rate and extent of absorption) of two tansulosine 0,4 mg capsule formulations. An open, randomized, two-period crossover study with a seven-days washout interval was conduced in 32 healthy male volunteers. The plasma samples were obtained up to 72 hours after drug administration. A sensitive and specific LC-MS/MS method was developed and validated for the determination of tansulosine in human plasma. Bioequivalence between the products was determined by calculating 90% confidence intervals for the ratio of Cmax, AUC 0-72h and AUC 0--inf.

The study protocol was approved by Local Ethics Committee (UNICAMP - Campinas, Brazil). The study was performed with 32 healthy male volunteers. They were within 10% of their ideal body weight. Biochemical test and physical examination were carried out. Their medical history was also obtained. . Volunteers did not drink caffeine-containing drinks 48-hours before the study. The volunteers gave written informed consent to participate in study.

The study was designed as two-single-dose, randomized, open-label, balanced, crossover study, with two periods separated by 7-days washout. In both periods after a standard breakfast volunteers were given a single dose of their formulation (reference or test) of tansulosine with 200 mL of water. Blood samples (8 ml) were collected at 0 (pre-dose) and at 01:00; 02:00; 03:00; 04:00; 04;30; 05:00; 05:20; 05:40; 06:00; 06:20; 06:40; 07:00; 07:30; 08:00; 08:30; 09:00; 10:00; 12:00; 24:00; 48:00; 72:00h. These samples were centrifuged immediately and kept frozen at -20°C until the time of analysis. Standard meals were served at 4 and 8h after administration. During hospital confinement, volunteers were always under medical supervision.

Eligibility Criteria:
Inclusion Criteria:

* They were within 10% of their ideal body weight.
* Biochemical test and physical examination were carried out.
* No concomitant medications were allowed.
* Volunteers did not drink caffeine-containing drinks 48-hours before the study.
* The volunteers gave written informed consent to participate in the study.

Exclusion Criteria:

* Chronic disease
* Smokers
YOGA-CF (Yoga Outcomes Get Assessed in Cystic Fibrosis)

The goal of this clinical trial is to investigate the effects of yoga participation for adults with cystic fibrosis.

The main question it aims to answer is: does participation in yoga affect health-related quality of life for adults with cystic fibrosis?

Researchers will compare a group completing a 12-week yoga programme alongside usual cystic fibrosis care, to a group completing usual care alone to see if the addition of yoga effects health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of CF (confirmed by standard criteria; (Farrell et al. 2017))

Sixteen years of age or over

Home internet access

Ability to complete questionnaires in English

Stable CF disease as judged by the investigator, a senior CF clinician

Exclusion Criteria:

Inability to consent for treatment or measurement

Current participation in another interventional study

Current haemoptysis (greater than streaking in the sputum)

Known pregnancy at time of recruitment

Forced expiratory volume in 1 second (FEV1) below 30% predicted at baseline

Use of ambulatory oxygen therapy, long-term oxygen therapy (LTOT) or non-invasive ventilation

Current regular participation in yoga practice

Current neurological or musculoskeletal injury which would prevent completion of yoga

Diagnosis of osteoporosis (bone density Z score \<-2.5) or history of spontaneous spinal fractures

Uncontrolled gastroesophageal reflux

Acute pulmonary exacerbation within 28 days of screening
Ketamine and Postoperative Depressive Symptom-PASSION

Perioperative depression symptom (PDS) is one of the common mental comorbidity, and influences the clinical outcomes and prognosis. However, there is no rapid acting treatment to deal with it during the limited hospital stay. This study aims to determine whether ketamine could improve the depressive symptom of peirioperative patients. It will also examine the safety for administrating ketamine as an antidepressant intraoperatively. Meanwhile, it will show if ketamine could improve anxiety, postoperative pain or delirium. This trial also will bring great concerns on patients with perioperative mental health and explore the measures to improve their psycho-related prognosis.


Eligibility Criteria:
Inclusion Criteria:

1. Brain tumor located supratentorial area and need to receive elective craniotomy;
2. Moderate to severe depressive symptom measured by the qualified psychiatric doctors.
3. Ages between 18 and 65 years old.
4. American Society of Anesthesiologists physical status I-III

Exclusion Criteria:

1. History of epilepsy;
2. Major depression disorder patients undergoing antidepressive therapy within 2 weeks; 3 Psychiatric illness; 4 Drug abuse; 5 History of allergy to the research drug; 6 Tumor located in the Wernick area, Broca area or the frontal pole; 7 Hyperthyroidism; 8 Patients can not cooperate with investigators on psychiatric assessments; 9 Pregnant or breast-feeding woman; 10 refuse to sign inform consent.
Translation and Validation of the Intensive Care Unit Mobility Scale (IMS)

Intensive care unit acquired weakness (ICUAW) is a common issue in critically ill patients. Early mobilization can reduce the occurrence of ICUAW. This requires a standardized procedure based on validated scales. One such scale is Carol Hodgson's ICU Mobility Scale (IMS).

The subject of the study is the translation of the IMS into German and the validation of its reliability and predictive power with regard to various clinical outcomes. Furthermore we want to investigate the communication about the mobilisation status of ICU-patients between the different medical disciplines that are involved in patient care.


Eligibility Criteria:
Inclusion Criteria:

* Critically ill adults (age: ≥ 18 years)
* Expected length of stay in ICU \> 24h
* Ventilation support

Exclusion Criteria:

* Patients transferred from other ICUs
* Patients with pre-existing functional limitations
* Patients with functional limitations due to the admission diagnosis (e.g. stroke. with hemiparesis)
A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia

This is a multicenter, open-label, adaptive, repeat-dose study to evaluate the safety, tolerability, and pharmacokinetics of iloperidone long-acting injection (LAI) in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent.
* Male or female patients 18 to 65 years of age (inclusive).
* Clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorder (DSM-5) for at least 1 year.
* Symptomatically stable within the past two months.

Exclusion Criteria:

* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs.
* Pregnant or nursing (lactating) women.
* A positive test for drugs of abuse.