cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Antihypertensive Efficacy of MK0954

After a 4 week placebo period, patients were randomized to Placebo or Losartan 50 mg arms, after 6 weeks non-responders were up titrated to 100 mg losartan for the remaining 6 weeks. This study evaluated if losartan is more effective than placebo in lowering sitting diastolic blood pressure and is well tolerated in patients with mild to moderate hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with mild to moderate hypertension (SDBP 95-115 mm Hg)
* Patient has no medical problems or treatments that might effect their blood pressure

Exclusion Criteria:

* Pregnant or lactating females
* Patient has secondary hypertension or malignant hypertension
* Sitting systolic blood pressure \> 210 mm Hg
* History of stroke
* History of myocardial infarction with in past year
* Current or prior history of heart failure
* Known hypersensitivity to losartan
* Prior exposure to losartan
* Patients known to be HIV positive
* Patient is abusing or has abused alcohol or other drugs within the past 4 years
Low Intensity Extracorporeal Shockwave Therapy for Patients With Erectile Dysfunction

This is a prospective, pilot study for assessing the safety and efficacy of the treatments performed with Renova (LI-ESWT) on symptomatic ED patients.


Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Vasculogenic ED for at least 6 months
* International Index of Erectile Function 6 (IIEF-EF) between 11 to 25
* Positive response to PDE5-I (able to penetrate on demand, Responders)
* Negative response to PDE5-I (unable to penetrate on demand even with maximum PDE5-I dosage,Non-responders)
* Stable heterosexual relationship for more than 3 months

Exclusion Criteria:

* Psychogenic ED
* Neurological pathology
* Hormonal pathology
* Past radical prostatectomy
* Recovering from cancer during last 5 years
* Any unstable medical, psychiatric, spinal cord injury and penile anatomical - abnormalities
* Clinically significant chronic hematological disease
* Anti-androgens, oral or injectable androgens
* Radiotherapy in pelvic region
A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight

This study will look at how well the new medicine CagriSema helps people with excess body weight lose weight compared to another medicine, semaglutide. The participants will receive one injection once a week. The study medicine will be injected with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1½ years.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age greater than to or equal 18 years at the time of signing informed consent
* a) Body mass index (BMI) greater than or equal to 27.0 kilograms per square meter (kg/m\^2) with greater than or equal to 2 obesity-related complications or b) BMI greater than or equal to 35.0 kg/m\^2 with greater than or equal to 1 obesity-related complication. At least one complication should be hypertension, dyslipidaemia or T2D

Diabetes-related for participant with T2D

* Diagnosed with T2D greater than or equal to 180 days before screening
* HbA1c 7.0-10.0 percent (53-86 millimoles per mole \[mmol/mol\]) (both inclusive) as measured by central laboratory at screening
* Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors \[AGI\], glinides, sodium-glucose cotransporter 2 inhibitor \[SGLT2i\]), thiazolidinediones, or sulphonylureas \[SU\] as a single agent or in combination) according to local label
* Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening

Exclusion Criteria:

Obesity-related

- Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening

Glycaemia-related for participant without T2D

* HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
* History of type 1 or type 2 diabetes

Diabetes-related for participant with T2D

* Renal impairment with estimated glomerular filtration rate (eGFR) lesser than 30 milli liter per min/1.73 meter square (mL/min/1.73 m\^2) as measured by central laboratory at screening
* Clinically significant or severe hypoglycaemia within 6 months of screening or history of hypoglycaemia unawareness
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Safety Study of Rituximab (SC) Administered in Participants With CD20+ DLBCL or CD20+ Follicular NHL Grade 1 to 3A

This open-label, single-arm study will evaluate the safety of rituximab subcutaneously (SC) administered during first line treatment for follicular non-Hodgkin's lymphoma (NHL) (Induction and/or Maintenance treatment plus 24 months of follow up), or diffuse large B-cell lymphoma (DLBCL) (treatment plus 24 months of follow-up).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, cluster of differentiation (CD)20+ DLBCL or CD20+ follicular NHL grade 1 to 3a, according to the world health organization (WHO) classification system
* Currently being treated with rituximab IV in the Induction or Maintenance setting, having received at least one full dose of rituximab IV, defined as standard full dose of rituximab IV 375 milligrams per square meter (mg/m\^2) administered without interruption or early discontinuation because of tolerability issues
* Expectation and current ability for the participants to receive at least four additional cycles of treatment during the Induction phase or six additional cycles of treatment during the Maintenance phase (participants with follicular NHL)

Exclusion Criteria:

* Transformed lymphoma or FL IIIB
* History of other malignancy that could affect compliance with the protocol or interpretation of results. This includes a malignancy that has been treated but not with curative intent, unless the malignancy has been in remission without treatment for greater than or equal to (\>/=) 5 years prior to dosing
Effect of Oxygen-supply on 6-Minute-Walking-Distance of COPD III/IV-patients

The aim of this study is to investigate the six-minute-walking-distance of COPD-patients with breathing oxygen in comparison to breathing normal air. Patients, who increase their walking-distance about more than 15% or 35m only because of breathing oxygen, are so-called "Oxygen Responders." The study is aimed to find attributes of Oxygen Responder and to investigate, if a patient can change the "respond" with higher performance and endurance.


Eligibility Criteria:
Inclusion Criteria:

* Chronic obstructive pulmonary disease III/IV

Exclusion Criteria:

* Severe exacerbations in the last 4 weeks prior to begin of study (definition of exacerbation: symptoms on more than 3 days with a relevant change in drug therapy (cortisone, antibiotics))
* Severe exacerbation during rehabilitation
* Cardiac insufficiency
Exercise Promotion in Primary Care

The investigators conducted a pilot study to determine if telephone counseling, in a health care setting that routinely assesses physical activity of its members, is a feasible approach to improve physical activity among patients with diabetes and prediabetes. The investigators built on an existing innovation at Kaiser Permanente, in which physical activity is assessed at every outpatient visit. The primary aims were to (1) pilot study elements, including database identification of patients; recruitment, training and engagement of health care providers; patient recruitment; data collection procedures; and a 24-week intervention, and (2) to assess feasibility and obtain feedback from key stakeholders on the approach.


Eligibility Criteria:
Inclusion Criteria:

* prediabetes or diabetes not prescribed insulin
* less than 30 min of physical activity per week
* cleared to increase physical activity by primary care provider

Exclusion Criteria:

* health condition that may limit unsupervised physical activity
* height and weight that were combined and resulted in a BMI \> 40 kg/m2
* disabling rheumatoid or osteoarthritis
* ongoing treatment for cancer
* unstable coronary heart disease
A Study Comparing the Risk of Serious Infections and Malignancies With Deucravacitinib or Biologics in Japanese Patients With Psoriasis

The purpose of this study is to further evaluate the safety of deucravacitinib treatment in Japanese patients with psoriasis in the real-world setting


Eligibility Criteria:
Inclusion Criteria:

* Participants with prescriptions in deucravacitinib or any biologics as comparator group during the indexing period.
* Participants with at least one confirmed diagnosis of disease code for psoriasis within 12 months prior to the index date.
* Aged 18 years or older at the index date

Exclusion Criteria:

* Participants with prescription in deucravacitinib or any biologics as comparator group prior to the index date.
* Participants with fewer than 12 months of available claim records prior to the index date.
* Participants with no claims record within 1-year after the index date (no visit after the index date).
* Specific for serious infection: Participants who had at least one disease code of hospitalized infection in the 60 days period before the index date.
* Specific for malignancy: Participants who had at least one disease code of malignancy prior to the index date
Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS

This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia or lymphoma, all with required disease features rendering them eligible for allogeneic transplantation.

Successful blood and marrow transplantation (BMT) requires the infusion of a sufficient number of hematopoietic stem/progenitor cells (HSPCs), capable of both homing to the bone marrow and regenerating a full array of hematopoietic cell lineages with early and late repopulating ability in a timely fashion.

A major drawback of Umbilical Cord Blood (UCB) is the low stem cell dose available for transplantation, compared to mobilized peripheral blood (PB) or bone marrow. This low stem cell dose can compromise the chances of engraftment and contributes to delayed kinetics of neutrophil and platelet recovery, as well as other transplant outcomes.

The aim of ex vivo expansion of cord blood is to provide a graft with sufficient numbers of cells that have rapid and robust in vivo neutrophil and platelet producing potential to enable successful transplantation.

NiCord® is a stem/progenitor cell-based product composed of ex vivo expanded allogeneic cells from one entire unit of UCB. NiCord® utilizes the small molecule nicotinamide (NAM), as an epigenetic approach to inhibit differentiation and to increase the migration, bone marrow (BM) homing and engraftment efficiency of Hematopoietic Progenitor Cells (HPC) expanded in ex vivo cultures. The chief aim of the study is to compare the safety and efficacy of NiCord® single ex-vivo expanded cord blood unit transplantation to unmanipulated cord blood unit transplantation in patients with hematological malignancies following conditioning therapy.

Eligibility Criteria:
Inclusion Criteria:

* Applicable disease criteria
* Patients must have one or two partially HLA-matched CBUs
* Back-up stem cell source
* Adequate Karnofsky/Lansky Performance score
* Sufficient physiological reserves
* Signed written informed consent

Exclusion Criteria:

* HLA-matched donor able to donate
* Prior allogeneic HSCT
* Other active malignancy
* Active or uncontrolled infection
* Active/symptoms of central nervous system (CNS) disease
* Pregnancy or lactation
A Clinical Trial of PRAX-114 in Participants With Major Depressive Disorder

This is a randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of PRAX-114 in participants with moderate to severe major depressive disorder (MDD). Participants will be randomized to receive 28 days of either 40 mg PRAX-114 or placebo in a 1:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

1. Recurrent MDD diagnosis with a current episode duration of at least 8 weeks and no more than 24 months.
2. HAM-D17 total score of ≥23 at Screening and Baseline.
3. Body mass index (BMI) between 18 and 38 kg/m2 (inclusive).

Exclusion Criteria:

1. Lifetime history of seizures, including febrile seizures.
2. Neurodegenerative disorder (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, or Huntington's disease).
3. Lifetime history of bipolar disorder, a psychotic disorder (eg, schizophrenia or schizoaffective disorder), or obsessive compulsive disorder or a history of a psychotic mood episode in last 2 years.
4. Any current psychiatric disorder (other than MDD).
5. Lifetime history of treatment resistant depression.
6. Received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS) within the last year or transcranial magnetic stimulation (TMS) within the last 6 months prior to Screening.
7. Daily consumption of more than 2 standard alcohol-containing beverages for males or more than 1 standard alcohol-containing beverages for females.
A Study of Pembrolizumab in Patients With Advanced Gynaecological Clear Cell Cancer

PEACOCC is a multi-centre, single arm, single stage phase II trial. The overall aim is to determine whether treatment with pembrolizumab is effective in patients with advanced clear cell gynaecological cancer.


Eligibility Criteria:
Main Inclusion Criteria:

1. Histological diagnosis of advanced clear cell ovarian (including primary peritoneal and fallopian tube), endometrial, vaginal, vulval or cervical cancer.
2. Have measurable disease based on RECIST 1.1.
3. Evidence of radiological disease progression.
4. Patient is willing to provide tissue from a newly obtained core or excisional biopsy of a tumour lesion at baseline, 6-8 weeks after start of treatment and at the time of progression.
5. ECOG Performance Status 0 or 1.
6. Patient has a life expectancy of at least 3 months from consent.
7. Received ≥ 1 line of prior chemotherapy .

Main Exclusion Criteria:

1. Has a known diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses \> 10mg prednisolone daily or equivalent or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
2. Has a known history of active TB (Bacillus Tuberculosis), Hepatitis B (e.g., HBsAg reactive), Hepatitis C or a known history of Human Immunodeficiency Virus (HIV).
3. Has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids (at a dose \>10mg predisolone daily or equivalent) or immunosuppressive drugs).
5. Has known history or evidence of active, non-infectious pneumonitis.
6. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
7. Has received a live vaccine within 30 days prior to the planned start of trial treatment.
A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)

This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.

The study may enroll up to 227 subjects in total. CTX110 is a CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells prepared for the treatment of B cell malignancies. The cells are from healthy adult volunteer donors that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR-associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).

Eligibility Criteria:
Key Inclusion Criteria:

1. For NHL patients: Age ≥18 years. For B cell ALL patients: age ≥18 years to ≤70 years
2. Refractory or relapsed non-Hodgkin lymphoma, as evidenced by 2 or more lines of prior therapy, or histologically confirmed B cell ALL, refractory or relapsed.
3. Eastern Cooperative Oncology Group performance status 0 or 1.
4. Adequate renal, liver, cardiac and pulmonary organ function
5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX110 infusion.

Key Exclusion Criteria:

1. For NHL patients: prior allogeneic HSCT. For B cell ALL patients: prior allogeneic HSCT within 6 months, and/or any evidence of GvHD.
2. History of central nervous system (CNS) involvement by malignancy
3. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
4. Presence of bacterial, viral, or fungal infection that is uncontrolled.
5. Positive for HIV, or active hepatitis B virus or hepatitis C virus infection.
6. Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥5 years.
7. For NHL patients: Use of systemic anti-tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of CTX110 infusion. For B cell ALL patients: Use of systemic antitumor therapy within 7 days of CTX110 infusion.
8. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
9. Women who are pregnant or breastfeeding.
Improving Adherence to Prescribing Guidelines for Cholesterol Lowering in Hospitalized Diabetic Patients

We hypothesize that when compared to usual care a greater proportion of hospitalized diabetic patients who are candidates for cholesterol lowering will be discharged with a prescription for a statin if their physicians are contacted by a pharmacist to discuss treatment guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with diabetes
* LDL \>= 100

Exclusion Criteria:

* Terminal illness
* Pregnancy
* Intolerance or contraindication to statin
Temocillin vs Meropenem for the Targeted Treatment of Bacteraemia Resistant to Third Gen Cephalosporins

A Phase 3, Multicenter, Randomised, Controlled, Open-Label Study to demonstrate noninferiority of temocillin (unauthorized investigational medicinal product IMP in Spain, but authorized in Belgium and UK) vs a carbapenem antibiotic (meropenem) in adults with bacteraemia due to third-generation cephalosporin-resistant Enterobacteriaceae.

The duration of treatment will be between 7 and 14 days. From the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.

The objective of the trial is to demonstrate the non-inferiority of temocillin (2g each 8 hours, intravenous) to carbapenems (meropenem 1g each 8 hours, intravenous) in terms of efficacy and safety in the targeted treatment of bacteraemia due to Enterobacteriaceae resistant to third-generation cephalosporins, and therefore provide evidence for the use of temocillin in these infections.

The duration of treatment will be between 7 and 14 days. From the 5th day of intravenous treatment, the sequential oral treatment is permitted if the patient meets appropriate conditions.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with monomicrobial bacteremia due to Enterobacteriaceae showing resistance to cefotaxime, ceftriaxone (MIC \>2 mg/L) and/or ceftazidime (MIC \>4 mg/L), and sensible to temocillin (MIC ≤8 mg/L, except in bacteremia only of urinary origin, for which the criterion is MIC ≤16 mg/L ) and meropenem (MIC ≤2 mg/L).
* Duration of intravenous treatment is planned to be at least 4 days.
* The patient signed informed consent form.

Exclusion Criteria:

* \<18 years
* Pregnancy
* Breastfeeding
* Palliative care
* Allergy to betalactams
* Polymicrobial bacteraemia
* Infections typically needing prolonged \>14 days of therapy (e.g., endocarditis, prosthetic joint infection, vascular graft infection, empyema, chronic prostatitis) or meningitis
* Active empirical treatment\> 96 hours after initial blood culture extraction
* Delay in inclusion\> 48 h
* Recruited in another clinical trial with active treatment
* Peritoneal dialysis or continuous hemofiltration
* extreme gravity or imminent death
Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone

The purpose of this study is to assess the safety and tolerability of Elotuzumab when given in combination with Lenalidomide and low-dose Dexamethasone in subjects with relapsed or refractory multiple myeloma (MM) in Japan.


Eligibility Criteria:
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

* Received between 1 to 4 prior lines of therapy
* Measureable disease
* Men and women of childbearing potential (WOCBP) must be using two acceptable methods of contraception
* Men must agree to use a latex condom and a second form of birth control during sexual contact with WOCBP and must agree to not donate semen during study drug therapy
* Subjects must be willing to refrain from blood donations during study drug therapy

Exclusion Criteria:

* Subjects with non-secretory or oligo-secretory or light-chain only myeloma or active/prior plasma cell leukemia or known /suspect POEMS syndrome
* Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
* Unable to take aspirin daily as prophylactic anticoagulation therapy. Prior history of inability to tolerate weekly 40 mg dexamethasone
* History of renal failure
* History of clinical significant thrombosis, such as treatment for thrombosis was required