cyrilzakka/clinical-trials huggingface dataset:
Study of Pazopanib and Paclitaxel in Advanced Non-small Cell Lung Cancer

The Phase I part of the study will identify the doses of pazopanib and paclitaxel that can be administered safely in combination. The Phase II part of the study will not be progressed as documented in Protocol Amendment 01.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* At least 18 years old
* Histologically- or cytologically-confirmed diagnosis of Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC (or for Phase I only, advanced solid tumor for which there is no standard therapy or for whom paclitaxel is standard therapy).
* No prior systemic first-line therapy for advanced disease
* Measurable disease
* ECOG performance status of 0 or 1
* Life expectancy of at least 12 weeks.
* Able to swallow and retain oral medication
* Adequate organ system function (hematological, renal, and hepatic)
* Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception

Exclusion Criteria:

* Active malignancy or any malignancy in the 3 years prior to first dose of study drug other than NSCLC (or for Phase I, other than the primary solid tumor)
* CNS metastases or leptomeningeal carcinomatosis, except for asymptomatic, previously treated CNS metastases
* Clinically significant gastrointestinal abnormalities
* Prolongation of corrected QT interval (QTc) \> 480 msecs
* History of any one or more cardiovascular conditions within the past 6 months prior to randomization
* Poorly controlled hypertension
* History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
* Major surgery or trauma within 28 days or any non-healing wound, fracture, or ulcer
* Evidence of active bleeding or bleeding diathesis
* Recent hemoptysis
* Endobronchial lesions and/or lesions infiltrating major pulmonary vessels
* Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
* Use of any prohibited medication
* Use of an investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug
* Ongoing toxicity from prior anti-cancer therapy that is \>Grade 1 and/or that is progressing in severity except alopecia
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib, paclitaxel, and/or carboplatin.
An Investigation With an Intra-vaginal Device for Stress Urinary Incontinence

This is a prospective, randomized, controlled, two-armed multi-center pre-market trial. Nighty-six (96) subjects will be recruited at sites in Sweden. Patients with diagnosed stress urinary incontinence (SUI), will be considered as potential study participants. After written informed consent has been acquired, a medical and surgical history, a physical examination (including pelvic examination), and a confirmation of the diagnosis of SUI will be performed, followed by a confirmation of the inclusion/exclusion criteria. The study subjects fulfilling all the eligibility criteria will thereafter be randomized 3:1 into either the TVS group or the standard of care (SoC) group.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent Form
2. Over the age of 18 years
3. Women diagnosed with stress urinary incontinence
4. Normal voiding without residual urine ≤100mL
5. Leakage of at least 10 grams per 24 hours (based on pad-weight test)
6. Provoking test with leakage

Exclusion Criteria:

1. History of dominated urgency's symptoms
2. Any contraindication for the investigational device; such as hypersensitivity to silicon rubber
3. Unexplained pelvic bleeding or vaginal discharge
4. Is hysterectomized,has a history of incontinent surgery or surgery for prolapse correction.
5. The woman is currently using prolapse ring
6. Women with prolapse reaching the hymus during coughing.
7. Pregnant or suspicion of pregnancy
8. Urinary tract or vaginal infection
9. History of not being able to use tampons
10. Neurogenic bladder dysfunction
11. The patient is to start, or change an ongoing, pelvic floor training
12. If the patient does not have a well adjusted diuretica, or is to start, or change an ongoing, diuretic treatment
13. The patient is participating in another study on SUI
14. Any other condition that as judged by the investigator may make follow-up or investigations inappropriate
15. Any patient that according to the Declaration of Helsinki is unsuitable for enrollment
Bursa Augmentation in Arthroscopic Rotator Cuff Repair

The aim of this first study is to investigate in a case series through sequential sonographic imaging, using Doppler ultrasonography, the postoperative morphology, especially vascularity and findings of neovascularity, after bursa augmentation in arthroscopic rotator cuff repair.

The outcome of rotator cuff (RC) reconstruction with and without bursa augmentation, considering also the inflammatory status of the bursa, will be systematically investigated for the first time. The influencing role of the inflammatory status of the bursa, of the RC tendon and the synovial membrane at the time of the operation on the tendinous healing rate, the patient-relevant outcome factors and the revision rate will be assessed. In a further approach, basic knowledge about the role of bursa inflammation and its influence in the development and regeneration of tendon pathologies shall be gained. The findings of the whole project could lead to improve tendon healing in the reconstruction of the rotator cuff, taking advantage of augmentation potential of the subacromial bursa.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years and older
* Patient with C-shaped posterosuperior rotator cuff tear (SSP / ± ISP, ± SCP Tear Lafosse ≤ 1 (SCP no repair, only debridement))
* Retraction ≤ 2 according to Patte
* Fatty infiltration ≤ 2 according to Goutallier
* Eligible for arthroscopic double row rotator cuff repair in Suture Bridge technique.
* Written informed consent

Exclusion Criteria:

* Legal incompetence
* Last subacromial cortisone infiltration ≤ 6 months
* Systemic rheumatologic-inflammatory disease
* Diabetes Mellitus
* Smoker
Somatosensation Device Trial

This research is being done to test a new device, called the Somatosensation Device, with people who have either a below knee amputation, or neuropathy (i.e. decreased sensation) in their legs. When people have lost sensation in their feet, it may make walking and balance more difficult. The Somatosensation Device is designed to substitute the loss of feeling in a foot by pressing on nerves on the surface of the leg. It presses on the nerves by using a pneumatic balloon to put pressure on your skin. If people receive this extra sensation feedback, it may help improve their walking and balance.


Eligibility Criteria:
Inclusion Criteria:

* Have a below-knee amputation (either unilateral or bilateral) or neuropathy in their lower limbs.
* Ability to wear the somatosensation device on their lower limbs
* Ability to wear test equipment and heart rate monitors.
* Ability to follow simple directions.

Exclusion Criteria:

* History of severe back pain in the last 3 months.
* History of severe knee pain in the last 3 months.
* Unable to walk for 3 minutes with or without an assistive device
* Poor skin integrity (i.e open wounds, skin breakdown) that could be made worse by wearing the somatosensation device.
Effectiveness of rTMS on Pain and Quality of Life in Patients With Cancer Neuropathic Pain. Clinical Trial.

The purpose of this study is to evaluate the effectiveness of Repetitive transcranial magnetic stimulation (rTMS) on pain and quality of life in patients with cancer neuropathic pain.

Although there are currently different therapeutic options for neuropathic pain, most are limited or restricted to pharmacotherapy. Transcranial magnetic stimulation (TMS) is a tool recently incorporated into neuroscience in the management of neuropathic cancer pain.

The study will include 10 patients with oncologic neuropathic pain who will receive 20 sessions of rTMS and the effect on pain and quality of life.

Neuropathic pain is defined as pain caused by a primary lesion or transient dysfunction of the central or peripheral nervous system. In cancer, it is generated as a consequence of multiple factors such as: direct compression of nerve structures, post-surgical nerve injuries, and nerve injuries secondary to chemotherapy. At least 3.5 million people around the world suffer from this symptom associated with cancer; Of this population, 38% experience pain in all stages and 80% in advanced stages, negatively impacting quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with neuropathic pain of oncological origin
* Patients of legal age (18 years old)
* Patients using their cognitive faculties

Exclusion Criteria:

* Pregnancy
* History of negative reaction to TMS
* History of seizure, history of epilepsy stroke, brain surgery and cranial metal implants.
PCSK9 Inhibitor Treatment for Patients With SPG5

Spastic paraplegia type 5 (SPG5) is a rare subtype of hereditary spastic paraplegia, a highly heterogeneous group of neurodegenerative disorders defined by progressive neurodegeneration of the corticospinal tract motor neurons. SPG5 is caused by recessive mutations in the gene CYP7B1 encoding oxysterol-7a-hydroxylase. This enzyme is involved in the degradation of cholesterol into primary bile acids. CYP7B1 deficiency has been shown to lead to accumulation of neurotoxic oxysterols. Oxysterols were found to impair metabolic activity and viability of human cortical neurons at concentrations found in SPG5 patients, indicating that elevated levels of oxysterols might be key pathogenic factors in SPG5. Monoclonal antibodies that inhibit proprotein convertase subtilisin-kexin type 9 (PCSK9) have emerged as a new class of drugs that effectively lower cholesterol levels. Evolocumab, a member of this class, is a fully human monoclonal antibody that reduces LDL cholesterol levels by approximately 60%. We thus performed this interventional trial with Evolocumab 420 mg for SPG5 patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 14-80 years
* Probands with clinically manifest hereditary spastic paraplegia
* Genetically confirmed diagnosis of SPG5

Exclusion Criteria:

* Comprised treatment with statins 3 months prior to enrolment
* Contraindications to PCSK9 inhibitor therapy
* Pregnancy was excluded in women of childbearing age
A 14-Month Study On The Effects Of CP-945,598 For The Prevention Of Weight Regain In Obese Patients

The purpose of this study is to determine if CP-945,598 is effective in the prevention of weight regain in obese subjects.

The CP-945,598 program was terminated on November 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval. No safety issues were involved in the termination decision.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be overweight (BMI) \>/=30 kg/m2, for subjects without co morbidities; \>/=27 kg/m2 for subjects with co morbidities
* Subjects who are willing and able to comply with 8 week Low Calorie Diet, scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria:

* Participation in a formal weight loss program or significant weight loss (fluctuation \>5% of total body weight) in the past 3 months.
* Subjects with serious medical or psychiatric conditions
Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative Colitis

Ulcerative colitis patients treated with Infliximab (IFX) in deep remission after at least 12 months of treatment will be randomized to continue IFX or to stop IFX and start Azathioprine (AZA).

Each patient will be followed for 12 months.

All eligible subjects will be able to participate in the study at any infusion occurred after 12 months since the beginning. They will be screened by medical history, physical examination, blood and faecal tests (included C-reactive protein and faecal calprotectin), as required by clinical practice. No children, pregnant or breastfeeding women, or elder subjects will be included. A colonoscopy + biopsies in the area of greater inflammation will be performed within ± 3 weeks since the baseline visit. The subjects can then be randomized and receive their first dose of study medication.

Subjects will be then evaluated every 8 weeks for the following 12 months from the randomization. Clinical and blood tests will be performed, and the partial Mayo Score will be calculated at each visit, until the final visit, when a new colonoscopy with biopsies will be repeated and the global Mayo Score will be evaluated. At final visit a new faecal sample for calprotectin will be collected.

Safety of the study treatments will be evaluated at each study visit. In case of study agent discontinuation, the patient will be managed according to usual practice and followed for the entire study period. Patients randomized in AZA arm, could restart IFX.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 -65 years
* Written informed consent and willing to adhere to study procedures.
* Therapy with infliximab since at least 12 months, with one infusion every 8 weeks (a maximum interval between two infusions of ± 3 weeks is allowed)
* Sustained steroid-free remission in the last 6 months prior to inclusion, except for use of steroids as a preventive measure for infliximab infusion reaction, if required by local guidelines.
* Global Mayo score at baseline ≤ 2
* All Mayo subscores ≤ 1
* Absence of rectal bleeding
* Effective methods to avoid pregnancy during the study period

Exclusion Criteria:

* Disabling and persisting extraintestinal manifestation at baseline
* Patients unable to comply with study procedures
* Known intolerance or previous allergic reaction to thiopurines
* Concomitant therapy with allopurinol
* Any disease not compatible with the use of infliximab or azathioprine, as per clinician's judgement.
* Need for dose escalation of infliximab in the last 12 months prior to baseline.
* White blood cell count \< 3000/mmc or absolute clinically relevant lymphopenia at baseline
* Active pregnancy or breastfeeding; willing for pregnancy during the study period
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease

The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥40% from baseline over at least 4 weeks, or renal death.


Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥18 years of age
* Type 2 diabetes mellitus (T2D) as defined by the American Diabetes Association
* Diagnosis of chronic kidney disease (CKD) with at least one of the following criteria at run-in and screening visits:

  * persistent high albuminuria (UACR ≥30 to \<300 mg/g in 2 out of 3 first morning void samples) and estimated glomerular filtration rate (eGFR) ≥25 but \<60 mL/min/1.73 m² (CKD EPI) and presence of diabetic retinopathy or
  * persistent very high albuminuria (UACR ≥300 mg/g in 2 out of 3 first morning void samples) and eGFR ≥25 to \<75 mL/min/1.73 m² (CKD-EPI)
* Prior treatment with angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) as follows:

  * For at least 4 weeks prior to the run-in visit, subjects should be treated with either an ACEI or ARB, or both
  * Starting with the run-in visit, subjects should be treated with only an ACEI or ARB
  * For at least 4 weeks prior to the screening visit, subjects should be treated with the maximum tolerated labeled dose (but not below the minimal labeled dose) of only an ACEI or an ARB (not both) preferably without any adjustments to dose or choice of agent or to any other antihypertensive or antiglycemic treatment
* Serum potassium ≤4.8 mmol/L at both the run-in and the screening visit

Exclusion Criteria:

* Known significant non-diabetic renal disease, including clinically relevant renal artery stenosis
* Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) ≥170 mmHg, sitting diastolic blood pressure (DBP) ≥110 mmHg at run-in visit, or mean sitting SBP ≥160 mmHg, sitting DBP ≥100 mmHg at screening)
* Glycated hemoglobin (HbA1c) \>12%
* Mean SBP \< 90 mmHg at the run-in visit or at the screening visit
* Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association \[NYHA\] class II - IV) at run-in visit (class 1A recommendation for mineralcorticoid receptor antagonists \[MRAs\])
* Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 30 days prior to the screening visit
* Dialysis for acute renal failure within 12 weeks of run-in visit
* Renal allograft in place or scheduled within next 12 months from the run-in visit
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CD for at least 3 months prior to Baseline.
* Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
* Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
* Demonstrated an inadequate response or intolerance to any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.
* If female, participant must meet the contraception recommendations.

Exclusion Criteria:

* Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
* Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
* Participant with the following ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
* Participant with ostomy or ileoanal pouch.
* Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome.
* Screening laboratory and other protocol pre-specified analyses show abnormal results.
Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain

RATIONALE: Radiation therapy such as boron neutron capture therapy may kill tumor cells without harming normal tissue.

PURPOSE: Phase I/II trial to study the effectiveness of boron neutron capture therapy in treating patients who have glioblastoma multiforme or melanoma metastatic to the brain.

OBJECTIVES:

* Determine the time course, uniformity, and severity of acute and chronic normal tissue reactions in patients with glioblastoma multiforme or intracranial melanoma treated with boronophenylalanine-fructose complex (BPA-f) followed by cranial neutron irradiation using a new fission converter beam facility.
* Determine the maximum tolerated dose of cranial neutron capture therapy in these patients.
* Determine, through serial objective measurements, the clinical response in patients treated with this therapy.
* Determine the pharmacokinetics of BPA-f in these patients.

OUTLINE: This is a dose-escalation study of cranial neutron capture therapy (NCT).

Patients receive boronophenylalanine-fructose complex IV over 90 minutes followed by cranial NCT on days 1 and 2.

Cohorts of 3-6 patients receive escalating doses of NCT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD.

Patients are followed at 1, 2, 4, 6, 9, and 12 months and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 16 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed glioblastoma multiforme OR
* Radiographically diagnosed brain metastases after a diagnosis of melanoma
* Contrast-enhanced tumor volume must not exceed 60 mL

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 6 months

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Creatinine normal

Cardiovascular:

* No prior severe cardiac disease, including the following:

  * Uncontrolled arrhythmias or conduction defects
  * Unstable or newly diagnosed angina pectoris
  * Recent coronary artery disease
  * Congestive heart failure

Other:

* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 6 months after study
* No prior phenylketonuria
* No cognitive impairment that would preclude informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No concurrent chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior cranial irradiation

Surgery:

* Not specified