cyrilzakka/clinical-trials huggingface dataset:
The Duration Study

The purpose of this study is to compare the efficacy of epoetin alfa (PROCRITÂ®) administered subcutaneously (sc) once every week (qw) vs. no epoetin alfa (PROCRITÂ®) treatment in patients with cancer who are anemic.

The purpose of this study is to evaluate hematologic response in patients receiving epoetin alfa (PROCRIT®) therapy for persistent chemotherapy-induced myelosuppression (anemia) after completion of chemotherapy administration as compared to patients who do not receive weekly epoetin alfa (PROCRIT®) immediately after cessation of chemotherapy. Further, the duration of treatment necessary to achieve these endpoints will be studied. A No/Delayed epoetin alfa (PROCRIT®) treatment control (whereby patients in the control group will receive epoetin alfa (PROCRIT®) if their Hb decreases to \< 10g/dL during the study) will be used to establish the frequency and magnitude of changes in clinical end points that may occur when epoetin alfa (PROCRIT®) treatment is not continued (or started) for patients with residual myelosuppression after chemotherapy administration has ended. A 2:1 randomization will be used to give every patient a greater chance to receive immediate treatment (66.6% epoetin alfa (PROCRIT®) treatment vs. 33.3% No/Delayed epoetin alfa (PROCRIT®) treatment). The study will be powered to show differences between the two groups in hematologic response.

In this study, the hematologic response is defined as the proportion of patients who are transfusion-free and are able to maintain their mean Hb level at \>= 11 g/dL during the study without a Hb drop to \<= 10 g/dL and/or transfusion.

The study hypothesis was that immediate epoetin alfa (PROCRIT®) treatment would be more effective in treatment of anemia than No/Delayed epoetin alfa (PROCRIT®) treatment in patients with cancer and persistent chemotherapy-induced anemia. Patients will be randomized 2:1 to receive epoetin alf or no epoetin treatment. The starting dose will be 40,000 Units weekly (QW) or the dose they were on prior to the study (30,000-60,000 Units QW). If the Hb level decreases to \<= 10 g/dL, PROCRIT will be initiated at a dose of 40,000 Units QW.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of non-myeloid malignancy
* Baseline hemoglobin value \>= 11 g/dL and \<= 12 g/dL unrelated to transfusion
* Female patients with reproductive potential must have a negative serum pregnancy test at screening. Patients must have signed an informed consent

Exclusion Criteria:

* Uncontrolled hypertension
* History (within 6 months) of uncontrolled cardiac arrhythmias, or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
* Transfusion within 28 days prior to first dose
* Planned myelosuppressive chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry.
Evaluating the Device FLEXITHERALIGHT Compared to the Conventional Photodynamic Therapy

This study compares the efficacy and tolerance of a new device (FLEXITHERALIGHT) for photodynamic therapy in the treatment of keratosis actinic in comparison of classical PDT with Aktilite®.

The study is an intraindividual comparison of two methods. The number of subjects to be enrolled is 47 patients. All participants will receive both two treatments in a single visit : a first period of 2.5 hours of illumination with FLEXITHERALIGHT device followed by a continuous red light Spectrum (between 7 and 10 minutes) with Aktilite® after an appropriate incubation of methyl aminolevulinate).

Patients will complete a pain assessment scale after receiving both treatments, then, 3 follow up visits will be scheduled.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of minimum 10 previously untreated not pigmented, non-hyperkeratotic AK lesions of Grade I and II of the forehead and/or scalp (according to Olsen et Al. JAAD 1991, cf. REF 31) where other therapies are unacceptable or considered medically less appropriate with a symmetrical repartition on both side of the forehead and/or scalp. The diagnosis of AK will be determined upon clinical evaluation (i.e. visual inspection and palpation) by the investigator.
* Symmetrical areas in terms of number and severity of lesions. The axis of symmetry between the two areas will be defined by the investigator according to the distribution of lesions.
* The two areas to be treated should not be coalescing. A minimum distance of 10mm is required between the lesions located on the 2 symmetrical areas. A minimum distance of 2 mm is required between the lesions on the same side.
* Minimum 5 lesions with similar dimensions at both symmetrical areas will be treated. If the number of lesions is \>7, only 7 lesions on each side will be considered.

Exclusion Criteria:

* Patients with porphyria.
* Patients immunosuppressed for idiopathic, disease specific or therapeutic reasons.
* Use of topical corticosteroids to lesional areas within 2 weeks before PDT.
* Patients receiving local treatment (including cryotherapy and curettage, any - Patients receiving topical treatment (including imiquimod, 5-FU and diclofenac, Picato) in face / scalp area within the last 3 months.
* Use of topical retinoids or alpha-hydroxy acids, urea or systemic retinoids, chemotherapy or immunotherapy within 4 weeks of PDT.
* Pigmented AK lesion(s).
* Known allergy to Metvixia, a similar PDT compound or excipients of the cream including arachis oil, or to peanut or soya.
* Participation in other clinical studies either currently or within the last 30 days.
* Female subjects must be of either:

Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or, Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to study treatment, to rule out pregnancy.

* Any condition which may be associated with a risk of poor protocol compliance.
* Patients currently receiving regular ultraviolet radiation therapy
Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients

The goal of this study is to evaluate long term effects of focused extracorporeal shock wave therapy (fESWT) on triceps surae spasticity in stroke patients according to the number of sessions applied.

Hypothesis: 3 sessions of fESWT on equinus foot in stroke patients improve spasticity and functionality for longer term than 1 session of fESWT.

Spasticity is a common complication as a consequence of suffering a stroke and one of the most important causes of disability in this pathology.

Global data estimate that 12 million people world-wide suffer from spasticity of the upper or lower limb. Equinus foot is the most common pattern of the lower extremities.

Previous studies have reported that extracorporeal shock wave therapy (ESWT) is a safe and noninvasive alternative treatment for spasticity.

Although the authors have shown a beneficial clinical effect of the ESWT, outcomes and duration of effect varied across studies.

This is a prospective randomized controlled trial. 60 stroke patients with spastic equinus foot post stroke will enroll in this study.

The participants will be randomly divided into two groups. The first group (control group) will receive 1 session of fESWT, while the second group (experimental group) will receive 3 sessions of fESWT, once a week, for 3 consecutive weeks.

Therapy will be administered directly to the muscle bellies of the gastrocnemius medial and lateral and soleus. The muscle belly will be located by ultrasonography.

The primary outcome is modified Ashworth scale. Secondary outcomes are passive range of ankle motion, mobility and balance test, spasm frequency scale and quality of life scales.

Participants will be evaluated by the same researcher before the first shock wave therapy and after the last session of fESWT will be done periodic revisions on weeks 1, 4, 8, 12, 20, 24, 36 and 48. Adverse events will be monitored during the study.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years old
* Time from stroke (ischemic o hemorrhagic) onset of at least 6 months
* Spastic equinus foot: triceps surae tone grade at least 1+ on the MAS score
* Ability to walk alone with or without aids

Exclusion Criteria:

* Fixed ankle joint contracture
* Severe medical problems
* Treatment of the affected leg with botulinum toxin in the las 6 months
* Cognitive impairment
Use of Hydralazine and Valproic Acid in Advanced Solid Tumor Malignancies

1. Primary Objective:

   The primary endpoint to this study will be to document the toxicities, and reversibility of toxicities, of this regimen of hydralazine and valproic acid in patients with advanced, unresectable, previously treated lung cancers, for whom no acceptable standard therapy is available. A primary endpoint will be to determine any potential dose limiting toxicities, and the Maximal Tolerated Dose of this regimen.
2. Secondary Objectives:

The secondary endpoint of this study will be to determine any potential anti-tumor effects, as determined by the objective tumor response (complete and partial responses), clinical benefit (complete and partial responses, and clinical benefit), the time to tumor response, the time to tumor progression, and the overall survival.

This study will be an open-label, non-randomized, dose-escalation phase I trial which will enroll in sequential cohorts.

Eligibility Criteria:
Inclusion Criteria:

1. All patients with lung cancer who have disease which has been previously treated and/or for which there is no acceptable standard treatment regimen available, and cannot be treated definitively with either surgery or radiotherapy.
2. All will be appropriate candidates for treatment, and are not candidates for treatment with protocols of higher priority.
3. All patients should have an ECOG/Zubrod/SWOG performance status of less than 2 at the time of the initiation of therapy
4. Adequate end-organ function
5. No severe comorbid disease
6. Ability to provide informed consent.
7. Signed Informed Consent
8. ECOG/Zubrod/SWOG Performance Status less than 2
9. Life expectancy greater than 8 weeks
10. Male or female' age greater than 18 years
11. Patients of childbearing potential must be using an effective means of contraception.
12. Histologic diagnosis of lung cancer that is advanced and cannot be treated adequately by radiotherapy or surgery; or metastatic disease, and for which there is no standard chemotherapeutic option remaining or available
13. All participants must have either previously received or refused standard chemotherapy
14. Baseline laboratory values (bone marrow, renal, hepatic):

Adequate bone marrow function:

1. Absolute neutrophil count greater than 1000/µL
2. Platelet count greater than 100'000/µL

Renal function:

a. Serum creatinine less than 2.0 mg %

Hepatic function:

1. Bilirubin less than 1.5x normal
2. Serum calcium less than 12 mg/dl

Exclusion Criteria

1. Pregnant or lactating females
2. Myocardial infarction or ischemia within the 6 months before Cycle 0' Day 0
3. Uncontrolled' clinically significant dysrhythmia
4. Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion
5. Prior autoimmune disease
6. Uncontrolled metastatic disease of the central nervous system
7. Radiotherapy within the 2 weeks before Cycle 1' Day -14
8. Surgery within the 2 weeks before Cycle 1' Day -14
9. Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
Prediction of Outcome of Lupus Nephritis

The purpose of this study is to clarify the mechanisms involved in the formation and glomerular deposition of immune complexes in lupus nephritis.

The determination of an antibody pattern specific for systemic lupus erythematosus and lupus nephritis may also have a role in predicting disease progression in patients with systemic lupus erythematosus without renal impairment. As for the patients enrolled in the study, the determination of their antibody patterns may contribute to a more targeted and personalized treatment, allowing a prediction of disease progression and the introduction of early targeted treatments, in order to block the onset and/or progression of renal damage.

Prospective multicenter study on the validity of levels of circulating antibodies to glomerular neo-autoantigens (alpha-enolase and annexin AI) and implantable antigens (anti-DNA, histone, istone3, istone4, C1q) as a surrogate biomarker for the diagnosis of lupus nephritis.

The study will involve the collection of serum from patients with lupus nephritis at onset and during subsequent follow-up at 6, 12, 24 and 36 months for the titration of circulating autoantibodies.

As a control the investigators will use the sera of patients with systemic lupus erythematosus without nephropathy, collected at the same time intervals.

The investigators will also assess the antibody positivity in groups of patients with rheumatologic disease similar to lupus (rheumatoid arthritis) and in patients with autoimmune nephropathy without extrarenal clinical signs.

Regarding patients with systemic lupus erythematosus the investigators will collect sera of both incident and prevalent patients in order to monitor changes in antibody levels in conjunction with the development of renal disease.

Clinical tests (renal function, complete blood count, C reactive protein (CRP), ANA, native DNA (nDNA), urine analysis) will be performed at 6, 12, 24 and 36 months and the surplus of blood samples will be used to create the serum bank of the study.

Samples will be collected in the pediatric nephrology of Giannina Gaslini Children Hospital, Genoa (coordinator centre) and in 5 rheumatological (Genoa, Pisa, Pavia, Padova, Brescia) and 6 nephrological (Milan, Genoa, Parma, Brescia, Bologna and Reggio Emilia) italian adults departments .

Eligibility Criteria:
Inclusion Criteria:

* Age between 4 and 65 years
* Diagnosis of lupus nephritis-systemic lupus erythematosus (systemic lupus erythematosus, rheumatoid arthritis and membranous nephropathy for controls)
* Informed consent

Exclusion Criteria:

* Severe infections in place
* Malignancies of any current or history
* Chronic hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) positive
* Breast-feeding or pregnant
* Known hypersensitivity to drugs
Acute-phase Response & Periodontal Treatment in Patients With Hypertension

The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus full-mouth treatment (FM-SRP) in terms of acute-phase responses following non surgical periodontal treatment in patients affected by periodontitis and high blood pressure.

Periodontal treatment, consisting in both supra- and sub-gingival mechanical instrumentation of the root surface (scaling and root planing), will be performed by a single periodontist on patients with periodontitis and hypertension.

The aim of this study is to compare quadrant scaling and root planing (Q-SRP) versus full-mouth treatment (FM-SRP) in terms of acute-phase responses following non surgical periodontal treatment in patients affected by periodontitis and high blood pressure.

Treatment will be provided using both hand and ultrasonic instrumentation with ﬁne tips.

FM-SRP patients will received treatment within 24 h. Q-SRP patients will received four quadrants sessions of periodontal treatment with an interval of 1 week between sessions.

Vital, endothelial function and blood inflammatory parameters will be evaluated at baseline, 24 hours after the first treatment and after 3 months. Periodontal parameters will be evaluated at baseline and after 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by Periodontal Disease
* 20% of periodontal pockets of the entire dentition
* 20% bleeding on probing of the entire dentition
* Documented radiographic bone loss
* Diagnosis of Hypertension as measured through international standards

Exclusion Criteria:

* age younger than 18 years and older than 80 years
* pregnant or lactating females
* need of antibiotic coverage for periodontal treatment
* treatment with statins and/or acetylsalicylic acid
Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation

To gain a better understanding of the underlying dysmotility in constipation in children, we will use a novel minimal invasive method called 3D Transit. We will examine four groups of children aged 7 to 17 years: healthy children, chronically constipated children (ROM IV criteria), children with neurofibromatosis type 1 and finally children receiving chemotherapy (vincristin) for acute lymphoblastic leukemia.


Eligibility Criteria:
Inclusion Criteria applicable to all participants:

• Children between 7-17 years of age where permission is granted for the participation by habitable parents with custody of the child. In case of joint custody, permission must be obtained from both parents.

Inclusion criteria applicable only to healthy participants:

• Gastrointestinal healthy children without chronic constipation

Inclusion criteria applicable only to constipated participants:

• Chronic constipation defined by Rom IV criteria, which is a diagnostic score for chronic constipation

Inclusion criteria applicable only to children in vincristine treatment:

• Children with cancer in treatment with vincristine

Inclusion criteria applicable only to patients with NF1:

• Diagnosis of NF1 with gastrointestinal symptoms

Exclusion Criteria:

* Children with parents who are unable to understand the given particpant's information
* Children with known dysregulated metabolic disease
* Previously major intra-abdominal surgery
* CNS surgery
* Other treatment-requiring gastrointestinal disorder
* Systemic steroid treatment within the last week
* Children with difficulty swallowing
* Children with known gastrointestinal obstruction or perforation
* Acute infections
* Diagnosed malabsorption including bile acid malabsorption
* Menarche in girls
Effects of Clustering Care on the Physiological Stability of Preterm Infants.

This crossover design experimental study aims to compare the physiological stability of premature newborns during and after a cluster of care compared to a period when they receive standard non clustered care at the neonatal unit.

The cluster care will take place at the time of feeding of the premature infants. The intervention will start with a calm period of 20 minutes before the start of care (no manipulations will be allowed), the baby will then received the cluster care for 20 minutes and a quiet period of 30 minutes will follow after the cluster care.

Eligibility Criteria:
Inclusion Criteria:

* between 26 to 31 6/7 weeks of gestation at birth
* more than 72 hours of life,
* receive a respiratory aid such as endotracheal tube, NIPPV (non invasive positive pressures ventilation), CPAP (continuous positive airway pressure) or nasal prongs with oxygen,
* are fed intravenously (IV) or by central venous catheter (CVC),
* one of the parents speaks and reads English or French,
* one of the parents is at least 18 years old to sign the consent.

Exclusion Criteria:

* severely ill (necrotizing enterocolitis, septicemia),
* under respiratory assistance or on a high frequency mode,
* having a congenital or cardiac abnormality,
* requiring surgery,
* sedatives or opioids,
* diagnosed with grade II, III or IV intraventricular hemorrhage and / or hydrocephalus,
* have a device for invasive blood pressure,
* having an oxygen requirement of more than 30% to maintain oxygen saturation within the limits indicated by the NICU (neonatal intensive care unit).
* one of the parents is at least 18 years old to sign the consent.
Repair vs Non-repair of the Pronator Quadratus Muscle in Distal Radius Fractures. RCT.

The purpose of this study is to determine the functional outcome of repairing the pronator quadratus (PQ) muscle in subjects operated for a distal radius fracture (DRF) with volar locked plating.

Fractures of the distal radius are common in the elderly. A frequent treatment of an unstable DRF is surgery with volar plating using the modified Henry's approach. In some cases the fracture mechanism has injured the PQ muscle and subsequent reconstruction of the muscle can be difficult. When the PQ muscle is not injured the plate is fixated through a radial and distal release of the PQ muscle and resuture/repair of the PQ muscle is attempted by most surgeons.

The clinical relevance of repairing the PQ muscle has not previously been investigated in a randomised clinical trial and we hypothesise that there is no difference in functional outcome whether the PQ muscle is repaired or not.

Eligibility Criteria:
Inclusion criteria:

* patients over 18 years.
* patients with an unstable DRF AO type 23 A2, A3, C1, C2 or C3 elected for surgery with volar plating. Unstable is defined as one of the following: 1) More than 10 degrees dorsal angulation of radius' joint surface in lateral plane measured from an orthogonal axis through radius. 2) Ulnar variance more than 2 mm. 3) Fracture line involving joint surface with more than 2 mm dislocation. 4) Incongruence of the DRJ.
* patients that can undergo the surgery in plexus brachialis block (so the operation can be performed in the outpatient department).
* patients with the ability to read and understand Danish.

Exclusion criteria:

* patients with an open fracture.
* patients with a neurologic disorder affecting the fractured upper extremity.
* patients with a history of fracture to the same wrist.
* patients with dementia, substance abuse or severe psychiatric disorder.
* patients who do not agree to be randomised.
* patients unable to continue follow-up.