cyrilzakka/clinical-trials huggingface dataset:
Study on Clinical Features and Outcomes of Breast Sarcoma

This is multi-institutional retrospective study in order to identify the most relevant clinical characteristics, treatment strategies, to explore the impact on principal clinical outcomes and finally, to suggest some principles for management and treatment of breast sarcomas.

The study will collect data about patients affected by breast sarcoma referred to participating Institutions between January 2000 and June 2020

In the field of soft tissue sarcomas, breast sarcomas are a truly peculiar family of rare tumors for both their clinical history and biology of disease.

Surgery (if feasible) is the main therapeutic approach for all the patients with localized disease, while a pharmacological (chemotherapeutic) and/or radiotherapeutic treatment is reserved to those with high-risk/recurrent-relapsing/metastatic disease.

Unfortunately, there is a lack of specific prospective trials in breast sarcoma to guide the clinical decision-making and breast sarcoma patients are often sent to sarcoma referral centers only after surgery Due to sarcoma-specific clinical features, it is clear that both diagnostic and clinical strategies mandate a different approach compared to epithelial tumors. This is of key importance to reach the correct diagnosis, design the best therapeutic decision-making and subsequent follow-up.

Even if retrospective data limitations and biases, in the lack of prospective data collection, these data may be a unique and precious source of information For this reasons this multi-institutional retrospective study is aimed to identify the most relevant clinical characteristics, treatment strategies, to explore the impact on principal clinical outcomes and finally, to suggest some principles for management and treatment of breast sarcomas.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years at diagnosis
* primary or secondary breast sarcoma
* availability of medical data needed for the study (histopathological data, surgery, chemotherapy, including preceding chemotherapeutic regimens for secondary breast sarcomas, radiation therapy)

Exclusion Criteria:

* sarcoma metastases to the breast
* chest wall sarcomas not arising in the mammary gland
* cutaneous sarcomas
A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer

This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Signs of a bleeding in the stomach
* One endoscopically confirmed bleeding ulcer in the stomach or duodenum

Exclusion Criteria:

* Malignancy or other advanced disease.
* Major cardiovascular event.
* Severe hepatic disease
Valiloxybate (XW10172 MR) Efficacy and Safety Parkinson's Disease Study

Following screening visit and verification of inclusion/exclusion criteria and informed consent, participants will undergo a multiple sleep latency test (MSLT) and polysomnogram (PSG) assessments to confirm eligibility for randomization. Participants will be randomized to two groups: placebo or XW10172 MR. The drug will be taken orally at bedtime for 6 weeks of treatment that will consist of a 2-week dose escalation/titration period and a 4-week stable-dose maintenance period. There will be a 2-week safety period following dosing.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease consistent with the UK-PD Society Brain Bank Criteria and PD duration at least 1 year with modified Hoehn and Yahr stage 1-3 in the OFF state.
* Patient reported history of excessive daytime sleepiness (e.g., frequent dozing, nodding, or naps).
* Anti-Parkinson's medications at stable doses for at least 1 month prior to the Baseline Visit and can maintain a fixed, stable dose throughout the study
* Epworth Sleepiness Scale score of \>10 at screening.
* Female participants of childbearing potential must test negative in a serum pregnancy test at Screening and have a negative urine pregnancy test at the Baseline and Visit. Women with childbearing potential must use an acceptable method of contraception during the study and for at least 30 days after completion of dosing.

Exclusion Criteria:

* Atypical or secondary parkinsonism
* Significant medical conditions.
* Evidence of moderate or severe sleep disordered breathing.
* Drugs that affect sleep including CNS depressants and stimulants.
* Montreal Cognitive Assessment (MoCA) examine score \<24.
* Hospital Anxiety and Depression Scales (HADS) \>11.
* Have an occupation that requires variable shift work or routine night shifts or travel across two or more-time zones.
Anti-VEGF Therapy Versus Dexamethasone Implant for DME

We look at a randomized comparative study of 2 FDA approved anti-VEGF agents(aflibercept and ranibizumab) and see how they compare against the dexamethasone implant for phakic as well as pseudophakic eyes with treatment naive diabetic macular edema in terms of efficacy and safety over two years.

A randomized, partially masked, observational/interventional trial looking at the efficacy and safety of 2 FDA approved anti-VEGF agents vis-a-vis the dexamethasone implant as primary therapy for treatment naive diabetic macular edema in phakic as well as pseudophakic patients.

Patients with treatment naive clinically significant macular edema will be randomized to receive one of the aforementioned therapies in a 1:1:1 distribution. Primary inclusion criteria are :

Well controlled diabetes(HbA1c\<7%) and co-morbidities. Central Subfield Thickness of 300 microns or greater BCVA \< or equal to 6/12.

Exclusion Criteria:

Contraindications to the aforementioned drugs Confounding Ocular co-morbidities that can affect visual assessment(except Cataract Grade II or less as per the LOCS III classification) Refusal for enrolment

A comprehensive ocular and systemic examination will be performed along with fundus fluorescein angiography, optical coherence tomography and intraocular pressure measurements with the Goldmann Applanation Tonometer. The BCVA will be recorded using Snellen's chart

Intravitreal injections will be administered using a standardized technique and under strict asepsis. No postoperative antibiotics will be given.

Patients will be followed on postoperative days 1, 7 and then monthly for 2 years.

At each visit, the BCVA, IOP, ocular exam and OCT scans will be performed at each visit.

Patients will be treated as per the guidelines laid out for the treat and extend study. For the dexamethasone implant, re-injections will be allowed first 3 months after the first injection.

Switch therapy is permissible for anti-VEGF agents after 6 months; first to the other anti-VEGF(for 6 more injections) and then to the dexamethasone implant. Rescue Laser therapy is as per physician's description.

Primary outcome measure: The BCVA in each group from baseline to final follow-up at 2 years.

Secondary outcome measure: Change in CST from baseline to years, the number of injections required per group and the complications, if any.

Statistical Analysis will include demographic descriptions, the Shapiro Wilk test to look for normality of distribution, multiple measures ANOVA test, Fisher's exact test, Chi-Square test and paired and unpaired t-test wherever appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Well controlled diabetes(HbA1c\<7%) and co-morbidities. Central Subfield Thickness of 300 microns or greater BCVA \< or equal to 6/12.

Exclusion Criteria:

* Contraindications to the aforementioned drugs Confounding Ocular co-morbidities that can affect visual assessment(except Cataract Grade II or less as per the LOCS III classification) Macular ischemia or proliferative Disease Refusal for enrolment
Clinical Application of Annual Liver Multiscan and MRCP+ in Primary Sclerosing Cholangitis

Primary sclerosing cholangitis (PSC) is a chronic progressive biliary disease that affects approximately 1200 patients in the Netherlands and around 80,000 in the Western world. It is often accompanied by ulcerative colitis (UC) or Crohn's disease affecting the large bowel. The cause of PSC is unknown, there is no medical therapy available that has proven to halt disease progression and the median time until death or liver transplantation is 13-21 years.

Diagnosis is made by magnetic resonance cholangiography (MRC), or in the case of so called small duct disease by liver biopsy.

Due to the heterogeneous disease course and the relatively low clinical event rate of 5% per year it is difficult to predict prognosis of individual patients or to recommend any surveillance strategy for malignancies. Also, the lack of surrogate endpoints impedes performing clinical research. Recently, two new post-processing tools have been developed to characterize and quantify abnormalities in the biliary tree as well as excretory function captured by MRC. These tools called MRCP+ (quantitative magnetic resonance cholangiopancreatography +) and LiverMultiscan (LMS) hold the prospect of adequately depicting and quantifying lesions of the biliary tree as well as capturing functional derailment. However, several features must be tested before the utility of this tools in clinical patient care can be concluded. Therefore, the aim of this study is to investigate the utility of these novel techniques in monitoring disease activity by performing consecutive annual MRI's.


Eligibility Criteria:
Inclusion Criteria:

* Established PSC diagnosis according to the IPSCSG definitions
* Age ≥ 18
* Able to give informed consent

Exclusion Criteria:

* Post LTx
* Known allergy for MRI contrast agents, implants non-compatible with MRI or extreme claustrophobia causing discontinuation of MRI studies.
Response of Individuals With Class II Malocclusion

This investigation aims at distinguishing the subjects that react in a favorable way to the treatment protocol we propose for the Class II treatment

Class II Division 1 is a prevalent malocclusion. Many methods have been utilized to correct it.

The purpose of our prospective study is to clarify the specific cephalometric indicators of biological responsiveness that lead to a successful Class II Div.1 treatment in growing individuals. These indicators will hopefully assist in the differential diagnosis of a "true" and a "pseudo" Class II, that is a masked Class I, that we presume will be relatively easy to treat and stable a treatment result.

70 -100 subjects with a Class II/I malocclusion will be recruited and treated with the exact mode of treatment. As Class II we consider the one that is a t least half molar cusp Class II. Patients will already erupted lower first premolars will be included as we presume this is the approximate time of the maximum growth spurt which we want to exploit using the functional appliance. Crowding in both arches should not exceed 4 mm so as to exclude any denoalveolar changes due to alignment. Any tooth agenesis, besides the third molars, will exclude the subject from the study. The medical history of the patient should be non-contributory regarding any hormonal abnormalities, arthritis and pain from the TMJ. Syndromic patients and those exhibiting craniofacial abnormalities will be excluded.

The skeletal age of each patient will be assessed by observing the cervical column.

Every patient will have his records taken, the latter including a lateral ceph and a panoramic x-ray. Standard intra- and extra oral pictures will be taken as well (T0).

The treatment protocol includes a first phase of 3-4 months of slow palatal expansions utilizing a removable palatal plate with a 0.25 mm jackscrew in the middle (T1). The screw will be turned once a week for two weeks and then twice a week until the upper posterior teeth are over-expanded 2 mm per side. During phase II (T2)the patient will be asked to wear the same appliance adjusted as such to incorporate a tongue crib that will force the mandible into a Class I relationship acthing the way the know functional appliances work (eg activator). The crib will incorporate 4 loops in the canine area and will be placed so as not to impinge in the lower lingual gingival region but it will be long enough so as the patient will not be able to shift the mandible back. If the initial overjet exceeds 5 mm the mandibular advancement will be gradual. Further adjustments will be made so as to maintain the Class I relationship. The patient will wear the appliance for 8-12 months (T3). New records will be taken at that time. If braces are needed, the patient will continue with fixed appliances.

Eligibility Criteria:
Inclusion Criteria:

* Class II Division 1 malocclusion
* Crowding no more than 4 mm per side
* Healthy subjects

Exclusion criteria:

* Hormonal imbalances
* TMJ symptoms
* Craniofacial abnormalities
* Arthritis
Evaluation of Enhanced Therapeutic Effect of Adipose Stromal Vascular Fraction Added With Human Platelet Lysate in Treatment of Osteoarthritis

Osteoarthritis (OA) is a highly progressive and debilitating joint disease. Recently, it was demonstrated the existence of an important link between OA inflammation and progression of structural changes. Therapy with intra-articular injection of stromal vascular fraction (SVF) holds great promises and its efficacy could be further augmented with the addition of biological adjuvants. In the present project, we aim at demonstrating that human platelet lysate (HPL) increases the intrinsic beneficial properties of SVF on cartilage regeneration and joint environment. Moreover, we want to verify if SVF-conditioned medium (CM) obtained from SVF primed with HPL yields comparable or superior outcomes than whole SVF.


Eligibility Criteria:
Inclusion Criteria:

OA patients

* Subscription of informed consent
* BMI \< 30
* age between 55-75 years included
* Kelgrenn-Lawrence equal or superior to grade III
* presence of synovitis
* patients undergoing knee replacement
* suspension of NSAIDs from one week before the surgical procedure according to the standard clinical practice Healthy subjects from aesthetic plastic surgery
* Subscription of informed consent
* BMI \< 30
* age between 18-50 years included
* subjects undergoing liposuction and/or abdominoplasty

Exclusion Criteria:

* HCV, HIV, HBV, TPHA infection
* Pregnancy (auto declaration)
Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001

A randomised, double-blind, parallel-group, study comparing the analgesic effect of intranasal CT001 to intranasal sufentanil, intranasal ketamine or placebo for treatment of acute pain in adults undergoing surgical removal of an impacted mandibular third molar, where bone removal is judged to be needed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (The American Society of Anaesthesiologists' Physical Classification System (ASA) I-II) male or female participants scheduled for surgical removal of an impacted mandibular third molar, where bone removal is judged to be needed
* Age: ≥ 18 and \< 56 years
* Body Mass index above (\>)18.5 or below (\<) 30.0 kg/m2
* Prior to randomisation: Numeric Pain Rating Scale (NRS anchored by 0 = "no pain", 10 = "worst pain imaginable") ≥ 5 at rest within 4 hours after the administration of the last dose of local anaesthetic

Exclusion Criteria:

* Current or history of any clinically significant disease or disorder, which, in the opinion of the investigator, may put the potential subject at risk when participating in the study, or influence the potential subject's ability to participate in the study or influence the study results.
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational product that is likely to introduce additional risk factors, jeopardize study integrity, or to interfere with the study assessments or procedure
* History of increased bleeding tendency
* Clinically significant mental illness
* Opioid Risk Tool score of \>3
* Pain Catastrophizing Scale score, total points \>30
* Hospital Anxiety and Depression Scale (HADS), points ≥ 11 for anxiety or ≥ 11 points for depression
* Daily intake of analgesics
* History of alcohol or drug abuse or use of illicit drugs or positive screen for drugs of abuse at screening or on admission to the Clinic prior to the administration of the investigational product.
* Abnormal nasal cavity/airway
Study to Assess the Effect of Food on the Pharmacokinetics of Meloxicam After Single Administration and to Investigate Dose-proportionality Over a Dosage Range

Study to assess the effect of food on the pharmacokinetics of meloxicam after a single p.o. administration of 22.5 mg meloxicam oral suspension and to investigate dose-proportionality over a dosage range of 7.5 mg to 22.5 mg


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects as determined by results of screening
* Age range from 21 to 50 years
* Broca-Index +- 20%
* In accordance with Good Clinical Practice (GCP) and the local legislation all volunteers will have given their written informed consent prior to admission to the study

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastro-intestinal tract (except appendectomy)
* Disease of the central nervous system (such a epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study
* Use of any drugs which might influence the results of the trial (\<= one week prior to administration or during the trial)
* Participation in another trial with an investigational drug (\<= two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (\>= 100 mL within four weeks prior to administration or during the trial
* Excessive physical activities (within the last week before study)
* Anl laboratory value outside the reference range of clinical relevance
* History of haemorrhagic diatheses
* History of gastrointestinal ulcer, perforation or bleeding
* History of bronchial asthma

For female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception e.g sterilisation, intrauterine pessary, oral contraceptives
* Inability to maintain this adequate contraception during the whole study period
* Lactating
Comparison of High-Dose Chemotherapy + Rituximab and CHOP + Rituximab in High-Risk Follicular Lymphoma

The purpose of this study is to determine whether an intensified treatment plus Rituximab followed by autologous transplantation is superior to a conventional chemotherapy regimen also supplemented with Rituximab.

The place of intensified regimens with autologous stem cell transplantation (ASCT) is poorly defined in FL at diagnosis . Most data arise from studies performed in the pre-Rituximab age. According to these studies, ASCT improved overall survival versus standard salvage approaches in relapsed patients with a high proportion of patients achieving a durable molecular remission. Data at diagnosis are less clear. Three studies have been so far published with contradictory results. Two of these studies showed that intensive therapy ensures a better disease control although in one study a significant extra-mortality from secondary tumors was observed in the intensified arm. A third study found no advantage for patients treated intensively. These results led to the widespread notion that ASCT is not superior to conventional chemotherapy in unselected FL patients. Our previous non-randomized experience employing high dose sequential chemotherapy with a final TBI-free ASCT added some clues to these considerations. Our study employs an autografting procedure which is associated to fewer secondary tumors as it does not include total body irradiation. Moreover we have observed that the our regimen (named HDS) is particularly effective in high-risk patients, suggesting that this specific subgroup is the most appropriate setting for intensified regimens

The present multicenter open label randomized trial took advantage of these observations. In addition we have included Rituximab in both arms as the inclusion of this novel agent is expected to significantly modify the performance of available treatments. We have thus compared a Rituximab-supplemented version of HDS (R-HDS) regimen with six CHOP courses supplemented by an identical number of Rituximab courses. Aim of the study was verify if an intensified approach could be beneficial as first line treatment of high-risk FL patients in the Rituximab age.

Eligibility Criteria:
Inclusion Criteria:

1. Follicular Lymphoma at diagnosis
2. Stage \>I
3. age-adjusted I.P.I. score 2 or 3 or three or more adverse factors of the I.L.I. score

Exclusion Criteria:

1. Serum positivity for HIV, HCV. HBsAg-positive only if active viral replication, assessed by HBV-DNA was present.
2. Major alterations of heart, lung, kidneys, liver, except for those directly disease-related;
3. Evidence of second tumors;
4. Previous chemotherapy( except patients who received limited radiotherapy);
5. Cerebral or CNS involvement.
6. Drug addiction or severe psychiatric disease
Behavior of Cyclists in Response to Pain

A qualitative study, as a follow-up to an earlier study, that provides an opportunity to develop a deeper understanding of the injured cyclist's behavior related to seeking medical attention and endurance of pain. This study includes 10 club-level cyclists who have an injury and either have or have not sought medical attention.


Eligibility Criteria:
Inclusion Criteria:

* Have at least one year of cycling experience and will not compete in multi-sport events such as a triathlon.
* Have had an injury currently or in the recent past associated with biking and experiencing pain related to cycling injury(s).
* Must read and speak English.

Exclusion Criteria:

* Non-English speaking
Tying Devices as a Means of Increasing Exercise

The investigators propose that healthy behaviors such as exercise could be increased through the use of tying devices - mechanisms that force a coupling of addictive activities (listening to the next chapter of a page-turner novel) with engagement in a healthy behavior (exercise).

The study will test the effect of the following treatments as a means of increasing gym attendance over 10 weeks: 1. Participants receive access to 4 iTunes audio novels on their own iPods and prompted to listen to those novels only when exercising at the gym; 2: Participants receive 4 iTunes audio novels for a loaned iPod that they will only have access to at the gym; 3: Participants receive weekly emails asking them about their exercise.

Eligibility Criteria:
Inclusion Criteria:

* Stable health as determined by the screening of their medical history
* Own an iPod
* An interest in exercising more regularly
* Belong to the Pottruck Gym at University of Pennsylvania
* Interested in exercising more through the use of aerobic exercise machines

Exclusion Criteria:

* Recent myocardial infraction
* congestive heart failure
* uncontrolled hypertension
* self-report of 6 or more alcoholic beverages per day or use of any illicit drugs
* bulimia nervosa or related behaviors
* diabetes medication