cyrilzakka/clinical-trials huggingface dataset:
Register for Patients With Diabetic Foot Syndrome and Critical Limb Ischemia

Diabetic foot syndrome (DFS) is a disease caused by neurogenic (concerning the nervous system), vascular, mechanic and metabolic factors, which are further complicated by an impairment of the immune system and a corresponding increase in the risk for infections. Results from clinical trials about the efficacy of interventions aimed at reducing the number of patient-relevant end points are of limited comparability due to the heterogenity of patient characteristics. By their very nature, randomized clinical trials (RCT) can only focus on a limited section of the wide range of possible intervention regimes. In clinical practice, however, a number of patients with dfs will never have been part of a clinical trial. Furthermore, there are only very few contemporary registers for this indication from which conclusions with regard to the comparative merits of different therapeutic strategies may be drawn.

The register was conceived to find out to which extent RCT patients are representative for the overall patient collective with dfs and critical limb ischemia and to evaluate the therapeutic success of other treatment strategies. An RCT to assess the efficacy of urokinase versus placebo is imbedded in the register.

August-1 is a register to find out to which extent RCT patients are representative for the overall patient collective with dfs and critical limb ischemia and to evaluate the therapeutic success of other treatment strategies. An RCT to assess the efficacy of urokinase versus placebo is imbedded in the register.

Eligibility Criteria:
Inclusion Criteria:

* diabetic patients with dfs and critical limb ischemia
* age 18 and older

Exclusion Criteria:

* less than 1 year life expectancy
* prior major amputation
* planned major expectation
* prior treatment of the current episode of dfs with urokinase
* mechanical heart valve replacement
* cerebral event with changes in CT during the last three months
* non-remediated proliferating retinopathy
* uncontrolled hypertension (systolic \> 180 mmHg, diastolic \> 100 mmHg)
* hemorrhagic diathesis (spontaneous quick value \< 50%, spontaneous ptt \> 40 sec, thrombocytes \< 100 gpt/l)
* acute gastrointestinal bleeding or ulcers during the last 4 weeks
* prior reverse bypass operation
* concomitant participation in other clinical trials
* insufficient compliance
* premenopausal women not using a safe method of contraception (i. e. IUD, hormone implants, hormone depot injection, combined pill (estrogens and gestagens), vaginal ring or vasectomized partner).
Low Molecular Weight Heparin vs Unfractionated Heparin at Cardiac Surgery

Because the impairment of platelet function may cause excess peri-operative bleeding, pre-operative aspirin discontinuation and heparin bridging are common at cardiac surgery. We aimed to evaluate the impact of a low-molecular-weight-heparin (LMWH), enoxaparin, and unfractionated heparin (UFH) on coagulation parameters and peri-operative bleeding in patients undergoing elective coronary artery bypass grafting (CABG) surgery after aspirin discontinuation.

The specific hypothesis of this study was that a 12 h interval is sufficient not to cause excess peri-operative bleeding, and is therefore an optimal compromise between antithrombotic efficacy and haemorrhagic safety.

Since LMWH provide many pharmacokinetic advantages compared with UFH, and since they are a valid substitution for UFH in a number of settings, such as non-ST elevation acute coronary syndromes and prevention of venous thromboembolism, LMWH may provide a useful bridge to revascularization after aspirin discontinuation in patients undergoing CABG surgery. Obstacles to the spreading of this practice are mainly the absence of solid evidence of equivalence (or superiority) as to efficacy in this setting, and the proof of equal safety, namely the absence of excess bleeding because some studies have suggested an increased number of haemorrhagic complications after LMWH, particularly with the use of higher doses. This might here be a problem, as patients are here generally at high risk of thrombotic events and for this reason need higher doses than for prevention of venous thromboembolism.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 35-75 years with 3-vessel coronary artery disease (CAD)
* Candidates to elective CABG

Exclusion Criteria:

* Other additional (valve, carotid, etc.) simultaneous surgery required,
* Off-pump surgery,
* Any altered liver and kidney laboratory parameters,
* A history of any haemorrhagic disorders,
* Platelet count \<100,000 and \>450.000/μL,
* Treatment with ticlopidine or clopidogrel in the last month.
Theoretical Compared With hands-on Training of Vaginal Breech Management

This trial aims to assess the hypothesis that hands-on training of vaginal breech delivery on a pelvic model is significantly better in terms of a technical skills scoring system compared to frontal teaching.

Primary endpoint is a score describing technical proficiency, ie the OSATS score, consisting of 25 items. Each item, if done correctly, is awarded one point. The maximum OSATS score is 25.

Secondary endpoints are performance time in seconds, cinfidence using a scale from 1-5 with one being very confident and 5 having no confidence when performing the procedures, and self-assessment using a scale of 1-5 with 1 being the optimal grade.

This is a two-arm study. The experimental arm uses a hands-on training and the control arm a frontal teaching approach. The allocation is randomized and single-blinded.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* able to understand German
* Medical student

Exclusion criteria:

* significant language barrier
* previous experience with vaginal breech training
Contingency Management for Opioid and Stimulant Use Disorders in Primary Care

Contingency management (CM) is a behavioral intervention that involves incentivizing participants for target behaviors in a clinical setting. When applied to the treatment of substance use disorders, it has demonstrated efficacy in reducing the number of urine toxicology screens positive for illicit substances and increased engagement in treatment programs. However, there is a need to translate CM treatment to primary care settings. This study will implement and assess a CM program for patients with opioid use disorder, with or without comorbid stimulant use disorder, initiating outpatient addiction medicine services at a family medicine residency clinic. Eligible patients will earn monetary incentives for attending addiction medicine appointments and abstaining from substances during outpatient treatment. Data gathered from this pilot program will be used to improve patient outcomes, treatment, and retention for persons receiving medications for opioid use disorder (MOUDs) in a primary care setting.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Diagnosis of Opioid Use Disorder and/or Stimulant Use Disorder
* Recently initiated medications for opioid use disorder (MOUDs) at Broadway Family Medicine (BFM), within 2 weeks of recruitment
* Have an active prescription for buprenorphine-naloxone (Suboxone)

Exclusion Criteria:

* Prescription for an amphetamine would exclude patients from the abstinence-based CM, but they could participate in the attendance-only CM.
* Dementia, development disabilities, or cognitive functioning that is too low to participate in study measures, as determined by chart review and consultation with overseeing physician.
Reliability and Validity Studies of Turkish Version of Manual Ability Measure-36

This study aim was to investigate the validity and reliability of Turkish version of Manual Ability Measure-36 (MAM-36) in patients with neurological disease.

The reliability and validity of the scale were initiated by language equivalence and cultural adaptation. The MAM-36 scale was translated into Turkish by two experienced physiotherapists who are native Turkish speakers and have a good command of English, following the translation procedures. The two translations were compared with each other and a single Turkish draft was created. This draft was translated back into English by two translators who are native English speakers and have a good command of Turkish. The two back translations were compared to each other and converted into a single form. The resulting form was compared with the original form and the final back-translation scale was created. All translation formats of the scale were examined in detail by those who translated the scale into Turkish and a jury consisting of experienced physiotherapists. At the end of the meeting, the pilot study form of the scale was created. The created draft was applied to 30 healthy individuals as a pilot study. The final version of the scale was created by evaluating the feedback obtained. The clinical phase of the study was carried out on 250 volunteer individuals who applied to Dokuz Eylül University Hospital Neurology Department Polyclinics and were diagnosed with MS, Parkinson's disease, and stroke, and who had various degrees of problems in hand dexterity and functions due to their diseases. To evaluate the validity of MAM-36, Disability of Arm Shoulder and Hand (DASH), which can measure manual dexterity and was validated in Turkish, was used. The scales were repeated 15 days later to assess test-retest reliability.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with a neurological disease (Stroke, Parkinson's or MS)
* At least one upper extremity is affected
* Being conscious enough to complete the survey and knowing how to read and write
* Agreeing to participate in the research
* Being over 18 years old

Exclusion Criteria:

* Having an upper extremity operation within the last 6 months
* Having had an attack or seizure in the last month
* Participating in any physical therapy program during the study
Identification of EGFR-TKIs Sensitivity or Resistance Markers in NSCLC May Help in Optimal Patient Selection

The aim of this study was to retrospectively evaluate associations between EGFR and AKT DNA-polymorphisms involved in transcriptional regulation and overall survival in NSCLC patients treated with EGFR-TKIs.

DNA will be isolated from blood samples or paraffin-embedded tumor specimens and than a mutation analysis and SNPs genotyping will be done.

Eligibility Criteria:
Inclusion Criteria:

* Availability of tumor tissue or blood samples.
* Diagnosis of NSCLC
* At least one treatment with EGFR-TKIs inhibitors

Exclusion Criteria:

* Other than NSCLC primary diagnosis
* No treatment with EGFR-TKIs inhibitors
* No archival tissue available
Comparison of Subjective Outcomes and Changes of Ultrasonographic Morphology of Median Nerves of Mini-open and Endoscopic Carpal Tunnel Release in Patients With Idiopathic Carpal Tunnel Syndrome

A few studies have shown that the mini-incision release technique decreases the pathologic swelling of the median nerve at the inlet of the carpal tunnel and increases the flattening ratio of the median nerve in the carpal tunnel. However, it is unknown whether the endoscopic release technique similarly reverses these pathological changes in the median nerve along the carpal tunnel in patients with CTS compared with the mini-incision release.

Investigators therefore conducted the current study to compare the subjective outcomes and US-measured morphological changes in the median nerve in patients with CTS who received either mini-incision or endoscopic release. Investigators hypothesized that (1) subjective outcomes, as assessed by both the Boston Carpal Tunnel Questionnaire (BCTQ) symptom/function scores and the DASH scores, would be similar 24 weeks after either mini-incision or endoscopic carpal tunnel release; (2) changes in the morphology of the median nerve at each level of the carpal tunnel, as measured under high-resolution US, would be similar 24 weeks after either mini-incision or endoscopic carpal tunnel release; and (3) morphological changes would be correlated with improvements in subjective outcomes 24 weeks after mini-incision or endoscopic carpal tunnel release.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 20 years or older.
* Patients with idiopathic CTS that was confirmed by electrodiagnostic tests
* Patients with idiopathic CTS who were scheduled for carpal tunnel release

Exclusion Criteria:

* Patients with a history of wrist-area fracture or dislocation
* Patients with previous carpal tunnel release
* Patients with associated cervical radiculopathy, cubital tunnel syndrome, thoracic outlet syndrome, diabetes mellitus, hypothyroidism, arthritis, or Burger's disease
* Patients with cognitive impairment that affected the patient's ability to complete the questionnaires
* Patients with worker's compensation issues
* Patients with inadequate follow-up (i.e., less than 24 weeks post-operation)
Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients

ELITE (Eliminate Thromboembolism: Improving Anticoagulation in Non-valvular Atrial Fibrillation Patients) is a two year research project to assess warfarin management issues faced by atrial fibrillation (AF) patients in ambulatory settings.

ELITE will be a prospective, multicenter observational study of 500 participants to characterize demographics, comorbidities, risk profiles, socioeconomic status, and patient preferences related to anticoagulation management. The primary study endpoint will be warfarin discontinuation without resumption as documented in the medical record. Secondary outcomes of interest include warfarin adherence and factors associated with suboptimal adherence and/or permanent discontinuation. Clinical data, including demographics, medical history, and comorbidities, will be abstracted and entered by site coordinators. An internal survey developed by Duke Clinical Research Institute (DCRI) will be administered to patients during regularly scheduled clinic visits. Survey items will include patient treatment priorities, perceived risk of bleeding and/or stroke, barriers to adherence, and treatment satisfaction. Subjects will complete a survey at baseline and at the followup visit closest to 6 months after enrollment.

This study will provide the foundation for numerous potential future questions about medication adherence and barriers to treatment, such as a survey on physician preferences/ shared decision-making (concordance between physician and patient preferences), followup to capture clinical events, and interventions to improve long-term medication adherence in AF.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older at the time of enrollment
* Electrocardiographically confirmed AF
* Able to complete patient-reported outcomes surveys
* Initiated warfarin therapy in the prior 3 months
* Ability to adhere to regular clinical visits
* Ability to sign informed consent
* Ability to read/comprehend/speak English

Exclusion Criteria:

* Anticipated life expectancy less than six months (as determined by the site investigator)
* Transient AF secondary to a reversible condition (hyperthyroidism, pulmonary embolism, post-cardiothoracic surgery)
* Recent Deep Venous Thrombosis(DVT) or Pulmonary Embolism (PE) (within 6 months)
* Participation in a randomized trial of anticoagulation for AF
* Use of a home international normalized ratio (INR) monitoring system
The Influence of Feeding Position on Pulmonary Morbidity in Young Children

Supine feeding position is associated with serous otitis media. The hypothesis is that supine feeding is associated with recurrent otitis media, tonsillar and adenoid hypertrophy and recurrent pneumonia secondary to recurrent aspiration.

The aim of the study is to compare two "mother and child health clinic" stations with similar socioeconomic background. Mothers from the study station will be instructed to feed their children only in an upright position since birth. In the control station mothers will continue to feed their children as usual. Pulmonary morbidity will be evaluated prospectively through the computer system of the insurance companies.

Eligibility Criteria:
Inclusion Criteria:

* Newborn
* Mother's compliance

Exclusion Criteria:

* Bronchopulmonary dysplasia (BPD)
* Asthma
* Cystic fibrosis
* Heart disease
Dexmedetomidine and Bupivacaine With Bupivacaine in Ultrasonography Guided Fascia Iliaca Compartment Block in Adults

Few studies have reported the efficacy of adding dexmedetomidine to bupivacain for fascia illiaca compartment black. Comparison of dexmedetomidine and bupivacaine with bupivacaine alone on the quality of ultrasonography guided fascia iliaca compartment block in adults undergoing femur fracture fixation surgery at 2014.


Eligibility Criteria:
Inclusion Criteria:

* Adults with femural fracture

Exclusion Criteria:

* Hypersensitivity to drugs
* Neurological diseases
* Coagulation abnormalities
* Infection at the site of block
An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease

This is an observational study of OPTIVE PLUS® in patients with dry eye disease in a routine clinical setting. Treatment decisions are made by the physician and reflect the physician's current standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dry eye
* Physician decision to treat with OPTIVE PLUS® in accordance with the physician's standard practice

Exclusion Criteria:

* None
Dynepo Long-Term Safety Study

To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who complete Dynepo study SPD490-301.
2. Patients who continue to require epoetin (EPO) treatment and have had a Hb level of 10g/dL between Weeks 16 and 24 of study SPD490-301.

Exclusion Criteria:

1. Withdrawal, before Week 24, from study SPD490-301.
2. Pregnant or lactating women.
3. Uncontrolled hypertension.
4. Thrombocytopenia (platelet count \<75,000/mm3).
5. Active bleeding disorder (diathesis) (for example, gastrointestinal bleeding or genitourinary tract bleeding).
6. Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to enrolment in this study.
7. Androgen therapy in the 30 days immediately prior to enrolment in this study.
8. Known Human Immunodeficiency Virus (HIV) infection.
9. History of hypersensitivity to Dynepo.
10. Known to have Ab against EPO.
A Study To Assess Effects Of PF-04958242 On Bold Functional Magnetic Resonance Imaging During Working Memory Activation And Arterial Spin Labeling At Rest In Healthy Subjects

The primary objective of this study aims to determine whether the drug affects brain activity in healthy volunteers, either when the participants are performing a memory task, or when lying at rest. Subjects will undergo a brain scan under both of these conditions after a dose of either the study drug or a placebo is administered.The secondary objective is to evaluate the safety and tolerability of the four doses of PF-04958242 administered orally to healthy adult participants.

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

* Body Mass Index (BMI) of 17.5 to 30.5 kilograms per meter squared (kg/m2);
* Total body weight \>50 kilograms (kg) (110 pounds \[lbs\]);

Key Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing);
* Positive urine drug screen;
* Pregnant or nursing females, and females of child bearing potential;
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Adoptive Transfer of Specific HCC Antigens CD8+ T Cells for Treating Patients With Relapsed/Advanced HCC

This study enrolls patients who have relapsed/advanced hepatocellular carcinoma (HCC, BCLC stage C). The HCC tumor relapsed or metastasized through the body after standard treatment or the patients cannot receive standard treatment under current conditions. This research study uses specific HCC antigens CD8+ T cells, a new experimental treatment.

The purpose of this study is to evaluate the safety and tolerance as well as the potential clinical efficacy of an adoptive transfer of CD8+ T cells, sorted with human leukocyte antigen (HLA)-peptide multimers and specific for Glypican (GPC)-3 /New York Esophageal Squamous-1 (NY-ESO-1) /alpha-fetoprotein (AFP) antigens and cultured in vitro, to patients suffering from relapsed/advanced hepatocellular carcinoma (HCC).


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Patients with relapsed/advanced HCC (BCLC, stage C) proved by histopathology or proved by CT or MRI imaging system, proven GPC3/NY-ESO-1/AFP(+), relapsed after previous therapy and no effective therapies known at this time.
* Life expectancy of ≥ 12 weeks.
* WBC\>3.5×10\^9/L, LYMPH\> 0.8×10\^9/L, Hb\>85g/L, PLT\>50×10\^9/L, Cre\<1.5×the upper limit of normal value.
* Able to understand and sign the informed consent.

Exclusion Criteria:

* Any uncontrolled systematic disease: hypertension, heart disease, and et al.;
* Portal vein tumor thrombus, central nervous system tumor metastasis, or combined with other tumors;
* Receiving radiochemotherapy, local therapy, or targeting drugs within 4 weeks prior to this treatment;
* Unstable immune systematic diseases or Infectious diseases;
* Combined with AIDS or syphilis;
* Patients with history of stem cell or organ transplantation;
* Patients with allergic history to related drugs and immunotherapy;
* Patients with complications associated with liver diseases: moderate or severe pleural effusion, pericardial effusion, ascites, or gastrointestinal hemorrhage;
* Pregnant or lactating subjects;
* Unsuitable subjects considered by clinicians.
Survey for Parental Perception of Procedural Analgosedation in Pediatric Age.

The conduction of this study may provide useful information about how much parents know and understand about procedural sedation, helping to identify any gaps. In addition, expectations and concerns about procedural sedation may be highlighted so that strategies aimed at improving communication by health care personnel can be developed. The results may guide the development of training programs for health care personnel so as to improve the management of procedural sedation and interaction with parents.

The study involves the completion of a survey by Parents/Guardians, the remaining interventions will be performed following the normal care procedure outpatient regimen, according to normal clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children between the ages of 2 months and 14 years who are afferent to the withdrawal clinic

Exclusion Criteria:

* None