cyrilzakka/clinical-trials huggingface dataset:
Outcome for Patients With War-Associated Extremity Wound Infection

Extremity wounds and fractures constitute the majority of war-associated traumatic injuries, both for civilians and combatants. War-associated injuries are often contaminated with foreign material, leading to infection. Wound infections is considered a major risk to life and restoration of function in war-wounded patients surviving past the first hours. In a cohort study the investigators aim to assess whether the infection itself affects patient outcome (i.e. amputation, death) when comparing patients with and patients without infection.

Armed violence has occurred intermittently in northwestern Pakistan and neighboring Afghanistan since the beginning of the 1980s. In 1981 the International Committee of the Red Cross (ICRC) opened a hospital in Peshawar, Pakistan, to care for the injured from the armed conflict in Afghanistan. In 2004 the number of patients increased as a result of the emerging divergence between the State of Pakistan and militant groups in the Northwestern Pakistan. Yearly about 1000 patients with war-associated injuries, predominantly caused by gunshots and explosive devices have been treated for free at the ICRC hospital in Peshawar. The hospital is now closed.

War-associated injuries are generally treated according to the ICRC war surgical protocol. Research on the epidemiology of and risk factors for wound infection in patients with war-associated injuries is limited and primarily include military combatants, leading to a selection of young males. Due to the use of body armor and forward surgical teams this data may not be applicable to a civilian setting. It is unknown to what extent wound infection itself is a factor contributing to serious complications such as amputation and death. Knowledge is needed to gear resources towards those most in need. This research makes use of a unique database that contains both civilians and combatants of both sexes and all ages. The investigators aim to assess whether the infection itself affects patient outcome (i.e. amputation, death) when comparing patients with and patients without infection.

Eligibility Criteria:
Inclusion Criteria:

* Patients that have received treatment for war-associated extremity wounds
* Patients that present at the hospital within 72 hours of injury
* Patients with valid data on baseline wound status.

Exclusion Criteria:

• Patients that are re-admitted during the study period, i.e. patients that received treatment during the study period and are later re-admitted will only be counted as one patient.
Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid

The clinical trial will be carried out at the Gatot Soebroto Army Central Hospital, Jakarta and planned from June 2020 to December 2020. Clinical trials of Umbilical Cord-Mesenchymal Stem Cells (UC-MSCs) and Conditioned Medium Umbilical Cord-Mesenchymal Stem Cells (CM UC-MSCs) for Keloid were designed in three groups. Group 1 injected with The UC-MSCs at a dose of 2 million cells / cm3 using a 1 cc injection syringe (27G) by intra-lesion injection and booster with CM UC-MSCs at a dose of 1 cc / cm3 using a 1 cc injection syringe (27G) by intra-lesion injection and booster with CM UC-MSCs at the same dose 3 weeks later. Group 3 injected with Triamcinolon acetonide (TA) at a dose of 40 mg / cc / cm3 using 1 cc (27 G) syringe and booster with TA at 3 weeks later. The study subjects each group amounted to 7 patients suffering from Keloid. Patients were evaluated for 3 months after injection.


Eligibility Criteria:
Inclusion Criteria:

* Surgery history of more than 3 months
* Has keloid that the maximum size is 15 cm and thickness is 3-5 mm

Exclusion Criteria:

* Patients with kidney failure
* Pregnancy
* Breastfeeding
* Liver dysfunction
* Blood disorders
* Currently receiving immunosuppressant therapy (chemotherapy or steroids)
* Refusing to participate in the study
EXercise Training for Reducing Anxiety in First-Time Inmates

Clinical trial with 2 arms ("interval exercise training" or "waiting list") aiming at evaluating the anxiolytic effects of a 6 weeks-long exercise training program in first-time prisoners with elevated anxiety symtpoms


Eligibility Criteria:
Inclusion Criteria:

* First-time prisoners ; elevated state anxiety (\> 40 on the state anxiety inventory)

Exclusion Criteria:

* Symptoms of and/or known cardiovascular, metabolic, psychiatric, neurological or neurodevelopmental disease
A Study of Single-dose ALXN2050 in Healthy Adults

This was a phase 1, first-in-human, single-center, randomized, double-blind (participants and investigator blind, sponsor open) placebo-controlled, single-ascending dose study of ACH-0145228 (ALXN2050) conducted in healthy adult participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
* Had a body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of 50 kg.
* Female participant of nonchildbearing potential.
* Male participant agreed to abstinence or use of a highly effective form of contraception.

Key Exclusion Criteria:

* Had a history or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* Had any condition possibly affecting drug absorption.
* Had a body temperature greater than or equal to 38°Celsius on Day -1 or Day 1, Hour 0; had a history of febrile illness, or other evidence of infection, within 14 days prior to first study drug administration.
* Had a positive urine drug screen at Screening or Day -1; was a current tobacco/nicotine user or smoker; had consumed any alcohol within 72 hours before first study drug administration or had a history of regular alcohol consumption within 6 months of Screening.
* Had participated in a clinical study within 30 days prior to first study drug administration
* Had clinically significant laboratory abnormalities,
* Had donated blood or lost more than 500 milliliters of blood within 3 months prior to first study drug administration; had received a blood transfusion or blood products within 6 months prior to first study drug administration.
* Had a clinically significant history of drug allergy.
Efficacy and Safety of Oral Febuxostat in Participants With Gout

The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.

Renal impairment is common in subjects with gout, with the prevalence ranging from 50% to 70%. This population represents an unmet medical need as uricosuric drugs are contraindicated in these patients, and the only available treatment, allopurinol, may have to be dose reduced to avoid overt side effects.

Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.

Treatment duration will be 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Has one or more of the American Rheumatism Association criteria for the diagnosis of gout.
* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
* Must have a serum urate level greater than or equal to 8.0 milligram per deciliter (mg/dL).

Exclusion Criteria:

* Have a severe, unstable, or life threatening medical condition that would likely prevent them from completing this study.
* Has a known body reaction to febuxostat, allopurinol, naproxen, any other non-steroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine, or any components in their formulation.
* History of xanthinuria.
* Alcohol consumption greater than 14/week.
* History of significant concomitant illness.
* Active liver or peptic ulcer disease.
* Has rheumatoid arthritis requiring treatment.
* Has estimated creatinine clearance less than 30 milliliter per minute (mL/min) calculated using the Cockcroft-Gault formula corrected for ideal body weight.
* Requires therapy with any other urate-lowering drug other than the study drug; long-term use of NSAIDs and COX-2 inhibitors; salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; intravenous (IV) colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole;trimethoprim.
Comparison of Craniosacral Therapy vs Pelvic Floor Physical Therapy

The purpose of this study is to determine the efficacy of CST for the treatment of LUTS in patients with MS and evaluate the acute effects compared to PFPT.

A. Objectives To examine the effect of CST as compared to PFPT on QOL, SEMG resting biofeedback readings, and PVR ultrasonography measures in patients with MS and LUTS.

B. Hypotheses / Research Question(s) It is hypothesized that patients who receive CST will demonstrate improved QOL, bladder control and ability to empty bladder as compared to those who receive PFPT.

The purpose of this study is to determine if Craniosacral Therapy is an effective therapy for treating bladder dysfunction in patients with Multiple Sclerosis (MS). It will be compared to standard care for the treatment of bladder dysfunction, which is Pelvic Floor Physical Therapy. Bladder dysfunctions are extremely common in patients with Multiple Sclerosis. One of the most common symptoms of bladder dysfunction is called over-active bladder. Over- active bladder can be described by increased urges to urinate and frequency of urination, especially at night. Other common symptoms are: leakage of urine, with or without activity; inability to hold urine; and a decreased ability to empty bladder when urinating.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Multiple Sclerosis
* Currently have the following symptoms for at least three (3) months or longer: frequent urination, increased urge to urinate, nighttime urination, loss/leakage of urine with or without activity, and/or problems emptying your bladder.

Exclusion Criteria:

* Unable or unwilling to give consent to be treated
* Unable or unwilling to cover your portion of physical therapy treatment (i.e. co-pays and/or deductibles)
* Cannot speak or read English
* Have NOT had any urinary symptoms for at least three (3) months
* Do not have Multiple Sclerosis; or have NOT been diagnosed with Multiple Sclerosis
* Take medication to treat your urinary symptoms; or have taken medication in the past three (3) months to treat your urinary symptoms
* Use an indwelling catheter (i.e. tube inserted into your bladder for continuous urine drainage); or you require intermittent catheterization
* Currently are experiencing any of the following: shooting or radiating pain in your back or abdomen; pain that is not relieved with body position and/or medication; nausea; decreased appetite; pain with bowel movements or urination; and/or any symptom that is new and/or of unexplained onset (i.e. you do not know why it started or when it started)
* Currently have cancer/tumors (i.e. tumors in the spine, brain, pelvis, etc.) and/or aneurysms (i.e. abdominal aortic aneurysm)
* Received Botox injections in the past three (3) months
* Received Pelvic Floor Physical Therapy and/or Craniosacral Therapy in the past three (3) months
Belfort Dildy- Obstetrical Tamponade System Post-Marketing Surveillance Program

This is an open, post-marketing surveillance study obtaining data retrospectively on 300 women, of any age, treated with the BD-OTS for postpartum uterine bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Treatment with the BD-OTS device

Exclusion Criteria:

* None
Post Approval Commitment Study

An agreement has been made to conduct a post-approval commitment study that provides supplementary information relating to the use of Xiapex® as well as other non-pharmacological treatments for Dupuytren's contracture by health care professionals in a real world clinical setting.

phase 4, open label, multi-center, prospective non-interventional descriptive

Eligibility Criteria:
Inclusion Criteria:

* Adults with a palpable cord eligible for the treatment of Dupuytren's contracture

Exclusion Criteria:

none
BD SiteRite(TM) 9 Ultrasound System - Clinical Study

This post-market study is being conducted to generate safety and performance data on the SiteRite 9 System. The data will be utilized to support regional registrations (for example, EU MDR), and document any unforeseen residual risks.

This is an observational post-market, human subject study to evaluate the safety and performance of the SiteRite 9 System. Subjects will be recruited for participation based on need for Vascular Access Device (VAD) placement in a hospital setting.

Enrolled subjects will go through ultrasound-guided Vascular Access Device (USGVAD) placement as part of their clinical care. USGVAD is defined as a procedure in which an ultrasound machine is used to assist a qualified health care provider with IV cannulation from skin puncture through venipuncture via direct visualization on the ultrasound machine in real time.

Eligibility Criteria:
Inclusion Criteria

* Age 1 years, or older
* A patient who is a candidate for an ultrasound-guided VAD placement procedure using SiteRite 9 System as assessed per their clinician(s)
* Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the subject

Exclusion Criteria:

* Any patient in whom ultrasound procedure might interfere with medical care or create undue hardship
* Known, or suspected, allergy to materials contained in the SiteRite 9 System or accessories that may come in contact with the patient
* Localized skin, tissue, or other clinical factors that would prevent completion of the ultrasound procedure
* Previous medical history that would prevent completion of the ultrasound procedure
Interdisciplinary Perioperative Care in Minimally-invasive Heart Valve Surgery

Valvular heart diseases are among the most common cardiac pathologies in adult patients in Germany. Currently, the process of care before, during and after heart valve surgery does not follow a standardized and interdisciplinary optimal approach. An approach already established in other surgical disciplines is the Enhanced Recovery After Surgery (ERAS) protocol, which aims at optimizing the recovery process of patients. Within the INCREASE study, a care process inspired by the ERAS protocol will be established at the University Heart and Vascular Center (UHZ) of the University Medical Center Hamburg-Eppendorf (UKE) and the University Medical Center Augsburg (UKA). Executing the study at two facilities in different regions in Germany will help to demonstrate transferability of the process of care. The effectiveness of this process compared to the current treatment approach will be investigated in a randomized controlled trial. A total of 186 patients will be allocated by chance either to the intervention group (ERAS protocol) or the control group (treatment as usual). Patients in the intervention group will receive an optimized interdisciplinary care protocol including medical, nursing, physiotherapeutical and psychotherapeutical interventions. Measurements of effectiveness are the number of hospitalized days (due to cardiac causes) within one year and the physical condition of the patient as measured by the 6-minute walk test (6MWT) on the day of discharge.


Eligibility Criteria:
Inclusion Criteria:

* Indication for elective minimally invasive (open) aortic or mitral valve surgery
* Patient's ability to understand the nature and extent of the individual's requirements for participation in the new care setting
* Classification of the patient as "FIT" or "Pre-FRAIL" using the LUCAS functional index (frailty index) (Dapp et al. 2012)

Exclusion Criteria:

* Limited life expectancy less than one year (e.g., advanced tumor disease)
* Urgent or emergency interventions
* Severe chronic obstructive pulmonary disease (GOLD III or IV)
* Dialysis-dependant renal failure
* Advanced liver cirrhosis (Child stages B + C)
* Severe comorbidities or psychosocial reasons that militate against participation or do not allow for written informed consent (e. g., residual neurological impairment after prior stroke, major restrictions of mobility, neuropsychological disorders, depressive disorder, substance-related addictive disorders)
* Lack of a social environment that can provide supportive patient care
* Previous cardiac surgery (i.e., relative contraindication for minimally invasive technique)
Characteristic Transcriptomic, Proteomic and Metabolomic Molecular Studies of Nasal Secretions From Chronic Rhinitis

Chronic rhinitis is a common chronic nasal mucosal inflammatory disease. Its clinical symptoms and severity are diverse, mainly including allergic rhinitis, local allergic rhinitis, non-allergic rhinitis with hypereosinophilia syndrome and idiopathic rhinitis. All kinds of rhinitis have clinical symptoms such as nasal congestion, runny nose, sneezing, and nasal itching, but the causes are different. At present, the complicated diagnostic methods of different subtypes of chronic rhinitis are an important factor restricting the improvement of clinical diagnosis and treatment. Based on the found key markers of each subtype of chronic rhinitis, the establishment of a non-invasive classification diagnostic method of chronic rhinitis with nasal secretion as the core is of great practical significance for optimizing the existing clinical diagnosis system and improving the efficiency of clinical diagnosis

To study the characteristic transcriptome, proteome and metabolome molecules of nasal secretions of different subtypes of chronic rhinitis, and to establish a non-invasive diagnostic method for chronic rhinitis based on nasal secretions.Nasal secretions and blood were collected from patients with chronic rhinitis.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years old;
2. Patients with chronic rhinitis in the Department of Otorhinolaryngology, the First Affiliated Hospital of Nanjing Medical University;
3. Patients who are willing to provide specimens for free to promote the diagnosis of chronic rhinitis.

Exclusion Criteria:

1. Patients received glucocorticoids, immunomodulatory drugs, antihistamines, and other treatments that may affect the study results within the past 1 month.
2. Patients with unstable diseases (including severe asthma) and active immune system diseases;
3. Smoking;
4. Pregnant or lactating women; History of nasal surgery within 5.3 months;

6. Patients with low compliance and refusing to accept specimen and questionnaire collection
A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment

The purpose of the study is to assess the long-term use of lacosamide oral solution dosed at 2 mg/kg/day to 12 mg/kg/day when administered to pediatric study participants with epilepsy who have completed NCT01964560 (EP0034) or NCT00938912 (SP848).


Eligibility Criteria:
Inclusion Criteria:

* Participant is male or female, aged \<6 years at the time of signing the Informed Consent Form (ICF)
* Participant has completed participation in NCT01964560 (EP0034) or NCT00938912 (SP848)
* Participant is expected to benefit from participation, in the opinion of the Investigator

Exclusion Criteria:

* Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
* Participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol
* Participant is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
* Participant meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for NCT01964560 (EP0034) or NCT00938912 (SP848), or is experiencing an ongoing serious adverse event (SAE)
* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study
Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

Prospective randomized study comparing guarded Ex-PRESS to trabeculectomy. Primary outcome: IOP and success (complete success defined as IOP between 5-18 mmHg and 20% reduction from baseline without medication or additional glaucoma surgery and qualified success defined as IOP between 5-18 mmHg and 20% reduction from baseline with or without glaucoma medication but no additional glaucoma surgery). Secondary outcomes: number of glaucoma medications, visual acuity, number of complications, corneal pachymetry and corneal endothelial cell counts.

Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 85
* open-angle glaucoma uncontrolled medically
* intraocular pressure ≥ 18 mmHg
* trabeculectomy as the planned surgical procedure

Exclusion Criteria:

* any previous ocular incisional surgery with the exception of previous clear
* cornea cataract surgery
* uveitis
* vitreous present in anterior chamber
* patient unwilling or unable to accept randomization or to give consent or to attend the follow up visits
Carotid Ultrasound Sub-Study of the Familial Atherosclerosis Study-observational Study

This observational study looks at Carotid Stenosis in two groups of subjects using a non-invasive procedure, B-mode ultrasound.

One group of subjects has had long-term intensive lipid altering therapy (lowering LDL-C plus raising HDL-C). The second group of patients has been on conventional "standard of care" treatment for carotid stenosis.

The study will look at the Carotid Intima-media Thickness (CMIT) in both groups.

Hypothesis: CIMT will differ between the two groups, such that the CIMT will be less in the subjects on intensive lipid altering therapy.


Eligibility Criteria:
Inclusion Criteria:

* Intensive Lipid-lowering Therapy Group: Subjects currently enrolled in the Familial Atherosclerosis Treatment Observational Study.
* Usual Care Group: Subjects who were in the FATS OS Study in the past, but have since quit the study and opted for conventional "standard of treatment".

Exclusion Criteria:

* No past or present participation in the FATS OS Study.