cyrilzakka/clinical-trials huggingface dataset:
Drain-Less Abdominally Based Breast Reconstruction Using Lysine-Derived Urethane Adhesive

Drains are routinely utilized in breast reconstruction when using abdominal tissue of the patient to remove fluid buildup while the body heals after surgery. However, drains are associated with patient discomfort, anxiety, decreased mobility, increased hospital stays and outpatient visits. Drains can also serve as a site of origin for infection as the system is not completely closed, and infectious organisms could theoretically use the drain as point of entry.

This proposed study investigates a potential novel mechanism to prevent the development of seromas (pockets of clear fluid which can develop after surgery) in patients who undergo breast reconstruction with their own abdominal tissue. By eliminating the required use of a drain, the study team expects patients to have less pain and use less pain medication, as well as more satisfaction with their overall surgical experience.

Objectives:

1. Establish the safety of a lysine-derived urethane adhesive (TissuGlu, Cohera Medical) in patients undergoing autologous abdominal-based breast reconstruction. This will be assessed via analyzing complication profiles of patients post-operatively. The primary endpoints are rate of seroma development, need for seroma drainage and time to drain removal (if in drain group).
2. Determine if there is a difference in pain and other quality of life measures when comparing patients who do and do not have abdominal drains. This will be assessed via pain medicine utilization and by delivering a targeted survey pre-operatively, as well as at post-operative day three and four weeks.

Study Design:

Patients will be randomized to one of three arms: 1) Traditional closed-suction drains, 2) TissuGlu with closed-suction drains and 3) TissuGlu without closed-suction drains.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing Abdominally-Based Breast Reconstruction

  * Both unilateral or bilateral reconstruction is allowed
* Both delayed or immediate reconstruction is allowed

Exclusion Criteria:

* Diabetes
* BMI\>30
* Active smokers.
Objective Grading of MTS With LSCI and Thermography

Mesenteric traction syndrome (MTS) is defined as hypotension, tachycardia and facial flushing in the first hour of surgery, caused by mesenteric traction/abdominal exploration. MTS occurs frequently during abdominal surgery, with incidence around 80 % during open surgery, and lower during minimally invasive surgery. MTS can be divided into different severities using the degree of facial flushing, with the most severe level of MTS being associated with increased postoperative morbidity.

Today MTS is diagnosed and graded subjectively by the surgical team, with marked difficulty and limitations. Therefore the investigators developed a cut-off value using the Laser Speckle Contrast Imaging (LSCI), which the investigators wish to confirm in a new cohort, while also examining whether LSCI is interchangeable with digital thermography, which is simpler and cheaper to perfom.

The investigators will measure facial perfusion during the first hour of surgery and take blood samples at predefined timepoints to use for biochemical verification of the different severities of MTS.

Three cohorts we planned to include 45 open esophagectomies or gastrectomies 50 whipple surgery 20 robot assisted esophagectomies or gastrectomies These patients will be use in multiple articles examining different aspects of MTS

One study examining LSCI and thermography for the identification and grading of MTS will use 60 patients undergoing open esophagectomy or gastrectomy or whipple surgery, in this study patients will not be excluded if they are found to be disseminated.

However we ended up including 37 open esophagectomies - due to few patients undergoing open esophagectomy, this were included over a time period of almost 2,5 years 50 whipple 11 Robotic esophagectomies - due to LSCI being impossible to use on robotic esophagectomies and thermography being diffciult to fit on these patients and as such not being feasible


Eligibility Criteria:
Inclusion Criteria:

* Undergoing curative surgery for esopageal, gastric, doudenal or pancreatic cancer

Exclusion Criteria:

* Known flushing disease
* Patients recieving NSAID and corticosteroid presurgery, Whipple is allowed to recieve single dose of 125 mg Methylprednisone as part of the standard of care at our facility.
* Palliative surgery
* Surgery not completed due to disseminated disease - patients will still be used in examination of LSCI and Thermography analysis even if desiminated
Monofocal IOL Visual Outcomes When Targeting Mini Monovision

This study is a 3-month, prospective, up to 2 center, bilateral, randomized subject masked clinical evaluation of a monofocal intraocular lens (IOL) when both eyes are targeted for emmetropia and when the non-dominant eye is targeted for mini monovision (-0.75 D) in patients with or without astigmatism undergoing routine cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subject is undergoing bilateral cataract extraction with intraocular lens implantation.
* Willing and able to provide written informed consent for participation in the study
* Willing and able to comply with scheduled visits and other study procedures.
* Scheduled to undergo standard cataract surgery in both eyes within 6 - 30 days between surgeries.
* Subjects who require an IOL power in the range of +5.0 D to +34.0 D only.
* Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion Criteria:

* Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
* Uncontrolled diabetes.
* Use of any systemic or topical drug known to interfere with visual performance.
* Contact lens use during the active treatment portion of the trial.
* Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
* Clinically significant corneal dystrophy.
* Irregular astigmatism.
* History of chronic intraocular inflammation.
* History of retinal detachment.
* Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
* Previous intraocular surgery.
* Previous refractive surgery.
* Previous keratoplasty
* Severe dry eye
* Pupil abnormalities
* Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e. LASIK)
* Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
* Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
* Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
A Clinical Trial of Locally Made Titanium Miniplate and Screw in Maxillofacial Fractures Management

The study is a blind randomized clinical study on patients with midface maxillofacial fractures coming to Cipto Mangunkusumo Hospital. The subject is the fracture line who met the inclusion criteria and randomly allocated into the study (locally-made miniplate and screw) and control (BIOMET® miniplate and screw) group through a predetermined randomization list. The healing process is follow up using non-contrast head computed tomography immediately after surgery as a baseline, and 3 months post-op. Afterward, a radiologist consultant as a blinded evaluator will evaluate the score of bone density, and screw loosening, while local tissue reaction after fixation evaluates during the patient's visit outpatient clinic. All scores from points of the evaluation group will be collected and going to statistically evaluated using independent t-test or Mann Whitney test depending on the distribution of the data


Eligibility Criteria:
Inclusion Criteria:

* Midface fracture with the indication of surgery
* Midface fracture sustained within 2 weeks

Exclusion Criteria:

* Comminuted and defect fracture
* Midface fracture on patients with systemic diseases affecting bone healing.
* Midface fracture in children
* Midface fracture in multiple trauma patients with neurological deterioration
A Retrospective, Observational, Noninterventional Data Collection Study for Patients With Molybdenum Cofactor Deficiency Who Have Been Previously Treated With Cyclic Pyranopterin Monophosphate (cPMP)

The primary objective is to assess safety and efficacy data of Escherichia coli-derived cPMP in patients with molybdenum cofactor deficiency (MoCD).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female of any age.
2. Patient with MoCD type A, suspected type A, or type B.
3. Patient previously received cPMP only by intravenous route of administration.
4. Parent(s) or legal guardian(s), depending on local regulations, has voluntarily provided written informed consent for the Investigator, Investigator's designee, or Sponsor designee to review, collect, transmit, and analyze data extracted from the medical record. In the case of a deceased patient for whom the parents or legal guardians could not be located, the appropriate ethical review committee may assign another person as legal representative to provide consent, where applicable per local and country regulations.

Exclusion Criteria:

* Patient's parent(s) or legal guardian(s) are unable to understand the nature and scope of the study.
Graded Motor Imagery for Patients Within a Year After Stroke.

The aim of the study is to evaluate whether a graded rehabilitation approach including Implicit and explicit motor imagery training and mirror therapy is more effective than other treatments commonly provided in a neuro-rehabilitation department.

Graded Motor Imagery is a graded approach recently proposed for treating chronic pain patients. It included three subsequent steps:

1. Implicit Motor Imagery training (IMI), using a body part laterality discrimination task
2. Explicit Motor Imagery training, using pictures and videos for improving patient's ability in imagining movements
3. Mirror box therapy, using a 35x40 cm mirror,

We are transferring this approach into stroke rehabilitation in order to improve patients' upper limb motor functions.

All the patients, in both groups, will be training 2 hours a day, 5 days/week for 4 weeks. The first hour is standard treatment, the clinician in charge will decide treatment's priorities and the aim(s) of the treatment for each specific patient. The second hour will be focused on patient's upper limb function.

The treatment group will be treated accordingly to the GMI protocol. The control group will receive a second hour of standard treatment, centred on the upper limb. Standard treatments are decided by the interdisciplinary team and might include motor rehabilitation, bilateral arm training, virtual reality training or occupational therapy.

Eligibility Criteria:
Inclusion Criteria:

1. ischemic or hemorrhagic stroke within a year from the event;
2. age of participant between 21 and 85 years old;
3. absence of apraxia or global aphasia;
4. Mini-Mental State Examination score \>23.

Exclusion Criteria:

1. Presence of other neurological or orthopaedic disorders affecting upper extremity motor function,
2. Neglect,
3. Significant spasticity defined as a score ≥ 24 total points at Tardieu Rating Scale (TRS)
Guideline vs Usual Treatment in Schizophrenic Adolescents

The purpose of this study was to evaluate the applicability and usefulness of the guideline treatment for diagnosis and treatment of adolescents with schizophrenia, also to evaluate the compliance to the treatment according to the guidelines, and to compare the treatment compliance, severity of illness and social functioning of patients treated according to guideline treatment vs patients with the treatment as usual on a six month follow up.

The drug treatment of patients on the Guideline Treatment group followed an algorithm, where an atypical antipsychotic must be maintained during 6 weeks before the evaluation of medication change if the PANSS score did not show a reduction of 30% and the patients did not show functional improvement. Clozapine could be administered if two trials of antipsychotics were not effective. Benzodiazepines, antidepressants, anticholinergics or anticonvulsants were allowed for the treatment of comorbid disorders or side effects.

The psychosocial treatment included psychoeducation (three 90 min sessions with the family and two 45 min sessions with the patients), followed by a seven 45 min sessions training on social skills which focused on verbal and non-verbal communication, as well as in conversation skills. Patients were also trained in healthy life style habits and were included on a 30 min of exercise in group.

TAU included an antipsychotic and the psychosocial treatment decided by the clinician

Eligibility Criteria:
Inclusion Criteria:

* Total score ≥ 70 on the Positive and Negative Syndrome Scale (PANSS) and a score of at least 4 (moderate) on 3 of the follow core items (conceptual disorganization , hallucinatory behavior, suspiciousness, and unusual thought content).
* Patients were required to have a score of ≥ 4 symptoms on the Clinical Global Impression Improvement Scale (CGI-S)
* Had not received antipsychotic in proper doses/ a regular antipsychotic treatment for at least 4 weeks previous enrollment.

Exclusion Criteria:

* Unstable medical conditions
* Their diagnosis changed during the study
* Had a history of substance dependence or substance use (except cannabis), -Females with pregnancy
* Refusal to practice contraception during the study.
High Dose Intravenous Ascorbic Acid in Severe Sepsis

Despite an organized treatment approach outlined in expert-consensus guidelines for sepsis with fluid resuscitation to treat hypovolemia, antibiotics to target the infectious insult, and vasopressors for hypotension, mortality rates for sepsis remain high and the incidence continues to rise, making sepsis the most expensive inpatient disease.

1. Recent research has described the therapeutic benefits associated with ascorbic acid treatment for sepsis.
2. Researchers objectives are to perform a randomized-controlled clinical trial investigating the ability of ascorbic acid(vitamin C) administration to decrease organ dysfunction in severe sepsis. The widespread occurrence of microvascular dysfunction in sepsis leading to tissue hypoxia, mitochondrial dysfunction, and adenosine triphosphate (ATP) depletion, gives rise to organ failure.
3. Patients with organ failure and sepsis (severe sepsis) are at a higher risk of death than patients with organ failure alone. Critically ill patients may have an increased requirement for ascorbic acid in sepsis and these patients frequently have levels below normal. Ascorbic acid administration, has been shown to correlate inversely with organ failure (human literature) and directly with survival (animal studies).

4,5 Intravenous ascorbic acid therapy decreases organ failure by providing a protective effect on several microvascular functions including improving capillary blood flow, decreasing microvascular permeability, and improving arteriolar responsiveness to vasoconstrictors. Defining the utility of novel agents to augment researchers care for severe sepsis is an important task as investigators continue the institutional focus on sepsis care.


Eligibility Criteria:
Inclusion Criteria:

Patients with:

1. A suspected or confirmed infection with an order for intravenous antibiotics or antivirals
2. The presence of acute sepsis-induced organ dysfunction

Definition of organ dysfunction:

1. Arterial hypoxemia \[PaO2 /FiO2 \< 300\]
2. Hypotension \[systolic blood pressure (SBP) \< 90 mmHg or SBP decrease \> 40 mmHg\]
3. Lactic acidosis \[lactate \> 2.5 mmol/L\]
4. Acute kidney injury \[creatinine \>2.0 or urine output \< 0.5 ml/kg/hr for \>2 hours despite fluid resuscitation\]
5. Thrombocytopenia \[platelet count \< 100,000\]
6. Acute coagulopathy \[international normalized ratio (INR) \> 1.5\]
7. Hepatic failure \[bilirubin \> 2 mg/dL\].
8. Predisposition, Infection, Response, and Organ Failure (PIRO) score ≥ 10

Exclusion Criteria:

1. Age \< 18 years
2. Pregnancy or breastfeeding
3. Requirement for immediate surgery within the treatment protocol timeframe
4. Inability to obtain written informed consent from subject or surrogate
5. Patient to receive comfort measures only
Experience of Patients Starting Hemodialysis

Patients starting dialysis have significant and often daunting changes to their lifestyle, and investigators have only little information from the patient perspective on patient experiences during dialysis initiation. To explore patient perspectives when starting dialysis, this study aims to collect information on patient perspectives.

Patients starting dialysis have significant and often daunting changes to their lifestyle, and investigators have only little information from the patient perspective on patient experiences during dialysis initiation. To explore patient perspectives when starting dialysis, this study aims to collect information on patient perspectives, understand what made patient experiences better, and what could further improve their experiences when patients first start dialysis. The investigators will enroll patients within 90 days of starting dialysis, and conduct semi-structured recorded interviews with patients. All patients will provide informed consent. The interviews will be transcribed verbatim.

* The transcripts will be reviewed line by line by qualitative researchers to identify concepts and themes, and will be developed into a coding schema.
* The preliminary themes will be discussed among the investigators to facilitate consensus.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving in-center hemodialysis care at Satellite Healthcare at the start of the study period.
* Patients who started with in-center hemodialysis as a first renal replacement therapy.
* Patients receiving dialysis for ≤ 90 days.

Exclusion Criteria:

* Age \< 18 years.
* Unable to understand or communicate in English.
* Inability to participate because of cognitive impairment or active psychological condition.
Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma

Primary purpose： To evaluate the difference of hematopoietic response rate at 1 month after concurrent chemoradiotherapy between iron isomaltide and oral iron supplement for treating iron-deficiency anemia patients with locally advanced nasopharyngeal carcinoma.

Secondary purpose:

To evaluate the difference of hematopoietic response rate, tolerance, acute side effects, qualtiy of life at 2 months and 3 months after concurrent chemoradiotherapy between Iron Isomaltide and oral iron supplement for treating iron-deficiency anemia patients with locally advanced nasopharyngeal carcinoma.

Iron-deficiency anemia patients with locally advanced nasopharyngeal carcinoma will be enrolled and receive iron Isomaltide or oral iron supplement after randomised. The hematopoietic response rate, tolerance, acute side effects, qualtiy of life and long time survival would be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer and sign the informed consent in person.
* Aged 18-65
* Pathological diagnosis of non-keratinizing NPC (differentiated or undifferentiated, as WHO II, III type).
* Clinical stage of III-IVA（8thAJCC/UICC staging system）
* Complete induction chemotherapy and concurrent chemoradiotherapy.
* With ECOG score 0-1.
* Female subjects: surgical sterilization or postmenopausal patients, or agree to use a medical approved contraceptive measure such as Intrauterine device (IUD), contraceptives or condoms during the study period.
* HGB \<130g/L(male)，HGB\<120g/L(female).
* Serum ferritin≤800ug/L。
* Liver function: ALT, AST \< 2.5 times the upper limit of normal (ULN), total bilirubin \< 2.0 × ULN;
* Renal function: serum creatinine \<1.5×ULN.

Exclusion Criteria:

* Recurrence or distant metastasis nasopharyngeal carcinoma.
* Keratinizing squamous cell carcinoma (WHO type I).
* Pregnant or breastfeeding women, who are in their childbearing years and have not used effective contraception.
* Previous or concurrently with other malignancies, exclude cured skin basal cell carcinoma and cervical carcinoma in situ.
* Patients with severely diminished functions of the heart, liver, lung, kidney and bone marrow;
* Serious, unmanaged medical conditions and infections.
* Those with other therapeutic contraindications.
* Use of other investigational medications or clinical studies concurrently.
* Refused or incapacity to sign the informed consent to participate in the study.
* People having mental or personality disorders, disability, or limited civil capacity.
* Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
* HGB\>130g/L(male)，HGB \>120g/L(female).
* Received transfusion therapy before.
* Receipt of oral or IV iron supplements or ESAs up to 4 weeks before inclusion
* Ferritin \> 800 ng/ml
* Ongoing bleeding.