cyrilzakka/clinical-trials huggingface dataset:
Open-Label Study of Oral Treprostinil in Digital Ulcers

This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects with SSc and digital ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects who completed assessments for the final visit of the previous TDE-DU-201 controlled trial and who signed appropriate informed consent were eligible to enroll in this extension study.
* If a female of childbearing potential, the subject must have agreed to continue practicing an acceptable method of birth control (i.e., surgical sterilization, approved hormonal contraceptives, barrier methods \[such as a condom or diaphragm\] used with a spermicide, or an intrauterine device).

Exclusion Criteria:

* Have had any change in clinical status that, in the opinion of the Investigator, would pose a safety risk for participation in this extension study;
* Have been found to be unable to complete study assessments in the previous controlled trial;
* Have prematurely discontinued study drug during the previous study due to clinical worsening or treatment related adverse events.
Trilogy Comparison Study - Adults

The objective of this study (Part II) will be to compare the performance of the Trilogy device and a conventional ventilator (participant's current device). Both devices will be set to the participants' current mode and prescription settings.

A. Primary Hypothesis and end-point In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable level of gas exchange (measured as partial pressure of CO2 in arterial or venous blood)and SpO2 levels during various modes of ventilation.

B. Secondary Hypothesis and end-points In patients with respiratory insufficiency, when compared to conventional ventilators, the Trilogy device achieves comparable breathing pattern (tidal volume, respiratory rate, minute ventilation), hemodynamics (heart rate), and subjective measures of breathing comfort (measured by modified Borg dyspnea scale).

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 21 years of age; \< 85 years of age
2. Able to follow instructions
3. Able to provide informed consent
4. Considered clinically stable, with low flow oxygen requirements less than 15 LPM (or FIO2 less than 60 %) and PEEP no greater than 10 cm H2O.
5. Requiring mechanical ventilation through nasal/facial mask,tracheostomy or endotracheal tube (ET Tube)

Exclusion Criteria:

1. Clinically unstable, i.e.,

   1. Acute Respiratory Failure
   2. Participants with refractory hypotension defined as systolic blood pressure less than 90 mm Hg despite inotropic agents),
   3. Uncontrolled cardiac ischemia or arrhythmias,
   4. or as otherwise determined inappropriate for the study as determined by the investigator.
2. Patients suffering from metastatic or terminal cancer and patients with do-not-resuscitate orders
3. Pregnancy
Evaluation of Fluid Volume in Patients With Refractory Hypotension (Fresh-ER)

The objective of the study is to observe the change in hemodynamic variables (i.e. CO, SV, HR, SV) as assessed during rapid fluid bolus.

The Noninvasive Starling SV (Baxter Healthcare) is a portable, non-invasive, cardiac output detector system. The Starling SV system measures the cardiac output by employing electrical bioreactance. Bioreactance is a measure of the electrical characteristics of a volume of tissue and fluid. In the case of cardiac output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood.

The objective of the study is observe the change in hemodynamic variables (i.e. CO, SV, HR, SV) as assessed during the initial resuscitation of 30 ml/kg of fluid, to evaluate the feasibility of performing a larger prospective RCT of SV-guided resuscitation in patients who undergo a dynamic assessment of fluid responsiveness to help guide fluid administration.

This study is a prospective feasibility study. Patients will be evaluated by the Emergency Room team for Inclusion/Exclusion criteria. If the patient is found to fit the study inclusion and exclusion criteria, then the fully non-invasive Starling monitor will be applied to the patient and the patient's hemodynamic data will be prospectively collected during the initial fluid resuscitation.

Eligibility Criteria:
Inclusion Criteria:

Primary Criteria

1. MAP \<65
2. SBP \<90 or BP rapidly trending lower

   Secondary Criteria
3. Low urine output Acute change in urine output less than 50ml/4 hours
4. Persistent hyperlactatemia
5. A new vasopressor started
6. Acute change in HR less than 50 or greater than 120
7. New onset chest pain or chest pain different then admission assessment
8. Acute bleeding
9. Fever \> 39 degrees
10. Significant change in mental status: confusion, agitation, delirium, etc.
11. Unexplained lethargy
12. CRT \>2 seconds -

Exclusion Criteria:

1. Primary diagnosis of: acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmatics, major cardiac arrhythmia, drug overdose, or injury from burn or trauma
2. Known aortic insufficiency, or aortic abnormalities
3. Requires immediate surgery
4. Advanced directives restricting implementation of the resuscitation protocol
5. Known intraventricular heart defect, such as VSD or ASD
6. Prisoner
7. Pregnancy
8. Age \<18
9. Known allergy to sensor material or gel
10. Suspected intra-abdominal hypertension
11. Inability to obtain IV access
12. Patient should be excluded based on the opinion of the Clinician/Investigator
13. Patient has an unstable airway
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma

Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).

This phase II study will assess the clinical response rate to Ibritumomab Tiuxetan in patients with untreated nodal, splenic and non-gastric extranodal MZL as well as in antibiotic resistant patients with mucosa-associated lymphoid tissue (MALT) gastric lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old with previously untreated, histologically confirmed Marginal Zone Lymphoma (non-gastric extranodal MZL, splenic MZL and nodal MZL) or gastric MZL that did not respond to antibiotic therapy given up to 6 months prior to enrollment, but not less than 2 months)
* Measurable and evaluable disease
* All stages are eligible
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (Appendix B)
* Willing and able to provide written informed consent
* Women of childbearing potential must have a negative pregnancy test at study entry and must agree to use effective contraception while on treatment and for 6 months after treatment
* Life expectancy of at least 6 months

Exclusion Criteria:

* Prior chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy before beginning study treatment.
* ≥ 25% lymphoma bone marrow involvement
* Platelet count \< 100,000 cells/mm³
* Neutrophil count \< 1,500 cells/mm³
* Known history of HIV infection
* Pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
* Woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection.
* Physical or mental condition that makes patient unable to complete specified follow-up assessments
Role of 13C Methacetin Breath Test in Predicting Prognosis Among Patients With Acute or Acute on Chronic Liver Failure (ACLF).

Blood will be collected after venepuncture from all patients for complete blood counts, Serum bilirubin (direct and indirect), aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, prothrombin time and INR, urea, creatinine, sodium, potassium, serum total protein and albumin, within 24 hours after admission and twice a week there after or as and when needed.

Time line for blood tests and evaluation of clinical parameters \& 13C-MBT

For ALF patients:

On days 0, 1, 3, and 7

For ACLF patients:

On days 0, 7 (week 1), 14(week 2), 28 (weeks 4)

Blood tests would include:

Serum bilirubin (total and direct), aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyltransferase, Serum proteins (total and albumin), prothrombin time \& international normalized ratio (INR), Serum urea and creatinine, serum electrolytes, arterial ammonia and arterial blood gas analysis.


Eligibility Criteria:
Inclusion Criteria:

- All patients presenting with acute liver failure and acute on chronic liver failure (between 18 - 70 years of age) to Institute of Liver \& Biliary Sciences (ILBS), New Delhi, India.

Exclusion Criteria:

1. Patients with significant co-morbid illnesses such as cardiovascular or respiratory or intrinsic renal diseases which by themselves may have a bearing on the outcome.
2. Patients with previous intestinal bypass surgery for morbid obesity
3. Patients with extensive small bowel resection
4. Patients currently receiving total parenteral nutrition
5. Pregnant women
6. Patients with history of allergy to paracetamol
7. Patients on steroids or anti-fungal agents
8. Patients in encephalopathy
9. Patients unwilling to participate in the protocol
10. Patients on medications which can alter the activity of CYP 1A2 enzymes such as corticosteroids, amiodarone, tetracycline, niacin, valproic acid, methotrexate, stavudine and zidovudine.
Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus

OBJECTIVES:

I. Determine the safety of immune ablation with high-dose cyclophosphamide and anti-thymocyte globulin followed by peripheral blood stem cell support in patients with systemic lupus erythematosus.

PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 1 hour for 2 doses. Patients receive filgrastim (G-CSF) subcutaneously (SC) beginning 24 hours after completion of cyclophosphamide and continuing until leukapheresis is complete. Leukapheresis continues daily until target number of cells is harvested. CD 34+ cells are isolated from peripheral blood stem cells (PBSC) in vitro.

Patients then receive cyclophosphamide IV over 1 hour on days -5 to -2, anti-thymocyte globulin IV over 10 hours on days -4 to -2, and G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients undergo reinfusion of CD34+ PBSC on day 0.

Patients are followed weekly for 90 days, monthly for 1 year, and at 2 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of systemic lupus erythematosus with 1 of the following malignant features:

* Nephritis (WHO class III or IV)
* Failed NIH short-course cyclophosphamide therapy
* Vasculitis/immune complex deposition causing end organ signs or symptoms (e.g., cerebritis, transverse myelitis, pulmonary hemorrhage, cardiac failure, or renal failure)
* Hematologic cytopenias that are immune mediated and uncontrolled by conservative measures with any of the following:

Transfusion-dependent anemia with untransfused hemoglobin less than 8 g/dL

Platelet count less than 40,000/mm3 (without transfusions)

Granulocyte count less than 1,000/mm3

Catastrophic anti-phospholipid syndrome

--Patient Characteristics--

Cardiovascular:

* LVEF at least 35%
* No lupus-induced myocarditis
* No history of unstable angina

Pulmonary:

* FEV1/FVC at least 50% predicted
* DLCO at least 50% predicted

Other:

* HIV negative
* No prior or concurrent malignancy except localized basal cell or squamous cell skin cancer
* No uncontrolled diabetes mellitus
* No medical illness that would preclude study
* No psychiatric illness or mental deficiency that would preclude study
* No known hypersensitivity to E. coli-derived proteins
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
NOICE vs. Nothing | Thermode

This is a prospective, randomized, crossover study on healthy volunteers evaluating the impact of spatial audio on heat pain threshold (HPT). The primary center for this study will be Lucile Packard Children's Hospital (Stanford University, Palo Alto, CA) and other Stanford affiliated sites.

Virtual reality (VR) is a developing, non-pharmaceutical tool that has been shown to reduce perceived anxiety and pain among patients. Although the use of VR in clinical settings is becoming more prevalent, the technology's application has been limited by variable factors, one being patient reluctance in using the VR headset itself. For patients who are provided the opportunity to utilize VR, there are a subset of patients who find discomfort in utilizing VR, as the visual screen of the VR headset can obstruct the patient's view of their surroundings while undergoing a procedure. While spatial audio applications have been found to be an effective intervention for reducing stress and negative moods and evoking positive emotions for patients, it is unknown to what extent spatial audio can reduce pain perceptions.

This study aims to investigate the effects of spatial audio on heat pain threshold in clinical settings, using the novel NOICE device. Unlike traditional VR, NOICE is an immersive headset that provides only spatial audio elements, which can be modulated using a variety of hand gestures. This device will serve as an alternate form of distraction for participants who prefer to not have their vision obscured when undergoing a procedure.

The objective of this proposal is to evaluate the impact of spatial audio on heat pain threshold (HPT) and heat pain sensitivity (HPS), while also analyzing ergonomics, system usability, and device satisfaction of the NOICE device.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 years and older
* English-speaking
* Intact hearing

Exclusion Criteria:

* Use chronotropic heart medications
* Use pain medications
* Current hearing loss
NorMIGS - a Study of Micro-invasive Glaucoma Surgery

NorMIGS is a non-randomized clinical study of intraocular pressure lowering effect and complications after Preserflo microshunt implantation versus other types of glaucoma surgery. The study is conducted in the Department of Ophthalmology, Oslo University Hospital, Norway.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years or older at the time of signing the informed consent form. There is no upper age limit.
* Scheduled for implantation of Preserflo microshunt, trabeculectomy or other types of MIGS
* Ability to cooperate fairly well during the examinations
* Willing to participate in the study and capable of providing informed consent

Exclusion Criteria:

- High intraocular pressure due to increased episcleral venous pressure, hemorrhagic glaucoma, traumatic glaucoma or uveitis glaucoma
Multimodal PT With and Without Proprioceptive Training in Lumber FJS

This will be a randomized clinical trial. The study will be conducted at Pakistan Railways General Hospital Rawalpindi and Riphah International Hospital Islamabad. Patients with FJS will be included. The aim of this study is to find the comparative effects of multimodal physical therapy treatment and proprioceptive training along with multimodal physical therapy treatment on pain, lumbar ranges of motion, disability, fatigue, lumbar lordosis curvature and balance.

Participants will be assessed for pain, lumbar range of motions, lumbar lordosis, disability, fatigue and balance before treatment. The intervention duration is 06 weeks, 03 sessions per week will be given to all participants. Pain and lumbar ranges of motion will be measured on every visit. At the end of 06th week final readings for functional status, fatigue level, lumbar lordosis angle, fall risk and limits of stability will also be recorded. Data will be analyzed by SPSS v.23.


Eligibility Criteria:
Inclusion Criteria:

* Patients with facet joint syndrome diagnosed by standard criteria. This criterion includes:

  * One point tenderness under X-ray radiography
  * Kemp sign.
  * Catching pain.
  * Pain increases with lumbar extension.
  * Pain with bilateral SLR.
  * Or pain diminishes with Medial branch block or Facet joint block.
  * Provocation Maneuver. Acevedo sign (Facet stress sign) Unilateral facet palpation Percussion spinal test Impaired range of motion Jump test
  * Revel's criteria 05 out of 07- 1. age greater than 65 years and pain that was not exacerbated by coughing, not worsened by hyperextension, not worsened by forward flexion, not worsened when rising from flexion, not worsened by extension-rotation, and well-relieved by recumbency.

Standing flexion, returning from standing flexion, standing extension, the extension rotation test.

* On Biodex balance system (BBS), overall stability index between 0.7-2.8.
* On Biodex balance system (BBS) Limits of stability Anterior: less than 80, posterior: less than 40 and lateral: less than 160 (80 on each side) 75% LOS (moderate level).
* NPRS ratings greater than 4
* Constant or Intermittent pain worsening on repeated movements

Exclusion Criteria:

* T-score of -2.5 or lower.
* BMI is 30.0 or higher.
* Patients with Lumbar Postural Syndrome
* Patients with Lumbar Instability
* Post laminectomy/discectomy
* Spondylolisthesis
* Osteoporosis/Fractures
* Cauda equine syndrome
* Recent history of spinal trauma or surgery
* Lumbar myelopathy
* Patients with known metabolic diseases
* Participants having less than 20% ODI scoring
Ultrasound Guided Intermediate Cervical Plexus Block in Thyroid Surgery

studying the effect of dexmeditomidine addition to bupivacaine in bilateral intermediate cervical block for patients undergoing thyroidectomy under general anaesthesia

80 patients who will be undergoing elective thyroidectomy will be randomly allocated into one of two groups ; group A will receive 20 mg isobaric bupivacaine + 8 mg dexamethasone(diluted in 5 ml) group B will receive 20 mg isobaric bupivacaine + 1 ml normal saline. block will be done under complete a septic condition after induction of general anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgery
* ASA 1, II, AND III

Exclusion Criteria:

* Patient refusal
* Infection at the entry site
* BMI \> 3
Comparison of Efficacy in SBRT of Large HCC With or Without TACE

The study aims to compare efficacy and adverse reactions of large hepatocellular carcinoma participants (5-10cm) who receive stereotactic body radiation therapy with or without transcatheter arterial chemoembolization.The investigators will optimize the combined treatment schedule of SBRT for hepatocellular carcinoma participants by comparing overall survival rates, progression-free survival rates and local control and adverse reaction occurrence rates in the two groups.


Eligibility Criteria:
Inclusion Criteria:

* primary HCC diagnosed by a surgeon and/or radiologist and oncologist according to the international guidelines for the management of HCC or by pathology
* single lesion and longest tumor diameter were 5-10cm;
* CP-A or B classification;
* Eastern Cooperative Oncology Group (ECOG) score 0-1;
* distances between tumor and normal organs (esophagus, stomach, duodenum, bowel) are more than 5 mm
* unsuitable for other therapies, such as patients with heart disease, uncontrolled diabetes, uncontrolled hypertension, etc.
* rejecting other therapies such as resection, liver transplantation, etc.
* platelet count≥50 × 109/L, white blood count≥1.5 × 109/L;
* patients infected with hepatitis B virus who are treated with adefovir or entecavir; patients infected with hepatitis C virus whose HCV DNA are negative.

Exclusion Criteria:

* tumor thrombus;
* lymph node involvement;
* extrahepatic metastasis.
Clinical and Basic Study for Pediatric Liver Transplantation

Background: In mainland China, the development of pediatric liver transplantation (LT) has lagged behind that of adult LT during the past two decades, but it has been progressing immensely in recent years. Renji hospital(shanghai) is currently the largest pediatric transplant center in mainland China.

Aim and method: This study is performed for establishment of key techniques for pediatric LT in mainland China, including the indications and timing for pediatric LT, the criteria for donor selections, living donor LT planning, prevention and treatment for posttransplant complications, long-term follow-up management et al.

Outcome measures:

* Annual caseloads of pediatric liver transplantation
* Patient survival: 1-, 3- and 5-year patient survival after liver transplantation
* Graft survival: 1-, 3- and 5-year graft survival after liver transplantation
* Posttransplant complications, such as biliary complications, vascular complications, acute rejections, infections et al.
* Perioperative data, such as duration of operations, postoperative hospital stay et al.
* Clinical data for living donors.

Eligibility Criteria:
Inclusion Criteria:

* Children with end-stage liver diseases
* Children with metabolic disorders for whom liver transplantation are required
* Children with fulminant liver failure
* Children with unresectable hepatic tumors
* Other miscellaneous conditions which need liver transplantation

Exclusion Criteria:

* Recipient age ≥ 18 years
* Patients with metastatic liver tumors
* Severe systmatic infections
* Acquired Immune Deficiency Syndrome
Extended Retroperitoneal Lymphadenectomy and Nerve Plexus Clearance Versus Standard Lymphadenectomy in Pancreaticoduodenectomy

This clinical trial is about the survival benefit of extended lymphadenectomy and nerve clearance versus standard lymphadenectomy in pancreaticoduodenectomy of pancreatic adenocarcinoma，which is a multicenter，prospective，ramdomized clinical trials.

The purpose of this clinical trial is for assessing the survival benefit of extended lymphadenectomy and nerve clearance versus standard lymphadenectomy in pancreaticoduodenectomy of pancreatic adenocarcinoma. And we will focus on the R0 resection using LEEPP(Leeds Pathology Protocol) methods to check whether the tumor is eradicated or not.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years; Karnofsky performance\>70; preoperative diagnosis as resectable pancreatic head cancer; patients' relative have signed consent form.

Exclusion Criteria:

* also have severe cardiopulmonary disease, autoimmune disease, chronic renal failure disease; recurrent pancreatic tumor or unresectable tumor; benign pancreatic tumor; also have other malignant tumors.
4D Medical X-ray Velocimetry for Bronchoscopic Lung Volume Reduction Targeting

This study will investigate the utility of 4D Medical's X-ray Velocimetry (XV) imaging analysis software for the detection of hyperinflation, and compare endobronchial valve placement outcomes with predictive indices obtained utilizing this technique.


Eligibility Criteria:
Inclusion:

* CT chest and PFTs within the last two years
* Age over 18
* COPD with emphysema
* Global Initiative for Chronic Obstructive Lung Disease (GOLD) 3 - 4 classification OR modified Medical Research Council (mMRC) score of 2 or greater.

Exclusion Criteria:

* Pregnancy
* Presence of an additional pulmonary disease beyond COPD
* Inability to raise arms above 90 degrees as required for fluoroscopy