cyrilzakka/clinical-trials huggingface dataset:
Enhanced Recovery After Colorectal Surgery

Introduction: Multimodal rehabilitation (MMR), combines various elements in the management of the surgical patient which lead to a decrease in surgical stress and a more comfortable and faster postoperative recovery.

Objective: To assess the introduction of MMR in a specialized Colorectal Unit and compare the results with the traditional model assessing its´ efficacy as to recovery, and reduction of hospital stay and costs.

Materials y Methods: A prospective randomized trial was conducted which analyzed 119 patients who underwent elective colorectal surgery between 2009 and 2010. 58 patients were assigned to the traditional group and 61 patients to the MMR group. MMR included preoperative education, early feeding and mobilisation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent elective colorectal surgery between 2009 and 2010.
* Signed informed consent
* Live in Valencia metropolitan area

Exclusion Criteria:

* Emergency surgery
* No colonic resection
* Unable to continue follow-up
* Dependent on others for daily activities
Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer

A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients will be treated.

STUDY OBJECTIVES

Primary: Objective response rate

Secondary: Progression free survival, Overall survival and Safety of Tarceva

Study Design: Phase II trial, open label, non-randomized and multicenter.

Expected total enrollment: 46

Study start: January, 2006

Study completation: January, 2008

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years.
* Patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage IA- IIIB).
* Measurable disease.
* Written informed consent must be obtained prior to the inclusion into the trial.
* Karnofsky performance status of 80%.
* Patients must have been treated with no prior chemotherapy or radioterapy.
* Patients must have adequate bone marrow, liver and renal function.

  * Bone Marrow: WBC \> 3000 x 103/mm3,
  * Platelets \> 100 x 103/mm3,
  * Hgb \> 10.0 gm/dl,
  * ANC \>1500 x 103/mm3,
  * Hepatic:Bilirubin \< 2 mg/dl (34 µmol/l); AST, ALT, and Alkaline Phosphatase \< 5 x normal,
  * Renal:Creatinine \< 1.5 mg/dl (132 µmol/l).

Exclusion Criteria:

* Female patients who are pregnant or lactating.
* Patients who have used other investigational agents within 21 days prior to study entry.
* Patients who have received prior treatment with erlotinib or other anti-EGFR agent.
* Significant comorbidity.
NO Sensor to Record Wound Data in Acute or Chronic Wounds

The purpose of this research is to evaluate the ability of a Nitric Oxide (NO) Sensor to collect NO measurement data from an open wound. Previous research suggests that NO levels may indicate the stage of healing the wound is in. This study is being done to determine if the NO Sensor can measure how much NO is in a participant's wound. The researcher will place the NO Sensor into a participant's wound to collect NO measurements for 30-60 minutes. The participant will then have 2 follow-up appointments to see how the wound heals over time.


Eligibility Criteria:
Inclusion Criteria:

1. Extremity injury
2. Wound surface area 2-10 cm in diameter
3. Wound amenable to NO Sensor placement
4. Age at the time of consent ≥ 22 to ≤ 65 years
5. Cognitively able to undergo informed consent discussion and understand the study

Exclusion Criteria:

1. Chemotherapy
2. Pregnancy
3. Preexisting immunosuppressive conditions or immunosuppression therapy
4. Active hemorrhage in the wound bed
5. Physician discretion for patients with complex medical conditions or high mortality risks
6. Patients with an active implanted device, such as a pacemaker, defibrillator, or hypoglossal or vagal nerve stimulator
7. Patients requiring a legally authorized representative (LAR) for informed consent
Advance Care Planning in the Emergency Department

This is a two-armed, parallel-design, pre-/post-intervention assessment study. The investigators will conduct a randomized controlled trial for ED GOAL on a cohort of 120 older adults with serious illness to collect patient-centered outcomes and determine preliminary efficacy on increasing advance care planning engagement (self-reported and/or in the electronic medical record) one month after leaving the emergency department. The investigators will also conduct qualitative interviews with participants of ED GOAL.

ED GOAL, a 6-minute motivational interview conducted in the emergency department (ED), which engages participants to address advance care planning (ACP) conversations with their outpatient clinicians and avoids a time-consuming, sensitive conversation in the time-pressured ED environment. This study is designed to determine the preliminary efficacy of ED GOAL on increasing ACP engagement (by self-report and in the electronic medical record) one month after leaving the ED.

Eligibility Criteria:
Inclusion Criteria:

1. ≥50 years of age AND ≥1 Serious illness\* OR ED clinician would not be surprised if patient died in the next 12 months (a validated prognostic sign)
2. English-speaking
3. Capacity to consent

   1. Patient with mild cognitive impairment or mild dementia with capacity to consent (requires a caregiver/study partner to enroll)
   2. Caregiver of patient with moderate/severe dementia with capacity to consent

(\*) NYHA Stage III/IV congestive heart failure, chronic obstructive lung disease on home oxygen, chronic kidney disease on dialysis, or metastatic solid tumor cancer. In addition, patients with NYHA Stage I/II congestive heart failure, chronic obstructive lung disease not on home oxygen, chronic kidney disease not on dialysis will be included if recent hospitalization in the last 12 months exists.

Exclusion Criteria:

1. Acute physical or emotional distress
2. Determined by treating or study clinician not to be appropriate
3. Clearly documented goals for medical care\*\* (Unless the treating or study clinician recommends that the intervention is clinically indicated)
4. Delirium (assessed using 3D-CAM)
5. Already enrolled in this study
6. Unable/unwilling to schedule the follow-ups on the calendar
7. Receive both the outpatient care for serious illness and primary care outside of the Mass General Brigham health system

(\*\*)e.g., MOLST, medical order for life-sustaining treatment, documented serious illness conversations in clinician notes within the last 3 months, etc.
Intensity Modulated Radiotherapy With Concomitant Boost in Breast Cancer

To assess feasibility of postoperative IMRT with concomitant boost in moderate-high risk breast cancer in terms of late toxicity and local control

Patients treated conservatively with moderate-high risk breast cancer were treated with IMRT plus concomitant boost to surgical bed (up to a dose of 50 Gy to whole breast and 60 Gy to the tumor bed).

Aim of the study was to evaluate late toxicity and local control after this treatment compared with a historical control group (CG) of patients treated with 3D-conformal postoperative radiotherapy delivered with conventional fractionation.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed invasive breast cancer (pT1-4) with at least one of these characteristics: 3 or more metastatic axillary nodes, pre or peri-menopausal status, close resection margins
* breast conservative surgery

Exclusion Criteria:

* positive margins
* distant metastases
Evaluation of Post Operative Pain in Retreatment of Molars Using Different Irrigant

This study evaluates the efficacy of dexamethasone as a intracanal irrigant along with sodium hypochlorite 1% and 5.25% concentrations in post treatment pain for molar root canal retreatment.

Main objective of root canal retreatment is to alleviate pain and disinfect the rootcanal .However some patients may experience mild to severe pain following treatment , which leads to intake of painkillers orally for post operative pain management.

So , this study evaluates the efficiency of dexamethasone used as intracanal irrigant in post treatment pain for molar root canal retreatment sodium hypochlorite (1% \&5.25%) is used for disinfecting the canals patients will be grouped into Symptomatic and Asymptomatic patients requiring root canal retreatment and irrigants will be used in various combinations as mentioned below

1. 1% sodium hypochlorite alone 2.5ml in each canal along with ultrasonic activation
2. 1% sodium hypochlorite and dexamethasone 4mg,2.5ml in each canal along with ultrasonic activation
3. 5.25% sodium hypochlorite alone 2.5ml in each canal along with ultrasonic activation
4. 5.25% sodium hypochlorite and dexamethasone 4mg, 2.5ml in each canal along with ultrasonic activation calcium hydroxide is commonly used as intracanal medicament in all the patients post operative symptoms is evaluated at 12 hrs , 24 hrs,48 hrs, 72 hrs and 1 week followed by obturation is completed

Eligibility Criteria:
Inclusion Criteria:

* teeth previously treated or attempted root canal treatment,
* teeth with or without symptoms,
* periapical radiograph showing evidence of inadequate previous root canal treatment or periapical changes,
* only teeth or at least one canal where complete removal of root canal filling material was possible and reach the working length in first appointment.

Exclusion Criteria:

* patient not willing for follow up,
* teeth with extensive cervical or apical resorption that restricted the use of sodium hypochlorite irrigation,
* teeth with poor periodontal status, teeth not suitable for post endodontic restoration,
* patients with acute periapical abscess,
* patients with systemic conditions preventing radiograph exposure or multi visit treatment,
* pregnant patients,
* patients with allergy to any known dental materials.
Intervention of Growth Mindset for Intern Nursing Students

This is a 12-week growth mindset intervention for the nursing students during clinical rotation practice. It aims at promoting the core self-evaluation and professional self-efficacy for them.

64 intern nursing students from a hospital in China were recruited for this study and randomly assigned to the intervention group and control group.

Eligibility Criteria:
Inclusion Criteria:

* full-time intern nursing students including Junior college and undergraduate students；
* require a clinical nursing internship for at least 8 months ；
* know the purpose of the study and volunteer to participate in the study.

Exclusion Criteria:

* recently experienced significant stress events such as accidental injuries, nursing accidents, etc；
* receiving other training that may affect this intervention.
Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture in Laparoscopic Surgery

Clinical Trial to Evaluate the Safety and Efficacy of MONOFIX® PGCL Suture Compared to Quill MonodermTM Suture in Laparoscopic Surgery


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for hysterectomy by laparoscopic surgery

* Patients who are scheduled to undergo hysterectomy after being diagnosed with benign tumors in the uterus, including uterine myoma, according to the medical judgment of the investigator
* Laparoscopic surgery includes general laparoscopic surgery and robotic surgery.)

Exclusion Criteria:

1. Patients with contaminated wounds
2. Diseases that may affect wound healing
3. When gynecological malignancy or intra-abdominal metastasis is confirmed at the time of enrollment
Can the Electronic Nose Smell COVID-19?

Infection with SARS-CoV-2 causes Corona Virus Disease (COVID-19). The most standard diagnostic method is reverse transcription-polymerase chain reaction (RT-PCR) on a nasopharyngeal and/or an oropharyngeal swab. The high occurrence of false-negative results due to the non-presence of SARS-CoV-2 in the oropharyngeal environment renders this sampling method not ideal. Therefore, a new sampling device is desirable. This proof-of-principle study investigates the possibility to train machine-learning classifiers with an electronic nose (Aeonose) to differentiate between COVID-19 positive- and negative persons based on volatile organic compounds (VOCs) analysis.

Methods: between April and June 2020, participants were invited for breath analysis when a swab for RT-PCR was collected. If the RT-PCR resulted negative, presence of SARS-CoV-2 specific antibodies was checked to confirm the negative result. All participants breathed through the Aeonose for five minutes. This device contains metal-oxide sensors that change in conductivity upon reaction with VOCs in exhaled breath. These conductivity changes are input data for machine-learning and used for pattern recognition. The result is a value between -1 and +1, indicating the infection probability.


Eligibility Criteria:
Inclusion Criteria:

* Participants of whom an oropharyngeal or nasopharyngeal swab was collected to perform RT-PCR on.

Exclusion Criteria:

* Participants who were experiencing dyspnea or needed supplemental oxygen.
Donor Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma

RATIONALE: Giving chemotherapy and monoclonal antibody therapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

PURPOSE: This phase II trial is studying donor stem cell transplant in treating patients with mantle cell lymphoma.

OBJECTIVES:

Primary

* Determine progression-free survival in patients with mantle cell lymphoma undergoing low-intensity allogeneic stem cell transplantation.

Secondary

* Determine overall survival of these patients.
* Determine the toxicity by way of adverse event profile of this regimen in these patients.

OUTLINE: This is a multicenter study.

* Reduced intensity conditioning: Patients receive carmustine IV over 2 hours on day -6, etoposide IV over 1 hour and cytarabine IV over 15 minutes on days -5 to -2, alemtuzumab IV over 2 hours on days -5 to -1, and melphalan IV on day -1.
* Donor stem cell transplant: Patients undergo stem cell transplantation on day 0 with filgrastim (G-CSF)-mobilized peripheral blood stem cells or bone marrow stem cells.
* Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV or orally on day -1 to 30 and taper to day 100.
* Donor lymphocyte infusion (DLI) therapy: Patients with evidence of disease progression, mixed chimerism, or low level residual disease undergo DLI every 3 months for up to 15 months in the absence of GVHD.

After completion of study, patients are followed every 3 months for 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed diagnosis of mantle cell lymphoma
* No relapsed or progressive disease
* Achieved at least a partial remission following induction chemotherapy
* HLA-matched donor available
* Blood samples from both patient and donor available for chimerism studies
* No central nervous system involvement

PATIENT CHARACTERISTICS:

* ECOG performance status 2-4
* Considered fit for transplant by treating physician
* Serum bilirubin ≤ 1.5 times upper limit of normal
* Alkaline phosphatase ≤ 2 times normal
* Creatinine clearance ≥ 50 mL/min
* Ejection fraction \> 50% (no inadequate cardiac function)
* Not pregnant or nursing
* Negative pregnancy test
* No symptomatic respiratory compromise
* No serious concurrent disease which would preclude allograft
* No known serological positivity for hepatitis B, hepatitis C, or HIV
* No history of a psychological illness or condition that would affect compliance
* No previous malignancy within the past 5 years except nonmelanoma skin tumors or stage 0 (in situ) cervical carcinoma

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Interest of the HEART Score for the Management of Patients With Chest Pain in Emergency Department

Chest pain is a frequent reason of consultation in emergency department. Emergency physician have to identify patients at high risk of Acute Coronary Syndrome from those presenting a lower risk.

The aim of the study is to study the interest of the HEART score for the management of patients with chest pain in emergency department

Eligibility Criteria:
Inclusion Criteria:

men and women Aged more than 18 Chest pain Consulting in emergency department Agreeing to participate to the study

Exclusion Criteria:

aged less than 18 not agreeing to participate to the study
Oval-8 Splinting Versus Standardized Treatment With Tee Pee or Forearm Based Thumb Spica Splinting

The oval-8 splint has been developed for many uses in finger pathology and trauma. It has not, however, been used to treat thumb carpometacarpal (CMC) joint arthritis. When treating thumb CMC joint osteoarthritis, splinting is a very widely used and supported treatment option for non-operative management. Many studies have been performed showing that thumb spica splinting in abduction with either a hand based or forearm based splint improves pain. This study aims to compare the effects of a novel splinting approach with oval-8 splints for the hyperextended thumb interphalangeal (IP) joint vs. standardized treatment with Tee Pee splinting (hand based thumb spica) or forearm thumb spica splinting on pain and function of patients with thumb CMC joint arthritis.

This is a pilot study will address the following hypothesis: Splinting of the hyperextended thumb IP joint with oval-8 splints will lead to increased DASH scores and decreased pain on physical exam compared to splinting with thumb spica splints in patients with thumb CMC arthritis.

After informed consent is obtained and the patient has met all of the inclusion criteria and non of the exclusion criteria, the patient will be assigned a study ID number. The patient will be randomized with a ratio of 1:1:1 to a splint treatment with either a forearm thumb spica splint, Tee-Pee splint or oval- 8 splint at the time of initial visit to Orthopaedic Hand clinic (week 1 visit). The patient will be fitted and provided with the appropriate splint by Orthopaedic physician.

Baseline radiographs (3 views anterior-posterior, lateral and oblique) and data points will be gathered from initial clinic history and physical, as performed per normal clinical protocol: arthritis grade, hand involved, dominant hand, interphalangeal (IP) extension, MCP extension, pinch strength, grip strength, pain scale, location of pain, DASH scores, analgesic use, and work/hobby activity. Additionally, demographic data including age, gender and race/ethnicity will be gathered and patient will be asked to repeat pinch and grip tests with study splint applied and asked to repeat assessment of pain scale.

Eligibility Criteria:
Inclusion Criteria:

* Carpometacarpal (CMC) osteoarthritis
* greater than or equal to 35 degrees of passive thumb interphalangeal (IP) joint hyperextension on physical exam

Exclusion Criteria:

* History of hand surgery to affected hand
* Prior surgical treatment for thumb carpometacarpal (CMC) osteoarthritis.
* Patients with diagnosis of an autoimmune arthritis and post traumatic arthritis
RCT of Cognitive Therapy, Paroxetine, Combined CT and Paroxetine and Placebo

We aim to (1) evaluate the effectiveness of cognitive therapy and paroxetine and their combination, (2) investigate the patterns of change and the mechanisms of action involved during treatment by using psycho-physiological assessments in order to delineate some of the cognitive, behavioural and physiological mechanisms in the patients' response to CT, to paroxetine and placebo.One hundred patients with a primary diagnosis of social phobia will be selected and randomised into four treatment conditions. The first group (N=25) will be treated with CT alone, the second group (N=25) with CT plus paroxetine, the third group (N=25) with paroxetine and clinical management (TAU), the fourth group will receive placebo and clinical management (N=25). All patients will have 12 weeks of treatment in the acute phase, which includes 12 sessions of individual treatment for the two first groups. The 2nd and 3rd groups will in addition have 12 weeks of drug treatment in the maintenance phase. The 4th group will have placebo for 24 weeks and clinical management. The patients will be assessed at pre-treatment, at 12 weeks and at the end of treatment of the acute phase (12 weeks) and by the end of maintenance phase (24 weeks). Follow-up will be at 6 and 12 months.

Measures are based on all three main sources; self-report inventories, clinical assessments by independent raters and psycho-physiological assessments.


Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent obtained prior to entry in the study.
2. Diagnosed with primary social phobia, generalized or specific (DSM-IV, APA, 1994).
3. Symptoms present at least one year.
4. Age between 18-65 years.

Exclusion Criteria:

1. Known somatic diseases.
2. Pregnant (\*) or lactating women.
3. Psychosis
4. Acute suicidal symptoms
5. Major depressive disorder
6. Generalized Anxiety Disorder or PTSD
7. Cluster A or cluster B personality disorder
8. Substance abuse or dependence
9. Body dysmorphic disorder.
10. Not willing to accept random allocation.
11. Patients who take some form of SSRI medications currently or during the last 6 months
12. Patients not willing to withdraw psychotropic medication for a period of 4 weeks prior to entry to the trial or are taking herbal remedies that may be hazardous or inflict treatment response.