cyrilzakka/clinical-trials huggingface dataset:
Default Dosing Settings for Opioid Prescriptions to Adolescents and Young Adults After Tonsillectomy

This study will evaluate whether lowering the default number of doses for opioid prescriptions written in an electronic health record system can decrease opioid prescribing without causing unintended consequences such as worsened pain control.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents and young adults aged 12-25 years undergoing tonsillectomy at C.S. Mott Hospital, University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care from October 2019-July 2021, excluding April-May 2020 (owing to suspension of elective procedures due to COVID-19).
* Surgeon belongs to the Department of Otolaryngology at the University of Michigan Medical School
* Patients are not any of the following: patients living in foster care or with a legal guardian, patients with medical complexity or developmental delays, non-English speaking patients, patients with recent suicidal ideation documented in their chart, or patients undergoing emergent tonsillectomy.

Exclusion Criteria:

* Patients with prescription opioid use prior to surgery
* Patients undergoing additional procedures at the same time as tonsillectomy (other than minor procedures such as tympanostomy tube placement)
* Patients enrolled in another study
* Patients who are not prescribed opioids post-operatively at discharge
* Patients who are enrolled in the Michigan Pain-control Optimization Pathway (M-POP), which includes education about pain management and a small initial opioid prescription
* Patients with hospitalization with length of stay \> 1 day after surgery
* Patients who decline to enroll
* Additional exclusion criteria for secondary analysis: Patients who do not complete the baseline and post-operative day 14 surveys
A Study of HMPL-415S1 in Patients With Advanced Malignant Solid Tumors

The objective of this study is to evaluate the safety, tolerability and PK profile of HMPL-415S1 and determine MTD and/or RP2D in patients with advanced malignant solid tumor.

This study is expected to enroll 36-81 patients, including 26-66 patients for dose escalation, additional 10-15 patients will be enrolled at the dose level of determined RP2D.

Eligibility Criteria:
Inclusion Criteria:

All the following conditions must be met for enrollment:

1. Fully understand this study and voluntarily sign the ICF;
2. Dose escalation Patients with advanced malignant solid tumor confirmed by histopathology or cytology, who have failed, been intolerant or unavailable to, or have none standard treatment for various reasons; Dose expansion phase: Patients with advanced malignant solid tumor confirmed by histopathology or cytology, who have failed, been intolerant or unavailable to, or have none standard treatment for various reasons, carrying aberrant activating mutations in the KRAS pathway；
3. Presence of at least one measurable lesion (RECIST 1.1 criteria);
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 point;
5. Life expectancy ≥ 12 weeks as judged by the investigator;
6. Male of childbearing potential and their heterosexual partners of childbearing potential must agree to use effective methods of contraception.

Exclusion Criteria:

A patient may not participate in this study if any of the following conditions apply:

1. Patients who priorly received SHP2 inhibitors;
2. Receiving the approved systemic antitumor treatment within 4 weeks prior to the first dose, including: chemotreatment, targeted treatment, immunization treatment, biological treatment, etc. (wash-out for 2 weeks for hormone treatment or traditional chinese medicine and chinese patent medicine with clear antitumor indications);
3. Have been in the treatment period of other interventional clinical studies (including small molecule chemicals and large molecule antibodies) within 4 weeks prior to the first dose. If participating in a non-interventional clinical study (eg, epidemiological study), you can enroll in this study; if already in the survival follow-up period of an interventional clinical study, you can enroll in this study.
4. Major surgery or radical radiotreatment (except palliative radiotreatment for metastases to bone lesions) within 4 weeks prior to first dose.
5. Central nervous system (CNS) malignant tumor or known CNS metastasis;
6. Having multiple factors that affect the absorption, distribution, metabolism or excretion of orally administered drugs (such as inability to swallow drugs, frequent vomiting, chronic diarrhoea, etc.);
7. Any other disease, metabolic abnormality, physical examination abnormal, or clinically significant laboratory test abnormality that, in the judgment of the investigator, would compromise patient compliance or give reason to suspect that the patient has a disease or condition that would compromise the interpretation of study results or place the patient at high risk.
Geriatric-oncological Study on Quality of Life and Independence After Radiotherapy

Elderly patients \* with multiple comorbidities are underrepresented in most radio-oncology studies. In times of individualized therapy and when weighing up oncological over- or under-therapy, this observational study is a step towards the implementation of established geriatric instruments and concepts in radiation oncology. As part of the initial outpatient consultation on radiotherapy, the quality of life of patients older than 70 years before the start of therapy is assessed using the EORTC QLQ-C30 and ELD14 questionnaires. Furthermore, a geriatric screening is carried out using the G8 questionnaire. The geriatric screening carried out in routine clinical practice with little effort is used to filter out patients with no risk of increased vulnerability - these participants do not require any further examinations.

Vulnerable patients with deficits (G8 score \<15 pts) receive a geriatric assessment (Comprehensive geriatric assessment (CGA)) consisting of abbreviated comprehensive geriatric assessment (aCGA), appetite (Mini Nutritional Assessment (short form = MNA-SF)) at the beginning and end of radiotherapy ), physical functionality (Short physical performance battery) and measurement of hand strength. In addition, these patients receive an individualized inpatient geriatric-oncological complex treatment, which is already implemented analogous to the palliative complex treatment. The patients receive targeted support from trained nursing staff, social services, physiotherapy, nutritional advice, hospital pharmacies and psycho-oncology. At the end of the oncological therapy and for the first aftercare after the end of therapy, the questionnaires on quality of life are filled out again in order to analyze changes. Initially, 20 patients are to be treated in a first phase (feasibility) in this concept of geriatric-oncological complex treatment in order to build up and expand the necessary structures for an interdisciplinary complex treatment and to set parameters for adherence to the therapy concept and maintaining quality of life and independence in the activities of the daily life for this collective of patients. As part of a follow-up study, vulnerable patients are then to be stratified and randomized using these parameters so that a more detailed analysis is possible.

Eligibility Criteria:
Inclusion Criteria:

* Age from 75 years
* G8-Screening \<15Pkt
* Potentially curative radiotherapy

Exclusion Criteria:

* no written informed consent
* life expectancy\< 6 month
Validation of Drug Assays in Various Biological Matrices

This study aims to ensure that assays that measure drug concentrations are accurate and precise in different matrices when quantified using high performance liquid chromatography -tandem mass spectrometry (HPLC-MS/MS). The study involves collecting samples of various bodily fluids to quantify antimicrobials, antivirals, oral contraceptives and erectile dysfunction agents. Samples will also be obtained from individuals not receiving these medications for quality control purposes.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age

Exclusion Criteria:

* Unable to give informed consent
Barriers to Substance Use Disorder Recovery

The study purpose is to investigate how an inpatient recovery coaching intervention can overcome or mitigate specific risk factors and barriers to initiating and maintaining Substance Use Disorder recovery. This study will offer insight into how and why an inpatient link to recovery coaching is effective for promoting long-term Substance Use Disorder recovery.

Substance Use Disorder (SUD) is a prevalent disease that impacts an estimated 24 million Americans each year. The life-altering consequences of SUD are both diverse and severe, influencing mortality, the workplace, and economics. The goal of this study is to determine how specific risk factors of relapse and barriers to recovery, including neurocognitive, health, personal, social, financial, and situational barriers, can be overcome or changed through a recovery coaching intervention. This work seeks to provide a mechanism to demonstrate exactly how and why this potential new model of care (recovery coaching) is effective, rather than simply assessing if it can work. To accomplish this aim, the change between baseline and 6-month assessments will be assessed. Then, the difference in the change between individuals assigned to the current standard of care and patients assigned to inpatient recovery will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 60
* English speaking;
* Identified by healthcare provider as having Substance Use Disorder
* Recent substance use
* Currently admitted to the Medical Teaching Services, general medicine hospitalist services, or Infectious Disease Consult service at Greenville Memorial Hospital

Exclusion Criteria:

* Are unable to provide informed consent (intubation, confusion, etc.) during hospitalization
* Are admitted for marijuana use only
* Are admitted for cocaine use only
* Are pregnant
Prevention of Suicidal Behaviour With Telemedicine Techniques

This is a multicenter controlled intervention study that aims to assess the efficacy of a telephone follow-up program for the prevention of suicidal behavior in adults discharged from general hospitals after a suicide attempt.

The hypothesis is that the implementation of this program is associated with reduced rates of suicide reattempts in these patients and also with delayed reattempts in them.

Justification: Suicide is a global public health concern and is the leading cause of avoidable death in the Basque Country (Spain). The use of telemedicine techniques applied to high risk patients has shown to be useful in the prevention of suicide and suicidal behavior.

Objectives: To assess the efficacy of a telephone follow-up program for the prevention of suicidal behavior in patients who recently attempted suicide.

Design: This is a multicenter, prospective intervention study, non-randomized and with control group.

Method: A sample of adults discharged from 2 general hospitals after a suicide attempt are enrolled in a telephone follow-up program which is added to their usual treatment (TAU). The program consists of 5 short calls made by nurses during 6 months. The calls are intended to: 1) Assess the risk of suicide in that moment, 2) Improve patient's adherence to treatments, and 3) Provide general psychoeducation guidelines. The control group is composed of patients discharged from a third general hospital after a suicide attempt. These receive TAU but are not enrolled in the telephone follow-up.

Evaluation: All patients are followed during 12 months. Main outcome measures include the percentage of patients that make a second attempt and the average time to reattempt.

Patients sign and informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients discharged from a General Hospital after a suicide attempt and who live in the same health sector as the hospital.
* The suicide attempt must have been made within 24 hours prior to the appointment in the Emergency Service.

Exclusion Criteria:

* Patient with severe cognitive difficulties and in general any self-injury in which the patient does not understand the meaning or potential consequences of such behavior.
* Patients in which a regular telephone contact is not possible.
* Patients in which the psychiatrist who evaluates the case deems inappropriate their inclusion.
* Patients who remain hospitalized 6 months after the attempt.
A Study of Enterorenal Syndrome Assessed by Gastrointestinal Ultrasound Combined with Renal Artery Resistance Index

In this study, the patients with sepsis caused by abdominal infection were divided into survival group and death group by ultrasound examination of gastrointestinal function, superior mesenteric artery blood flow, and renal artery resistance index. The cross-sectional area of gastric antrum, average time flow rate of superior mesenteric artery, colon diameter, colon peristalsis frequency, and renal artery resistance index of the two groups were compared to determine the progression of entero-renal syndrome as soon as possible. To provide reliable objective basis for clinical decision-making, in order to improve the success rate of rescue.

Adult patients admitted to EICU of our hospital who met the diagnostic criteria for sepsis were included in the study. Patients with intra-abdominal sepsis were divided into survival group and death group for case control. Exclusion criteria: open chest and abdomen injury, advanced tumor, uremia, pregnancy. The primary endpoint was survival. Extraction time: ICU (0h), ICU (6h, that is, after fluid resuscitation), ICU (24h), ICU (48h, 08:00 a.m.), ICU (72h, 08:00 a.m.), ICU (120h, 08:00 a.m.); Monitoring indicators: antral cross-section area, colon diameter, colon peristalsis frequency, renal artery resistance index, CVP, ScvO2, IL6, blood lactic acid, blood creatinine, fluid intake, bladder pressure. The primary endpoint of the study was survival rate, and statistical analysis was performed to evaluate the progression of enterorenal syndrome, provide reliable objective basis for subsequent clinical decision-making, and improve the success rate of rescue.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with intra-abdominal infections
* Patients with sepsis or septic shock

Exclusion Criteria:

* Patients with open chest or abdominal injury
* Patients with advanced tumor
* Patients with uremia
* Pregnant women
Exploratory Pilot Study on the Prolonged Use of the ABLE Exoskeleton in Multiple Sclerosis

The goal of this study is to explore the potential clinical benefits of the ABLE Exoskeleton as part of a rehabilitation program in people with multiple sclerosis. The main question it aims to answer is:

Can a rehabiliation program with the ABLE Exoskeleton help to mantain the physical and psychosocial health of people with multiple sclerosis?

Participants will:

* Have a gait training session of 60 min with the exoskeleton once a week for 12 months at the clinic
* Have an evaluation (tests and questionnaires) every 3 months at the clinic


Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years old
* Diagnosed with multiple sclerosis
* Currently undergoing outpatient physical therapy treatment at the investigation site
* Ability to give informed consent

Exclusion Criteria:

* Significant osteoporosis that may increase the risk of fracture
* Unresolved fractures in the pelvis or extremities, or history of fragility fractures in the lower extremities in the last 2 years
* Spinal instability (or spinal orthoses, unless authorized by a physician)
* Severe spasticity: Level 4 on the Modified Ashworth Scale
* Orthostatic hypotension. Inability to tolerate a minimum of 30 minutes standing
* Uncontrolled autonomic dysreflexia
* Medical instability
* Unstable cardiovascular system (CVS), hemodynamic instability, untreated hypertension (SBP\>140, DBP\>90 mmHg), unresolved deep venous thrombosis (DVT)
* Serious comorbidities, including any condition that a physician deems inappropriate for use of the ABLE Exoskeleton or to complete participation in the study
* Skin integrity problems on the contact surfaces of the device or that would prevent sitting
* Grade I or higher on EPUAP (European Pressure Ulcer Advisory Panel, 2019) on areas that will be in contact with the exoskeleton
* Colostomy
* Anthropometric measurements outside the values compatible with ABLE Exoskeleton. In particular, height not between 1.5-1.9 m, or weight over 100 kg
* Anatomical constraints (such as eg length differences, users unable to position themselves inside the device) that are incompatible with the device
* Restrictions in range of motion that prevent normal gait from being achieved or preventing the completion of a normal transition from sitting to standing or standing to sitting
* Heterotopic ossification
* Known pregnancy or breastfeeding
* Cognitive impairment that results in the inability to follow simple instructions, particularly psychological or cognitive problems that do not allow a participant to follow study procedures
Trial of Lay-led Individualised Self-management Education for Adults With Asthma

Long term conditions often necessitate long term care. In many cases, giving control of their conditions to the patients themselves produces the best outcomes. Such patient education and the acquisition of self-management skills can be time consuming and the evidence suggests that the process is often not undertaken by doctors. Sometimes it is delegated to nursing colleagues, but all health professionals are in short supply. Patients carry credibility as a resource and this project is designed to determine, by means of a multi-centre randomised controlled trial, whether well trained lay educators can deliver training in self-management education to others with asthma, with outcomes equivalent to those achievable by a nurse.

This study will be a randomised controlled trial looking for equivalence; the investigators' central hypothesis is that lay-led education will be at least equivalent to professional-led education in terms of patient outcomes. Patients will be randomised to receive either lay-led or professional led self-management education. Patients will be followed up longitudinally for 12 months from initial intervention. Two sites were studied; Manchester and London. It is anticipated that 16 sites will be recruited in each of the two geographical areas; all sites will have an asthma register. Individuals will be eligible for inclusion if they are adults; have clinician diagnosed asthma; have persistent disease and require regular therapy, with some evidence of variability in their disease, such that a self management plan would be appropriate. Both genders will be eligible, as will those unable to see or read. Individuals will be excluded if they have severe cognitive impairment; they decline to be randomised; they decline to receive asthma education and follow-up solely from the designated educator, other than in an emergency situation, or their condition does not show variability.

The intervention in the study will be a disease-specific asthma self-management education programme delivery either by a professional (ie practice nurse) or a lay educator. Both lay and professional trainers will receive specific training in the content and delivery of this intervention. The intervention will consist of an initial 45 minute training session (including receipt of a written personal asthma action plan); a second face to face reinforcing session 3 weeks after the first session; 3 monthly telephone follow-up appointments to reinforce messages and to give ongoing advice with availability of the nurse or lay educator as a source of advice at all other times. Data will be collected on unscheduled use of health care, peak flow readings, patients' self-reporting of "adverse events", RCP three questions, perceptions of the interviews using MISS-21, QOL questionnaire and AQLQ. Demographics for all patients will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adults step two therapy (BTS)
* Evidence of poorly controlled disease

Exclusion Criteria:

* Unable to benefit from self management education
* Other respiratory conditions other than asthma
Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology.

The purpose of this study is to determine whether Bosentan is an effective and safe treatment to adolescent and adult (15 years and older) patients, born with one ventricle of the heart instead of two (single ventricle physiology) and who have undergone TCPC as a palliative surgical treatment. The aim of the TCPC operation is to use the one functioning ventricle to pump the blood flow to the body, while the blood to the lungs is received directly from the caval veins, and is thus a passive flow, without the aid of a ventricle to actively pump the blood through the pulmonary circulation. The resistance in the pulmonary circulation is therefore critical to these patients. These patients have markedly lower work capacity in bicycle test than the general public. Furthermore they have a high risk of developing complications e.g. loss of protein from the intestines.

Bosentan is a medication that lowers the resistance in the pulmonary circulation. It is routinely used for patients with pulmonary hypertension. Some studies have shown that drugs that lower the pulmonary resistance can increase exercise capacity significantly in patients with single ventricle physiology.

In this study 80 patients will receive either placebo or Bosentan for 14 weeks. Before and after the treatment, bicycle test along with blood samples, stool samples and quality of life interviews will be performed. Every four weeks during the study blood samples, physical exam and interviews will be performed to ensure the safety of the treatment.

The investigators expect to find a significant increase in work capacity after 14 weeks in the treatment group compared with the placebo group.

Moreover the investigators hope to find a decrease in intestinal protein loss and an improved quality of life.

In the statistical analysis the investigators wish to analyse interactions between the primary endpoint and predefined subgroups in order to distinguish responders from non-responders to the treatment. The predefined subgroups are:

NT-proBNP \> 100 (yes/no) Ventricular anatomy (RV/LV) CT-proEndothelin-1. In the latter, the investigators do not wish to predefine a specific value, due to limited experience with this analysis. We wish to use the data from the study to find a cut-off value, that is able to predict positive response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* TCPC operated
* Age \> 15 years old
* Clinical stability \> 3 months, evaluated by investigator from clinical record
* For women: Negative s-hCG and use of contraception

Exclusion Criteria:

* Severe heart failure (NYHA-class IV)
* Oxygen saturation \< 85 % at rest
* Pre-existing liver condition (transaminases 2x \> reference)
* Renal failure (creatinin \> 150 mmol/l)
* Obstruction of TCPC circulation
* History of work induced severe arrhythmia
* Systolic blood pressure below 80% of reference (BT \< 88 mmHg)
* Use of any of following drugs: Fluconazol, Ketoconazole, CiclosporinA, Lopinavir, Ritonavir, Rifampicin, Carbamazepin and Phenytoin
* Significant extra-cardiac condition e.g. neurological impairment