cyrilzakka/clinical-trials huggingface dataset:
Online Psychology Program for Chronic Pain After Surgery

This project will evaluate the feasibility of a new fully self-guided online Acceptance and Commitment Therapy (ACT) program entitled Advancing Online Psychology Tools for the Transitional Pain Service (ADOPT-TPS), developed on an online health application platform called Manage My Pain (MMP). The ACT program is designed to teach mindfulness skills and provide psychoeducation about post-surgical pain. The feasibility of the self-guided online program will be compared to a pre-existing psychologist-guided workshop that delivers the same program. It is anticipated that the self-guided online ACT program will be deemed feasible by participants.

The Transitional Pain Service (TPS) at Toronto General Hospital is a multidisciplinary treatment program that aims to prevent chronic post-surgical pain (CPSP) and persistent opioid use after surgery. CPSP is a major public health concern impacting from 10% up to 70% of patients, depending on the type of surgery. Those experiencing CPSP are at higher risk for prolonged opioid use, which introduces challenges like addiction, misuse, and overdose. Acceptance and Commitment Therapy (ACT) is an evidence-based psychology intervention that is effective in reducing patients' risk of CPSP and opioid use. However, access to this intervention is currently limited to predominantly in-person, specialized hospital-based clinic settings like the TPS, which prioritize patients at highest risk for CPSP and often require physician referrals for quick access. There is a need for such treatment approaches to spread to other institutions and to be available for lower-risk post-surgery patients, yet the shortage of specialized pain psychologists creates a barrier to widespread dissemination. The current project will evaluate the feasibility of a novel fully self-guided online ACT intervention entitled Advancing Online Psychology Tools for the Transitional Pain Service (ADOPT-TPS), developed on a mobile health application platform called Manage My Pain (MMP). A randomized, controlled pilot feasibility trial will evaluate the efficacy of ADOPT-TPS by comparing it to a pre-existing psychologist-guided workshop. Once tested, this scalable, evidence-based online intervention can be easily implemented at institutions across Canada and beyond to address CPSP and opioid use without the need for specialized pain psychologists on staff.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received a post-surgical referral to the TPS
* Patients who have access to a device that can connect to the Internet

Exclusion Criteria:

* Patients who have received TPS psychology treatment
* Patients with a known history of serious mental illness (e.g., psychosis and/or active mania)
* Patients who have limited comprehension of English or comprehension deficits due to dementia
Comparison of Routine Endotracheal Intubation With McGrath Videolaryngoscope and Pentax AirwayScope

Recently many kinds of indirect videolaryngoscopes were developed. These videolaryngoscopes provide easier intubation, help intubation difficulty, are used good tool for education. McGrath Videolaryngoscope and Pentax AirwayScope are kinds of these videolaryngoscopes.

The purpose of this study is to compare of routine endotracheal intubation with McGrath Videolaryngoscope and Pentax AirwayScope by means of providing better laryngeal view, easier and faster intubation.


Eligibility Criteria:
Inclusion Criteria:

* an American Society of Anesthesiologists physical status (ASA) 1 or 2

Exclusion Criteria:

* a suspected difficult airway (Mallampati score Ⅳ)
* known cervical spine injury
* required rapid sequence induction
* emergency operation
Thumb Hemi-Arthroplasty With Natural Kinematics (THANKS) Trial

This clinical trial aims to evaluate the safety and effectiveness of the lnDx Implant in the treatment of thumb base joint arthritis.

This clinical trial hypothesises that implanting the lnDx prosthesis will improve thumb opposition motion, decrease pain and stiffness, and increase grip and pinch strengths of the carpometacarpal joint in patients with thumb base joint arthritis.

Participants will undergo the following measures to assess their clinical performance:

* Hand X-Ray
* Range of Motion - Kapandji opposition score
* Grip strength, lateral pinch and tip pinch
* Visual Analogue Scale (VAS) for Pain
* Quick Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire


Eligibility Criteria:
Inclusion Criteria:

* The patient is at least 18 years of age;
* The patient has a confirmed Grade 1-111 osteoarthritis of the CMG joint on clinical examination and X-ray;
* The patient agrees to abstain from enrolment in any other clinical trials that will conflict or interfere with the interpretation of the results of this study, in the opinion of the Investigator, for the duration of the study;
* The patient is able to understand the aims and objectives of the trial and is willing to consent;
* Be willing and able to return for all study-related follow-up procedures;
* If female, is either using contraception or is postmenopausal, or male partner is using contraception; and
* Have been informed of the nature of the study, agreeing to its requirements, and have signed the informed consent approved by the institutional review board/ethics committee.

Exclusion Criteria:

* The patient is \<18 years of age;
* The patient is suffering from Rheumatoid Arthritis;
* The patient is suffering from Grade IV osteoarthritis of the CMG joint;
* The patient is suffering post-traumatic arthritis of the CMG joint;
* The patient is a pregnant/lactating female (tested as per institutional requirements);
* Active or latent infection, or sepsis;
* Insufficient quantity or quality of bone and/or soft tissue;
* Metal or polymer material sensitivity;
* Patients who are unwilling or incapable of following postoperative care instructions or protocol requirements;
* Muscular imbalance, peripheral vascular disease that prohibits adequate healing, or a poor soft-tissue envelope in the surgical field, absence of musculoligamentous supporting structures, or peripheral neuropathy;
* Patient with previous thumb surgery;
* In the opinion of the investigator, any medical condition that makes the subject unsuitable for inclusion in the study, including, but not limited to, subjects with a diagnosis of concomitant injury that may interfere with healing; subjects with clinically significant renal, hepatic, cardiac, endocrine, hematologic, autoimmune, or any systemic disease or systemic infection that may make interpretation of the results difficult; subjects who have undergone systemic administration within 30 days prior to implantation of any type of corticosteroid, antineoplastic, immunostimulating, or immunosuppressive agents;
* Comorbidity that reduces life expectancy to less than 36 months.
Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii Infection in Early Course Schizophrenia

This is an exploratory study in Egypt that will combine a treatment trial among early course schizophrenia (ECSZ) patients with key analyses suggested by rodent studies. Specifically, the study will test the provocative results from animal studies indicating an impact of Toxoplasma Gondii (TOX) exposure on novelty seeking. The study will also test whether exposure to TOX is associated with other cognitive and behavioral changes, as well as changes in overall social function. We will also explore the relative efficacy of Sodium Valproate (Depakote, DEP) in improving clinical and overall social function among TOX exposed and unexposed patients.

Hypotheses

1. At baseline, TOX exposure is associated with increased novelty seeking, clinical severity, and impaired cognitive and overall social function in patients with SZ.
2. Adjunctive DEP treatment improves clinical symptoms, cognitive and social function in SZ, particularly among TOX exposed SZ patients.
3. Exploratory hypothesis: adjunctive DEP reduces serological indices of TOX infection (VIP and TH levels).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Adult men or women (ages 18-50 years)
* Schizophrenia / schizoaffective disorder (DSM IV)
* Duration of illness \< 5 years (since onset of psychosis)
* On a stable dose of an antipsychotic for at least a month
* Scores 4 or more on at least one item of the Positive and Negative Syndrome Scale.

Exclusion Criteria:

* Substance abuse in the past month/dependence past 6 months
* History of / or current medical/neurological illnesses e.g. mental retardation (DSM-IV) or epilepsy;
* Medical conditions that are judged by the consulting internist and research staff to be unstable
* Pregnant or breast-feeding women
* Known allergy or serious adverse event to DEP, Received Chlorpromazine, Trimethoprim or DEP for up to 6 months prior to study entry.
Exercise Following Bariatric Surgery for Severe/Morbid Obesity (EFIBAR)

Severe/morbid obesity is an international public health issue that importantly increases the risk of cardiovascular events and cardiovascular and all-cause mortality. Likewise, severe/morbid obesity increases the risk of illness, reduces quality of life, and raises health-care costs. Bariatric surgery is the election method for the treatment of severe/morbid obesity, resulting in significant weight loss and remission of comorbidities. However, a relatively large proportion of bariatric patients regain weight and continue to be at high risk for cardiovascular disease and premature mortality. A healthy lifestyle following bariatric surgery is essential for optimizing and maintaining weight loss. Observational studies suggest that physical activity following bariatric surgery might be associated with additional weight loss and more effective weigh loss maintenance over time. However, very little experimental evidence exists regarding the effects of supervised exercise on obesity-related outcomes in this specific population.

The aim of the EFIBAR (Ejercicio FÍsico tras cirugía BARiátrica) randomized controlled trial is to determine the effects of a 16-week supervised concurrent (aerobic and strength) exercise intervention program, on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness and quality of life (secondary outcomes) in patients with severe/morbid obesity following bariatric surgery.

According to the study aims the investigators pursue the following hypothesis: Supervised exercise will result in larger weight loss than control.


Eligibility Criteria:
Inclusion Criteria:

* To comply with local bariatric surgery criteria:

  1. Patients with BMI ≥ 40 kg/m2 (or 35 kg/m2 with comorbidities).
  2. Acceptable surgical risk (defined by the approval of anesthetist).
  3. Obesity maintained for over 5 years.
  4. Failure of previous treatments.
  5. To sign informed consent for surgical treatment.
* Not to present contraindications for supervised physical exercise.
* To reside in the city of Almeria (Spain) or willingness/predisposition to attend the training sessions 3 times a week during 16 weeks

Exclusion Criteria:

* Severe psychiatric or neurological disorders such as schizophrenia, epilepsia, Alzheimer, Parkinson, personality disorders, eating behaviour disorders, untreated depression or suicidal tendencies.
* Adrenal or thyroid pathology that might cause obesity.
* Uncontrolled addiction to alcohol or drugs.
FertiScreen: an Online Application to Improve the Quality of Fertility Care

Objectives The investigators present an online application to empower and inform patients and improve guideline adherence in unexplained subfertility. Thereby the investigators expect to reduce overtreatment in fertility care with higher quality of care.

Methods The investigators conduct a prospective cohort study including couples with a diagnosis of unexplained subfertility. Couples consulting their general practitioner with an unfulfilled child wish will be offered to use FertiScreen. FertiScreen is an online application, in which patients are asked questions about their fertility problem (ie menstrual cycle, age, duration of child wish and the results of the Chlamydia Trachomatis antibody titre and semen analysis). FertiScreen then uses the validated prediction model of Hunault to calculate couples' chance of natural conception during the next twelve months. In addition, patients can find links to extra information concerning subfertility. Couples can then initiate an online consultation with their general practitioner and a gynaecologist, in order to discuss their results and prognosis. When the calculated prognosis of spontaneous conception within one year is \>30%, tailored expectant management for 6-12 months will be advised, as no benefit can be expected from fertility treatment.

Questionnaires will be sent to patients as well as to their caregivers (general practitioner, gynaecologist). These questionnaires will focus on the use of FertiScreen (System Usability Scale) and the different domains of quality of care (effectiveness, cost-effectiveness, safety, patient-centredness). For the latter, the investigators use the Hospital Anxiety and Depression Scale and the Patient Centredness Questionnaire for Infertility.

In order to be able to draw conclusions, the investigators will conduct a baseline measurement among couples with unexplained subfertility who have been referred to a fertility clinic. Their data will be abstracted from their medical records and they will receive the aforementioned questionnaires as well (except for the System Usability Scale).

The investigators will recruit couples presenting to general practitioners in the Nijmegen area (which for second line treatment consists of one general hospital and one academic hospital). To detect an increase in guideline adherence of the current 60% to 75% with a power of 80% (P\<0,05), the investigators need to include 152 couples in the before as well as in the after measurement.


Eligibility Criteria:
Inclusion Criteria:

* couple consulting their general practitioner with subfertility
* women \>18 years and \<38 years
* one of the partners Dutch speaking
* access to the Internet
* residing in the Netherlands
* unfulfilled childwish for at least 6 months
Assess the Use of rEBUS With a Guide Sheath to Increase Transbronchial Lung Biopsy Yield Rate

Whether using a guide sheath can increase the diagnostic yield rate after the lesion is located by radial endobronchial ultrasound

For lung nodules, there are several ways to acquire tissue for pathology study, including computed tomography (CT)-guided core needle biopsy, radial probe endobronchial ultrasound (rEBUS)-guided transbronchial lung biopsy (TBLB), convex probe EBUS transbronchial needle aspiration (TBNA), and echo-guided core needle biopsy. rEBUS-guided TBLB has relatively low limitation of lesion position, comparing to echo-guided core needle biopsy and EBUS-TBNA, and doesn't need to deal with the risk of radiation exposure.1 For peripheral pulmonary lesions (PPL), it has good yield rate and the operation is easy.2 However, when bleeding occurs, the procedure time is prolonged for hemostasis. Nonetheless, using a guide sheath can help with the problem. According to the literatures, biopsy yield rates vary but on average it is higher with a guide sheath (62\~90% vs. 41\~73%), while the complication rates are about the same (1.3\~4.4% 1.5\~5.0%). The investigators would like to know whether the diagnostic rate is higher with a guide sheath and so do the procedure time and the complication rate. Whether the lesion character affect the yield rate will also be studied.

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 20 years old. Radiographic evidence of peripheral pulmonary lesions. The lesion can be located by radial probe EBUS.

Exclusion Criteria:

B1 bronchus. Thrombocytopenia with platelet count \< 100K. Coagulopathy with INR \> 1.3. High oxygen demand (O2 mask \> 28%, 5L). Currently using anti-platelet drug or anti-coagulant.
CARE Study: Improving Treatment for the Most Severely Ill With Schizophrenia

This is a 9 week, multicentre, randomized, double-blind, placebo-controlled trial with two parallel groups. There is also an open-label extension phase of 18 weeks. Both medications to be used in the study, clozapine and risperidone, are fully approved for the treatment of schizophrenia.

Subjects may be inpatients or outpatients. All subjects will be treated throughout the study with clozapine, at a dose of 400 mg or more, unless limited by side effects. After screening, subjects will be augmented with placebo for 7 days. Any subject with a reduction in PANSS total score of 20% or greater will be discontinued from the study. Beginning on day 8, subjects will be randomized to continued augmentation of clozapine with placebo, or to augmentation with risperidone. The initial daily dose of risperidone will be 1.0 mg, increased in 1.0 mg increments to a total of 3.0 mg/day over a two week period. Subjects unable to tolerate at least one tablet of study medication will be dropped from the study. At the end of 8 weeks following randomization, at the choice of the investigator, open-label risperidone augmentation can be started.

The primary outcome measure is the PANSS total score at week 9. Subjects will be classified as responders if the improvement in PANSS total score is 20% or greater, and the proportion of responders in each group will be determined. Complementary outcome measures will be the CGI severity score, CGI improvement score, and SOFAS score. Safety and tolerance will be assessed by reports of adverse events and clinically significant changes in vital signs, weight, waist circumference, extrapyramidal side effects, metabolic and hematological measures.

Eligibility Criteria:
Inclusion Criteria:

* Subjects treated with clozapine for the indication of poor response to other antipsychotic medications.
* Treatment with clozapine is at a stable dose for at least 12 weeks. Dose must be 400 mg/day or more, unless side effects limited increase of dose.

Exclusion Criteria:

* Subjects with significant alcohol or substance abuse in the past 3 months.
* Subjects with a previous trial of risperidone augmentation of clozapine
* Subjects who are pregnant, breast-feeding, or women of child-bearing potential not using adequate contraception
* Subjects requiring treatment with anticonvulsants.
* Subjects with known hypersensitivity or allergy to risperidone.
* Subjects with hematological or other contraindications to continued clozapine treatment.
Precision Imaging to Evaluate Kaposi Sarcoma

AIM 1:

In Uganda and Kenya, Kaposi Sarcoma (KS) is one of the most common cancers and a leading cause of cancer-related deaths in men. However, tracking how well patients are responding to treatment is challenging, especially in busy clinics. Doctors must measure the size and changes in the areas affected by the cancer by hand, which can take a lot of time and can vary depending on the doctor. This method does not work well for patients with dark skin, which can lead to biases in treatment compared to patients with fairer skin.

To solve this problem, the investigators suggest the use of a simple, low-cost device that uses Artificial Intelligence (AI), the SkinScan3D (SS3D) device, to measure the cancer spots accurately and monitor changes over time. The goal of this study is to improve the SkinScan3D (SS3D) tool and the how it is used. The investigators will do this by talking to healthcare workers and patients, giving them surveys, and holding design workshops. The feedback from these activities will be shared with the device maker and local research teams to make the device better and ensure it is used properly.

AIMS 2 \& 3:

In this study the investigators seek to formally compare reproducibility and accuracy of KS lesion size measurements between SkinScan3D and the current standard of care manual measurement method. The investigators will then test the SS3D device on 100 patients in a variety of real-world practice locations to determine whether the device will be usable, acceptable, appropriate, and feasible in routine care settings.


Eligibility Criteria:
Inclusion Criteria - Aim 2 (Patients):

* Adults age ≥18 years old
* Histopathology-confirmed Kaposi Sarcoma
* At least 3 skin lesions
* Capable of informed consent
* On treatment for Kaposi Sarcoma

Exclusion Criteria - Aim 2 (Patients):

* Patients not initiating Kaposi Sarcoma treatment
* Very ill patients requiring hospitalization

Inclusion Criteria - Aim 3 (Patients):

* Adults age ≥18 years old
* Histopathology-confirmed Kaposi Sarcoma
* Capable of informed consent
* Initiating treatment for Kaposi Sarcoma

Exclusion Criteria - Aim 3 (Patients):

* Patients with Kaposi Sarcoma that participated in Aim 1 or Aim 2
* Prior or ongoing Kaposi Sarcoma treatment
Rapid Acute Coronary Syndrome Exclusion Using High-sensitivity I Troponin

As part of the planned implementation of a new clinical pathway using hs-cTnI, the investigators will measure patient outcomes and clinical processes in a real-world scenario throughout an integrated health system across 9 emergency departments (ED).

This is a pragmatic, implementation study testing the implications of a real-world execution of a rapid evaluation pathway for suspected ACS using the Beckman hs-cTnI assay. As the new protocol is executed across 9 EDs within an integrated health system, the investigators will study its effects on patient and system-level metrics. A modified stepped wedge design will be utilized that allows comparison of the RACE-IT pathway with standard of care management

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old presenting to the ED for whom a treating clinician suspects ACS and orders a baseline ECG and cardiac troponin.

Exclusion Criteria:

1. ST-segment Myocardial Infarction (STEMI) leading to immediate reperfusion therapy
2. Any ED-drawn hs-cTnI value \> 99th percentile (18 ng/L)
3. Clear traumatic cause for symptoms (e.g., direct chest wall trauma, motor vehicle accident)
4. A transfer from another facility
5. Primary residence outside the state of Michigan
6. Previous inclusion in the study
7. Enrolled in hospice