cyrilzakka/clinical-trials huggingface dataset:
Hypnosis Intervention for the Management of Pain Perception During Joint Lavage

The purpose of this study is to determine whether hypnosis intervention added to usual care is more effective than usual care alone to control pain during lavage procedure in patients with knee osteoarthrosis

Joint lavage can be used in acute knee osteoarthritis, and can be repeated when it is effective. This procedure can generate pain and anxiety which are prevented by systematic prescription of analgesics and anxiolytics. To assess the benefit of hypnosis intervention, the investigators designed a monocentric prospective controlled randomised, single-blind study. Patients with acute and painful knee osteoarthritis, having an indication of lavage according to the rheumatologist, will be randomized to standard care, versus standard care and hypnosis. The hypothesis is that hypnosis intervention will decrease the level of pain during lavage, and the analgesics consumption during the week following the lavage. The sample size will be 100, 50 patients per group. Inclusion is scheduled for 18 months, and duration of the study will be 2 years. The main efficacy criterion is the pain score (assessed using VAS) difference between the 2groups; no interim analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of knee osteoarthritis
* indication for a lavage

Exclusion Criteria:

* People who have had both knees washed on the same day.
* People who have already received a joint lavage.
* Patients with psychotic disorders.
* Refusal to participate.
* People who do not understand and/or speak French or who are deaf.
MiniMUD Study - Unrelated Reduced Intensity Conditioning With Treosulfan® for Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies

In this study, treosulfan is evaluated for conditioning in allogenic stem cell transplantation. The procedure and the follow-up are the same as in standard allogenic transplant.

The donor is unrelated (identical HLA). The graft is haematological peripheral blood stem cell.

The conditioning with reduced intensity is: fludarabine (from day -6 to day -2), treosulfan (from day -6 to day -4) and thymoglobuline (from day -2 to day -1).


Eligibility Criteria:
Inclusion Criteria:

* AGE: \>= 18 years and \<= 65 years
* Patients with a too high transplant-related mortality (TRM) after standard transplantation (multiple myeloma, chronic lymphoid leukemia, non Hodgkin's lymphoma, myelodysplasia)
* Patients with visceral contra-indication for standard transplantation:

  * cardiac: myocardiopathy; forced expiratory volume (FEV) \< 50%;
  * respiratory: abnormal carbon monoxide diffusing capacity (DLCO);
  * renal: creatinine clearance \< 50ml/min;
  * hepatic: transaminases and bilirubin \> 2 upper normal limit;
  * infectious: controlled fungal infection.
* Karnofsky score \>= 70%
* Unrelated donor HLA identical (ABC, DRB1; DQB1)
* Signed informed consent

Diagnosis :

Chronic myelogenous leukemia (CML):

* In first chronic phase, resistant to interferon with or without aracytine or refractory or resistant to Glivec
* In complete response (CR) or in 2nd partial response (PR) after being in blastic phase

Multiple myeloma (MM):

* Relapse after autograft if the therapeutic response was evaluated to 50%

Non-Hodgkin's lymphoma (NHL):

* Mantle cell lymphoma after first relapse but in case of chemosensitivity ≥ 50% except for high grade lymphoma
* In 2nd CR or PR chemosensitive in response ≥ 50% after autograft

Chronic lymphocytic leukemia (CLL):

* In 2nd CR or PR or in response ≥ 50% after autograft or in 2nd relapse after 2 lines of treatment but in case of chemosensitivity ≥ 50%

Acute myeloid leukemia (AML):

* In 2nd CR or in 1st CR for high risk criteria \[high risk criteria defined by: LAM 7; leukocytes \> 30,000/mm3; chromosomal abnormalities: t(6,9); abnormalities of 11q23, 17p, 11q, 20q, 21q, -5, del(5q), -7/del7q, del 9q et inv 3q\]

Acute lymphoblastic leukemia (ALL):

* In 2nd CR or in 1st CR if high risk criteria patients who are defined by chromosomal abnormalities t(9,22); t(1,19); t(4,11); abnormalities of 11q23

Myelodysplastic syndromes (MDS):

* Patients without prior chemotherapy, with intermediate or high International Prognostic Scoring System (IPSS) score and blast cells \< 1% in bone marrow (BM)
* CR or PR after chemotherapy for patients with 20 to 30% of blast cells in BM
* Secondary AML patients with a response to chemotherapy (\< 30% blasts in BM and \< 5% of blast cells in blood)

For all:

* Adequate contraception in female patients of child bearing potential
A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children with SCN1A-positive Dravet Syndrome (Australia Only)

WAYFINDER is a Phase 1/2 study in Australia to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet syndrome aged 6 to \<84 months. The study follows an open-label, dose-escalation design.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have a predicted loss of function pathogenic or likely pathogenic SCN1A variant.
* Participant must have experienced their first seizure between the ages of 3 and 15 months.
* Participant must have a clinical diagnosis of Dravet syndrome or the treating clinician must have a high clinical suspicion of a diagnosis of Dravet syndrome.
* Participant is receiving at least one prophylactic antiseizure medication.

Exclusion Criteria:

* Participant has another genetic mutation or clinical comorbidity which could potentially confound the typical Dravet phenotype.
* Participant has a known central nervous system structural and/or vascular abnormality (indicated by an MRI or CT scan of the brain).
* Participant has an abnormality that may interfere with CSF distribution and/or has an existing ventriculoperitoneal shunt.
* Participant is currently taking or has taken antiseizure medications (ASMs) at a therapeutic dose that are contraindicated in Dravet syndrome, including sodium channel blockers.
* Participant has experienced seizure freedom for a period of 4 consecutive weeks within the 6-month period prior to informed consent.
* Participant has previously received gene or cell therapy.
* Participant is currently enrolled in a clinical trial or receiving an investigational therapy.
* Participant has clinically significant underlying liver disease.
Study of Brain Function Evaluation System for Acute and Prolonged Disorders of Consciousness

The research focuses on establishing a system for detecting loss of consciousness, developing clinical prognostic and awakening-related brain function testing criteria.

A framework for the acquisition of neural features, feature selection and mechanism analysis of consciousness deficits in patients with acute and prolonged disorders of consciousness(DOC). Based on the multimodal data of three types of patients with DOC, the investigators established a comprehensive scientific collection of brain function features of acute and prolonged consciousness disorders; Revealed the key neural nodes and circuits of consciousness deficits, and elucidated the neural mechanisms of consciousness deficits in patients with prolonged consciousness disorders from EEG time-frequency-spatial features;

Eligibility Criteria:
Admission criteria for patients with prolonged disorders of consciousness

Inclusion Criteria:

1. Age 14-60 years;
2. In accordance with the diagnostic criteria of unresponsive arousal syndrome or minimally conscious state by international research;
3. Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness;
4. right-handed；
5. The patient's family members signed the informed consent form;

Exclusion Criteria:

1. The history of mental illness and a history of hearing impairment;
2. Intracranial arterial clamp, pacemaker and other metal implants;
3. During the experiment, sedatives and other drugs that affect the excitability of the cortex;
4. The presence of uncontrolled seizures or involuntary movements;

Admission criteria for patients with acute disorders of consciousness

Inclusion Criteria:

(1)Age 14-60 years; (2）Meets diagnostic criteria for coma recognized in international studies； (3)the GCS score was less than 8; (4)Brain Trauma, stroke and hypoxic-ischemic encephalopathy lead to disturbance of consciousness; (5) right-handed； (6)The patient's family members signed the informed consent form;

Exclusion Criteria:

1. The history of mental illness and a history of hearing impairment;
2. Intracranial arterial clamp, pacemaker and other metal implants;
3. During the experiment, sedatives and other drugs that affect the excitability of the cortex;
4. The presence of uncontrolled seizures or involuntary movements; Admission criteria for patients with acute disorders of consciousness;
5. No spontaneous breathing;
6. Status Epilepticus;
7. Need emergency neurosurgical treatment can not cooperate with the examination;
The MARVIN Chatbots to Provide Information for Different Health Conditions

This research is a continuation of a usability study with the MARVIN chatbot. The investigators aim to adapt the MARVIN chatbot to open it to other health domains (e.g. breast cancer) and populations (e.g. pharmacists). Therefore, this protocol constitutes a master research protocol that will englobe different research projects with individual chatbots. The investigators adopt an adaptive platform trial design, which will allow flexibility in handling multiple interventions adapted to different populations while retaining the characteristics of a platform trial design allowing early withdrawal of ineffective trial arms based on interim data (implementation outcomes) and introduction of new trial arms.

From 2020, the Principal Investigator's team has developed an innovative chatbot named Minimal AntiretRoViral INterference (MARVIN), for people with HIV. The primary objectives with this master protocol are to: 1) develop or adapt the MARVIN chatbots for different healthcare contexts through co-construction; 2) evaluate the global usability of individual chatbots in their respective use scenarios with a small sample of research participants; 3) evaluate the implementation and user outcomes (e.g., fidelity, appropriateness) of individual chatbots in their respective use scenarios with a larger sample of research participants. This includes also documentation of factors that inhibit or enhance the utilization of the chatbots and outcomes; and 4) establish and evaluate, through the previous objectives, different partnerships with research participants and research team members to co-construct chatbots that will respond to their needs and encourage continued use of the tool.

Eligibility Criteria:
Inclusion Criteria for all objectives:

* being 14 years or older;
* being fluent in English and/or French;
* being able to understand the requirements of study participation and provide informed consent during the duration of the study;
* having access to a smartphone, tablet, or computer at home/at workplace;
* having access to an internet connection at home or data plan on their device.

Inclusion Criteria Specific to objectives 2 and 3:

* accept to use a Facebook Messenger-based Chatbot;
* accept to use or create a personal Facebook account;
* accept Facebook's privacy and data security policies.

Exclusion Criteria:

* not meeting the inclusion criteria
* any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving a chatbot (e.g., cognitive deficit)
RECLEAN Pilot Study

This is an exposure assessment pilot study tailored for families of construction workers living with a child. The investigators will compare home dust metal levels and resident's blood metal levels before and after an educational and environmental intervention. A baseline and a post intervention period assessment will be conducted with home and car lead inspections and risk assessments with collection of dust, urine, blood and toenail samples and a survey.

Objectives of this research are to:

1. To characterize pre-intervention home exposures to lead and other metals in households with one construction worker inhabitant living with a child, by assessing household members' biospecimens and home dust metal levels.
2. To develop and evaluate customized home interventions (including environmental and educational approaches) to reduce metals exposure in three tiers of intervention.
3. To characterize home exposures to lead and other metals post intervention and determine adapted behaviors and whether the degree of metals exposure reduction (including take home exposures) in the households depends on the level of intervention.


Eligibility Criteria:
First, construction workers will be recruited. Second, household members of the construction worker will be recruited.

Inclusion Criteria:

Construction workers must meet all of the following inclusion criteria:

1. 18 years of age or older
2. works full time in construction with high risk for metal exposures
3. lives in the Greater Boston area
4. lives with at least 1 child household member 1 year of age or older (does not have to be a child of the worker but interested in participating in the study)
5. speaks English or Spanish.

Household resident participants must meet all of the following inclusion criteria:

1. child (1 - 17 years of age) or adult (18 years of age or older)
2. lives in the Greater Boston area with the worker participating in this study
3. speaks English or Spanish.

Exclusion Criteria: None
Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer

Patients with esophageal cancer to be treated with concurrent preoperative proton therapy along with carboplatin and paclitaxel.

1. To identify the maximally tolerated radiation dose (MTD) of dose-escalated proton radiotherapy in combination with carboplatin/paclitaxel in the preoperative setting for esophageal cancer.
2. To estimate pathologic response rates by esophagectomy surgical specimens after escalated doses of chemoradiotherapy.
3. To assess the utility of circulating tumor cells and tumor vesicles as biomarkers to predict treatment response to chemoradiotherapy

Eligibility Criteria:
Inclusion Criteria:

* Patients with a histologic diagnosis of adenocarcinoma of the esophagus located distal to the carina
* Patients with AJCC 7th edition clinical stage IIB-IIIC
* Patient must be \>18 years of age.
* Patients must have an ECOG Performance Status of 0-1
* Patients must be able to provide informed consent.
* Patients must be surgical candidates with adequate hematologic, renal, hepatic and pulmonary function
* serum AST and ALT \< 2 times the upper limit of normal
* Patients must have bilirubin \< 1.5 × normal.
* WBC \> 3000/mm3, platelets \> 100,000 mm3.
* Hemoglobin \> 10 g/dL serum creatinine \< 1.5 times the upper limit of normal
* Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented.

Exclusion Criteria:

* Patients with primary tumors exceeding 8 cm in length or 5 cm in width ( length should be measured by endoscopic findings, width should be measured by diagnostic CT or CT portion of PET/CT)
* Patients with primary tumors located at or above the carina
* Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
* Pregnant women, women planning to become pregnant and women that are nursing
Preoperative Nutritional Status in Patients Undergoing Elective Total Knee Arthroplasty and In-hospital Postoperative Complications

Malnutrition has long been linked to postoperative complications and adverse outcomes in a variety of surgical fields , such as increased susceptibility to infection, delayed wound healing, and increased frequency of decubitus ulcers. In particular, it is a modifiable risk factor, as evident by studies that have associated optimization of preoperative nutrition with improved surgical outcomes. Therefore, it is important to identify these patients who are at risk so that appropriate nutritional support can be implemented.

A range of options for nutritional status assessment have been proposed; a comprehensive assessment may include measurements of dietary intake, clinical assessment, anthropometric measurements, and biochemical measurements of serum protein, micronutrients and metabolic parameters . Many of the signs of malnutrition, however, only manifest in extreme cases. Thus it is crucial to identify sensitive markers that can be utilized to screen for clinical as well as subclinical malnutrition patients.

In orthopaedic patients, the prevalence of clinical and subclinical malnutrition has been reported to be up to 42.4%. Common markers of malnutrition that have been studied include low serum albumin as a marker of protein status, low total lymphocyte count (TLC), and excessively high or low body mass index (BMI). They have been compared against various adverse surgical outcomes, including surgical site infections (SSI), delayed wound healing, unplanned intubation and ICU admission , postoperative anemia and cardiac complications , and length of hospital stay. However, conflicting results have been reported; for example, while hypoalbuminemia (serum albumin \<3.5mg/dL) have been associated with increased risk of SSI and longer than average hospital stay, its effect on wound healing is less clear - Marin et al. reported no significant predictive value of hypoalbuminemia on wound healing, yet Greene et al. reported a 5-time increase in frequency of major wound complication.

The purpose of this retrospective cohort study was to identify biomarkers of malnutrition in patients undergoing elective total knee arthroplasty (TKA) that are predictive of adverse in-hospital postoperative complications, which would facilitate the identification of at risk patients for nutritional optimization before surgery.

Six-hundred and twenty-six patients who underwent elective TKA between 2013 and 2017 in the Prince of Wales Hospital in Hong Kong were reviewed; the preoperative serum albumin, TLC, and BMI were compared against in-hospital postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* All elective Total Knee Arthroplasty cases from 2013 to 2017
* All patients must have undergone elective Total Knee Arthroplasty in Prince of Wales Hospital Hong Kong

Exclusion Criteria:

* Revision of Total Knee Arthroplasty
A Randomized Comparison of CLOpidogrel Monotherapy Versus Extended Dual-antiplatelet Therapy Beyond 12 Months After Implantation of Drug-eluting StEnts in High-risk Lesions or Patients; A-CLOSE Trial

We hypothesized that clopidogrel mono-therapy will not be inferior to the extended DAPT in terms of the occurrence of both ischemic and bleeding events, for lesions or patients at high risk for either ischemic or bleeding complications 12 months after drug-eluting stent (DES) implantation.

Patients at high risk for either ischemic or bleeding complications, but who were stable without clinical evetns for 12 months after DES implantation will be included in this study. Eligible patients will be randomized to continue DAPT (aspirin plus clopidogrel) for further 24 months or to change to single antiplatelet therapy with clopidogrel (clopidogrel-alone). Randomization will be stratified according to 1) clinical presentation (acute coronary syndrome or stable coronary artery disease) and 2) age (≥75 or \<75). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative. All of study subjects will be have an outpatient visit as scheduled in outpatient clinic. Occurrence of study endpoints will be documented at clinical visit or telephone interview every 6 months up to 24 months after randomization. Antiplatelet drugs will be open-label and prescribed by attending physician.

Eligibility Criteria:
Inclusion criteria (must all met)

1. Patients \>19 years old
2. Patients who underwent DES implantation 12 months (-1 to +5 months) previously.
3. High risk characteristics (clinical or lesion) for ischemic events (must at least one)

High risk patients; clinical criteria

1. Acute coronary syndrome
2. Previous history of cerebrovascular accidents
3. History of peripheral artery intervention
4. Heart failure (left ventricular ejection fraction ≤40%)
5. Diabetes treated with medication
6. Chronic renal insufficiency including end-stage renal diseases

High risk lesions; angiographic or procedural criteria

1. Left main diseases
2. Bifurcation lesions
3. Chronic total occlusion
4. In-stent restenotic lesions
5. Graft lesions
6. Diffuse long lesions requiring total stent length ≥28 mm
7. Calcified lesions requiring atherectomy
8. Multivessel coronary artery disease with multiple stents
9. Small vessel disease requiring stent diameter of ≤2.5 mm

Exclusion criteria

1. Age\> 80 years
2. Pregnant women or women with potential childbearing
3. Life expectancy \< 1 year
4. Refusal or inability to understand of informed consent
5. Need for chronic oral anticoagulation
6. History of major bleeding within 3 months prior to randomization
Urinary Prostaglandin as a Potential Predictive Marker for Thiazide-induced Hyponatremia

Thiazides and thiazide-like diuretics are one of the five major classes of antihypertensive drugs. This study is to investigate whether urinary PGE2 concentration at baseline (prior to thiazide initiation) is associated with the development of TIH within the first four weeks of treatment.

Thiazides and thiazide-like diuretics are one of the five major classes of antihypertensive drugs. They act by inhibiting the apical Na+-Cl- -cotransporter in the distal convoluted tubules of the kidneys. Thiazides and thiazide-like diuretics often cause adverse effects, importantly a drop in plasma sodium levels that is called thiazide-induced hyponatremia (TIH). Data suggest a crucial role of urinary PGE2 in water reabsorption. Since urinary PGE2 concentrations were higher in patients with TIH, quantification of urinary PGE2 prior and after thiazide initiation might allow identification of patients at risk for TIH, presenting PGE2 as a potential novel predictive marker for the development of TIH.

This study is to investigate whether urinary PGE2 concentration at baseline (prior to thiazide initiation) is associated with the development of TIH within the first four weeks of treatment. Hospitalized and ambulatory patients in whom a thiazide or thiazide-like diuretic will be newly prescribed are screened for inclusion.

The study procedure contains the screening and inclusion, visit 1 before thiazide initiation, visit 2 4 weeks (+/-7days) after thiazide initiation and a 3-months follow-up (visit 3). An additional visit (visit 2.1) will only be added in case of a dose change of the thiazide or thiazide-like diuretic (4 weeks +/- 7 days after the dose change). The 2 hours- challenge is optional if the patient agrees to additional testing.

Eligibility Criteria:
Inclusion Criteria:

* Newly prescribed thiazide or thiazide-like diuretic
* ≥ 18 years of age
* Informed Consent as documented by signature

Exclusion Criteria:

* Intake of thiazide or thiazide-like diuretic in the preceding month
* Hyponatremia (plasma sodium \<135 mmol/L) at baseline
* Acute infectious / inflammatory disease (CRP ≥ 20 mg/L \[1, 11\])
* Symptomatic urinary tract infection
* Chronic treatment with NSAID and / or NSAID intake 48 hours prior to urine sampling at visit 1 and 2 (intake of acetylsalicylic acid will be no exclusion criteria)
* End of life care, no informed consent or inability to follow the procedures of the study, e.g., due to language barriers, psychological disorders, dementia