cyrilzakka/clinical-trials huggingface dataset:
Cost-utility Analysis of Ambulatory Dose Escalation of Bispecific Antibodies in Multiple Myeloma.

Multiple myeloma is the second most common haematological cancer. Recent innovations have made it possible for relapsed/refractory patients to benefit from the innovative immunotherapy of bispecific antibodies. These antibodies stimulate the immune system to attack tumour cells. The treatment involves an escalating dose of three subcutaneous injections every 2 to 4 days for a total of about 10 days, followed by a weekly treatment phase.

The University Hospital of Toulouse was the first centre in France to offer outpatient dose escalation for this innovative treatment. This form of treatment depends on clinical and logistical feasibility. Where appropriate, patients are treated in a conventional unit. An analysis carried out at Toulouse University Hospital suggests a response to treatment, with no increased risk of complications in the outpatient setting. Patients' quality of life may also be unaffected. In addition, given the increasing demand for care in a context of finite resources, the economic evaluation of healthcare initiatives is becoming essential if we are to maintain a high-quality healthcare system that is accessible to all.

The study has two arms: patients treated in the outpatient unit and patients treated in the conventional unit. The prospective data collection is based on quality of life at three time points during the dose escalation phase. The following questionnaires will be used: EQ-5D-5L for utility analysis, QLQ-C30 validated in cancer patients and QLQ MY20 validated in multiple myeloma patients. Clinical data will be collected as well as economic data related to hospital stays.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed and/or refractory multiple myeloma
* Treated with teclistamab, elranatamab ou talquetamab
* More than 18 years old
* Having received the information from the study and not having objected to participate
* Day hospital care in case of clinical feasibility (good general condition, no rapid progression or major tumor burden, no current infection) and logistics (accommodated less than 30 minutes from the IUCT Oncopole for 48 hours after each dose escalation) or in conventional hospitalization at the IUCT Oncopole

Exclusion Criteria:

* Illiterate subjects or those with a language barrier
Magnesium Sulfate Combined With Intraarticular Cocktail Injection for Analgesia After Simultaneous Bilateral Total Knee Arthroplasty

Total knee arthroplasty is a safe procedure with excellent outcome. In recent years, simultaneous bilateral total knee arthroplasty has become more popular. In views of enhanced recovery after surgery, intraarticular cocktail injection for pain control has been developed. However, the safety accumulation dose for simultaneous bilateral knee injection is still an issue. Recently, adding magnesium sulfate to intraarticular cocktail injection in unilateral total knee arthroplasty has been proved effective for prolong pain control. We tempt to conduct a double blinded study to evaluate that whether adding magnesium sulfate intraarticular cocktail injection to one of the knees in simultaneous bilateral total knee arthroplasty patient could effectively decrease pain score with less analgesia dose or not.


Eligibility Criteria:
Inclusion Criteria:

* bilateral knee advanced osteoarthritis or osteonecrosis who tend to receive simultaneous bilateral total knee arthroplasty

Exclusion Criteria:

* hypersensitivity to magnesium sulfate
* hypermagnesemia
* severe cardiac, hepatic or renal compromised
ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)

This study will investigate the efficacy of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumor antigen status and whose esophageal or esophagogastric junction (EGJ) cancer expresses the MAGE-A4 protein.


Eligibility Criteria:
Key Inclusion Criteria:

* Age ≥18 and \<75 years
* Diagnosis of Esophageal cancer or Esophagogastric junction cancer.
* Previously received treatment for advanced or metastatic disease.
* Measurable disease according to RECIST v1.1.
* HLA-A\*02 positive
* Tumor shows MAGE-A4 expression confirmed by central laboratory.
* ECOG Performance Status of 0 or1.
* Left ventricular ejection fraction (LVEF) ≥50%.

Note: other protocol defined Inclusion criteria may apply

Key exclusion criteria

1. Positive for any HLA-A\*02 allele other than: one of the inclusion alleles
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study
3. Active autoimmune or immune mediated disease
4. Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases
5. Other prior malignancy that is not considered by the Investigator to be in complete remission. Clinically significant cardiovascular disease
6. Uncontrolled intercurrent illness
7. Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
8. Pregnant or breastfeeding

Note: other protocol defined Inclusion/Exclusion criteria may apply.
Assessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI.

This research is being done to find out if using the contrast agent MultiHance can be used to show how a liver tumor responds to the chemotherapy given during Transcatheter Arterial Chemoembolization (TACE).

MultiHance is approved by the Food and Drug Administration (FDA) for use as a contrast material for Magnetic Resonance Imaging (MRI) scans of the central nervous system. It is believed that using MultiHance may be able to help doctors tell normal liver cells apart from active tumor and from tumor affected by the chemotherapy. In this way, MultiHance may improve the way patients with hepatocellular carcinoma are managed clinically.

We hypothesize that the Multi-Hance contrast material will provide better image definition of treated liver tumor(s) on MRI imaging in comparison to other commercially available contrast agents.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients between the ages of 18 - 80 seen in the cardiovascular and interventional radiology clinic who are scheduled for TACE.
* International Normalized Ratio (INR) \<1.4
* Platelet count \> 80,000

Exclusion Criteria:

* Contraindications to TACE procedure
* Unable to have an MRI Scan
* Allergy or hypersensitivity reactions to gadolinium or any other ingredients, including benzyl alcohol
* Patients with sickle cell anemia , hemoglobinopathies and other hemolytic anemias
* Known clinical hypersensitivity or a history of asthma or allergic respiratory disorders
* Patients with advanced renal failure (those currently requiring dialysis or with a Glomerular Filtration Rate\<15cc/min)
* Pregnancy
Horizontal Ridge Augmentation With or Without Autogenous Block Grafts

To evaluate dimensional bone alterations following horizontal ridge augmentation using guided bone regeneration (GBR) with or without autogenous block graft (ABG) for the rehabilitation of atrophic jaws with dental implants.

Forty-two patients with 42 severe horizontal bone atrophy sites in the maxilla or mandible will be randomly assigned to two groups: ABG or GBR.

In the ABG group, a combination of ABG with particulate xenograft, covered with collagen membrane, will be used, while only a combination of particulate xenograft and collagen membrane alone will be in the GBR group. After 6-9 months of healing, implants were inserted. All implants will be definitively restored 6 months after implant placement. Radiographic examination (cone beam computed tomograms, CBCT) will be performed to evaluate the amount of horizontal bone width (HBW) gain immediately after bone grafting procedure (T0), at 6 months (T6), and at 18 months (T18). Patient demographic information, amount of width augmentation, implant survival, complications, and contributing factors will be gathered and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old, who required an implant supported restoration in at least one site, with severe atrophy of the alveolar ridge in the horizontal plane (class III-IV atrophy according to Cawood and Howell classification),
* adequate oral hygiene
* no history of previous bone augmentation procedures at the implant site, and
* able to understand and sign an informed consent form.

Exclusion Criteria:

* uncontrolled systemic conditions, irradiation in the head and neck area, - immunosuppressed or immunocompromised,
* presented with oral disorders (such as lichen planus),
* treated or under treatment with intravenous amino-bisphosphonates,
* untreated periodontitis, poor oral hygiene and motivation,
* parafunctional habits,
* pregnant or lactating,
* drug or alcohol abuse,
* psychiatric disorders,
* a history (within the last 3 months) of using (at least weekly or more frequently) smokeless chewing tobacco, smoking a pipe, cigar or cigarette (at a rate of more than 10 cigarettes per day),
* acute/chronic infection/inflammation in the area, or
* an extraction with less than 3 months of healing
A Sub Study of the Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)

This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH)

This optional sub study is a part of the phase 1b, Open-Label Study is to assess the safety, efficacy of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH).

All patients who participated in the current study (CORT118335-861) or the Corcept Phase 2a NASH study (CORT118335-860), and who received at least one dose of miricorilant will be eligible for participation in an observational follow-up study; this includes patients who either terminated early or are study completers.

Eligibility Criteria:
Inclusion Criteria:

* Have participated in either Study CORT118335-861 (current study) or Study CORT118335-860 (Corcept Phase 2a NASH study) and received at least one dose of miricorilant; this includes patients who terminated early from the study or completed the study.
* Have not participated in any other clinical trial following study completion in either Study CORT118335-861 or Study CORT118335-860.
Remdesivir Efficacy in Coronavirus Disease

COVID 19 treatment using Remedesvir.

COVID 19 treatment using Remedesvir. Is this drug effective?

Eligibility Criteria:
Inclusion Criteria:

* COVID 19 patients

Exclusion Criteria:

* allergy or contraindication to the drug
Feasibility of Additional Physiotherapy for Patients Aged 75 and Older

On average, people become physically weaker during even a short stay in hospital. This study is a feasibility/pilot study to see if additional physiotherapy exercises undertaken in hospital is feasible and acceptable to patients.

The study will compare two different types of physiotherapy exercise. Both exercise programmes involve twice-daily physiotherapy provided by one of the hospital's physiotherapy assistants, but only one of the two exercise programmes expected to provide benefit. This is on top of the care that people would normally receive, and will last for the first 7 days of their hospital admission (or until they are discharged if this is earlier).

Patients will be asked to consent to the study during the first 36 hours of their hospital admission. If patients provide consent, they will undergo a baseline assessment of their functional ability (including testing of their muscle strength) before being randomly assigned to one of the two exercise programmes. The study aims to recruit 15 patients to each group (30 in total).

Once randomised patients will be seen twice a day by a physiotherapy assistant who will supervise the exercise programme.

On the day that participants are discharged (or day 7 of their admission if earlier) the assessor will repeat measures of the participants functional ability. Following these measures participants will be invited to be interviewed to discuss their experience of taking part in the study.

Approximately one month after discharge, a researcher will visit the participant to repeat measures of their functional ability at their home.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to CUH, who are aged 75 or older, able to give informed consent and expected to be hospitalised more than 24 hours.

Exclusion Criteria:

* Admitted more than 36 hours prior to recruitment; unable to provide informed consent (e.g. due to dementia, delirium, cognitive impairment); receiving end of life care or oncological treatment for diagnosed cancer; inability to cooperate in muscle strength testing (e.g. unable to sit in chair, or presence of skin integrity problems contraindicating the use of a hand-held dynamometer); transferred to or from the intensive care unit; bed-bound or requiring a hoist to transfer from bed to chair 2 weeks prior to hospitalisation; or if the Consultant in charge of the patient has any other clinical concerns regarding participation in a strengthening exercise programme.
The Effectiveness of a Mindfulness Application on Perceived Stess

Mindfulness has become increasingly popular and positive outcomes have been reported for mindfulness-based interventions (MBIs) in reducing stress. The aim of this study is to investigate if a non-guided mindfulness mobile phone application can decrease perceived stress in a non-clinical Dutch population over the course of eight weeks, with follow-up at six months.

Background:

Mindfulness has become increasingly popular and positive outcomes have been reported for mindfulness-based interventions (MBIs) in reducing stress. These findings make room for innovative perspectives on how MBIs could be applied, for instance through mHealth.

Objectives:

The aim of this study is to investigate if a non-guided mindfulness mobile phone application can decrease perceived stress in a non-clinical Dutch population over the course of eight weeks, with follow-up at six months.

Methods:

A randomized controlled trial (RCT) was performed, comparing the experimental group that made use of a structured 8-week mHealth mindfulness program and a control group after 8 weeks, with follow-up after six months. Participants were recruited via a national television program. The primary outcome measure was perceived stress as measured by the Perceived Stress scale (PSS), secondary outcomes were symptoms of burnout (VAS) and psychological symptoms (measured by the four-dimensional symptom questionnaire ; 4DSQ at follow-up). Outcomes were analyzed using a multilevel regression model.

Eligibility Criteria:
Inclusion criteria:

\>18 years

Exclusion criteria:

There were no other eligibility criteria
Intravenous Immunoglobulin (IVIG) Versus Plasma Exchange (PE) for Ventilated Children With Guillain Barre Syndrome (GBS)

Comparing whether intravenous immune globulin or plasma exchange is superior in treating mechanically ventilated children with Guillain Barre syndrome.

Children with Guillain Barre syndrome (GBS) admitted to PICU at Mansoura University Children Hospital, Mansoura, Egypt with the need for mechanical ventilation were prospectively enrolled in the study.

Cases were diagnosed according to clinical criteria. The decisions to initiate, wean and terminate mechanical ventilation were made independently by the attending consultant in accordance with the unit guidelines.

Outcome variables measured were duration of mechanical ventilation, length of PICU stay and ability to walk unaided 4 weeks after PICU discharge.

Eligibility Criteria:
Inclusion Criteria:

* Age: children from 1 month - 18 years old
* Clinical diagnosis of Guillain Barre syndrome
* Requirement of mechanical ventilation

Exclusion Criteria:

* Need for mechanical ventilation beyond 14 days from disease onset
* Child receiving IVIG or PE prior to enrollment
Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol

The investigators plan to develop a novel method of estimating 5-ASA levels in the rectum at a mucosal level using in vivo rectal dialysis technique towards the eventual goal of determining the optimal dosing of Asacol® that would provide therapeutic levels of 5-ASA in the left colon.

Asacol® is mesalazine in a pH-dependent tablet (Eudragit S) that remains intact until reaching the terminal ileum. The tablet dissolves at a pH 7 or greater, allowing mesalazine release in the terminal ileum and throughout the colon; hence, it would be anticipated that this form of 5-ASA will produce higher concentrations in the left colon in patients with active ulcerative colitis compared to other immediate release forms of 5-ASA. However, preliminary research using dynamic computer modeling and simulation predicted that patients with active ulcerative colitis (characterized by an increased stool frequency) treated with Asacol® and Lialda (another delayed release formulation) will achieve very low 5-ASA levels in the sigmoid colon and rectum. The model predicts that these 5-ASA preparations will be relatively ineffective in treating the left side of the colon in active ulcerative colitis.

Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects would be healthy males and females
* 18-45 years of age (inclusive)
* Within 20% of normal body weight at screening
* Who are able to give written informed consent.

Exclusion Criteria:

* History of any chronic illness
* Evidence of significant organic or psychiatric disease on a brief health questionnaire
* A history or presence of any condition causing malabsorption or an effect on gastrointestinal motility
* A history of any gastrointestinal surgery
* A history of acute or chronic renal insufficiency
* Pre existing liver disease
* A history of severe allergic reaction to salicylates, aminosalicylates or any of the ingredients of Asacol® tablets or a history of multiple food/drug allergies or if they are pregnant or lactating.
* Subjects will be required to refrain from any prescription or nonprescription drug or herbal products except their birth control medications for gastrointestinal disorders for 7 days prior to dosing and during the study, till its completion at the end of the fifth visit.
PERsonalized SPEeCh Therapy for actIVE Conversation

Background: Up to 70% of the patients with Parkinson's Disease (PD) experience speech problems, which cause a diminished intelligibility. A reduced intelligibility has a profound negative impact on social interaction and quality of life. Since pharmacological treatment only has limited effects on speech, non-pharmacological treatment, like speech therapy, is particularly relevant. Cochrane reviews (Herd et al., 2012a; Herd et al., 2012b) showed that evidence for speech therapy in PD is increasing, but is still inconclusive. Moreover, only very intensive standardized treatment programs have been studied, which are only feasible for people with mild to moderate PD, but too intensive for people with advanced PD. Here, the investigators will perform the first large-scale study to demonstrate the efficacy of speech therapy in PD patients in all disease stages on quality of life and speech quality.

Objective: The aim is to demonstrate the effectiveness of personalized and home-based speech therapy on quality of life, intelligibility and social participation for people with Parkinson's disease who have a reduced intelligibility of speech.

Methods: The investigators will perform a single blind, randomized and controlled trial. A total of 215 patients (18 years and older) with PD in all disease stages who have difficulty with intelligibility affecting daily communication will participate in this study. The patients will be randomly allocated to either speech therapy or a waiting list control group (1:1 ratio). Speech therapy using telerehabilitation will be provided for 8 weeks which consists of 12-16 sessions. The control group will receive deferred treatment after 8 weeks. The measurements will take place before the randomization (To), after 8 weeks (T1), and for the experimental group also after 24 weeks (T2). The primary outcome measure is quality of life, as measured using the total score on the PDQ-39. Secondary outcome measures include speech and voice, speech intelligibility, non-motor symptoms and caregiver burden.

Hypothesis: The investigators hypothesize that patients in all disease stages can improve their speech intelligibility by using the explicit feedback from external cues provided by instructed caregivers plus a dedicated smartphone/ tablet app (the Voice Trainer app).


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of idiopathic PD;
* Problems in intelligibility affecting daily communication (as indicated by the patient and/or the caregiver);
* A desire for improvement;
* willing and able to receive online treatment

Exclusion Criteria:

* Recent (\<1 year) speech therapy;
* Voice or speech problems due to other causes;
* Communication difficulties based on language problems without predominantly reduced intelligibility;
* inability to receive online treatment
Methylnaltrexone for Treatment of Opiate-Induced Constipation in the Intensive Care Unit

The purpose of this study is to determine if there will be a significantly higher incidence of a bowel movement with methylnaltrexone vs. placebo within 4 hours +- 45 minutes with decreased need for rescue medications in the intensive care unit in patients with opioid-induced constipation. Patients will also be managed with an aggressive bowel management protocol.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older in the ICU
* Opioids for analgesia for at least 24 hours.
* Opioid-induced constipation with no bowel movement within the last 72 hours.
* Women of childbearing potential had negative pregnancy tests.

Exclusion Criteria:

* Contraindication to use of the GI tract
* Diarrhea on admission
* Bowel surgery within 8 weeks of admission
* Ileostomy or colostomy
* Not expected to live or stay more than 3 days in the intensive care unit
* Constipation that was not primarily caused by opioids (as determined by the investigator)
* No opioid use in the last 24 hours,
* Mechanical gastrointestinal obstruction
* An indwelling peritoneal catheter
* Clinically active diverticular disease
* Fecal impaction
* Acute surgical abdomen
* History of Crohn's disease or ulcerative colitis
* On Palliative care
* Less than 18 years old
* Bowel movement in last 72 hours.