cyrilzakka/clinical-trials huggingface dataset:
The Potential Efficacy of the Chinese Health Improvement Profile- A Pilot Clustered Randomised Controlled Trial

The investigators programme of research will evaluate an existing physical health care screening intervention with the aim of helping Community Psychiatric Nurses (CPN) to improve the physical health wellbeing of people with a SMI.

This pilot clustered randomised controlled trial aims to establish the potential efficacy and acceptability of the Chinese Health Improvement Profile (CHIP) in improving the physical health of people with severe mental illness.

This pilot study will use a non-blinded parallel group clustered randomised controlled trial design.

The study will be carried out by CPNs with community-dwelling people aged 18-65 who have a psychiatric diagnosis of SMI (i.e. schizophrenia, schizoaffective disorder, other psychotic disorder or bipolar affective disorder) and at the point of recruitment are being treated in the community. It will investigate the potential clinical impact of the use of the CHIP tool when used by CPNs with this patient group. Because the CHIP is designed to be used as both an enhanced physical health risk screening tool and as an instrument to direct appropriate clinical interventions the investigators will ask the patients' allocated CPNs to recruit consenting patients , collect outcome measure data and where appropriate use the CHIP tool with patients that they work with within their routine clinical practice.

Primary objective:

To test the potential efficacy and acceptability of the CHIP intervention compared to treatment as usual on patients' physical well- being over a 12 month period.

Secondary objectives:

To measure and compare changes in perceived mental well-being between the groups as measured at baseline, and at 6 months and 12 months after the start of the intervention.

To establish differences in the objective physical health state of patients between the groups at 12 months as indicated by data routinely recorded in medical/outpatient/nursing notes during the duration of study.

To establish changes in health behaviours and physical indicators of cardiovascular risk within the intervention group between baseline and 12 months after the start of the intervention.

Eligibility Criteria:
Inclusion Criteria:

Those psychiatric outpatients under the care of the community psychiatric nursing service who are:

* Aged 18-65 years;
* Having a case-note diagnosis (as confirmed by a registered clinician) within the illness group entitled "severe mental illness" (SMI) containing schizophrenia, schizoaffective disorder, other psychotic disorders, depressive or bipolar affective disorder (type 1 or 2); and
* Able to speak Chinese/English
* Able to provide written informed consent and considered safe and competent to participate in the study (as suggested by attending psychiatrist).

Exclusion Criteria:

* Co-morbidity of learning disability or organic brain diseases.
Pain Treatment With Combinations of NSAIDs

The search for new safe and effective methods of pain relief after surgery on large joints is still an urgent problem. The most optimal approach in the treatment of postoperative pain is the use of multimodal analgesia with a different mechanism of action that act on various mechanisms of pain and can include opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, anticonvulsants, NMDA antagonists, alpha-2-agonists, and sodium and calcium channel blocking agents, as well as local anesthetics. NSAIDs are the most popular and safe means for pain relief. Therefore, a lot of efforts are aimed at increasing the effectiveness of NSAIDs use. The aim of this study was to evaluate the effectiveness of simultaneously administering two or three NSAIDs, compared to using only one NSAID, for pain relief after surgery on large joints such as hip or knee arthroplasty.

This is 6 days, randomized, double blind, parallel group, single-center study in 105 subjects. The distribution into groups was carried out by sequentially alternating the set into 4 groups celecoxib 400 mg orally daily, aspirin 100 mg and ketorolac 90 mg orally daily, ketorolac 90 mg and celecoxib 400 mg orally daily; aspirin 200 mg, ketorolac 90 mg and celecoxib 400 mg orally daily.

Eligibility Criteria:
Inclusion Criteria:

* The patients with diagnosis of osteoarthritis of the knee or hip joint (M15.0, M16, M17) after primary knee or hip arthroplasty.
* Informed consent.

Exclusion Criteria:

* Patients who cannot cooperate with the trial.
* Pregnant or breast feeding women,
* Оpioid addiction,
* Contraindication to NSAIDs (allergy to NSAID, history of ulcer and gastrointestinal bleeding, liver failure, renal failure (eGRF \< 60 ml/kg/1,73m2) and chronic kidney disease 2-5, known thrombocytopenia (\<100 mia/L)
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Pulmonary Diseases

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Pulmonary Diseases

In this patient funded trial, patients with pulmonary disease will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pulmonary disease
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
Autologous Transplantation for Multiple Myeloma

The present study was designed in an attempt to prospectively evaluate in a randomized fashion whether further cytotoxic dose intensification, as delivered with two sequential autologous stem-cell transplantations, improved the outcome of younger patients with newly diagnosed multiple myeloma in comparison with a single autologous transplantation.

Following demonstration that single autologous transplantation for the treatment of younger patients with newly diagnosed multiple myeloma prolonged overall survival in comparison with conventional chemotherapy, double autologous transplantation was tested, initially in refractory myeloma and subsequently to include also patients with newly diagnosed disease. To explore the role of double autologous stem-cell transplantation as part of up-front therapy for multiple myeloma, in 1996 we launched a prospective, randomized trial comparing a single course of stem-cell-supported melphalan with the same regimen followed, after three to six months, by a second autologous transplantation in support of melphalan and busulfan. The study was designed to detect a 15 percent increase in complete or near complete response rate with double transplants compared to a single transplantation. With a 2-sided significance level α = 0.05 and a power 1-β = 0.80, 162 patients were required in each treatment arm of the study to detect a statistically significant increase in complete or near complete response rate from 30% in the single-transplant arm to 45% in the double-transplant arm. Primary study endpoint was the complete or near complete response rate. Secondary study endpoints were relapse-free survival, event-free survival and overall survival. The recruitment target was 324 patients.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated
* Younger than 61 years
* Symptomatic myeloma
* Measurable disease
* Fit to receive high-dose chemotherapy

Exclusion Criteria:

* M-GUS
* Solitary plasmacytoma
* Plasma cell leukemia
* AL Amyloidosis
Effect of Lidocaine Plus Dexmedetomidine Infusion on PONV

BACKGROUND: Few researches have manifested that intravenous (IV) lidocaine or dexmedetomidine decreased the incidence of postoperative nausea and vomiting (PONV). The investigators investigated whether IV lidocaine plus dexmedetomidine infusion could better reduce the incidence of PONV after laparoscopic hysterectomy.

METHODS: One hundred and twenty women with elective laparoscopic hysterectomy were randomly divided into two groups: patients in the lidocaine combined with dexmedetomidine group (LD group, n=60) received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine (0.5 μg/kg loading, 0.4 μg/kg/h infusion) respectively. Patients in the control group (CON group, n=60) received the equal volume of saline. Primary outcome was the incidence of the first 48 h nausea, vomiting and PONV after surgery. The secondary outcomes included perioperative propofol and remifentanil consumption, postoperative fentanyl requirement, Ramsay sedation score, and bradycardia during post-anaesthesia care unit (PACU) stay.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical statusⅠand Ⅱ
* Aged 40-55 years
* Scheduled for elective laparoscopic hysterectomy

Exclusion Criteria:

* History of allergy to local anesthetics
* Severe respiratory disease
* Renal or hepatic insufficiency
* History of preoperative opioids medication and psychiatric
* preoperative bradycardia
* preoperative atrioventricular block
* Subjects who experienced severe hypotension (mean arterial pressure \[MAP\] \<60 mmHg) or bradycardia (heart rate \[HR\] \<40 bpm), urticaria, or arrhythmia during lidocaine and dexmedetomidine infusion period
Effect of Ascites Replacement Strategy on Time to 1st Flatus After LDLT

The aim of this study is to evaluate difference in the rate of recovery of intestinal motility according to different ascites replacement strategy after living donor liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Adults (19 years or older)
* Elective living donor liver transplantation

Exclusion Criteria:

* Previous abdominal surgery
* Renal failure requiring renal replacement therapy
* Contraindications for 5% albumin use

  1. Condition with potential risk caused by increased circulating plasma (heart failure, renal failure combined with oliguria, pulmonary edema)
  2. Hemolytic anemia
* Contraindications for Hartmann solution

  1. Progressive lactic acidosis
  2. Hypervolemia
  3. Hypernatremia
The Proportion of Patients Diagnosed With Dry Eye by the Asia Dry Eye Society (ADES) Criteria in Taiwan (DECS-TW)

The study aims to determine the proportion of patients diagnosed with dry eye by the Asia Dry Eye Society (ADES) criteria, among patients diagnosed with dry eye disease under current hospital-based practice in Taiwan.

This real-world, observational study aims to show in a descriptive manner to characterize the patient profile of dry eye disease in Taiwan, and to understand the local practice and its difference compared with Asia Dry Eye Society (ADES) criteria. Specific objectives include:(1) to determine the proportion of patients diagnosed with dry eye by the Asia Dry Eye Society (ADES) criteria, among patients diagnosed with dry eye disease under current hospital-based practice in Taiwan, (2) to compare the patient profile including ocular condition and dry eye-related characteristics of dry eye diagnosed with ADES criteria versus hospital-based real-world practice in Taiwan, and (3) to determine the disease characteristics of patients diagnosed with dry eye in Taiwan medical institutions.

This study will enroll patients who are diagnosed with dry eye, aged 20 years (inclusive), and are willing to provide signed informed consent. These patients will be categorized into Group I or II according to the inclusion criteria.

Clinical data of eligible patients at the time of dry eye diagnosis on medical charts will be collected. If any return visit is scheduled per routine practice before the end of data collection (Feb-28-2022), follow-up data regarding dry eye evaluations and treatments will be collected at the first follow-up visit for Group I; and within 6 months after the cataract surgery for Group II.

Eligibility Criteria:
Inclusion Criteria:

Patients who meet the criteria of either Group I OR Group II are eligible.

Group I

Patients with signed informed consent and who satisfy all of the following criteria will be included:

1. 20 years old or older (regardless of sex)
2. Outpatients
3. Newly-diagnosed with dry eye disease (DED) within 6 months prior to signing the informed consent under hospital-based practice in Taiwan

Group II

Patients with signed informed consent and who satisfy all of the following criteria will be included:

1. 20 years old or older (regardless of sex)
2. Outpatients
3. Patients who had undergone cataract surgery and

   1. was suspected to have dry eye disease (dry eye evaluations conducted based on the routine practice) within 6 months prior to signing the informed consent or
   2. was diagnosed with dry eye disease within 6 months prior to signing the informed consent

Exclusion Criteria:

Patients who meet ANY one of the following criteria are not eligible.

1. Patients who have ocular comorbidities, and appear dry eye sign and symptoms that interfere with diagnosis of dry eye disease (DED)
2. Patients who cannot confirm subjective symptoms of dry eye
3. Patients who cannot read or write, and/or could not understand dry eye questionnaire appropriately which may compromise the accuracy of questionnaire score.
4. Patients who participate in other interventional trials in the past 30 days
Treatment With ATRA-IV and Depakote in Patients With Advanced Solid Tumor Malignancies

The purpose of this study is to find out the highest tolerated dose of Depakote in combination with liposome encapsulated all-trans retinoic acid (ATRA-IV) in patients with advanced solid tumor malignancies.

To determine the maximum tolerated dose of Depakote in combination with liposome encapsulated all-trans retinoic acid (ATRA-IV) in patients with advanced solid tumor malignancies.

This will be a 2-step dose escalation study. Once the patient starts therapy at a designated dose level, it will not be escalated for that patient. Three patients at each dose level must complete 4 weeks of therapy before escalating to the next higher level. If none of the patients experience dose limiting toxicity (DLT), then 3 new patients will be treated with the next higher dose level.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologic confirmation of a solid tumor malignancy with clinical evidence of metastatic disease.
* Patients must have failed at least one standard therapy, if available, for their malignancy. Patients may be entered on the trial without prior therapy if there is no standard effective therapy available.
* No active brain metastases or epidural tumor.

Exclusion Criteria:

* Concomitant administration of steroids.
* Irradiation or chemotherapy within 14 days of start of protocol.
* Evidence of another active cancer, except for non-melanoma, carcinoma of the skin and in-situ carcinoma of the cervix curatively treated, Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for greater than 5 years.
* Women who are pregnant or lactating. Women or men of reproductive age who are unwilling to use two forms of effective contraception.
* Patients with clinically significant cardiac, renal or hepatic disease; severe debilitating pulmonary disease; or history of diabetes mellitus prone to ketoacidosis.
* Patients with a history of pancreatitis.
* Patients with known hypersensitivity to retinoids or retinoic acid derivatives.
* Patients with coagulation disorders, such as thrombophlebitis or pulmonary embolism.
* Patients with pre-existing psychiatric condition, especially depression or a history of severe uncontrolled psychiatric disorder.
* Patients with pre-existing thyroid abnormalities whose thyroid function cannot be maintained in the normal range.
* Patients with chronic moderate to severe nausea.
* Patients with history of epilepsy or a seizure disorder taking anti-convulsant medication.
ApTOLL for the Treatment of COVID-19

There is a clear and urgent medical need of developing new medicinal products for COVID-19 since there are poor pharmacological tools to block the progression of patients to cytokine storm syndrome (CSS). To this aim, this Phase Ib clinical study (APTACOVID) pretends to determine whether ApTOLL, in combination with the standard of care, is safe and shows any biological effect) in those patients infected with SARS-CoV-2 who are not developed CSS yet.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women with age ≥18 and ≤85 years.
2. In case of women of childbearing potential (WOCBP), they should confirm menstrual period and a negative highly sensitive urine or serum pregnancy test to be included.
3. Laboratory-confirmed SARS-CoV-2 infection.
4. Informed consent obtained .
5. Hypoxia (SpO2\<95%).
6. Documented lung opacities/infiltrates.
7. Confirmed hyperinflammation.

Exclusion Criteria:

1. Onset of symptoms of COVID-19 \>14 days.
2. Pregnant or nursing (lactating) women.
3. Hospitalized \>10 days for COVID-19.
4. Need of high concentration non-rebreather mask, high-flow nasal cannula , non-invasive mechanical ventilation or invasive mechanical ventilation.
5. Systolic blood pressure \< 90 mmHg.
6. Serious concomitant illness.
7. Recent treatment with cell-depleting therapies.
8. Enrolled in another clinical trial.
9. Severe renal dysfunction.
10. In the opinion of the investigator, unable to comply with the requirements to participate in the study.
Plasma Brain Natriuretic Peptide Levels in Pregnancy

To evaluate the maternal blood concentrations of brain natriuretic peptide (BNP) during the second and third trimesters of a normal pregnancy. We will attempt to define a normal range for pregnancy and any outliers that may serve as markers for abnormal cardiovascular physiology.

The brain natriuretic peptide (BNP) is a useful marker for volume overload, increased filling pressures and stretching of the myocardium. The current literature contains limited and unreliable information regarding normal BNP values in pregnancy. After baseline echocardiogram to detect individuals with asymptomatic structural defects, the participants will submit to 3 blood draws during the second and third trimester and at delivery to determine normal pregnancy values.

Eligibility Criteria:
Inclusion Criteria:

* women age 18 to 40
* second trimester of pregnancy

Exclusion Criteria:

* known cardiac or valvular disease,
* atrial fibrillation or other arrhythmia,
* pulmonary hypertension,
* chronic hypertension,
* hypertensive disorders of pregnancy,
* morbid obesity (BMI \> 40 kg/meter squared)
* history of sleep apnea
* multiple gestation
* known renal dysfunction
* medications known to affect cardiac function
* current or past abnormal echocardiogram
Post-ICU Follow-up Study in Covid-19 Patients

A follow up study of adult patients who have been treated in the ICU at Mölndal hospital due to Covid19 in the period of 2020 to 2022.

The spread of Covid19 in the population in Sweden from 2019 and onwards posed new and serious strain on our ICU capacity. The disease presented with initially influenza like symptoms and evolved into multiorgan failure. 5% of all patients with verified Covid 19 were in need of critical care and among them the in-hospital mortality rate was 20%.

Patients will be followed up with after a minimum of three months after discharge from the ICU with regards to organ function.

Examinations within the scope of the study are;

* Comprehensive heart investigation including ultrasound
* Arterial blood gas and lung function tests including computer tomography of the lungs.
* Cognitive function with validated questioners
* Standardized test of physical function
* A panel of blood samples to assess organ function

Eligibility Criteria:
Inclusion Criteria:

* Patients treated at the Intensive Care Unit at Mölndals hospital from 2020 to 2022 for Covid19
* More than 3 months passed since ICU discharge
* Over 18 years of age at time of inclusion
* Swedish resident with Swedish unique personal identification number.
* Informed consent

Exclusion Criteria:

* Under 18 years of age at time of inclusion
* Not a Swedish resident
* Unwillingness to participate
Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Metastatic Melanoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Clinical trial to study the effectiveness of chemotherapy plus bone marrow transplantation in treating patients with metastatic melanoma that has not responded to previous therapy.

OBJECTIVES: I. Determine the response rate and survival of patients with metastatic malignant melanoma who have failed first-line therapy when treated with match-related allogeneic bone marrow transplantation.

OUTLINE: This is a pilot study. Patients receive a preparative regimen of busulfan and cyclophosphamide. Busulfan PO is administered every 6 hours on days -7 to -4. Cyclophosphamide IV is administered on days -3 to -2 followed by one day of rest. Bone marrow infusion occurs on day 0. Cyclosporine begins on day -1 and continues until day 180. Methotrexate IV is administered on days 1, 3, 6, and 11. Granulocyte colony-stimulating factor is administered as a continuous IV every 2 hours starting on day 12 and continuing until absolute neutrophil count is greater than 1,000 g/dL for 2 consecutive days. Patients receive weekly follow up for the first 180 days and monthly thereafter. Patients are followed until death.

PROJECTED ACCRUAL: 6 patients with melanoma will be accrued.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Biopsy proven relapsed malignant melanoma that has failed prior standard regimen for metastatic disease Must have HLA-matched or related bone marrow donor (5- or 6-antigen match) No history of CNS metastases

PATIENT CHARACTERISTICS: Age: 16 to 44 Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: SGOT and SGPT less than 1.5 times upper limit of normal Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL AND/OR Creatinine clearance greater than 75 mL/min Cardiovascular: No history of cardiac disease No symptomatic cardiac disease Ejection fraction greater than 50% Pulmonary: FEV1 greater than 50% predicted (greater than 75% if received thoracic irradiation) DLCO greater than 50% predicted Other: Not pregnant Fertile women must use effective contraception HIV negative No active bacterial, fungal, or viral infection Hepatitis B negative

PRIOR CONCURRENT THERAPY: At least 1 prior standard regimen for metastatic disease