cyrilzakka/clinical-trials huggingface dataset:
Development of an Instrumental Activities of Daily Living Scale

This study is to develop an IADL Scale for patients with SCI (IADL-SCI) and examine its psychometric properties in three years.

This study is to develop an IADL Scale for patients with SCI (IADL-SCI) and examine its psychometric properties in three years. In the first year, we will devote ourselves to the development of IADL-SCI - first version. About 150 patients will be recruited in this year.

In the second year, the study will be focused on investigating the psychometric properties of IADL-SCI in order to construct the formal version of IADL-SCI in about 120 patients with stable condition.

In the third year, we will be engaged in analyzing and comparing the psychometric properties of the three IADL scales (IADL-SCI, Frenchay Activities index, and Lawton IADL) to confirm that IADL-SCI is the best among the three. About 50 inpatients receiving rehabilitation will be recruited in this year.

Eligibility Criteria:
Inclusion Criteria:

patients with spinal cord injury

Exclusion Criteria:

patients with other major diseases (e.g., cancer)
IPF mHealth Exercise Study

Patients with idiopathic pulmonary fibrosis (IPF) who are stable on antifibrotic therapy at least 3 months will be randomized to complete a 12-week home exercise intervention using an mHealth platform, plus a pre- and post-intervention monitoring period (4 weeks each) and in-person study assessments.

Contemporary walk test endpoints in IPF trials may under-represent patient functional gains with antifibrotic therapy, which may be more effectively captured with long-term activity monitoring. Traditional pulmonary rehabilitation centers create a barrier to patient exercise accessibility and compliance, which is eliminated in a mobile health (mHealth) exercise training approach. In this study, 30 patients with IPF will be randomized into one of two arms. The exercise arm will receive a 12-week home exercise intervention using an mHealth platform plus pre- and post-intervention monitoring (4 weeks each). The non-exercise arm will be monitored for the same study duration. The primary end point is change from baseline in daily physical activity as a number of weekly exercise minutes qualifying as moderate to vigorous physical activity (MVPA), METS\*minutes of exercise per week, and sedentary time minutes. Assessments will be performed primarily via in-person study visits at week 4 and week 16, as well as via daily recordings from mHealth monitoring devices.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-80 yrs at randomization
* Diagnosis of idiopathic pulmonary fibrosis (IPF), consistent with the ATS 2018 Guidelines
* Percent Forced Vital Capacity (%FVC) ≥50%
* Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30%
* Willing and able to participate in an exercise regimen
* Ambulatory without the use of an assistive device
* Stable on antifibrotic therapy (pirfenidone or nintedanib) at least 3 months
* No changes in other medication for at least 4 wks before enrollment
* Must be able to read, write, and verbally communicate in English

Exclusion Criteria:

* Forced expiratory volume in one second (FEV1)/FVC ratio \<0.7 after administration of bronchodilator at screening
* Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization
* Known explanation for interstitial lung disease
* History of asthma or chronic obstructive pulmonary disease
* Active infection
* Ongoing IPF treatments including investigational therapy, immunosuppresents (other than prednisone 20 mg daily and below) and cytokine modulating agents
* Participation in a supervised exercise program including pulmonary rehab within the previous 12 months
* History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months
* Major orthopedic, psychiatric, neurological, or other conditions that would impair performance of the study exercise outcomes
* Require \>5LPM supplemental O2 at rest
* Currently pregnant
Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy

Cytoreductive surgery with intraperitoneal chemotherapy is one of the most important treatments for patients with colorectal cancer and peritoneal metastasis. For the best survival rates, complete removal of all metastatic lesions is the most important part of treatment, and various surgical procedures are required for the complete cytoreduction. Therefore, the postoperative morbidity rates are higher than those of localized colon cancer surgeries and patients can experience a prolonged recovery period and deterioration of physical activities over a long period. The aim of this study is to investigate the change of quality of life after cytoreductive surgery and intraperitoneal chemotherapy for colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer peritoneal metastasis
* Pseudomyxoma peritonei
* ECOG (Eastern Cooperative Oncology Group) performance status 0-3
* Normal bone marrow, kidney, and liver function
* Patient must sign and date the informed consent

Exclusion Criteria:

* Palliative surgery
* Palliative intraperitoneal chemotherapy
* Psychotic disorder
* Drug abuser
OPtimal Adult Heart Transplant Immunosuppression With MicroRNA Levels (Optimal)

This study aims to develop and refine a miR biomarker panel that can be used to phenotype net immune state after heart transplantation.

The study objectives will be accomplished in a prospective, longitudinal, multicenter, multiracial, multiethnic cohort study that includes adult heart transplant patients from geographically and socioeconomically diverse regions of the U.S. Patients will be screened for eligibility and enrolled \~1 month (± 2 weeks) after transplant.

All patients will follow the center's standard of care surveillance schedule after transplant. Blood samples will be collected for miR evaluation at

1. specified time intervals after transplant
2. when a clinical event of interest occurs, including rejection or infection.

Research samples will be collected and used to evaluate microRNA expression as well as other biomarkers related to heart transplantation and immunosuppressive medications. Additional data collection will include demographics, medical history, medications, human leukocyte (HLA)/donor specific antibody (DSA) evaluations, endomyocardial biopsy (EMB), echocardiography, donor-derived cell-free DNA (dd-cfDNA), and other post-transplant events and testing.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at enrollment
* Receipt of orthotopic heart transplant (OHT) within the prior 1 month ± 2 weeks
* Planned follow-up at the transplant center for a minimum of one-year.
* Patient able and willing to comply with the study visit schedule, study procedures, and study requirements.

Exclusion Criteria:

* Recipient of a multi-organ transplant
* History of prior solid organ transplant before the index heart transplant
* Ongoing mechanical circulatory support or hemodynamic instability (e.g., inotrope or vasopressor therapy)
* Ongoing need for renal replacement therapy and/or dialysis
* Active infection requiring either a) hospitalization b) treatment with antimicrobial therapy or c) reduction in immunosuppression
* Active rejection being treated with intravenous medications or plasmapheresis
Pulmonary Complications After Heart Surgery.

Abstract: Post-operative pulmonary complications after cardiac surgery

Background The Catharina Hospital performs approximately 1700 heart operation each year. One third of the patients stay at the Catharina hospital during their entire post-operative period. Two years ago they abolished the pulmonary support by a physiotherapist. Subjectively, the pulmonary complications increased over the last two years. During an investigation of the contentment of the patients an increase of the pulmonary problems came forward after eliminating the pulmonary support. There have been no further examinations to the pulmonary complications post-operatively.

Objectives The aim of this study is to give the department of cardio-thoracic surgery an advice about the post-operative pulmonary support for patients who underwent heart surgery.

During the study a budgetary analysis will be made.

Methods 120 patients are prospectively randomised in three groups. Randomisation takes place through block randomisation every three weeks. 40 patients will be supported by a physiotherapist. Another 40 patients will be supported by the nurses on the cardiothoracic surgery ward and the last 40 patients will use an incentive therapy with 'Airlife' by a self-management method.

The study population are all patients undergoing heart surgery and spend their entire post-operative period at the Catharina Hospital. In- and exclusion criteria are specified in the protocol on pages 3 and 4.

Outcome The primary outcome is to qualify the pulmonary complications within the three groups. These complications will be objectified by measuring peak flow, an instrument to determine the lung function, and an x-ray of the thorax.

The secondary outcome is the contentment of the patient, which will be determined by a VAS-score (Visual Analogue Scale).

Risks There are no risks for the patient when participating on this study. The patient will have to fill in the VAS-score and measure lung function with the peak flow at two different moments. The study takes place in a clinical setting. There is no extra insurance in conformity with the advice of the METC.


Eligibility Criteria:
Inclusion Criteria:

* Euroscore \< 8
* Age \> 18 year
* Patients whereby ECC is peri-operatively used
* No psychological history
* Informed consent obtained
* Follow -up at Catherina Hospital

Exclusion Criteria:

* COPD
* Mitral valve plasty or reconstruction
* Off-pump
* Cognitive problems
* Expected comlpications during operation
* Patients with decompensation
* Day 5 post- ok thoracic drains insitu
* Pain score grater than 4
* Abnormal chest x-ray
Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life

A phase III multicenter randomized double blind clinical trial will be conducted. After obtaining written consent the infant will be randomized, during the first two weeks of life, to a study group to receive either 400 IU or 1,000 IU / day of vitamin D to the year of age.

Baseline and all follow up visits (2, 6, and 12 months of life) will include anthropometric measurements and a questionnaire about health issues. A blood sample will be obtained at baseline for analysis of 25OH vitamin D, and at 6 and 12 months for analysis of 25 OH vitamin D, and calcium.

Healthy term born infants of appropriate size for gestational age will be included. We will need to include 359 children in each group.

The primary objective of the study is to decrease the proportion of infants with acute bronchitis during the first year of life by supplementation of 1,000 IU/day vitamin D. Secondary otcomes are: To check that the administration of 1,000 IU/day vitamin D decreases the proportion of infants with upper respiratory tract infections, the proportion of children under one year of age hospitalized for acute bronchiolitis, and the demand on the healthcare system due to respiratory infections and absences from work for parents and achieves a higher proportion of children with adequate blood levels 25 OH vitamin D.


Eligibility Criteria:
Inclusion Criteria:

* Healthy term born infants of appropriate size for gestational age
* Parents provide informed consent to participate

Exclusion Criteria:

* Infants with small size for gestational age
* Infants with gestational age \< 37 weeks
* Infants with congenital anomalies
* Infants with chronic gastrointestinal tract, liver, kidney, heart, or neurological diseases
* Infants with disorders of vitamin D or calcium metabolism or others inborn errors of metabolism
Long-term Extension Trial in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Trials - ECZTEND

The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.


Eligibility Criteria:
Inclusion Criteria:

* Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1334, -1339, -1341, -1342, -1343, -1346, or TRA-WEI-0015-I.
* Complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
* Able and willing to self-administer tralokinumab treatment (or have it administered by a caregiver) at home after the initial 3 injection visits at the trial site (in this trial).
* Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.

Exclusion Criteria:

* Any condition that required permanent discontinuation of trial treatment in the parent trial.
* More than 26 weeks have elapsed since the subject received the last injection of investigational medicinal product (IMP) in the parent trial (to be assessed at baseline).
* Subjects who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to tralokinumab by the investigator, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject.
* Subjects who, during their participation in the parent trial, developed an AE that was deemed related to tralokinumab by the investigator and led to temporary discontinuation of trial treatment, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject.
* Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to baseline.
* Treatment with topical phosphodiesterase 4 inhibitors or topical JAK inhibitors within 2 weeks prior to baseline.
* Clinically significant infection within 4 weeks prior to baseline.
* A helminth parasitic infection within 6 months prior to the date when informed consent is obtained.
* Tuberculosis requiring treatment within 12 months prior to screening.
* Known primary immunodeficiency disorder.
Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection

This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess safety and tolerability. Part B will start only after PK data from Part A had been analyzed.


Eligibility Criteria:
Inclusion Criteria:

* History or laboratory evidence of herpes simplex infection
* Clinical evidence or suspicion of herpes simplex infection

Exclusion Criteria:

* Patients unable to swallow
* Concomitant use of probenecid
* Positive pregnancy test

Additional protocol-defined inclusion/exclusion criteria may apply. For detailed information on eligibility, please contact the study center nearest to you or call the following numbers: 1-862-778-3544 or 1-434-951-3228
Metabolic Profile and Anthropometric Changes in Schizophrenia

"No clinical differences will be found between the three antipsychotics under study - olanzapine, risperidone and haloperidol - on the patients' metabolic profile and weight. "

we aimed to study the effects of antipsychotics, olanzapine, risperidone and haloperidol on development of metabolic syndrome in a drug naïve population suffering from first episode schizophrenia and compared it with a matched healthy control group. We also aimed to examine the prevalence of metabolic syndrome as defined by the two most widely accepted definitions, the ATP IIIA and the IDF.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-40 years
* Diagnosis of schizophrenia
* Drug naive on admission

Exclusion Criteria:

* Other psychiatric co-morbidity
* History of severe physical illness
* Alcohol and substance abuse or dependence
* History of pre-existing diabetes or hypertension
* Family history of hypertension or diabetes
Acupuncture for Chemical Therapy Induced Nausea and Vomiting

This is an expertise-based randomized controlled trial. The hypothesis of this study is that the differences in expertise of acupuncturist may impact clinical effect. In this study, patients will be randomized to 4 group, receiving the treatment from senior acupuncturist, junior acupuncturist, junior acupuncturist by only acupuncture Neiguan(P6), or not receive the acupuncture. All patients receive the basic cisplatin chemotherapy. The duration of treatment is from the first day receiving cisplatin until two days after cisplatin on each group. NCI and Rhode scale will be used to measure the control of nausea and vomiting.

This is an expertise-based randomized controlled trial. The hypothesis of this study is that the differences in expertise of acupuncturist may impact clinical effect. In this study, 102 patients will be randomly divided into 4 groups which separately receiving the treatment from senior acupuncturist(clinical experience\> 15 years, considered in this trial as highly expertised), junior acupuncturist(clinical experience\< 5 years, considered in this trial as lower expertised), junior acupuncturist only acupuncture Neiguan(P6), or not receiving the acupuncture. All participants receive the cisplatin-based chemotherapy and 5-HT3 as antiemetic treatment will be included. Acupuncture treatments are given once daily, the duration of treatment is from the first day receiving cisplatin until two days after cisplatin. NCI and Rhode scale will be used to measure the control of nausea and vomiting. only outcome assessors are blinded. Generalized estimating equations will be used to compare the effects among groups.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of cancer
* Must receive cancer chemotherapy containing cisplatin
* Use 5-TH receptor antagonists as an antiemetic drug in the chemotherapy duration

Exclusion Criteria:

* Concurrent neoplasms or illness that induces nausea independent of chemotherapy
* Received acupuncture treatments for other conditions less than 4 weeks before chemotherapy treatment
* Severe infection
* Severe heart, liver, kidney and brain diseases
* Cardiac pacemaker
* Radiotherapy or hormone therapy during chemotherapy treatments
Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment

Development of white spot lesions (enamel demineralization) will be evaluated quantitatively during clear aligner orthodontic treatment compared to conventional fixed appliances using quantitative light induced fluorescence (QLF)

White spot lesion (WSL) may develop around fixed orthodontic appliances. With clear aligners, however, the issue is not controversial. WSL will be monitored in 2 groups of patients; one group using clear aligners and one group wearing fixed orthodontic appliances for 3 months. QLF images will be taken before treatment (T0) and 3 months after commencement of the treatment (T1). The results will be compared between the two groups

Eligibility Criteria:
Inclusion Criteria:

* Healthy patients from both genders aged (17 - 24 years).
* Class I malocclusion with mild to moderate crowding (≤ 5 mm).
* Non-extraction treatment plan.
* Optimum oral Hygiene before treatment with no signs of gingivitis and/or periodontitis.
* Maximum of 3 restored teeth.
* Absence of defective enamel formation in the form of hypocalcification or hypoplasia.

Exclusion Criteria:

-Patients with poor oral hygiene, defective enamel, extensive restorations and salivary glands diseases were excluded.
Evaluation of Raltegravir Plus Maraviroc Therapy in Controlled HIV Patients Presenting With Lipohypertrophy

Evaluation of antiretroviral therapy combining Raltegravir and Maraviroc in patients with virological success, presenting with clinical lipohypertrophy.

Assess the ability to maintain the plasma HIV viral load below the threshold needed for detection (\< 50 copies/mL) at 24 weeks of raltegravir/maraviroc therapy without NRTIs and PIs, in patients with virological success and presenting with clinical lipohypertrophy.

Eligibility Criteria:
Inclusion Criteria:

* Patients infected with HIV-1 type B or CRF02.
* ≥ 18 years old
* Patients who have been receiving antiretroviral therapy for at least 5 years, and whose treatment has been stable for at least 6 months.
* Patients whose plasma viral load has been undetectable (below 200 copies/mL) over the last 24 months, and \< 50 copies/mL for at least 12 months.
* Patients with an R5\* tropic virus, as determined through DNA and with CD4 nadir ≥ 100/mm3
* Patients presenting with clinical lipohypertrophy recognized by themselves and by their doctors, and defined by increased volume of the abdominal and/or thoracic and/or cervical area (buffalo hump).
* Patients who have never been treated with raltegravir.
* Patients who have never been treated with maraviroc.
* Efficient contraception for women
* Free and informed written consent, signed by the patient and the investigator.
* Patients with health insurance. \* To increase the certainty of selecting patients with an R5 virus, the HIV-1 tropism will be determined by the genotype method and interpreted with the Geno2pheno\[coreceptor\] algorithm and a false positive rate threshold for X4 virus at 20%, rather than the usual 10%.

Exclusion Criteria:

* X4, X4/5 or undetermined tropism of the HIV virus.
* HIV-2 or coinfection HIV-1/HIV-2.
* Chronic viral hepatitis B.
* Chronic viral hepatitis C requiring specific treatment over the first 24 weeks.
* Treatment with growth hormones.
* Hypolipemic or diabetes treatment, begun within the last 3 months.
* Pregnant or breastfeeding women.
* Haemoglobin \< 7g/dl, neutrophils \< 500/mm3, platelets \< 50 000/mm3, creatinine clearance \< 50 mL/min, alkaline phosphatases, ASAT, ALAT or bilirubin ≥ 3 times the upper limit of the normal range (N).
* Antiretroviral treatment associated to enzymatic inducer.
* Chronic alcohol consumption.
* Subjects under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship.
* Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase.