cyrilzakka/clinical-trials huggingface dataset:
Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE

To test the efficacy of a web-based stepped collaborative care intervention to reduce symptoms of depression, pain, and fatigue and improve health-related quality of life (HRQL) in advanced cancer patients and to reduce stress and depression, and fewer CVD risk factors in caregivers.

The intervention is designed to maintain quality of life for those in greatest need and least access to resources. This innovative and scalable web-based collaborative care intervention is expected not only to improve patients' quality of life, at the end of life, but also reduce caregiver stress and depression, and potentially health morbidity and mortality of patients and spousal and intimate partner caregivers from socioeconomically disadvantaged backgrounds. Study findings are expected to lead to research examining the dissemination and implementation of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients:

Biopsy and/or radiograph proven diagnosis of hepatocellular carcinoma, cholangiocarcinoma, gallbladder carcinoma or breast, ovarian, or colorectal cancer with liver metastases with a life expectancy of at least one year; age \>21 years; no evidence of thought disorder, delusions, or active suicidal ideation is observed or reported.

* Caregivers:

A spouse or cohabitating intimate partner of an advanced cancer patient being evaluated the UPMC's Liver Cancer Center and age \>21 years

Exclusion Criteria:

* Patients:

Age \< 21 years, Lack of fluency in English, Evidence of thought disorder, delusions, hallucinations, or suicidal ideation.

* Caregivers:

Age \< 21 years, Lack of fluency in English, Evidence of thought disorder, delusions, hallucinations, or suicidal ideation.
Consolidation Treatment With Y90-Ibritumomab Tiuxetan After R-CHOP Induction in High Risk Patients According to Follicular Lymphoma International Prognostic Index (FLIPI) With Follicular Lymphoma

To evaluate the complete clinical response rate according to the International Working Group criteria with a consolidation treatment with 90Y-ibritumomab tiuxetan (Zevalin®) in patients with high-risk follicular lymphoma with either partial or complete response to R-CHOP induction chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* Signature of the written informed consent by the subject or his/her legal representative before initiation of any trial specific procedure.
* Patients older than 18.
* Histologic diagnosis of CD20+, grade 1-3a follicular lymphoma as per the WHO classification.
* High-risk patients according to FLIPI before initiation of induction chemotherapy.
* Stage II-IV prior to initiation of induction treatment, or any stage in patients with grade 3 follicular lymphoma.
* Complete or partial response to the induction scheme.
* ECOG scale performance status 0 - 2.
* Life expectancy greater than 3 months.
* In women of childbearing age, use of a reliable contraceptive method.
* A suitable bone marrow reserve:

  * Lower than 25% Bone marrow infiltration by lymphoma.
  * Hb 10 g/dL. PMN leukocytes 1,500 cel/mm3, platelets 100,000/mm3
  * Suitable hepatic, renal and cardiac function:

    * creatinine \<2,5 x UNL (upper normality limit).
    * bilirubin or ALT/AST \< 2,5 x UNL

Exclusion Criteria:

* Patients with no objective clinical response to induction chemotherapy.
* \> 25% bone marrow infiltration following induction chemotherapy.
* Platelets \< 100,000 before radioimmunotherapy.
* Severe and/or uncontrolled concomitant disease:
* Hepatic, renal, cardiovascular, neurological or metabolic disease.
* Cardiac failure, ischemic cardiopathy, ischemic cardiopathy with a history of myocardial infarction or angor, or major ventricular arrhythmia.
* Positive regarding HBV, HCV, HIV.
* Active acute or chronic infection.
* Social, psychic or geographic disability to satisfy any of the treatment schemes.
* Pregnant and/or breastfeeding women, or adult patients of childbearing age who are not using a safe birth control device throughout the study treatment and at least 12 months thereafter.
* Known or suspected hypersensitivity, or confirmed or suspected adverse reaction to the study drugs and other related compounds (Rituximab, Ibritumomab tiuxetan, a history of sensitivity to murine proteins, dexametasone, cyclophosphamide and other anthracyclines, cytarabine).
Octreotide Efficacy and Safety in First-line Acromegalic Patients

Primary Acromegaly is a clinical and metabolic disease caused by growth hormone (GH) hypersecretion from a pituitary adenoma and is an insidious, chronic disease that is associated with bony and soft tissue overgrowth. Goals of therapy are to eradicate the tumor, suppress GH secretion, normalize IGF-I levels, and preserve normal pituitary function.

This study will evaluate the safety and efficacy of octreotide as primary therapy for the treatment of acromegaly and as therapy for patients with acromegaly and a pituitary macroadenoma or microadenoma.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 and \< 80 years old.
* Recently diagnosed not previously treated patients with acromegaly.
* Presence of a pituitary tumor (microadenoma or macroadenoma), documented by a MNR performed in the 12 weeks before enrolment.
* Absence of nadir suppression of the nadir of GH to \< 1.0 ng/mL, after oral administration of 75 g of glucose (OTTG).
* IGF-I levels over normal upper limits, e.g. 97 percentile (age- and sex-matched).
* Tolerance shown with a test of a subcutaneous injection of octreotide
* Written Informed Consent before any procedure specific to the study. Inclus

Exclusion Criteria:

* Previously treated patients with any therapy for acromegaly, including surgery, radiotherapy, bromocriptin, and somatostatin analogues.
* Compression of optic chiasm that produces any impairment of field of vision.
* Need of surgery to improve any neurological sign or symptom associated with a direct incidence on the tumour.
* Intolerance to octreotide or to any component of Sandostatin® LAR® preparation.
* Patients with an hepatic condition such as cirrhosis, active or persisting chronic hepatitis, or other hepatopathy of fast evolution.
* Pregnant women
* History of alcohol or drug abuse in the six months prior to the inclusion visit.
* Patients suffering from any condition that may jeopardize the interpretation of study results or may impede to obtain informed consent
* Intake of an investigational drug during the study and 30 days before patient inclusion in this study

Other protocol-defined inclusion / exclusion criteria may apply.
Deep Brain Stimulation (DBS) Frequency Effects on Gait in Parkinson's Disease(PD)

In this study the investigators will evaluate the effect of both low and high frequency Deep Brain stimulation of the subthalamic nucleus (STN) in Parkinson's patients who have noted a change in their walking. The investigators' hypothesis is:

1. Stimulation at 60 Hertz (Hz) is associated with improved gait with increased stride length and faster time on the Stand walk sit test.
2. There is no worsening of the Unified Parkinson's Disease Rating Scale (UPDRS) at 60 Hz.


Eligibility Criteria:
Inclusion Criteria:

* Be a patient at the Vanderbilt Movement Disorders clinic.
* Report a change in their gait.
* Be able to walk independently when off PD medications for 12-16 hours.
* Have a stable dose of PD medications for the prior three months .
* Not cognitively impaired, so as to give informed consent.
* MMSE \> 24.

Exclusion Criteria:

* See inclusion criteria.
Effect of Selenium Supplementation on Influenza Vaccination

The study is designed to assess whether selenium supplementation can boost the immunity response to influenza vaccination in healthy adults. This is a randomized, prospective study enrolling a total of 60 healthy subjects, 18-55 years old.

Background: Selenium is an essential trace element required for human health and wellbeing. Despite mouse studies and human clinical trial suggest selenium supplementation might enhance immunity, little is known for the effects of selenium supplementation on humoral immunity. Vaccination is the most effective medical intervention to prevent infections and to reduce disability and mortality associated with infectious disease. However, some individuals, in healthy or disease conditions, mount less effective humoral immune responses to vaccination. Therefore, new strategy to enhance humoral immunity upon vaccination is highly sought after. Using mouse models, we have observed that selenium supplementation significantly increased antigen-specific antibody responses. Thus, we hypothesize that selenium supplementation may be beneficial in enhancing humoral immunity in humans.

Objectives: To investigate whether selenium supplementation will boost the humoral response to influenza vaccination in healthy adults.

Design and trial size: This is a randomized prospective study. A total of 60 healthy subjects, 18-55 years old, will be enrolled in this study.

Intervention and duration: The enrolled subjects will be randomized into selenium supplementation and control group. The selenium supplementation group will receive 200 μg selenium daily by taking two selenium-enriched yeast tablets (SelenoPrecise®, Pharma Nord) once daily for 60 days. The control group will not receive selenium supplementation. Thirty days after allocation, both groups will receive standard seasonal influenza vaccination for the 2019-2020 season. Peripheral blood samples will be collected at baseline (day 0, prior to treatment), day 30, day 37 (7 days after vaccination) and day 60 (30 days after vaccination).

Eligibility Criteria:
Inclusion Criteria:

18-55 years, healthy subjects

Exclusion Criteria:

1. With the history of selenium supplementation as taking supplementation products or living more than 2 years in selenium-enriched area;
2. Had the symptoms of selenium toxicity or serum selenium level greater than 328 μg/L;
3. With the history of the administration of influenza vaccine in past three years or allergic to influenza vaccine;
4. With any current immunologic disorders, including autoimmune and allergic diseases;
5. With any cardiovascular, metabolic, mental, or psychological disorders;
6. Pregnancy or breastfeeding;
7. With the history of infectious diseases including airway infections in past three months;
8. Who are currently participating in other clinical studies or who have participated in other clinical research within 90 days
Use of nMoABs for the Treatment of COVID-19 in Patients With HM.

This is a multicenter retrospective, non-interventional observational study to evaluate the efficacy of nMoAbs in HM patients.

This is a multicenter retrospective, non-interventional observational study. The participating centres will retrospectively review all episodes of SARS-CoV-2 infection occurring in HMs identified at their institutions from February 2020 to May 2021 and treated with nMoAbs, to evaluate their efficacy.

Eligibility Criteria:
Inclusion Criteria:

* All patients must meet all the following criteria for study entry:

  1. Age equal to or greater than 18 years of age.
  2. Diagnosis of HM (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma, chronic myeloprolipherative disorders) at any stage/status.
  3. Third generation rapid molecular or antigen test positive for SARS-CoV-2 from February 2020 until May 2021
  4. Treatment with anti SARS CoV 2 nMoAbs approved by AIFA
  5. Not hospitalized for COVID-19 at the time of nMoAbs administration
  6. Not on oxygen therapy at the time of nMoAbs administration
  7. At least one of the following symptoms for no more than 10 days:

     * Fever
     * Cough
     * Anosmia
     * Ageusia / dysgeusia
     * Pharyngodynia
     * Asthenia
     * Headache
     * Nausea
     * Diarrhea
     * Myalgia
     * Dyspnea
     * Tachypnea
  8. Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable).

Exclusion Criteria:

* 1. Hematological diseases, other than HM.

  2. Not tested positive for SARS-CoV-2

  3. Patients in disease remission "off therapy" for more than 6 months

  4. Immune plasma treatment in the previous two months
Efficacy of Calcitriol in Recent Onset Type 1 Diabetes

Reduction in vitamin D levels has been reported in subjects with recent onset type 1 diabetes. Several studies suggest that vitamin D supplementation in early childhood decreases the risk of developing type 1 diabetes, therefore vitamin D deficiency might play a role in the disease pathogenesis. We investigated whether the supplementation of the active form of vitamin D (calcitriol) in subjects with recent-onset type 1 diabetes can protect residual beta cell function evaluated by C peptide and improve glycaemic control as evaluated by HbA1c and insulin requirement.

Thirty-four subjects (age range 11-35 years, median 18 years) with recent-onset type 1 diabetes (\<12 weeks duration) and high basal C-peptide \>0.25 nmol/l were randomized in a double-blind trial to calcitriol (the active form of vitamin D, 1.25-dihydroxyvitamin D3 \[1,25-(OH)2D3\] ) at the dose of 0.25 ug/day or placebo, and followed up for 2 years.


Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of type 1 diabetes according to the American Diabetes Association (ADA) guidelines;
2. age at presentation between 11 and 35 years;
3. duration of clinical disease (since the beginning of insulin therapy) \<12 weeks;
4. baseline C-peptide \>0.25 nmol/l;
5. no medical contra-indications or any other major chronic disease;
6. willingness and capability to participate in a regular follow-up.

Exclusion Criteria:

1. cardiovascular disease;
2. renal disease;
3. liver disease;
4. neurological disorders;
5. allergic diathesis;
6. hyperparathyroidism;
7. neoplasia.
Distalization by Miniscrew

This study aimed to compare the effectiveness and efficiency of miniscrew-supported and standard frog molar distalizing appliances.

A prospective randomized clinical trial study was carried out on twenty healthy Egyptian subjects, each required molar distalization as part of their comprehensive orthodontic treatment. The subjects were selected and treated at the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Ain-Shams University.

The inclusion criteria in this subject selection in this study was as follows;

1. All the subjects had an age range from 11 to 16 years with a mean of ±13.5 years.
2. All the subjects had skeletal Class 1 or mild skeletal Class 2 due to maxillary excess.
3. All the subjects had bilateral Class II molar relationship.
4. All subjects were free from any dental anomalies.
5. All subjects had good oral hygiene. The exclusion criteria in this study was as follows; 1- Missing permanent teeth with exception of 3rd molar. 2- Previous orthodontic treatment. 3- Systemic disease that may influence orthodontic treatment and drug intake. 4- Periodontal disease. 5- Functional mandibular deviations and facial asymmetry. 6- History of parafunctional habits.

The subjects were equally and randomly divided into two groups; group A and group B which included ten subjects per group. These groups were classified according to the type of distalizer utilized:

* Group A: included ten subjects utilizing the conventional frog molar distalizing appliance (CF).
* Group B: included ten subjects utilizing the Miniscrews-supported frog molar distalizing appliance (MSF)

The pretreatment and post-distalization Database Records All subjects had the following records; a clinical diagnostic sheet, orthodontic study cast (according to ABO index), extraoral and intraoral photographs, and CBCT.

These records were obtained at T1 before distalization and at T2 after distalization.

The study protocol was approved by the local ethics committee, faculty of dentistry, Ain-Shams University. Before commencing with treatment, all the subjects and their guardians received a full explanation of the treatment protocol. After which they were asked to sign a detailed written consent.

Eligibility Criteria:
Inclusion Criteria:

1. All the subjects had an age range from 11 to 16 years with a mean of ±13.5 years.
2. All the subjects had skeletal Class 1 or mild skeletal Class 2 due to maxillary excess.
3. All the subjects had bilateral Class II molar relationship.
4. All subjects were free from any dental anomalies.
5. All subjects had good oral hygiene.

Exclusion Criteria:

1. Missing permanent teeth with exception of 3rd molar.
2. Previous orthodontic treatment.
3. Systemic disease that may influence orthodontic treatment and drug intake.
4. Periodontal disease.
5. Functional mandibular deviations and facial asymmetry.
6. History of parafunctional habits.
Efficacy of Parecoxib on Patients With CRPS

The complex regional pain syndrom is a weighty disease that often results in a lifelong disability. Mostly this disease appears unilateral after comparatively mundane fractures or operations. In early stages CRPS shows inflammatory processes. These inflammatory components can be seen as edema and vasodilatation. These inflammatory processes lead us to the hypothesis that selective COX-2-inhibitors might help patients with CRPS.


Eligibility Criteria:
Inclusion Criteria:

* Patients with saved diagnosis of CRPS of the upper extremity based on the current used criteria for diagnosis plus a positiv 3-phase-sceletal-scintilgraphy, if they show pathological PPT-values in QST on the ipsilateral site (Z-values \> 2 in age- and gender-based Z-transformation of the raw values)• age ≥ 18 years• Existence of an age-based normal creatinin-clearance (calculated with a defined formula)

Exclusion Criteria:

* Important cardiovascular illness for the purpose of heart failure (NYHA II - IV), coronary heart disease (CHD), peripheral artery occlusive disease (PAOD) or unstable hypertension (values constantly over 140/90 mm Hg)

  * Florid kidney disease
  * Cerebral disease
  * Neurological systemic disorder (exception: beginning polyneuropathy with normal values of the PPT on the opposite side)
  * Lesion of the median nerve (ipsi- oder contralateral)
  * Acute bleeding disease
  * Known ulcer of the stomach or duodenum
  * Inflammatory bowel disease
  * Positive anamnesis of a gastrointestinal bleeding in the last 5 years
  * Important hepatic dysfunction (Child- pugh \> 9)
  * Hypersensitivity to the agent or to sulfonamides
  * Known allergy to acetylsalicylic acid, nonsteroidal antiinflammatory drugs or other selectiv cyclooxygenase-inhibitors
  * Pregnancy and lactation period
  * Intake of one of the following drugs (current or in the last 3 days)

    * selective-serotonin-reuptake-inhibitor
    * cetoconazole
    * rifampicin
    * phenytoin
    * carbamazepine
    * dexamethasone or other systemic corticoids
    * traditional nonsteroidal antiphlogistics
    * cyclooxygenase-inhibitors
    * immunsupressives
    * TNF-α-inhibitors
Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity (COFTASD)

The objective of this study is to find the predictive factors of improvement of the quality of life of operated patients from spinal deformity.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years-old
* Diagnosis of Adult Spinal Deformity with any of the deformity characteristics following:

  * Scoliosis with a Cobb angle ≥ 20 °
  * Vertical sagittal axis (SVA) ≥ 5 cm
  * Pelvic tilt ≥25 °,
  * Thoracic kyphosis with a Cobb angle ≥ 60 °
* Eligible for surgery
* Having given their participation agreement
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* Age under 18 years-old
* Patient unlikely to comply with follow-up
* Patient with long-term complete paraplegia
* Patient unable to understand and answer questionnaires in due to language difficulties or cognitive impairment
* Pregnant or breastfeeding woman
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Study of Bemnifosbuvir on Cardiac Repolarization in Healthy Subjects

This study will assess the effects of Bemnifosbuvir on cardiac repolarization in healthy Adult Subjects


Eligibility Criteria:
Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities
Evaluation of the Analgesic Effect of Music Therapy in Critically Ill Patients During Potentially Painful Nursing Procedures: a Pilot Study

Pain is a common problem encountered in about 60 % of critically ill patients who can communicate. Its occurrence can be related to several causes, mainly dominated by invasive procedures.

Pain management is typically based on a combination of prevention, evaluation, and therapeutic agents. However, it appears important to develop adjuvant approaches. Music therapy is one of them and that has been evaluated in various medical conditions.

The aim of our study is to evaluate the analgesic effect of music therapy in critically ill patients during potentially painful nursing procedures.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients (age≥18 years) hospitalized in Intensive Care Unit
* Requiring mechanical ventilation
* Who cannot communicate
* With a Richmond Agitation Sedation Scale (RASS) score \[-3; +4\]

Exclusion Criteria:

* Age \< 18 years
* Receiving neuromuscular blockade
Use of Toric Intraocular Lens to Neutralize Keratometric Astigmatism

The purpose of this study is to evaluate neutralization of keratometric astigmatism in patients with cataract and astigmatism higher than 1 diopter, with phaco surgery and the implantation of a toric intraocular lens.

Patients with Cataract are treated with phacoemulsification of the lens with an implantation of an intraocular lens. Besides cataract, almost 25% of these patients have some degree of Astigmatism; when it is higher than 1 diopter, it is possible to neutralize it with an implantation of a toric intraocular lens.

Eligibility Criteria:
Inclusion Criteria:

* Symmetrical keratometric astigmatism ≥ 1.0 D and cataract.

Exclusion Criteria:

* Irregular astigmatism,
* Keratoconus,
* Previous Refractive Surgery.