cyrilzakka/clinical-trials huggingface dataset:
Baseline-characteristics of Patients Referred to a Secondary Spine Centre

A retrospective cohort study will be conducted in Zuyderland Medical Centre Heerlen, the Netherlands. All patients that were referred to the spine-centre between 01.01.2019 and 31.12.2019 will be included for analysis.

This study aims to evaluate baseline characteristics, including baseline questionnaires, and information about the given treatments for all patients referred to the spine centre.

The incidence of back and neck pain is increasing in our ageing population. Back pain is amongst the conditions with the highest burden of disease in terms of years lived with disability (YLD). The majority of people experiences at least one period of back pain in their lifetime. The incidence of back complaints increases with age. Due to ageing of the population, the number of patients with back pain exponentially increases. Since 1980, the global population of people older than 60 years has doubled and this number is expected to double again by 2050. Patients with back or neck pain and/or symptoms of radiculopathy, and suspected spinal pathology, are often referred to a secondary spine centre. A large number of these patients will receive conservative treatment and only a small number eventually receives a surgical intervention. There is a broad array of conservative treatment options, including medication, manipulative care, physical therapy, treatment by pain specialists, and rehabilitation. The increasing incidence of spinal pathologies likewise leads to an increase in spinal surgeries. The ageing population is one of the most prominent factors by which the number of spine surgeries has increased and will even increase further in the future. Previous studies concerning the national US bill for spine related care in 2006 estimated that direct medical expenditures were over $85 billion. Over the last decades, the costs of spine related healthcare have increased at an alarming rate and will even increase further. To limit the increase of healthcare-related costs concerning spine-related healthcare in an ageing population, the selection and profiling of subgroups of patients requiring different types of treatment should be ameliorated to optimize spinal care. To date, adequate knowledge on baseline characteristics is lacking, and thereby insufficient to perform patient profiling.

This study aims to evaluate baseline characteristics, including baseline questionnaires, and information about the given treatments for all patients referred to the spine centre. Insight in the specific characteristics of different patient groups, for example different types of conservative interventions or conservative versus surgical interventions, could provide a valuable insight during counselling.

Eligibility Criteria:
Inclusion Criteria:

* Newly referred patients visiting the spine-centre at Zuyderland Medical Centre Heerlen in 2019, from 01.01.2019 until 31.12.2019.
* Minimum age of 18 years.
* Documented treatment (surgical or conservative).

Exclusion Criteria:

* Documented objection to participate in scientific research.
* No baseline questionnaires available
High-dose Dexamethasone Plus Hetrombopag vs High-dose Dexamethasone Alone as Frontline Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Prospective, Multicenter, Randomized Trial

The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of Hetrombopag plus high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

The investigators anticipate to undertaking a parallel group, randomised controlled trial of 100 ITP patients. One part of the participants are randomly selected to receive hetrombopag with starting dose 5mg po qd for 8 weeks（increase daily dose to a maximum of 7.5 mg/day if platelet count\<50000 per μL following at least 2 weeks of treatment) combining with dexamethasone (given at a dose of 40 mg qd for 4 consecutive days). The others are selected to receive high-dose of dexamethasone alone. Patients who do not respond to dexamethasone may receive another cycle of high-dose dexamethasone therapy within 2 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. The purpose of this study is to report the efficacy and safety of Hetrombopag combining with high-dose dexamethasone therapy for the treatment of newly diagnosed ITP.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Meet the diagnostic criteria for newly diagnosed immune thrombocytopenia (diagnosed within 3 month);
* platelet count \<30\*10\^9/L, or \< 50\*10\^9/L with bleeding manifestations, both;
* Willing and able to sign written informed consent

Exclusion Criteria:

* secondary thrombocytopenia or graded MF≥2 myelofbrosis based on the European Consensus Scale
* Previous history of treatment for ITP, except Platelet transfusion, ITP-directed Prednisone therapy no more than 2 weeks or TPO therapy no more than 1 week and stopped ≥1 week before randomization
* No response to TPO-RA or rhTPO
* HIV, hepatitis C or B virus infection
* pregnancy or lactation;
* arterial or venous thromboembolism within the 6 months before screening
* total bilirubinalanine, aminotransferase or aspartate transaminase\>3×upper limit of normal (ULN), serum creatinine\>1.5×ULN
* congestive heart failure (New York Heart Association \[NYHA\] class III/IV);
* neoplastic disease within the past 5 years;
* liver cirrhosis
* people who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.
Housing, Insulation and Health Study

In six communities we will seek out households where someone who has a history of respiratory problems. For the first winter we will measure temperature and humidity of the house and health of occupants. We will insulate half the houses and the next winter compare them with the uninsulated houses to see if warmer houses improve health.

Damp, cold indoor environments are bad for the health of people who live in them, particularly if they have respiratory problems or are vulnerable, such as the young or the very old. This is a community based study designed to test the hypothesis that insulating domestic houses will make them warmer and that this increase in indoor temperature will improve their health and wellbeing.

Following two pilot studies, the first among older people in city council flats and the second among home owners in Waitara. We have followed the "Waitara model" where community networks will be mobilised to identify households in each community where there is someone with a on going respiratory problem. Seven communities have been selected to help test these hypotheses and have agreed to participate Otara, Gisborne, Mahia/Nuhaka, Taranaki, Porirua, West Coast and Christchurch. Low income areas with high Maori populations have been deliberately selected to maximise the potential health gains.

Two hundred houses in each community will be insulated free of charge to the occupants. The workers who will insulate the homes will be local people employed through the Department of Work and Income (WINZ).

Once the houesholds are selected they will be randomly assigned to intervention or control groups. During the first winter, all 1400 households will be monitored for temperature and humidity and their comfort, health and healthcare utilization will be recorded. Half the households, assigned to the intervention group, will be fully insulated during the spring. The following winter, all the initial measurements taken from both the intervention and control group will be repeated. At the end of the study period, all control houses will be insulated.

This study has developed from a natural intervention being carried out by the Energy Efficiency Conservation Authority (EECA) to insulate domestic houses in New Zealand and is a major collaborative effort, which will shed light on the effectiveness of insulation in improving health and wellbeing. The impact of housing refurbishment on health has not previously been examined. There is considerable government and policy interest in promoting healthy housing and there is strong community interest in ensuring the housing stock is improved in order to lower health risks.

Eligibility Criteria:
Inclusion Criteria:

* Live in Study area
* At least one person in the household must had had respiratory illness within the last year, well members of the same household may also participate
* house currently uninsulated
* interested in taking part in research

Exclusion Criteria:

* Intending to move within study period
Optimizing Research With Diverse Families - Feasibility and Acceptability Study (FAST)

Evaluate feasibility and acceptability of recruiting Black and Hispanic families for an open label clinical trial of multinutrients while collecting real-time parent-reported child behavior data and collecting at-home biospecimens to explore their potential as biomarkers, in a study of pediatric ADHD.

This study will test the feasibility of recruiting and completing a multinutrient trial with racially and ethnically diverse participants (N=30), focused on Black and Hispanic families, and the acceptability of the intervention, and refined collection methods. The 8-week, open-label, study will evaluate the feasibility and acceptability of collecting (a) real-time ecological momentary assessment (EMA) data on child's target behavior problem, as identified by parent and (b) two types of bio-specimens (blood and urine) collected at home while taking the multinutrients daily.

Eligibility Criteria:
Inclusion Criteria:

* Children, ages 6-17 years at enrollment, with suspected or definite ADHD based on parent report in a majority of families that identify as Black or Hispanic or multicultural
* Meet criteria on Child and Adolescent Symptom Inventory-5 (CASI-5) ADHD scale (6+ symptoms ≥ 2), occurring in \>1 setting, plus one impairing irritability symptom (≥2) from Oppositional Defiant Disorder (ODD) or Disruptive Mood Dysregulation Disorder (DMDD) subscale
* Able and willing to swallow up to 8 pills per day
* Medication free for 2 weeks prior to baseline
* Willing to use Tasso® OnDemand SST+ to collect blood at home and filter cards to provide urine samples
* Able to communicate in English
* Parent/care giver identifies child as Black/African American or Hispanic/Latina/o or more than one race (target 70-100%)

Exclusion Criteria:

* Neurological disorders
* Medical conditions (e.g. cancer, kidney or liver disease, diabetes, hyperthyroidism)
* Psychiatric conditions requiring hospitalization
* Allergy to any supplement ingredient
* In people with a uterus: sexually active, pregnancy or suspected pregnancy
* Abnormality of mineral metabolism
Impact of Adjuvant FOLFOX on Quality of Life and Sensory Neurotoxicity in Patients With Advanced Gastric Cancer

The primary objective of this trial is to determine the impact of the FOLFOX regimen on quality of life and the incidence of chemotherapy induced neurotoxicity.

Gastric cancer is one of the main cancer-related causes of death in the world. There is more than one standard treatment for non-metastatic advanced disease. Among the therapeutic alternatives there is high level of evidence to recommend surgery followed by chemoradiotherapy or chemotherapy and for perioperative chemotherapy. These strategies have not been compared in adequate powered trials, so there are important regional differences in their use. Postoperative chemotherapy with oxaliplatin based chemotherapy may offer some advantages in limited resource settings, because of its lower logistic requirements and it could be specially useful in centers with high quality surgery. On the other hand one of its most important downsides could be a higher impact on quality of life particularly related to oxaliplatin induced neuropathy which can last long after the end of treatment. This is a prospective observational trial in which after consent subjects are going to be evaluated with the EORTC (European Organization for Research and Treatment of Cancer) questionnaires C30 and CIPN20 during FOLFOX (5-fluorouracil/leucovorin with oxaliplatin) adjuvant treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of gastric adenocarcinoma
* ECOG (Eastern Cooperative Oncology Group) functional status of 0 or 1
* Treated with surgery with curative intent
* TNM stage II - III or TNM stage I with positives lymph nodes

Exclusion Criteria:

* Surgery with microscopical or macroscopical residual tumour
* Adjuvant chemotherapy refusal
* ECOG functional status of 2 or more
* Previous peripheral neuropathy
* Significant cardiovascular disease or other organ disfunction
Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease

The goal of the study was to evaluate descriptively the effect of crizanlizumab + standard of care and standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy.

Approximately 50 patients were to be randomized 1:1 to receive either crizanlizumab (5 mg/kg) + standard of care or standard of care alone. Patients were stratified at randomization based on chronic kidney disease (CKD) risk category (moderate risk or high/very high risk) and hydroxyurea/hydroxycarbamide (HU/HC) prescription (Yes/No). The CKD risk categories used for stratification were based on both Estimated glomerular filtration rate(eGFR) and albuminuria assessed by Albumin/creatinine ratio (ACR).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of SCD (HbSS and HbSβ0-thal SCD genotypes are eligible)
* Patients with eGFR ≥ 45 to ≤ 140 mL/min/1.73 m2 based on CKD EPI formula (patients ≥ 18) or the Creatinine-based "Bedside Schwartz" equation (patients \< 18)
* Patients with ACR of ≥ 100 to \< 2000 mg/g (taken as an average of the three screening ACR values to determine eligibility)
* Receiving at least 1 standard of care drug(s) for SCD-related CKD: If receiving HU/HC, the patient must have been receiving HU/HC for at least 6 months and on a stable dose for 3 months, and/or an ACE inhibitor and/or ARB for 3 months and on a stable dose for those 3 months.
* Hb ≥ 4.0 g/dL, absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L, and platelet count ≥ 75 x 10\^9/L
* Adequate hepatic function as defined by:

  * Alanine aminotransferase (ALT) \< 3.0 x upper limit of normal (ULN)
  * Direct (conjugated) bilirubin ≤ 3.0 x ULN
* Written informed consent (or assent/ parental consent for minor subjects) prior to any screening procedures

Exclusion Criteria:

* History of stem cell transplant
* Patients with evidence of AKI within 3 months of study entry (can decrease interval to within 6 weeks of study entry only if renal function has returned to pre-AKI values prior to study entry)
* Blood pressure \> 140/90 mmHg despite treatment
* Patients undergoing renal replacement therapy (ie. hemodialysis, peritoneal dialysis, hemofiltration and kidney transplantation)
* Received blood products within 30 days of Week 1 Day 1
* Participating in a chronic transfusion program
* History of kidney transplant
* Patients with hypoalbuminemia
* Body mass index of ≥ 35
* Currently receiving or received voxelotor within 6 months of screening
* Patient has received crizanlizumab and/or other selectin inhibitor or plans to receive it during the duration of the study.
A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds

This is a study to assess the performance and safety of GP0045 when injected in the nasolabial folds.

There is an 18 months follow up period.


Eligibility Criteria:
Inclusion Criteria:

* Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability to give consent to participate in the study
* Signed and dated informed consent to participate in the study, including photo consent
* Subjects with intent to undergo correction of both nasolabial folds

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel
* Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics
* Any condition (medical or other) that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
* Participation in any other clinical study with an investigational product within 30 days before treatment
Fibrin Sealant in Preventing Fluid Build Up During Surgery in Patients Undergoing Breast Reconstruction

The purpose of this study is to investigate the efficacy of an alternative surgical technique and the use of fibrin sealant in preventing post-operative seroma formation. A seroma is a build-up of clear bodily fluids in a place on the body where tissue has been removed by surgery. Seromas can happen after breast surgeries. Seromas can appear about 7 to 10 days after surgery, after the drainage tubes have been removed. The breast area involved in the surgery may have a spot that's swollen and feels like there is liquid under the skin

PRIMARY OBJECTIVES:

I. To evaluate differing surgical techniques (sharp dissection v. electrosurgical, use of fibrin glue) in latissimus dorsi donor flap harvest and their effect, if any on the prevention of post-operative seromas.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo sharp dissection technique with fibrin sealant closure.

ARM II: Patients undergo standard electrocoagulation dissection technique.

After completion of study treatment, patients are followed up for 90-180 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will be undergoing latissimus dorsi donor flap harvest reconstruction and evaluated by the Department of Plastic and Reconstructive Surgery at Oregon Health and Science University (OHSU)
* These patients will be undergoing reconstructive surgery for a mastectomy/wide local excision of breast cancer defect or other soft tissue defect resulting from trauma, infection, undesirable surgical outcome, oncologic resection, etc.
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients who will not qualify for latissimus dorsi donor flap reconstruction based on anatomical limitations specific the subjects respectively; to be evaluated by the plastic surgeon
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to fibrin glue sealant
* Patients with evidence of hematological disorders resulting in deficient coagulation whereby sharp dissection would result in undesirable bleeding otherwise performed more safely with electrosurgery
The Effect of Wearing the 'Nike Free'Shoe on Isokinetic Muscle Strength of Foot and Ankle and on Proprioception.

To evaluate the effect of wearing the 'Nike Free'Shoe on isokinetic muscle strength of foot and ankle and on proprioception the following protocol will be used.

The test population consists out of students of the physical education department. They will at random be divided in three groups. One group will wear the shoe only for daily activities, the second group will wear the shoes for the warming up part of the sport classes and the control group will not wear the shoe at all. There will be two moments for evaluation: one at the beginning of the study and one after four months, during which the shoe will be used. The isokinetic strength will be measured with an isokinetic device (Biodex) and the proprioception will be evaluated with a force platform (Neurocom Balance Master).


Eligibility Criteria:
Inclusion Criteria:

* being a physical education student of the second or third year
* having read and signed the informed consent
* being new to the Nike Free Shoe

Exclusion Criteria:

* neurological or systemic diseases
* overuse injuries or orthopaedic surgery to the lower limbs during the previous six months
* familiar to or used to wear the Nike Free Shoe
Impact of the Implementation of Dance Therapy Workshops on the Quality of Life of Dependent Elderly People Institutionalized Within the Establishments of the Univi Group

Dance is a multimodal activity involving motor, cognitive, sensory and sensory-motor skills as well as emotional and social skills. A growing body of research shows that the creative arts and physical exercise are able to alleviate disability, improve social interactions, and slow the progression of Alzheimer's disease and related disorders.

The Associative Group UNIVI wants to evaluate through this study the effects of the practice of dance on the quality of life of the people accommodated in its USLD and EHPAD

This research is an interventional study involving the human person of category 2 involving only minimal risks and constraints, it is multicentric and longitudinal prospective. This is a before/after study to measure the effects of the implementation of a dance therapy activity on the quality of life of the elderly population housed in the 30 establishments of the univi group.

The dance therapy will be deployed in all the medico-social establishments participating in the study over a period of 12 weeks.

To do this, dance therapists will be recruited to provide these classes.

The dance-therapy will be carried out:

* in groups of 10 to 12 people who have given their informed consent,
* at least twice a week per group,
* over a period of 30 to 45 minutes maximum twice a week for 3 months. Several groups per establishment can be planned depending on the number of people who can and want to be included in the dance workshop.

  940 participant in the study will be inclued and followed at 1 month, 3 months and 6 months after the end of the dance therapy workshops.

Eligibility Criteria:
Inclusion Criteria:

* People aged over 60
* Dependent elderly people residing in EHPAD or USLD including people under guardianship and curatorship
* People having signed an informated and weitten consent
* People with a minimum of language skills to understand instructions and simple questions

Exclusion Criteria:

* Participants in palliative care
* Contraindication to the practice of dance
* Severe cognitive and/or behavioral disorders that do not allow you to follow a dance workshop
* Permanent bed rest
* Non-affiliation to a social security scheme
CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

This multinational, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent transcatheter mitral valve implantation (TMVI), in comparison to those screened for TMVI but deemed ineligible, who subsequently underwent interventional mitral valve edge-to-edge repair, mitral valve surgery or medical/conservative therapy.


Eligibility Criteria:
Inclusion Criteria:

* clinically significant mitral insufficiency
* patient underwent screening for TMVI
* echocardiography data at baseline (and after TMVI, E2E and surgery)
* follow-up of at least 30 days

Exclusion Criteria:

- age under 18 years