cyrilzakka/clinical-trials huggingface dataset:
Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy

The Spanish Registry of Systemic therapy in atopic eczema, BIOBADATOP, assesses drug safety and treatment effectiveness as well as treatment impact on quality of life in children and adults with atopic eczema receiving systemic immuno-modulatory therapies in Spanish daily practice.

The main objectives are:

1. To assess short and long-term safety of systemic therapies (including phototherapy) for atopic eczema (pharmacovigilance).
2. To assess short and long-term effectiveness of systemic therapies, providing a basis for shared decision making and guidelines.

Secondary objectives are:

1. To assess short and long-term safety of topical therapies for atopic eczema.
2. To assess effectiveness of different methods of care, including patient training.
3. To describe atopic dermatitis comorbidities.


Eligibility Criteria:
Inclusion Criteria:

1. Paediatric and adult patients with atopic eczema who due to the severity of their disease and/or impact on quality of life are commencing on or switching to a specific systemic immuno-modulatory agent (e.g. CyA, AZA, MTX or new/biologic treatments) for the first time in their life (might have received others, but not this specific one).
2. Diagnosis of atopic eczema in keeping with the UK/Irish diagnostic criteria.
3. Willingness to comply with all study requirements.

Exclusion Criteria:

1. Insufficient understanding of the study by the patient and/or parent/guardian.
2. Patients who are currently participating in a randomised clinical trial.
3. Intention to move to a different geographical area in a short-term (next 3 months).
Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty

The primary objective of this project is to investigate, using RSA, acetabular implant migration of the OsseoTi™ G7 acetabular cup in comparison to conventional PPS coated G7 acetabular cup, and compare liner wear of thinnest available E1™ liner, allowing for the largest possible femoral head (36mm-44mm) to E1™ liner holding a 32mm femoral head in the G7 acetabular system with endpoint assessment being performed at the 2 year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* • Participants with primary hip osteoarthritis set to receive a primary unilateral uncemented total hip arthroplasty.

  * Participants must be 18-75 years of age.
  * Participants must be able to speak and understand Danish (or depending on country where patient is enrolled).
  * Participants must be able to give informed consent and be cognitively intact.
  * Participants must be expected to be able to complete all postoperative controls.
  * Participants must not have severe comorbidities, ASA-score ≤ 3.

Exclusion Criteria:

* Terminal illness.
* Rheumatoid arthritis.
* Previous fracture of the hip.
* Osteonecrosis of the hip.
* Previous infection of the hip.
* Severe bony deformity warranting the use of non-standard implants.
* Metastasis in the periarticular bone or proximal femur.
* Female patients that are pregnant or planning pregnancy during follow-up period
* If bone stock or femoral canal type, assessed on preoperative x-ray, warrants the use of cemented fixation.
* Documented osteoporosis with patient in active medical treatment.
* Comorbidity with altered pain perception (e.g. DM with neuropathy).
* Participants that develop deep infection in the follow-up period are excluded from the project.
Reducing Delirium After Cardiac Surgery: A Multifaceted Approach Of Perioperative Care

The objective of this study is to reduce the incidence of postoperative delirium after cardiac surgery in the elderly patient. This proposal is a clinical trial designed to reduce delirium in patients undergoing cardiac surgery by replacing standard postoperative sedation protocols (propofol, midazolam, opioids) with a new alpha2-adrenergic receptor agonist (dexmedetomidine) possessing sedative, analgesic, and antinociceptive properties. Resource utilization analysis will be performed to determine cost effectiveness of the new treatment modality.

The proposed study will be a prospective, randomized, open label study comparing multimodal protocols for postoperative sedation after cardiac surgery. Patients will be randomly allocated to either dexmedetomidine or propofol (control) groups according to a computer generated randomization code in predetermined size blocks of four.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥60 years, undergoing high risk cardiac surgery, signed informed consent.

Exclusion Criteria:

* Patients with symptomatic cerebrovascular disease, history of delirium, schizophrenia or preoperative use of psychotropic medications.
Clinical Trial to Assess the Efficacy and Safety of 'INNOCELL Immuncell-LC' With Temozolomide in Newly Diagnosed Glioblastoma of Korea

This clinical study was planned in order to assess the superiority of INNOCELL Corp. "Immuncell-LC" in aspects of therapeutic efficacy and safety when administered with Temozolomide to glioblastoma patients when compared with the control group who did not receive administration of the drug.

\<Primary Purpose\> Compare clinical efficacy of group treated with cell theraputic INNOCELL Immuncell-LC evaluated by progression free survival with that of untreated group.

\<Secondary Purpose\> Compare clinical efficacy of group treated with INNOCELL Immuncell-LC, a drug for treating glioblastoma evaluated by overall survival, therapy reaction, EORTC QLQ-C30, and Karnofsky Performance Status (KPS) and that of untreated group, and evaluate adverse reactions, clinical pathological tests, and its safety.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who, prior to the study, received explanation of the purpose and content of study and of characteristics of the test drug from the test administrator and have consented to the study by providing signature of self, guardian, or legal representative.
2. Patients who are between 18 and 70 years of age
3. Patients whose cause of cancer has been found to be glioblastoma via pathological testing
4. patients who have received surgery for glioblastoma (Complete or partial extirpation or biopsy) 2 weeks prior to the study
5. Patients whose survival is expected to be longer than 3 months
6. Patients whose KPS is greater than 60
7. Patients who satisfy the following conditions of the blood test, kidney function test, and liver function test

   * Hemoglobin is bigger than 10 gm%
   * Platelet Count is bigger than 100,000/µL
   * Absolute granulocyte count is bigger than 1,500/µL
   * BUN or Creatinine 1.5 x upper normal limit
   * Bilirubin level is smaller than 2.0 mg/dL
   * SGOT, SGPT, alkaline phosphatase is smaller than 1.5 x upper normal limit

Exclusion Criteria:

1. Patients who have been determined to have serious Cardio - Pulmonary function disability by the clinical study staff
2. Patients who are immune deficient or have a history of auto immune diseases (Ex. Rheumatoid Arthritis, Systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-Dependent Diabetes Mellitus, etc.)
3. Patients who have a history of malignant tumors in the recent 5 years prior to the study with the exception of skin cancer, local prostate cancer, and cervical cancer.
4. Patients with history of severe allergies
5. Patients with serious mental illness
6. Patients who are pregnant or nursing
7. Patients who have participated in other clinical tests in the recent 4 weeks prior to the study
Verbal Stimulation of Orientation on Emergence Agitation

The purpose of this study is to investigate whether information of the orientation such as time, place, and patient's own name can reduce emergence delirium after general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective laparoscopic or robot-assisted abdominal surgery

Exclusion Criteria:

* Patients' refusal
* Change in operation schedule
* American Society of Anaesthesiologists (ASA) physical status Ⅳ
* Day surgery
* BMI ≥35
* Neurocognitive impairment, hearing disorder
* Psychological drug intake
* Experience of general anesthesia or sedation within 1 month

Drop out Criteria

* Changes in operation schedule (e.g. unexpected collaborative surgery, conversion to laparotomy, delay of the schedule to night-duty hours)
* Significant protocol violation
Identification of New Genes Implicated in Rare Neurosensory Diseases by Whole Exome Sequencing

Next Generation Sequencing (NGS) strategy is a powerful tool to identify genes implicated in very rare diseases for which the previous genetic explorations remain negative to date. The aim of this project is based on groups of patients with original clinical phenotypes including neurosensory impairment without genetic cause identified to date. The investigators will study these families using whole exome sequencing to potentially identify new genes and new underlying biological pathways involved in neurosensory diseases.


Eligibility Criteria:
Inclusion Criteria:

* Original phenotype with neurosensory diseases
* Written, informed consent obtained

Exclusion Criteria:

* Refusal to participate at the study
* Prior inclusion in a similar study (NGS)
A Pilot Study of Hand Function in Children With Cerebral Palsy Undergoing Intensive Neurophysiological Rehabilitation

The aim of the study is to observe the effects of Intensive Neurophysiological Rehabilitation System on hand function in children with spastic cerebral palsy.

Intensive Neurophysiological Rehabilitation System is a novel multimodal rehabilitation approach that combines different treatment modalities. The treatment course lasts for 2 weeks with daily therapy up to 4 hours. Main treatment programs include biomechanical correction of the spine, extremity joint mobilization, physical and occupational therapy, reflexotherapy, special massage system, rhythmical group exercises, mechanotherapy and computer games therapy and some other.

Preliminary observational studies indicate an improvement of gross and fine motor functions in children with Cerebral Palsy after the treatment course.

The aim of the study is to observe the effects of Intensive Neurophysiological Rehabilitation System on hand function in children with spastic cerebral palsy.

About 50 patients with spastic forms of cerebral palsy with mild to moderate impairment of hand function (Level I to III according to Manual Abilities Classification System) would be evaluated before and after the two-week treatment course.

This study may help to generate the hypothesis of the effects of the Intensive treatment course on hand function abilities and to prepare a future randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Spastic cerebral palsy: uni- and bilateral
* Age: 6-15
* Level I-III according to Manual Ability Classification System (MACS)

Exclusion Criteria:

* Ataxic or dyskinetic cerebral palsy
* Non-cooperative behavior
* Moderate to severe mental deficit
* Severe contractures of upper extremity joints
* Upper extremities trauma within 6 months prior to the study
* Previous hand surgery
* Epilepsy with frequent seizures
The Effect of Montelukast on Asthma Control in Overweight/Obese Atopic Asthmatics

Background: In recent years, the prevalence of both asthma and obesity has risen dramatically among children and adolescents in the United States. Given the concurrent rise in the two epidemics, there may be an underlying link. Obesity contributes to asthma severity and control, and may play a role in its underlying cause. Obesity is associated with a state of heightened inflammation that may lead to an increase asthma symptoms and severity. Obese adult patients treated with montelukast, an anti-inflammatory agent, seemed to have better asthma control than those treated with other standard asthma medications. The use of montelukast in obese children and adolescents has not been specifically studied.

Hypotheses and Specific Aims: The use of montelukast will improve asthma symptoms and objective markers of asthma to a greater degree in obese, as opposed to non-obese children and adolescents. The investigators would like to determine if the use of montelukast will improve objective asthma scores, pulmonary function, markers of inflammation and medication use to a greater degree in obese as opposed to non-obese children/adolescents.

Potential Impact: Given the growing epidemic of obesity-associated asthma in the U.S., a tailored approach focused on obese asthmatic children may help reduce the burden of this disease, health care costs and potential long-term complications as these children enter adulthood. Furthermore, this study may help clarify the underlying mechanisms that link asthma and obesity. Although this proposal is focused on one medication, it provides an example of how certain medications may have differential efficacy in the obese asthmatic.


Eligibility Criteria:
Inclusion Criteria:

* mild to moderate persistent asthma based on 2007 NIH Asthma Guidelines
* age 7-17 years old

Exclusion Criteria:

* present smoking or smoking history
* other significant pulmonary or cardiac condition
* recent (within the past three months) use of montelukast
* on allergen immunotherapy
* on omalizumab
* pregnancy
Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation

Tobacco, alcohol and opioid use disorders threaten the health of HIV-infected patients. What if evidence-based counseling and medication treatments for tobacco, alcohol and opioid use disorders (herein refered to as addiction treatments) were routinely provided in HIV clinics? Implementation Facilitation is an established strategy to increase the uptake of evidence-based treatments. Our goal is to evaluate the impact of Implementation Facilitation on the use of addiction treatments in four large HIV clinics.

The purpose of the WHAT-IF study is:

Aim 1. Among key stakeholders, to use quantitative and qualitative (mixed) methods to identify the site-specific evidence, context and facilitation-related barriers and facilitators to the integration of addiction treatments to help tailor an Implementation Facilitation for each clinic.

Aim 2. To evaluate the impact of Implementation Facilitation on:

2a: Organizational readiness to deliver addiction treatments 2b: Provider readiness to deliver addiction treatments 2c: Provision of addiction treatments 2d: Changes in organizational models of care used to deliver addiction treatments

Aim 3. To evaluate the impact of Implementation Facilitation on antiretroviral therapy receipt, HIV viral suppression, VACS Index, and retention in HIV care among patients eligible for addiction treatment.

The Working with HIV clinics to adopt Addiction Treatments using Implementation Facilitation (WHAT IF?) study will evaluate the impact of Implementation Facilitation on the adoption of addiction treatment services in four HIV clinics. We will use a stepped wedge design . The primary comparison is of the change that occurs from the pre-implementation period to two post-implementation periods, the initial six months (evaluation) and the following six months (maintenance). This proposal will consist of three main components in each of four clinics: 1) formative evaluation with key stakeholders at each site to guide and refine the Implementation Facilitation, 2) conduct of the Implementation Facilitation and 3) an evaluation of the impact of the Implementation Facilitation on organization and provider-level readiness, provision of addiction treatments, and HIV outcomes.

Eligibility Criteria:
Inclusion Criteria:

Patient inclusion criteria:

* HIV-infected
* Receiving HIV care in the index clinic
* Age \>18 years old
* Meets criteria for lifetime or current tobacco, alcohol and/or opioid use disorder regardless of addiction treatment status
* Able to provide verbal informed consent

Staff inclusion criteria:

* Employed at participating HIV clinic for at least 6 months
* Able to provide verbal informed consent.

Payer/health insurance provider inclusion criteria:

* Employed at an organization or agency that provides funding for medical services for HIV-infected individuals for at least 6 months.
* Able to provide verbal informed consent.

Exclusion Criteria:

* Unable to provide verbal informed consent
Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Cachexic Adult Indian Cancer Patients

Investigators are evaluating the nutritional role of IAtta supplementation along with nutritional counselling in delaying the progression of cachexia to refractory cachexia in adult cancer Indian patients. Patients will receive IAtta (100 g) or whole wheat flour (100 g) for daily consumption for 6 months. Dietary and physical activity counseling will be imparted every fortnight to patients.

Nutritional, biochemical, quality of life and anthropometric estimations will be assessed at baseline, after 3 months and at 6 months of intervention for all patients.

Investigators hypothesize that intake of nutrient rich bread mix IAtta (along with dietary and physical activity counselling) for six months will improve the health status and quality of life in free-living patients suffering from cancer cachexia.

Patients will be randomly distributed into two groups i.e. control and intervention group. 75 patients will be allocated in intervention group and receive nutrient rich flour mix i.e. IAtta (100 g) along with dietary and physical activity counseling and 75 patients will be allocated in the control group who will receive whole wheat flour with dietary and physical activity counseling. Intervention group patients will collect 14 packets of 100 g of IAtta every fortnight during their clinician appointments while the control patients will collect 14 packets of 100 g of whole wheat flour at every clinician visit for 6 months.

Dietary counseling for 30 minutes will be imparted to all patients on each visit by the nutritionist. Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), will be encouraged daily during counseling sessions.

Nutritional, biochemical, quality of life and anthropometric estimations would be assessed at baseline, after 3 months and at 6 months of intervention for all patients.

Eligibility Criteria:
Inclusion Criteria:

* Female, age 18 years and above.
* Diagnosed with cancer.
* Weight loss \>5% from pre-treatment weight or BMI\<20kg/m2.
* Hemoglobin level \<12 g/dl.
* Energy intake \< 1500 kcal/d (to be assessed on consultation)

Exclusion Criteria:

* Incapable to provide written consent.
* Patient diagnosed with refractory cachexia.
* Life expectancy \< 3 months.
* Unresponsive to anti-cancer therapy.
* Patient is a pregnant woman or a nursing mother.
* Suffering from secondary illnesses.
* Gastrointestinal tract defects which affect nutrient absorption.
Study of H-FICB ＆ PENG Block in Elderly Patients' THA on the Post-operative Quality of Recovery

Total joint replacement is projected to become the most common elective surgical procedure in the coming decade; the prevalence of total hip arthroplasty (THA) was estimated as more than 2.5 million individuals in the entire United States population. Orthopedic procedures involving the hip have remained challenging for regional anesthesia given the complex innervation, painful nature contributing to difficulty positioning, and a desire to maintain mobility to hasten postoperative recovery.

By comparing the intraoperative and postoperative rehabilitation indexes of high fascia iliac nerve block and hip pericapsular nerve block, we can choose a more suitable analgesic method for this operation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 to 80 years male and female
* Scheduled for elective single-incision laparoscopic cholecystectomy
* The patients volunteered to participate in the study and signed the informed consent

Exclusion Criteria:

* Preexisting neuropathy
* Coagulopathy
* Local skin infection
* Hepatic, renal or cardiorespiratory failure
* Local anesthetic allergy
* Pregnancy
* Complications of gallstone with gallbladder perforation
* Diffuse peritonitis
* Acute pyogenic cholangitis
Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes

This study looks at how well a new medicine, called semaglutide, works at helping people with obesity and prediabetes.

This study will look at how much weight participants lose, and if participants can go from having blood sugar that is higher than normal (prediabetes) to having normal blood sugar.

Semaglutide is compared to a "dummy" medicine. The "dummy" medicine looks like semaglutide but has no effect on the body.

In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight.

Participants will either get semaglutide or "dummy" medicine - which treatment they get is decided by chance. Participants are 2 times as likely to get semaglutide as "dummy" medicine.

Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm.

The study will last for about 19 months. Participants have to take the study medicine every week for the first 12 months. The last 7 months participants will not take any medication.

Participants will have 14 clinic visits and 1 phone call with the study staff. At 9 of the clinic visits Participants will have blood samples taken. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged greater than or equal to 18 years at the time of signing informed consent.
* BMI greater than or equal to 30.0 kg/m\^2
* Prediabetes defined as at least one of the following:

  * HbA1c between 6.0 and 6.4 percent (42 and 47 mmol/mol) (both inclusive) as measured by central laboratory at screening.
  * FPG between 5.5 and 6.9 mmol/L (99 and 125 mg/dL) (both inclusive) as measured by central laboratory at screening.

Exclusion Criteria:

* History of type 1 or type 2 diabetes.
* Treatment with glucose-lowering agent(s) within 90 days before screening.
* HbA1c greater than or equal to 6.5 percent (greater than or equal to 48 mmol/mol) as measured by central laboratory at screening.
* FPG greater than or equal to 7.0mmol/L (126 mg/dL) as measured by central laboratory at screening.

A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records.

* Treatment with any medication for the indication of obesity within the past 90 days before screening.