cyrilzakka/clinical-trials huggingface dataset:
Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty.

Total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. Cemented hip arthroplasty is mainly indicated for elderly patients with poor bone quality and multiple comorbidities. Bone cement implantation syndrome is associated with cemented hip arthroplasty and it has been shown to increase cardiovascular and renal complication and brain damage postoperatively. The aim of this project is to elucidate whether remote-ischemic preconditioning (RIPC) has multi-organ protective effect in cemented hip arthroplasty patients.

Total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. Cemented hip arthroplasty is mainly indicated for elderly patients with poor bone quality and multiple comorbidities. Cemented hip arthroplasty is strongly associated with bone cement implantation syndrome (BCIS). It is characterized by hypoxia, hypotension and/or unexpected loss of consciousness occurring around the time of cementation, prosthesis insertion or reduction of the joint. It has been shown to increase cardiovascular and renal complication and brain damage postoperatively. Remote-ischemic preconditioning has shown kidney, myocardial and brain injury protective effect on non-cardiac surgery patients. The aim of this project is to elucidate whether remote-ischemic preconditioning (RIPC) has multi-organ protective effect in cemented hip arthroplasty patients.

Eligibility Criteria:
Inclusion Criteria:

* age \>65 years
* undergoing total hip cemented hip arthroplasty

Exclusion Criteria:

* previously diagnosed peripheral artery disease on both upper limb
* RIPC is contraindicated
Investigating the Effects of Osteopathic Manipulative Treatment on Stress Management in Medical Students

The goal of this clinical trial is to evaluate stress biomarkers, subjective stress levels, and cognitive function in medical students. The main question\[s\] it aims to answer are:

Does regular osteopathic manipulative treatment affect stress in medical students? Does regular osteopathic manipulative treatment affect cognitive function in medical students?

Participants will be split into two groups, control and treatment, and undergo a designated protocol for six weeks. The treatment protocol will include weekly sessions of three OMT techniques: paraspinal inhibition, rib raising, and condylar decompression. Concurrently, participants' salivary cortisol levels will be collected weekly and analyzed using an Invitrogen ELISA Immunoassay Kit. Additionally, cognitive function will be assessed weekly via Lumosity, while stress levels are gauged using the College Student Stress Scale (CSSS) survey.

Researchers will compare one cohort of medical students who receive weekly OMT and another cohort of medical students who have weekly check-ins without OMT to see if OMT can affect changes in stress biomarkers, subjective stress scales, and cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* First-year medical students
* Not currently receiving osteopathic manipulative treatment (OMT)

Exclusion Criteria:

* Pregnant
* History of spinal surgery
Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES)

This project will conduct a confirmatory efficacy trial of two novel psychosocial interventions, Cognitive Enhancement Therapy and Enriched Supportive Therapy, for the treatment of persistent negative symptoms in schizophrenia.

This project will conduct a confirmatory efficacy trial to examine the efficacy of Cognitive Enhancement Therapy (CET) and Enriched Supportive Therapy (EST) for the treatment of schizophrenia patients with significant and persistent negative symptoms. A total of 90 stabilized schizophrenia outpatients with moderate-to-severe persistent negative symptoms will be randomized to 18 months of CET or EST. Comprehensive data on persistent negative symptoms, social and non-social cognition, and functional outcome will be collected prior to treatment and at frequent 6-month intervals to (1) confirm the efficacy of CET and EST for improving persistent negative symptoms; (2) confirm the impact of cognitive target engagement on reduced negative symptoms; and (3) examine the short-term durability of CET and EST effects on negative symptoms and functioning.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria will be evaluated longitudinally in a 4-week evaluation period. Patients will be included if they are outpatients and:

1. are between 18-60 years of age;
2. have a diagnosis of schizophrenia or schizoaffective disorder confirmed by the SCID;
3. have a clinical history of persistent negative symptoms lasting at least 3 months as identified from the medical record;
4. have observed persistent negative symptoms at the beginning and end of the 4-week evaluation period;
5. have been stabilized on antipsychotic medication at the beginning and end of the 4-week evaluation period;
6. have stabilized depressive symptoms at the beginning and end of the 4-week evaluation period;
7. have mild or absent extrapyramidal symptoms at the beginning and end of the 4-week evaluation period;
8. have had changes to their primary antipsychotic medication within the previous 3 months;
9. have current IQ \> 80; and
10. are able to read (sixth grade level or higher) and speak fluent English. -

Exclusion Criteria:

Exclusion criteria are intended to avoid likely treatment confounders and contraindications and include:

1. the presence of organic brain syndrome;
2. comorbid medical disorders producing cognitive impairment (e.g., mild brain injury, previous concussions with loss of consciousness);
3. persistent suicidal or homicidal behavior;
4. significant clinician-estimated medication non-adherence; and
5. SCID-verified substance use disorder.
The Effect of Clinical Parameters on Muscle Oxygenation in Patients with COPD

The aim of this study is to examine the peripheral muscle oxygenation of patients with Chronic Obstructive Pulmonary Disease at rest, during submaximal exercise and recovery, and to examine the effects of disease severity and respiratory functions on peripheral muscle oxygenations. In this study, the effect of disease severity and respiratory problems on peripheral muscle metabolism of patients with COPD will be explained.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with COPD (according to GOLD Staging: GOLD 1, GOLD 2, GOLD 3, GOLD 4)
* Being between the ages of 40-80
* Body Mass Index \<35
* Not having an acute exacerbation in the last 3 months

Exclusion Criteria:

* Patients who do not want to participate in the study
* Arthritis causing weakness in the lower extremity, neurological disease, deep vein thrombosis, peripheral arterial disease, muscle weakness, fracture etc. patients with the condition
* Common diseases such as malignancy, pulmonary embolism, vasculitis, collagen tissue diseases, interstitial fibrosis, severe pneumonia patients with parenchymal destruction
* Patients with severe dyspnea and hemodynamic instability who cannot perform the 6 Minute Walk Test
The Effect of Telephone Consulting on HbA1 and Self-Management

The aim of this study was to investigate the effect of telephone counseling (12 weeks) based on the Information, Motivation, Behavioral Skills (IMB) Model in patients with type 2 diabetes mellitus (T2DM) on self-management and HbA1c.

The aim of this study was to investigate the effect of telephone counseling based on the Information, Motivation, Behavioral Skills (IMB) Model in patients with type 2 diabetes mellitus (T2DM) on self-management and HbA1c. This study was conducted with a randomized controlled trial. This study, between January 2019 and September 2019 were conducted in endocrine clinic. A total of 63 patients (31 interventions, 32 controls) diagnosed with T2DM were included. The intervention group received 45-60 minutes of patient training based on the Information, Motivation and Behavioral Skill Model (IMB). A weekly short reminder message and a two-weekly phone call were made and a total of 12 weeks of follow-up was conducted. As a result, there was a statistically significant difference between pre-test HbA1c, weight and systolic blood pressure (p\<0.05). Also, after three months of follow-up, self-efficacy, self-management and self-management perceptions were significantly higher in the intervention group (p\<0.05).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with type 2 DM at least six months previously
* Using a mobile phone
* HbA1c greater than 7%
* Living in the city
* Physical and mental health levels adequate for participation in the research

Exclusion Criteria:

* Having severe hearing or perceptual deficits that impaired communication
* Patients who did not agree to participate in the study
* Receiving inpatient treatment
Smart Textile ECG Monitoring

This research is a clinical evaluation of the Skiin chest band, a smart garment with embedded electronic textile (e-textile) electrodes, to record body surface electrocardiogram (ECG) signals. Developed by Myant Textile Computing Inc., the Skiin chest band (i.e. as part of the Skiin Underwear family of garments) is a component of the Myant Health Platform (MHP). The MHP also consists of: (a) a mobile phone application (Skiin Connected Life Application; SCLA), and (b) the Myant Virtual Clinic Portal (MVCP). In this study, participants will wear the Skiin chest band to collect their ECG for a period of 14 days. Participants will also be provided with a smartphone that is pre-loaded with the SCLA to record any symptoms (e.g. palpitations, shortness of breath, fatigue, light- headedness, fainting, etc.) they may experience over the 14 day ECG monitoring period. The data collected in this study will be used to develop new algorithms and patient monitoring tools to detect and predict cardiovascular health problems.


Eligibility Criteria:
Inclusion Criteria:

* Being referred to the Partners in Advanced Cardiac Evaluation (PACE Cardiology), and having been prescribed a 14-day ambulatory ECG monitoring by their physician.
* Able to understand and speak English language, enough to provide informed consent.

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Cardiovascular Implantable Electronic Devices (CIED), including Implanted cardioverter defibrillator (ICD) or pacemakers
* Absence of chest band that fits the participant's body
* Open wound or dressing on a body part that needs to be in contact with the Skiin garment
Risk Factors for Recurrence of Thrombosis or Thrombotic Extension, in the Event of Acute Non-cirrhotic Portal Vein Thrombosis Secondary to a Local Cause.

In case of acute portal vein thrombosis (PVT) prothrombotic factors are identified in about 60% of cases, while a local condition is present in 30% of cases. Prothrombotic factors may indicate a long term anticoagulant therapy whereas the risk of recurrence seems low when a local condition is isolated (cholecystitis, angiocholitis, liver abces, diverticulitis, appendicitis, acute/chronic pancreatitis, chronic bowel inflammatory disease, acute hepatitis due to cytomegalovirus, bacteroïdes pylephlebitis, abdominal neoplasia such as adenocarcinoma of the colon, abdominal traumatism or surgery such as cholecystectomy, bariatric surgery or splenectomy). To date the impact of prothrombotic factors associated with local conditions responsible for acute PVT has not been well studied except for acute or chronic pancreatitis. No significant association has been pointed out in this pathology. The aim is to determine what are the risk factors of thrombotic recurrence or extension associated with local conditions responsible for acute non cirrhotic PVT, and to evaluate the rate of secondary long term anticoagulant therapy.


Eligibility Criteria:
Inclusion Criteria:

* acute portal thrombosis segmental or truncal, diagnosed in the context of a local inflammatory, infectious, trauma or abdominal surgery cause, dating from less than 3 months.
* patients already included in european cohort ENVIE-VALDIG

Exclusion Criteria:

* liver cirrhosis
* liver, biliary or pancreatic neoplasia
* thrombosis limited to mesenteric vein, splenic vein or splenomesaraic confluence
* cavernoma or Budd-Chiari syndrom
Attitude and Practice for Deep Caries Management Between Egyptian and Indian Dentists : a Cross Sectional Study

Study type: Observational Study To assess and compare the attitudes, and practices of dentists in Egypt and India regarding the removal of deep dentin caries and preferred restorative strategies. In addition to correlate between dentist's understanding of caries and its treatment and factors such as age, gender, degree of education and clinical setting.

Study type:Observational study To evaluate and compare the views and practices of dentists in Egypt and India concerning the removal of deep dentin caries and their preferred restorative approaches. Additionally, the study aims to examine the relationship between dentists' understanding of caries and its treatment, along with factors such as age, gender, level of education, and clinical environment.

primary outcome-Attitudes, and practices of dentists in Egypt and India regarding the removal of deep dentin caries and their preferred restorative strategies.

secondary outcome:The relationship between dentists' attitudes and their practices in managing deep caries treatment may be affected by factors such as age, gender, education level, and clinical experience.

comparison groups: Population (P1): Dentists practicing in Egypt

- Population(P2) : Dentists practicing in India

Eligibility Criteria:
Inclusion Criteria:

* Inclusion: Licensed dentists actively practicing in Egypt or India.

Exclusion Criteria:

* Exclusion: Dentists not currently practicing or recent graduates without practical experience
Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib versus anagrelide in subjects with essential thrombocythemia who are resistant to or intolerant of hydroxyurea.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of essential thrombocythemia according to revised World Health Organization (WHO) 2016 criteria.
* Resistant to or intolerant of hydroxyurea, that is, fulfilling at least 1 of the following criteria:

  * Platelet count \> 600 × 10\^9/L after 3 months of at least 2 g/day of hydroxyurea (2.5 g/day in subjects with a body weight over 80 kg) OR at the subject's maximally tolerated dose if that dose is \< 2 g/day.
  * Platelet count \> 400 × 10\^9/L and WBC count \< 2.5 × 10\^9/L or hemoglobin \< 10 g/dL at any dose of hydroxyurea.
  * Presence of leg ulcers or other unacceptable mucocutaneous manifestations at any dose of hydroxyurea.
  * Hydroxyurea-related fever.
* Platelet count ≥ 650 × 10\^9/L at screening.
* WBC ≥ 11.0 × 10\^9/L at screening.

Exclusion Criteria:

* Subjects previously treated with anagrelide or Hydroxyurea (HU).

  1. Prior anagrelide use is allowed provided the reason for discontinuation is not AE-related and anagrelide is stopped at least 28 days before the start of study medications (ie, Day 1).
  2. Treatment with HU can be stopped at any time once one of the inclusion criteria for HU refractoriness or resistance have been met, and up to the day before the first dose of study treatment (ie, Day 1).
* Inadequate liver function at screening and Day 1 (before drug administration) as demonstrated by:

  * Total bilirubin \> 1.5 × upper limit of normal (ULN)
  * Aspartate aminotransferase or alanine aminotransferase \> 1.5 × ULN
  * Hepatocellular disease (eg, cirrhosis)
* Inadequate renal function at screening as demonstrated by creatinine clearance \< 40 mL/min calculated by Cockcroft-Gault equation.
Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer

The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug measuring progression free survival.

To evaluate the incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicity in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC) treated with AMG 386 in combination with pemetrexed and carboplatin

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, unresectable stage IV non-squamous non small cell lung cancer (NSCLC)
* Radiographically evaluable disease (measurable or non-measurable) per RECIST 1.1 with modifications
* Adequate hematological, renal, and hepatic function, normal coagulation profile, calculated CrCL ≥ 45 mL/min
* Other criteria may apply

Exclusion Criteria:

* Any prior chemotherapy or targeted therapy for non-squamous NSCLC
* Subjects with adenosquamous histology or any histology subtype containing greater than 10% squamous cells
* Subjects with an epidermal growth factor receptor (EGFR) mutation sensitive to treatment with a tyrosine kinase inhibitor (TKI)
* Subjects with known anaplastic lymphoma kinase (EML4-ALK) translocations
* History or presence of central nervous system metastases
* Central (chest) radiation therapy within 28 days prior to enrollment/randomization, radiation therapy to any other site(s) within 14 days prior to enrollment/randomization
* History of pulmonary hemorrhage or gross hemoptysis within 6 months
* History of arterial or venous thromboembolism within 12 months
* History of clinically significant bleeding within 6 months
* Clinically significant cardiovascular disease within 12 months
* Other criteria may apply
A Phase 1 Study to Evaluate Safety and Tolerability of Single and Multiple Ascending Doses of XEN-101

The goal of this study is to assess the safety and tolerability of single and multiple ascending doses of XEN-101

Single ascending dose (SAD) study to evaluate the safety and tolerability of XEN-101 in healthy participants. Multiple ascending dose (MAD) study to evaluate the safety and tolerability of XEN-101 in healthy participants.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age 18-60 years at Screening
2. SAD part: BMI 18-30 kg/m2; MAD part 2a: BMI 22-27 kg/m2; MAD Part 2b: BMI 30-40 kg/m2
3. Stable body weight for at least 3 months (fluctuation of less than or equal to 5% and not exceeding 4 kg) in all study Parts.
4. Women of childbearing potential shall agree to use an adequate method of contraception from the date of signing of the informed consent, throughout the study, and for 4 weeks after the final (EOS) study visit. In addition, they must be advised not to donate ova during this period. From the date of signing of the informed consent, throughout the study, and for 8 weeks after the last dose of study medication, non sterilized male subjects who are sexually active with a female partner of childbearing potential must use barrier contraception (e.g., condom with spermicidal cream or jelly). In addition, they must be advised not to donate sperm during this period.
5. Females of childbearing potential must have a negative pregnancy test at Screening and on Day -1 (baseline)
6. Able to provide Informed Consent
7. Willing and able to comply with this protocol and procedures, including feces pro-cessing and be available for the entire duration of the study.

Exclusion Criteria:

1. Currently enrolled in another investigational device or drug study, or less than 30 days or 5 time the half-life of the drug candidate, whichever is longer, passed at Screening since ending the treatment period the previous investigational device or drug study
2. History of diabetes mellitus, hypertension, sleep apnea, liver, kidney, auto-immune disease
3. Current nicotine use or in past 6 months (smoking, vaping, etc)
4. Uncontrolled psychiatric disorder
5. History of eating disorder (e.g. anorexia nervosa, bulimia, binge-eating disorder)
6. History of alcohol, nicotine, or substance misuse in the last 5 years
7. Use of antibiotics, antivirals, antifungals during past 3 months
8. Use of proton pump inhibitors or non-stable dose antidepressants
9. Use of anti-obesity medications (e.g. GLP-analogues, stimulants, bupropri-on/naltrexone, etc.)
10. Use of obesogenic medications (e.g. anti-diabetics, anti-convulsives, anti-histamines, beta-blockers, etc.) in past 3 months
Physical Functioning Throughout Lung Cancer Treatment

This trial investigates the impact of lung cancer treatment on physical status, symptoms and quality of life. Furthermore this trial investigates possible underlying causes and consequences of deconditioning.

Preliminary evidence suggests that patients with lung cancer experience a decrease of exercise tolerance and muscle strength during the course of their treatment. The underlying mechanisms and impact of this change has not yet been investigated. In light of this, our trial will prospectively follow a convenience sample of 150 patients with lung cancer who are undergoing treatment. Patients will be assessed before, during and at the end of the treatment (surgery and/or chemotherapy and/or radiotherapy and/or immunotherapy). The aims of the study are to

1. Investigate physical status, before start of treatment in lung cancer patients in comparison with healthy controls (primary outcome).
2. Investigate changes in physical status over the course of treatment in lung cancer patients (primary outcome).
3. Investigate the relationship between changes in physical status with physical activity and symptoms during treatment for lung cancer (secondary outcome).
4. Investigate the relationship between physical status after treatment for lung cancer and comorbidities, hospitalizations and cancer-related and all-cause mortality (exploratory outcome).

Eligibility Criteria:
Inclusion Criteria:

* undergoing treatment (surgery, chemotherapy, immunotherapy, radiotherapy, and combination of the previous ones)
* WHO performance status of maximal 2

Exclusion Criteria:

* presence of other neoplasms in the last 2 years
* bone metastasis
* progressive neuromuscular and neurological diseases
* unstable cardiac disease
* pulmonary hypertension
* interstitial lung disease
* orthopedic conditions that significantly impair functional status
* mental or psychiatric disorders that impair the ability to comply with study procedures.
* a history of cerebrovascular accident with remaining functional consequences
* a history of lung cancer
* difficulties in understanding and speaking Dutch
The Influence of the Femoral Nerve Block on Quadriceps Strength

Total knee replacement is a frequent procedure in Québec's hospitals and the muscular strength of the quadriceps is the best indicator of the patient's functional recovery post surgery. Thus, the importance of the patient's recovery leads to the evaluation of the influence of the femoral nerve block on the muscle strength.

The purpose of the study is to compare the short term and long term recuperation of the quadriceps' motor strength of after a total knee arthroplasty using different types of analgesics such as the continuous femoral nerve block, the single dose femoral nerve block and the systemic analgesic, a patient controlled analgesic pump.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* men or women needing an elective total knee replacement surgery

Exclusion Criteria:

* unicompartmental arthroplasty
* revision surgery for knee arthroplasty
* previous surgery on same knee
* previous fracture of femur/patella with functional after-effects
* allergies or contraindication to any medication used during study or to local anaesthesia technique
* preexisting neurological deficit
* severe anomaly of intracardiac conduction
* previous vascular surgery near the site of introduction of the catheter
* pregnancy or breastfeeding
* ASA IV or V14 class
* Men or women \> 18 years old unfit to consent
* \< 18 years old
* Refusal to sign consent form