cyrilzakka/clinical-trials huggingface dataset:
Long-term Follow-up of Conservative and Surgical Treatment Results of Patients With Lumbar Spinal Stenosis

Total of 60 patients with a diagnosis of spinal stenosis is planned for 30 patients, with physical therapy modeling and exercise, and 30 patients with surgical treatment. Patients will be evaluated by the same physician 5 times, before early primary treatment, 1st month, 3rd month, 6th month and 12th month after treatment.

Patients between 40-85 years old who are hospitalized and treated with the diagnosis of LSS in Physical Medicine and rehabilitation, Orthopedics and Neurosurgery Clinics will be included in the study. The diagnosis of LSS will be made by MR and / or CT and neurogenic claudication history.

Total of 60 patients with a diagnosis of spinal stenosis is planned for 30 patients, with physical therapy modeling and exercise, and 30 patients with surgical treatment, and the duration of the study is considered to be 24 months. Patients will be evaluated by the same physician 5 times, before early primary treatment, 1st month, 3rd month, 6th month and 12th month after treatment.

Clinical evaluation will be done by the same physician. In patients with spinal stenosis, pain (movement, rest, night) VAS, functional status walking distance and ILBDI (Istanbul waist pain disability index) inquiry form, Nottingham Extended Life Profile will be used.

Eligibility Criteria:
Inclusion Criteria:

1. To be between 40-85 years old
2. Defining neurogenic claudication in patient anamnesis
3. Diagnosis of lumbar stenosis in MR and / or CT imaging
4. The duration of the symptom should be at least 4 weeks
5. Other causes of low back pain have been ruled out

Exclusion Criteria:

1. Having had lumbar surgery before
2. Physical therapy for lumbar spinal stenosis less than 3 months ago
3. Any lumbar injection has been applied before
4. Patients with inflammatory low back pain
5. Patients with spinal stenosis due to spondylolysis and / or spondylolisthesis
6. Patients with a history of trauma and suspected Vertebral fracture
Lysosomal Movement and Anabolic Resistance

Age-associated loss of muscle mass, termed sarcopenia, is strongly associated with functional impairment and physical disability in the elderly. Maintenance or growth of muscle mass is mainly driven by increased muscle protein synthesis (i.e. the generation of new muscle protein) in response to exercise and feeding. However, several investigations have shown that elderly individuals have a blunted protein synthetic response following protein intake. This inability of the elderly to properly respond to growth stimuli has been termed anabolic resistance and plays a significant role in the development of sarcopenia. However, the precise mechanisms underpinning anabolic resistance are unknown.

It is well established that muscle protein synthesis at the molecular level is regulated by a cellular protein complex called mTORC1. When exposed to a growth stimulus, mTORC1 has been shown to associate with lysosomes, i.e. the intracellular organelles responsible for the breakdown of cellular proteins, and subsequently moving towards the cell periphery.

This movement of lysosome-associated mTORC1 within the cell is believed to be vital for the activation of protein synthesis, as inhibition of lysosomal movement blunts mTORC1 activation in response to amino acids. Thus, dysregulation of lysosomal movement in ageing muscle may represent an underlying mechanism in the development of anabolic resistance. However, this area of research is unexplored in the context of human skeletal muscle. The investigators hypothesize that dysregulation of lysosomal movement plays a central role in the development of age-associated skeletal muscle anabolic resistance.


Eligibility Criteria:
Inclusion Criteria:

Be a non-smoking male within the specified age range for each group (young; 18-35 yrs, old; 65-75 yrs)

Have a BMI (body mass index, body weight/height in m2) between 18 and 25 kg/m2, which is considered a normal body mass index.

Be in good general health: no cardiovascular diseases or metabolic diseases.

Exclusion Criteria:

Health problems such as: heart disease , metabolic disease such as phenylketonuria, rheumatoid arthritis, uncontrolled hypertension, poor lung function, or any health condition that might put the participant at risk when participating in this study.

Generalized neuromuscular disease (such as Parkinson's disease or motorneuron disease).

Involvement in regular structured resistance exercise training at the time of the study.

Consumption of any analgesic drugs, anti-inflammatory drugs, or medication that is known to affect protein metabolism (beta-blockers, corticosteroids, NSAIDs).

Participants who have undergone muscle biopsy testing or isotope infusion procedures within the last 5 years.

Allergic to lidocaine
Clinical Trial on the Articular Pain With a Cucumber Supplement in Patients Diagnosed With Arthrosis

Randomized, controlled, double-blind clinical trial of two parallel branches to analyze the efficacy of a supplement extracted from the cucumber on the joint pain of patients diagnosed with osteoarthritis.

The subjects that meet the selection criteria will make a total of two visits to the research laboratory and will carry out the pre-established tests in the protocol. Subsequently, a statistical analysis will be carried out with the variables measured in the study to obtain results.

Eligibility Criteria:
Inclusion Criteria:

* Age over 40 years.
* Subjects diagnosed with osteoarthritis with functional grades I-III according to the modified criteria of the American College of Rheumatology.
* Subjects must have persistent knee pain associated with osteoarthritis with a baseline score of at least 30 mm on the VAS pain assessment.
* Subjects should not present narcotic drugs or steroidal anti-inflammatory drugs or immunosuppressants in their treatment.

Exclusion Criteria:

* Serious or terminal illnesses.
* Subjects currently taking glucosamine, chondroitin sulfate, collagen or hyaluronic infiltrations or any supplement indicated for joint health.
* Subjects with chronic inflammatory diseases that affect the musculoskeletal system (rheumatoid arthritis, gout, pseudo-gout, Paget's disease, chronic pain syndrome, etc.).
* Subjects with a body mass index above 32.
* Pregnant or lactating women.
* Inability to understand informed consent.
Clinical and Radiographic Evaluation of Indirect Pulp Capping Using Platelet Rich Fibrin Versus Mineral Trioxide Aggregate in Deep Carious Molars: a Randomized Controlled Trial

The aim of this study is the clinical and radiographic evaluation of (Platelet-Rich Fibrin (PRF) versus Mineral Trioxide Aggregate (MTA) in indirect pulp capping when used with deep carious molars over 1 year follow up.

-PICOTS : P: Asymptomatic deep carious molars. I: Indirect pulp capping using PRF. C: Indirect pulp capping using MTA.

O:

Outcome name Measuring device Measuring unit

Primary outcome:

clinical findings : Pulp sensibility using cold test (Sharma A et al., 2020).

Secondary outcome:

Radiographic findings :Dentin bridge measurement in mm using digital radiographic ruler Digital Periapical using paralleling technique (Sharma A et al., 2020).

T:

T0: Baseline T1: 3 months T2: 6 months T3: 12 months S: Randomized clinical trial.

- Research question: Will PRF provide comparable clinical and radiographic outcomes to MTA in indirect pulp capping when used in deep carious molars?

Eligibility Criteria:
Inclusion Criteria:

* o Patients with asymptomatic deep carious molars.

  * Patients with clinically and radiographically confirmed deep carious lesions that do not exhibit spontaneous pain.
  * Permanent molars only.
  * Teeth with intact or minimally restored occlusal surfaces (i.e., no extensive restorations or fractures).
  * No history of previous endodontic treatment or direct pulp capping on the study tooth.
  * No signs of periapical pathology based on radiographic evaluation.
  * Patients willing to participate and follow up for 12 months.
  * Patients who agree to return for scheduled follow-ups at 3, 6, and 12 months.

Exclusion Criteria:

* o Patients with systemic conditions affecting bone or tissue healing (e.g., uncontrolled diabetes, osteoporosis, immunosuppressed conditions).

  * Pregnant or lactating women (if applicable to your study).
  * Teeth with pulp exposure or necrotic pulp.
  * Presence of symptomatic irreversible pulpitis (e.g., spontaneous pain, lingering pain).
  * Periapical pathology or internal/external resorption detected radiographically.
  * Severely broken down or non-restorable teeth.
  * Calcified root canals or excessive sclerosis that could affect pulp testing reliability.
  * Any pre-existing root canal treatment on the selected tooth.
  * Patients who have undergone recent fluoride treatment, pulpotomy, or other pulp therapies in the past 6 months.
  * Patients using medications affecting bone and tissue regeneration (e.g., bisphosphonates, corticosteroids).
  * Patients unwilling or unable to commit to the 12-month follow-up schedule.
  * Patients with poor oral hygiene or high caries risk that could compromise treatment outcomes.
Study on Efficacy and Safety of Givinostat Versus Hydroxyurea in Patients With Polycythemia Vera

The goal of this clinical trial is to compare the efficacy and safety of givinostat to hydroxyurea in Jak2V617F-positive high risk polycythemia vera patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have been diagnosed with PV according to the 2016 WHO criteria within 3 years before randomization
* Patients must have JAK2V617F-positive disease
* Patients with PV must meet the definition of HR for thrombosis (i.e., HR) at screening as follows:

  * Age ≥ 60 years, and/or
  * Prior thrombosis.
* Patients must be in need of treatment at screening, defined by the presence of at least one of the following:

  * HCT ≥ 45% or HCT \< 45% with at least 1 phlebotomy performed in the 3 months before screening, or
  * WBC count \> 10 × 109/L, or
  * PLT count \> 400 × 109/L.
* Patients must have normalized HCT (i.e., HCT \< 45%) at randomization

Exclusion Criteria:

* Patients pre-treated with HU with a documented history of resistance or intolerance to HU defined by the original ELN criteria
* Patients with a QTcF value of \> 450 msec for males and \> 460 msec for females at the Screening visit (as the mean of 3 consecutive readings 5 minutes apart in the event a first ECG demonstrates a prolonged QTcF interval); congenital or acquired history of QTc prolongation or ventricular arrhythmias, at the Screening visit
* Splanchnic thrombosis and/or thrombosis of the cerebral venous sinuses and/or splenectomy in the medical history
* Patients with clinically significant cardiovascular disease
* Patients with myocardial infarction, stroke or unstable angina within the 6 months prior to screening.
* Patients with inadequate liver or renal function at screening
* Uncontrolled hypertriglyceridemia at screening, i.e., triglycerides ˃ 1.5 × ULN
* Previous treatment with a JAK2 or HDAC inhibitor or 32-phosphorus (radioactive isotope) therapy.
* Patients being treated concurrently with any investigational agent or prior participation in an interventional clinical study within the 30 days prior to screening or within 5 half-lives of the investigational product, whichever is longer.
* Pregnant or nursing women
Echocardiographic and Arterial Pressure Waveform Changes After Reducing Heart Rate With Esmolol in Septic Shock Patients

Clinical study suggests that beta-blockers by decreasing heart rate together with an increase in stroke volume do not negatively affect cardiac output allowing an economization of cardiac work and oxygen consumption in patients with septic shock. Whether this hemodynamic profile leads to an amelioration of myocardial performance is still unclear. The objective of the present study is therefore to elucidate whether a reduction in heart rate with esmolol is associated to an improvement of cardiac efficiency in patients with septic shock who remained tachycardic after hemodynamic optimization.

After 24-36 hours of initial hemodynamic stabilization, 44 septic shock patients with heart rate \> of 95 bpm and requiring norepinephrine to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation,will receive a continuous esmolol infusion to maintain heart rate between 94 and 80 bpm. Norepinephrine will be titrated to achieve a MAP between 65 and 75 mmHg. To investigate myocardial performance, we will simultaneously assess LV ejection fraction (LVEF), tricuspidal annular plane solid excursion (TAPSE) by echocardiography, the dP/dt MAX and the cardiac cycle efficiency (CCE) both estimated from the arterial pressure waveform. Finally we will analyze changes in static arterial elastance. Data will be obtained at baseline and after four hours once achieved the predefined heart rate threshold.

Eligibility Criteria:
Inclusion Criteria:

* septic shock criteria
* presence of heart rate \> 95 bpm.

Exclusion Criteria:

* Pregnancy
* age \< 18
Effect of Yohimbine on Colon Transit

This study is being done to learn if yohimbine, a naturally occurring drug, affects the speed at which food travels through the stomach, intestines and colon, and if yohimbine affects the amount of liquid you can drink in a short period of time. Understanding how yohimbine works on the gut may help develop new treatments for patients with constipation. Yohimbine has been approved by the Food and Drug Administration (FDA) for routine clinical use, however, its use as proposed in this study is considered investigational.


Eligibility Criteria:
* Healthy male or non-pregnant, non-breastfeeding female volunteers, -18-65 years old;
* Able to provide written informed consent before participating in the study;
* Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
Fenofibrate and Propranolol in Burn Patients

The proposed study will test the hypothesis that Propranolol, fenofibrate and fenofibrate plus propranolol have therapeutic, physiological, and metabolic effects that will improve clinical outcomes, and the long-term recovery, rehabilitation, and QOL in burned patients.

Determine the clinical benefits and underlying mechanisms whereby the metabolic perturbators fenofibrate and propranolol impact burn patient outcomes. The investigators hypothesize that these metabolic regulators given for one year will maintain body mass, improve muscle function by increasing protein synthesis, augment wound healing, reduce fibrosis, improve cardiovascular function, reduce systemic inflammation, restore insulin sensitivity, and decrease liver dysfunction without the risk of the hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* 0 through 80 years
* ≥ 20% Total Body Surface Area Burn injury

Exclusion Criteria:

Pregnancy

History or existence of pre-burn injury conditions

* Allergies to propranolol or fenofibrate
* Asthma requiring treatment
* Congestive heart failure (measured ejection fraction \< 20%)
* Renal or hepatic disease
* Medical condition requiring glucocorticoid treatment
* History of AIDS, Aids Related Complex or HIV
* History of Cancer within 5 years

Decision not to treat due to burn injury severity or futility as deemed by the clinical team
Improved Diagnostics in Food Allergy Study

The investigators will conduct low-dose intranasal allergen challenges on children and young people with an indeterminate diagnosis of food allergy to cow's milk or peanut. Blood samples will also be taken, for conventional blood allergy diagnostics (allergy-specific Immunoglobulin E) and mast cell activation test (MAT). The data will be used to determine the diagnostic accuracy of two complementary, novel approaches to diagnose food allergy, in a representative clinical cohort.


Eligibility Criteria:
Inclusion Criteria:

* IgE-sensitisation to peanut, (hen's) egg or cow's milk, with indeterminate clinical (allergy) status, defined as IgE-sensitisation below 95% positive predictive value (PPV) for diagnosis for either allergen-specific IgE or SPT, using published cut-offs OR clinician suspicion of tolerance (on basis of clinical history) despite IgE sensitisation \>95% PPV cut-offs.
* Written informed consent from parent/guardian, with assent from children aged 6 years and above wherever possible. Participants aged over 16 years will need to provide their own informed consent.

Exclusion Criteria:

* Acute illness or current unstable asthma, defined as:

  1. Febrile ≥38.0oC in last 72 hours
  2. Acute wheeze in last 72 hours requiring treatment
  3. Recent admission to hospital in preceding 2 weeks for acute asthma
* Current medication

  1. Asthma reliever medication required in preceding 72 hours
  2. Recent administration of a medicine containing antihistamine within the last 3 days
  3. Current oral steroid for asthma exacerbation or course completed within last 2 weeks
* Unwilling or unable to fulfil study requirements
Study With a Topical Gel Containing TRIAC and DHEA in Subjects With Skin Atrophy Due to Glucocorticoids

An open, uncontrolled pharmacokinetic study with a new topical combination gel containing triiodothyroacetic acid (TRIAC) and dehydroepiandrosterone (DHEA) in subjects with skin atrophy due to topical treatment with glucocorticoids.

At the Baseline Visit (Day 1) and after completion of all evaluations, each subject who qualifies for entry will will receive a dose of 0.5 g IMP on the back of a hand affected with skin atrophy.

PK-samples will be withdrawn at 0, 2, 4, 6, 24, 48 and 72 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent has been obtained prior to initiating any study specific procedures
2. Men and women of at least 18 years old
3. Subjects with hand eczema and confirmed skin atrophy on the back of a hand caused by treatment with topical glucocorticoids for at least 6 months
4. Atrophic skin area of approximately 100 cm2 (back of a hand)
5. Females of childbearing potential must have a negative urine pregnancy test result upon entry into the study
6. Females of child-bearing potential may participate only if using reliable means of contraception

Exclusion Criteria:

1. Skin atrophy with open ulcer(s) involved
2. Participation in any other study involving investigational drug(s) within 30 days prior to study entry
3. Use of systemic or topical glucocorticoids, thyroid hormones, vitamin A analogues, DHEA, and testosterone within 3 weeks before entry into the study
4. Known thyroid disease of any type
5. Women with polycystic ovary syndrome (PCO), congenital adrenal hyperplasia or other androgen excess syndromes
6. Subjects who have previously participated in this study
Chronic Inflammatory Activation in Fat Tissue: An Atherogenic Factor in Severe Coronary Artery Disease

Chronic inflammatory activation in fat tissue can be the link between adiposity and an increased risk for atherosclerosis. The aim of this study is to investigate how molecular alterations in fat tissue can be influenced by regular physical exercise training alone or in combination with a medical therapy (glitazone or metformin) in obese patients with severe coronary artery disease (CAD) and impaired glucose tolerance.


Eligibility Criteria:
Inclusion Criteria:

* Either impaired glucose tolerance (2 hour plasma glucose concentration \> 7.8 and \< 11.1 mmol/L during an oral glucose tolerance test) or impaired fasting plasma glucose concentration ( \> 6.0 and \< 7.0 mmol/L)
* Body mass index (BMI) \> 25
* Severe coronary artery disease determined by coronary angiography
* Male patients aged 35-75 years

Exclusion Criteria:

* Diabetes mellitus type I
* Diabetes mellitus type II in combination with glycosylates hemoglobin \> 6.0%, previous medication with oral antidiabetic agents or insulin, fasting plasma glucose concentration \> 11.0 mmol/L
* Unstable angina pectoris
* Myocardial infarction within the last 4 weeks
* Reduced left-ventricular systolic function \< 30%
A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection

The purpose of this study is to evaluate the Pharmacokinetic parameters of JNJ-63623872 in combination with oseltamivir in elderly participants (aged 65 to \<= 85 years) compared to adults (aged 18 to \<= 64 years) with influenza A infection.

This is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the effect of JNJ-63623872 in combination with oseltamivir in participants with influenza A infection. The study consists of 3 Phases: Screening visit (1 Day), participants who meet all eligibility criteria will be randomized in a 2:1 ratio to receive study drug in double-blind treatment Phase (7 Days) and follow up Phase (21 Days). The duration of participation in the study for each participant is approximately 28 Days. Primarily Pharmacokinetic parameters of JNJ-63623872 will be measured. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participant requires hospitalization to treat influenza infection and/or to treat complications of influenza infection
* Participant tested positive for influenza A infection within 1 day of signing of the informed consent form (ICF)/assent form using a polymerase chain reaction (PCR)-based rapid molecular diagnostic assay
* Participants must be capable of swallowing study medication tablets and capsules
* Each participant (or their legally acceptable representative) must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
* Participant must be willing and able to adhere to the prohibitions and restrictions specified in the protocol

Exclusion Criteria:

* Participant received more than 3 doses of the influenza antiviral medication oseltamivir, zanamivir, or peramivir since the start of the influenza symptoms, or ribavirin within 6 months prior to Screening
* Participant is unwilling to undergo regular nasal Mid-turbinate (MT) swabs or has any physical abnormality which limits the ability to collect regular nasal specimens
* Participant is immunocompromised, whether due to underlying medical condition (example, malignancy) or medical therapy (example, medications, chemotherapy, radiation, post-transplant)
* Participant is undergoing peritoneal dialysis, hemodialysis, or hemofiltration
* Participant has an estimated glomerular filtration rate (eGFR) less than or equal to (\<=)30 milliliter (mL)/minute (min)/1.73 meter\^2 (m\^2) according to the Modification of Diet in Renal Disease (MDRD) equation, assessed at Screening or based on the most recent clinically relevant creatinine value if available
Thoracic Paravertebral Block : Effect on Acute Pain and Chronic Pain of Hepatectomy With Right J-shape Subcostal Incision

This prospective, randomized study,control study aims to compare the analgesic effect,opioids consumption,quality of recovery,length of hospital stay and incidence of chronic pain,et al. single-injection TPVB +continuous(pulsatile infusion) TPVB and intravenous patient-controlled analgesia (IPCA) alone in patients undergoing hepatectomy with right J-shape subcostal incision.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 yrs
* American Society of Anesthesiologists physical statusⅠ-Ⅲ
* Undergo hepatectomy with J-shape subcostal incision
* Informed consent

Exclusion Criteria:

* A known allergy to the drugs being used
* Coagulopathy, on anticoagulants
* Analgesics intake, history of substance abuse
* Participating in the investigation of another experimental agent
* Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)