cyrilzakka/clinical-trials huggingface dataset:
Comparing Back Extensor and Core Stability Training in Kyphosis

To compare the effects of back extensor strengthening exercises versus core stability exercises on thoracic kyphosis in patients, assessing improvements in posture, spinal alignment, and overall functional outcomes

Kyphosis is the normal forward curvature of our spine and when this curvature becomes excessively increased is referred to as hyper kyphosis or Hunch back. Its normal value is between 20 and 40 degrees. When the thoracic kyphotic angle exceeds 40 degrees, it is referred to as hyper kyphosis. The three main types of kyphosis often seen in individuals are postural, Structural and congenital. Postural kyphosis is caused by high external load on individual spine having overall poor muscle strength. Sagittal misalignment can be caused by poor posture while sitting and standing as well as prolonged sitting.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-40 years with a diagnosis of mild to moderate thoracic kyphosis (Cobb angle between 40° and 60°).
* The presence of back pain or discomfort is attributed to kyphosis.
* Willingness to participate and commit to the study's duration (6 weeks of intervention and follow-up).
* Ability to provide informed consent.

Exclusion Criteria:

* Severe thoracic kyphosis (Cobb angle \> 60°).
* Other spinal conditions such as scoliosis or spinal fractures.
* Previous spinal surgery or contraindications to physical activity.
* Neurological disorders affecting motor function.
* Pregnancy or severe medical comorbidities that would preclude participation.
Knowledge, Attitude and Practice of a Group of Egyptian Dental Interns Toward Caries Risk Assessment

Scientific background(Statement of the problem):

Dental caries is a disease that occurs through complex interaction of four major factors: the host, acidogenic bacteria, fermentable carbohydrates and time. There are many factors which contribute to dental caries incidence but do not seen in clinical examination. Those things are considered as dental caries risk factors, such as socioeconomic, attitudes, knowledge and behavior toward oral health. These risk factors play an important role in incidence of the disease, significantly associated with disease progression . The traditional "drill and fill "concept has served to restore function and esthetics but it has failed to prevent development of new carious lesions. In recent years; better understanding of nature of carious process has changed this operative treatment concept to non destructive risk -based caries management. Caries risk assessment is a procedure used to predict dental caries development before clinical onset of disease, through assessing risk factors contributing to progress of dental caries and let oral health care professionals to be more active in identifying and referring high risk patients for proper treatment and required prevention.

Rationale for carrying out this study : Many studies have measured dentists' knowledge toward caries risk assessment all over the world, but no studies have examined Egyptian Dentists' subjective ratings of the importance of specific caries risk factors or tested whether they use this information in treatment planning.

So the aim of this study to assess knowledge, attitude and practice toward caries risk assessment and management among group of dental interns in Egypt.

Benefits to the Dental interns:

* Challenge the knowledge of the intern dentists regarding caries risk assessment.
* Encourage the concept of minimally invasive dentistry to be applied in clinical practice.
* Accurate caries risk assessment in patients can guide clinician to give attention of their resources to high risk patients.

Benefits to the patients:

* Will benefit from proper knowledge, attitude and practice of dentists, thus proper treatment will be provided.
* Behavioral modification of patients toward oral hygiene practices.
* Reducing patient risk of developing advanced disease and may even arrest disease process.

Benefits to the Community:

-Imparting knowledge of Caries risk assessment to dentists will benefit their patients especially high-caries risk patients by giving proper preventive interventions that help to reduce the expected elevated incidence and severity of caries in the future, therefore the whole community will benefit.


Eligibility Criteria:
Inclusion Criteria:

1. Egyptian dental interns who completed their Pediatric Dentistry round in Pediatric Dentistry and Public Health Department ,Faculty of Dentistry , Cairo University.
2. Intern dentists irrespective of age and sex.

Exclusion Criteria:

1. Undergraduate dental students.
2. Post graduate dentists.
3. Dental interns who refused to participate in the study.
Microvascular and Cardiac Dysfunction in Paroxysmal Nocturnal Hemoglobinuria and Sickle Cell Disease

The purpose of this study is to examine how abnormal blood flow in the small vessels (microvessels) of the heart, muscle and kidney in paroxysmal nocturnal hemoglobinuria (PNH) or sickle cell disease leads to poor functioning of the heart and kidney. To test this question, the investigators will perform imaging tests (contrast ultrasound perfusion imaging) to look at the flow and function of these microvessels and compare this information to heart and kidney function. To further look at this question, patients who have PNH will be studied before and after starting a new drug (Soliris) that decreases damage to blood cells. In patients with sickle cell disease, patients will be studied at baseline (not during a pain crisis) and also during a pain crisis if one develops.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of PNH or SCD Age \> 18 years old

Exclusion Criteria:

* Pregnant or lactating women Presence of significant right to left shunting Allergy to ultrasound contrast agent Reactive airways disease Significant peripheral or coronary artery disease
Effect of Cognitive Behavioral Therapy on Chronic Low Back Pain With Sensitization

PURPOSE:

The main objectives of the study are:

1. To find the efficacy of using cognitive behavioural therapy on chronic low back pain with central sensitization.
2. To assist in planning an ideal physical therapy rehabilitation program for these patients.

BACKGROUND:

Recent research has shown that CLBP is a multifactorial disorder comprising psychosocial factors like pain catastrophization, fear avoidance and central sensitization. Central sensitization has been defined as "An amplification of neural signaling within the central nervous system that elicits pain hypersensitivity", and "increased responsiveness of nociceptive neurons in the central nervous system to their normal or subthreshold afferent input".

Maladaptive behavior, false beliefs and misinformation regarding the cause of the pain are all contributing factors to the chronicity of LBP.

Central sensitization has been attributed to cortical reorganization and amplification of the somatosensory representation of the back causing increased pain and further contributing to the maladaptive behavior and beliefs.

Cognitive behavioral treatment has been an important intervention for psychological disorders for decades and recently has gained a lot of interest as an intervention for chronic pain in general and CLBP in specific.

HYPOTHESES:

It will be hypothesized that: Cognitive behavioural therapy will have a significant effect on centrally sensitized pain intensity and disability.

RESEARCH QUESTION:" Does cognitive behavioral therapy have a significant effect on chronic low back pain with central sensitization"


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18- 50.
2. Patient must have experienced low back pain for at least 3 months.
3. Patient must have a score above or equal 40 in the Central Sensitization Inventory (CSI) (Neblett R. C., 2013) (Neblett R, 2015) (Neblett H. M., 2016) (R. De Pauw, 2015) (Mayer TG N. R., 2012) .
4. Patient must have a score of 3 and above on the Numerical Pain Rating Scale.

Exclusion Criteria:

* Patients were excluded if they had taken pain medications on the day of the assessment.
* Patient who had serious spinal pathologies, such as fractures, tumors or inflammatory diseases, such as ankylosing spondylitis, narrowing of spinal canal and other conditions or severe cardiorespiratory diseases.
* Uncontrolled mental health condition that prevents successful compliance.
Boston Migraine and Contraception Study

The objectives of this prospective, descriptive study are to:

1. generate estimates of the incidence, prevalence, persistence, clinical impact and attributable risk of migraine due to hormonal contraception (HC) use; and
2. identify predictive factors for clinically significant changes in headache attributable to HC use.

The investigators hypothesize that:

1. Most women with pre-existing migraine will have no significant change from baseline headache frequency or clinical impact attributable to HC at 3 months following initiation; a minority will report clinically significant worsening or improvement
2. The incidence of headache and migraine in HC users will not be significantly different from their incidence in NHC users
3. There will be identifiable risk factors for development or worsening of headache/migraine in the minority of HC users where that occurs.


Eligibility Criteria:
Inclusion Criteria:

* Proficiency in English
* Medically eligible for her chosen form of contraception per standard PPLM clinic protocol
* (For Study Arm A) Desire initiation of an estrogen/progesterone contraceptive method at time of clinic presentation and evaluation
* (For Study Arm B) Desire initiation of a progesterone only contraceptive method at time of clinic presentation and evaluation
* (For Control Arm) Initiating a non-hormonal contraceptive, or not initiating any contraceptive method
* (For Control Arm) Stated intention of not initiating any hormonal contraception over the 3 month study period
* Agreeing to study procedures

Exclusion Criteria:

* Inability to speak and read English
* (For Control Arm) Use of hormonal contraceptive in the past 3 months
* (For Control Arm) Been pregnant in the past 3 months
* States an intention to discontinue use of their newly initiated contraceptive (or lack of contraceptive) before the end of the 3 month study period
* Unwilling or unable to comply with study follow-up procedures
* Inability to give informed consent
* Previous participation in this study
Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese Subjects

The purpose of the study is to demonstrate safety and efficacy of Olopatadine 0.2% compared to its vehicle in Japanese subjects in the treatment of acute allergen-mediated conjunctivitis using the conjunctival allergen challenge (CAC) test.


Eligibility Criteria:
Inclusion Criteria:

* Japanese ethnicity.
* Seasonal Allergic Conjunctivitis--asymptomatic.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Manifest signs and symptoms of clinically active allergic conjunctivitis in either eye (\>1 for redness in any of the 3 vessels beds - conjunctival, episcleral, ciliary - or itching \>0) at the start of any visit.
* Other protocol-defined exclusion criteria may apply.
Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)

This study is an open-label extension to evaluate the safety and tolerability of long-term dosing of Losmapimod in patients with FSHD1 who participated in the ReDux4 study.

This study is an open-label extension study to evaluate the safety and tolerability of long-term dosing of Losmapimod in patients with FSHD1 who participated in the ReDux4 study.

This study is a multi-center clinical trial. It will be conducted in North America, Canada and Europe. Only patients who participated and competed all study procedures in the ReDUX4 Study treatment period will be eligible to participate in this open label extension study.

Patients who complete the randomized, placebo-controlled portion of the study will have the option to roll over into the open-label extension study.

Patients will receive 15 mg of losmapimod by mouth twice daily for a total of 30 mg by mouth daily. All patients will attend clinic visits approximately every 12 weeks.

Participation in this open-label extension study will continue until 90 days after losmapimod becomes commercially available, the patient withdraws from the study, or the Sponsor decides to close the study.

The primary endpoint of the study is to evaluate the safety and tolerability of long-term dosing of losmapimod in patients with FSHD.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have consented to participate and must have provided signed, dated and witnessed an IRB-approved informed consent form that conforms to federal and institutional guidelines.
* Male or female subjects
* Patients must be between 18 and 65 years of age, inclusive
* Must be will and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines and other study procedures.
* Will practice an approved method of birth control

Exclusion Criteria:

* Has a history of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. This may include, but is not limited to, a history of relevant drug or food allergies; history of cardiovascular or central nervous system disease; neuromuscular diseases except FSHD (eg, myopathy, neuropathy, neuromuscular junction disorders); or clinically significant history of mental disease.
* For subjects who are on drug(s) or supplements that may affect muscle function, as determined by the treating physician, or that are included in the list of drugs presented in the protocol, subjects must be on a stable dose of that drug(s) or supplement for at least 3 months prior to the first dose of study drug and remain on that stable dose for the duration of the study. Changes to the dose or treatment discontinuation during the study can only be done for strict medical reasons by the treating physician with clear documentation and notification to the sponsor.
Eccentric Exercise Training as Novel Rehabilitation for Chronic Obstructive Pulmonary Disease (COPD)

The main purpose of this project is to establish the additional value of eccentric versus concentric exercise to optimize muscle function in patients with severe COPD. With this pilot project the investigators expect that an eccentric endurance training protocol adapted to severe COPD patients will lead to gains in muscle strength, the primary outcome, and cellular adaptation (muscle morphology and oxidative capacity, mitochondrial respiratory capacity) when compared to a concentric training approach.

This information will be essential if the investigators want to design and power a randomized clinical trial that will allow assessing effectiveness of this novel rehabilitation approach.

Chronic obstructive pulmonary disease (COPD) is a major respiratory illness that is both preventable and treatable. Dyspnea is the most important symptom that COPD patients experience and this can have a major impact on their daily live. While COPD is characterized by a spectrum of disease severity, most patients experience poor exercise intolerance attributable to ventilatory limitation as well as peripheral muscle fatigue, ultimately leading to severe disability.

Endurance exercise is an important component of pulmonary rehabilitation and is aimed at preventing this decline in functional capacity. The effects of pulmonary rehabilitation are largely attributable to the exercise training component involving concentric muscle contractions, traditionally trough dynamic, large muscle exercise on a cycle ergometer or treadmill. However, many patients are unable to partake and benefit from such rehabilitation because of locomotor muscle weakness and severe ventilatory limitation that prevent them from exercising at intensities sufficient to provoke improvements in cardioventilatory and skeletal muscle function. Eccentric exercise is known for its unique physiologically fundamental characteristics: the lower metabolic demand for a same power output and greater muscle gains compared to the concentric exercise. For this reason, eccentric endurance training has been proposed as a novel adjunctive rehabilitative countermeasure for certain chronic diseases (such as coronary disease and COPD) and can play an important role for patients with advanced disease.

Eligibility Criteria:
Inclusion Criteria:

* male patients with severe COPD (FEV1/FVC \< 0.70 and FEV1 ≤ 50% predicted of normal)
* Patients aged 40 to 80 years old in whom exercise is not contraindicated
* Current and ex-smokers
* Patients who do not require oxygen therapy

Exclusion Criteria:

* Patients presenting neurological or orthopedic problems, morbid obesity, acute medical condition or recent exacerbations (in the last four weeks)
* Patients with recent or current participation in a rehabilitation program
Fructose in Exercising Individuals With Type 1 Diabetes Using Insulin Degludec

To determine and compare the time-to-hypoglycaemia (defined as plasma glucose \<3.9mmol/L) in individuals with type 1 diabetes treated with ultra-Long acting insulin degludec during aerobic exercise with or without prior ingestion of a single oral fructose load.

Glycaemic control remains complex and demanding during exercise for type 1 diabetes (T1D) patients. Traditional treatment guidelines for exercise emphasizing the reduction of insulin doses and/or ingestion of additional carbohydrates are of limited applicability for patients treated with ultra-long acting basal insulin analogues. Dose reductions may require two to three days for modern basal insulin analogues in order to achieve an adapted steady state, hereby increasing the risk of inadequate insulin-following exercise. If T1D patients engage in recreational exercise - as recommended by every international treatment guideline - current treatment strategies may simply not be sufficient.

As a consequence for patients treated with modern basal insulin analogues, it seems more adequate not to modify insulin doses but to apply alternative strategies for recreational exercise. The ingestion of fructose, an insulin-independent carbohydrate, which increases lipid oxidation but attenuates the dependency on carbohydrates may offer a novel strategy. Up to date, only preliminary data for fructose have been produced regarding clinical effectiveness and underlying mechanisms in the prevention of hypoglycaemia. The present comprehensive study aims to investigate the clinical efficacy, feasibility, and safety of a pre-exercise oral fructose load without modification of insulin degludec in T1D patients.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes as defined by the World Health Organization (WHO) for at least 1 year or confirmed negative C-peptide (\<100pmol/l with concomitant blood glucose \>4 mmol/l)
* Male subjects aged between 18-45 years
* HbA1c \<8.0% (64mmol/mol) based on analysis from the central laboratory unit of the University Hospital Bern.
* Basal/Bolus-insulin regimen with insulin degludec for at least 3 months, with good knowledge of insulin self-management
* Regular physical activity (at least 30 min of moderate exercise 3 times weekly)
* Written informed consent

Exclusion Criteria:

* Relevant diabetic complications as judged by the investigator
* Total daily insulin dose \>2 IU/kg/day
* Hypoglycaemia unawareness (Gold score \> 4) or any episode of severe hypoglycaemia as defined by the American Diabetes Association within the last 6 months
* Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
* Current treatment with drugs known to interfere with metabolism, e.g. systemic corticosteroids, statins etc.
* Known fructose-intolerance or malabsorption
* Known allergy to one of the study drugs
A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer

This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK104 combined chemotherapy versus Tislelizumab combined chemotherapy in first-line treatment of Locally advanced or metastatic NSCLC with PD-L1 TPS \< 1%.


Eligibility Criteria:
Inclusion Criteria:

1. The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.
2. Aged ≥18 years when the subject signed the informed consent.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy ≥ 3 months.
5. Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) that not amenable to complete surgical resection and not amenable to radical concurrent/sequential chemoradiation or metastatic (Stage IV) NSCLC (American Joint Committee on Cancer \[AJCC\] 8th edition).
6. No prior systemic therapy for advanced or metastatic NSCLC was received.
7. PD-L1 TPS \< 1%.
8. No EGFR sensitive mutations or ALK gene translocation alterations.

Exclusion Criteria:

1. Histologically confirmed small cell lung cancer (SCLC).
2. NSCLC with driver gene mutations for approved targeted drug indications.
3. Active central nervous system (CNS) metastases were present.
4. Pulmonary radiation therapy \> 30 Gy within 6 months prior to first dose.
5. Active malignant tumors within the past 5 years, except for tumors in this study and scured local tumors.
6. Pregnant or lactating women.
7. Clinically significant cardiovascular or cerebrovascular disease.
8. Subjects with a known history of severe hypersensitivity to other monoclonal antibodies. A known history of allergy or hypersensitivity to all investigational drugs or any of their components.
9. Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment, or autoimmune diseases that may relapse or require scheduled treatment as judged by the Investigator.
10. Known active pulmonary tuberculosis.
11. Patients with active hepatitis B or active hepatitis C.
12. Known medical history of immunodeficiency or positive HIV test.
Stem Cell Therapy for Amyotrophic Lateral Sclerosis

The effect of autologous bone marrow mononuclear cells on duration of survival in Amyotrophic Lateral Sclerosis patients.

Survival duration in Amyotrophic Lateral Sclerosis patients who received cellular transplantation was compared to patients who did not receive cellular transplantation. Kaplan-Meier survival analysis was used for this comparison.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnoses of definite amyotrophic lateral sclerosis.
* Clear information about date of onset of symptoms, documented contact information and follow up information

Exclusion Criteria:

* Patients with diagnoses of Progressive Lateral sclerosis, Progressive bulbar plasy, Progressive spinal muscular atrophy, Progressive muscular atrophy, monomelicamyotrophy or madras motor neuron disease.
* patients with co-morbidities like presence of acute infections such as Human Immunodeficiency Virus/Hepatitis B Virus/Hepatitis C Virus, malignancies, bleeding tendencies, renal failure, severe liver dysfunction and other acute medical conditions such as respiratory infection and pyrexia.