cyrilzakka/clinical-trials huggingface dataset:
Effects of Pilates and Burpees Exercises in Core Strengthening and Dynamic Balance.

This study will be a randomized clinical trial will be conducted in Ayub national park cricket club Sample size will be 48 to evaluate the effects of Pilates and Burpees exercises training among cricket players with an age range of 16-24 years. Non probability convenient sampling technique would be used. Participants will be randomly assigned to 2 groups. Group A will include participants who received Pilates exercises training (6 weeks) along with the warm up. Group B participant who will receive burpees exercise training (6 weeks) and warm up. Outcomes of both trainings are the effects on core strengthening and dynamic balance on players in A group and the B group. Post interventional assessment was done via Star excursion balance test, prone bridge test and 1 minute sit-up test. Data will be collected at baseline and 6 weeks. Data will be analyzed by SPSS version 25

Cricket is a most popular sport played throughout the world. It is played in three common formats depending on the duration of the game, firstly a Test match is played over 4-5 day's with around 90 overs per day Secondly One day match is shorter with 50 over on each side and the Last one is T-Twenty match much shorter with 20 over on each side. As each format places different physical demands on the players the require an extensive combination of tactics, skills and physical fitness in the form of strength, flexibility and balance. In our study we can focus on the basic core strengthening which is essential for physical fitness and better performance in the game. Primary the aim of this study is to evaluate the comparative effects of Pilates and Burpees exercises of core strengthening and dynamic stability of body in young cricket players

Eligibility Criteria:
Inclusion Criteria:

* Partipant should be a cricket player.
* Individual with age group of 16-24 years.
* Only male players without any history of fracture

Exclusion Criteria:

* Player who recieved any type of physical therapy session during last 2 months.
* Any type of soft tissue injury reported.
* Any type of deformity.
* Past history of surgical procedures.
Effects of Phosphate Binding With Sevelamer in Stage 3 Chronic Kidney Disease

The purpose of this study is to determine whether lowering phosphate in patients with early chronic kidney disease with the phosphate binder sevelamer has beneficial effects on cardiovascular structure and function.


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease patients aged 18 to 80 years
* Chronic kidney disease stage 3 (defined as a glomerular filtration rate of 30-60 ml/min/1.73m2)
* Office blood pressure controlled to less than 140/90 mmHg for 12 months before entry into the study
* Total cholesterol less than 5.5 mmol/l

Exclusion Criteria:

* Existing or previous treatment within 1 year with a phosphate binder or vitamin D analogue
* Uncontrolled hyperphosphataemia (serum phosphate \>1.8 mmol/l)
* Uncontrolled secondary hyperparathyroidism (PTH \>80 pg/ml)
* Diabetes mellitus
* Pregnancy
* Moderate-severe cardiac valvular disease
Laparoscopic Cholecystectomy vs Hybrid Natural Orifice Translumenal Surgery

The purpose of the study is to determine the feasibility of cholecystectomy made by a transvaginal approach with a NOTES procedure (natural orifice translumenal endoscopic surgery).

Natural orifice transluminal endoscopic surgery (NOTES) makes it possible to perform intraperitoneal surgical procedures with a minimal number of access points in the abdominal wall. At the present time these procedures are hybrids. It is expected a better cosmetic result and lower incidence in parietal complications in front of laparoscopic cholecystectomy, but is necessary to investigate that these benefits should not be associated with complications of the new access to abdominal cavity.

Methods. Prospective randomized clinical series of 60 female patients with gallstones that underwent endoscopic surgery, 20 of them operated with conventional laparoscopic approach, 20 by transumbilical endoscopic approach and 20 of them by transvaginal endoscopic approach. Variables as surgical wound infection, urinary tract infection, evisceration, hernia, mortality and other complications will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 and under 65
* symptomatic cholelithiasis with an indication for performing laparoscopic surgery
* absence of any gynecological condition that could complicate the procedure (pelvic inflammatory disease or endometriosis)
* perforated hymen
* agreement on the patient's part not to use the vagina for two weeks after the surgery
* signed specific informed consent upon providing specific information about the new surgical approach.

Exclusion Criteria:

* age under 18 or over 65
* unperforated hymen
* presence of illness or condition with an increased risk of pelvic damage with transvaginal approach.
A Single-cell Approach to Identify Biomarkers of Pulmonary Toxicity for Immune Checkpoint Blockade

The main goal of this prospective non-interventional exploratory monocentric study is to characterize the immune cell composition of bronchoalveolar lavage (BAL) fluid from cancer patients experiencing cancer therapy-induced pneumonitis on a single-cell scale. These mechanistic insights can directly lead to putative diagnostic biomarkers and therapeutic targets.

A second highly clinically relevant hypothesis is that single-cell profiling of blood samples will reveal circulating biomarkers of ICB toxicity, making non-invasive diagnosis feasible.

The investigators will apply single cell RNA- and TCR-sequencing on up to 5,000 single cells per sample. Additionally, cell surface protein expression can be integrated with the transcriptional information. Various bioinformatics pipelines, including Seurat, will be used to identify different cell clusters, which through marker gene expression will be assigned to known cell types, cellular subtypes or phenotypes. For instance, this will make it possible to monitor the abundance of PD-1/PD-L1 expressing T-cells, cytotoxic T-cells, immune-suppressive myeloid cells etc. The following parameters at single-cell level will be relevant, amongst others:

* The composition and relative abundancies of established immune cell types (e.g. T cells (CD4+, CD8+ and regulatory subsets), NK cells, B cells, MDSCs, macrophages, neutrophils, dendritic cells). Transcriptomic data for each of these immune cell subtypes will be analyzed, allowing characterization of specific gene expression programs that define specific phenotypic states.
* Composition of all stromal cellular subtypes identified by single-cell transcriptomics.
* A gene regulatory network for each cell type and cellular subtype (or cell state) will be established and master transcriptional regulators will be identified. Individual T-cells and T-cell subclusters will be classified based on interferon activation, high rates of proliferation and transcription and increased granzyme expression, which are all indicative of T-cell activation.

Blood samples will be subjected to similar single-cell experimental procedures. First, peripheral blood mononuclear cells (PBMC) are isolated using Ficoll density gradient centrifugation. Single-cell transcriptome analysis in combination with CITE-seq will be performed on 5000 PBMC. Cellular composition will be determined using the same bioinformatic pipelines as used for processing the BAL fluid cells.

Eligibility Criteria:
Inclusion criteria:

* Adult M/F/X (\>= 18 years)
* Patients receiving or having received treatment per guidelines
* Patients undergoing bronchoscopy with BAL, for possible cancer treatment-induced pneumonitis
* Not included in other clinical trials
* Signed informed consent form

Exclusion criteria:

• Collected material not suitable for further processing in this study (e.g. bad quality). This decision will be made in consultation with a lab technician and/or bio-informatician, specialized in single-cell analysis.
Comparison of Postoperative Quality of Recovery by Anesthetic Method in Patients Undergoing Shoulder Arthroscopy

The aim of this study is to compare the quality of recovery in patients undergoing arthroscopic shoulder surgery depending on the type of anesthesia used:

1. general anesthesia with preoperative brachial plexus block for intra- and postoperative analgesia
2. regional anesthesia (brachial plexus block) with intraoperative sedation.


Eligibility Criteria:
Inclusion Criteria:

* Patients of age 19 years and above, scheduled for shoulder arthroscopic surgery

Exclusion Criteria:

* emergency operation
* inflammation or infection at the site of nerve block administration
* inability to perform the quality of recovery questionnaire due to dementia or delirium
* severe lung disease (e.g. chronic obstructive pulmonary disease or interstitial lung disease)
* contraindication to brachial plexus block
* history of hypersensitivity or side effect to ropivacaine
Myofascial Massage in the Treatment of Chronic Low Back Pain

The purpose of the study is to determine the effectiveness of an approach that combines massage therapy with elements of neurocognitive rehabilitation such as motor imagery and the words of the physiotherapist compared to a traditional massage therapy in reducing pain in patients with chronic low back pain (CLBP) and to evaluate if and how the pain reduction is linked to the interoceptive awareness and which is the patient's ability to relax through the measurement of the hearth rate variability (HRV).


Eligibility Criteria:
Inclusion Criteria:

* Presence of chronic nonspecific low back pain for at least three months
* Subjects aged between 18 and 50 years

Exclusion Criteria:

* Presence of acute low back pain
* Low back pain due to other causes (vertebral fractures, spondylolisthesis, herniated discs, lumbar canal stenosis)
* Disorders of central and/or peripheral nervous system
* Systemic inflammatory disease (eg rheumatoid arthritis)
* Systemic infectious disease
* Neoplastic disease
* Previous Surgery
* Cognitive impairment
* Pregnancy
Screening for Amyloidosis Before Aortic Valve Elective Replacement

Previous studies detected that up to 15% of patients undergoing aortic valve replacement (AVR) for degenerative aortic stenosis have concomitant transthyretin amyloidosis (ATTR) cardiomyopathy (Castano, 2017). The aim of this study is to investigate the effectivity and practicability of a systematic ATTR-Screening in patients undergoing planned AVR. Moreover, we plan to develop a screening algorithm to detect ATTR in aortic stenosis (AS).

Untreated cardiac amyloidosis is accompanied with an impaired prognosis. Amyloidosis is often associated with ventricular hypertrophy which leads to severe heart failure and occurs frequently in conjunction with bradycardic or tachycardic malignant arrhythmia. Patients with degenerative aortic valve stenosis suffer more frequently from cardiac ATTR. However, it remains unclear whether the development of aortic stenosis is promoted by ATTR. Due to very similar symptoms (shortness of breath during physical exertion, reduced walking distance) diagnosis of aortic valve stenosis is more often diagnosed in a typical cohort of patients aged between 70-80 years but, in contrast, leads to underdiagnosis of patients with additional cardiac amyloidosis. Six to fifteen percent of patients with aortic valve replacement due to degenerative aortic valve stenosis exhibit a cardiac amyloidosis. Since cardiac amyloidosis without therapeutic intervention is associated with significantly reduced life expectancy, it can be assumed that these patients will not benefit to the same extent from the AVR alone as patients without ATTR. New therapeutic approaches for patients exhibiting ATTR lead to a reduction of mortality and hospitalizations. The primary aim of this study is to establish a simple ATTR screening tool in patients with planned AVR in the clinical routine and, furthermore, to compare the clinical course following AVR between patients with and without ATTR.

Eligibility Criteria:
Inclusion Criteria:

* age ≥40 years
* written informed consent from the patient or of his/her legal guardian
* hospitalization for AVR due to degenerative aortic valve stenosis

Exclusion Criteria:

* hemodynamically unstable patient
* severe co-morbidities with an estimated life expectancy of \<1 year
Effect of Lifestyle Changes on Erectile Dysfunction in Obese Men: a Randomized Controlled Trial

Healthy lifestyle factors are associated with maintenance of erectile function in men. To determine the effect of weight loss and increased physical activity on erectile and endothelial functions in obese men.

Randomized, single-blind trial of 110 obese men without diabetes, hypertension, or hyperlipidemia, who had erectile dysfunction that was determined by having a score of 21 or less on the International Index of Erectile Function (IIEF).

The 55 men randomly assigned to the intervention group received detailed advice about how to achieve a loss of 10% or more in their total body weight by reducing caloric intake and increasing their level of physical activity. Men in the control group (n = 55) were given general information about healthy food choices and exercise.


Eligibility Criteria:
Inclusion Criteria:

* Obese, sedentary (\<1 hour per week of physical activity) men with erectile dysfunction (a IIEF score lower than 22)and no evidence of participation in diet reduction programs within the last 6 months

Exclusion Criteria:

* Diabetes mellitus or impaired glucose tolerance (plasma glucose levels of 140-200 mg/dL \[7.8-11.1 mmol/L\] 2 hours after a 75-g oral glucose load)
* Impaired renal function, including macroalbuminuria, pelvic trauma, prostatic disease, peripheral or autonomic neuropathy
* Hypertension (blood pressure \>140/90 mm Hg)
* Cardiovascular disease
* Psychiatric problems
* Use of drugs or alcohol abuse (500 g of alcohol per week in the last year).
Ultrasound in Diagnosing Patients With Skin Lesions

This trial studies the use of a novel non-invasive ultrasound technique in diagnosing patents with skin lesions. Diagnostic procedures, such as ultrasound, may be a less invasive way to check skin lesions for skin cancer and other skin disorders.

PRIMARY OBJECTIVES:

I. Characterize a wide variety of lesions including but limited to:

I a. Malignant lesions: basal cell cancers, squamous cell cancers, Merkel cell cancer, melanoma, etc.

I b. Non-malignant lesions: keloids, surgical scars, actinic keratosis, benign and dysplastic nevi, cysts, lipoma.

I c. Inflammatory conditions: psoriasis, eczema, alopecia, acne, wounds, etc). I d. Determine if ultrasound can be used to more effectively/accurately administer treatment (injections, surgical procedures, etc).

II. Characterize pre and post treatment changes in the lesion as well as the surrounding normal tissue stroma (examples, but not limited to: changes to hair follicles, epidermis, dermis, subcutaneous tissue, erector pillae muscles, vessels, nerves, etc).

III. Correlate ultrasonographic findings with histological findings for lesions that would have been removed surgically and/or are biopsied (examples, but not limited to: removal of a skin cancer where ultrasound is used to characterize peripheral extent of the lesion as well as depth of penetration, a benign versus malignant lesion, pigmented versus \[vs\] non-pigmented lesion, etc).

IV. Determine if ultrasound can be used to monitor acute and late toxicity. V. See if ultrasound can also image sentinel lymph nodes that may potentially contain cancer.

OUTLINE: Patients are assigned to 1 of 3 cohorts.

COHORT I: Patients with skin lesions undergo at least 1 ultrasound during the consultation. Patients may undergo at most 2 additional scans after the standard of care approach for non-malignant lesions at the discretion of the radiation oncologist and/or dermatologist.

COHORT II: Skin cancer patients who undergo surgery or radiation undergo 2-5 ultrasounds over a 1 year period (a baseline ultrasound scan may be performed prior to treatment, followed by 1 scan during and/or after radiation, and additional ultrasounds may be conducted \[at the discretion of the treating physician\] upon completion of radiation and/or surgery, at approximately 1, 6, and 12 month follow-up examinations).

COHORT III: Participants with inflammatory skin disorders (psoriasis, eczema, alopecia, acne) undergo ultrasound at baseline and follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Candidate with skin lesions.
* Signed study-specific informed consent prior to study entry.

Exclusion Criteria:

* Prior surgery or radiotherapy to the area to be treated.
NDT on Fall Risk in Cerebral Palsied Children

Children with spastic cerebral palsy experience falls due to weakness in balance skills and abnormalities in gait parameters. It is necessary to improve the quality of life of these children by reducing the frequency of falling. Aim of this study was to investigate the effect of Neurodevelopmental Treatment on the risk of falling and balance and to contribute to the literature on this subject. Cases were randomized into study and control groups. At the beginning of the study, the balance skills of all the cases with spastic cerebral palsy were measured with the Pediatric Balance Scale, and the gait parameters and fall risks were measured with the LEGSys Temporospatial Gait Analysis Device. Then, an 8-week, case-specific, neurodevelopmental therapy program with intensive gait and balance training was applied to the study group in a 45-minute single session, 2 days a week. The control group received 8 weeks of conventional physiotherapy. At the end of the treatment process, the evaluations were repeated with the same methods.


Eligibility Criteria:
Inclusion Criteria:

* Cerebral Palsy diagnosis
* Spastic type
* Gross Motor Function Classification System Level I and II

Exclusion Criteria:

* Tendon release surgery or Botox application in the last 6 months
The Effects of Angel Sounds and Guided Imagery Technique Played to Expectant Couples

The study sample consisted of 177 pregnant women and their partners who met the inclusion criteria and participated in a prenatal education class. Expectant couples were randomized into three groups: Group 1 (FHS) listened to fetal heartbeat sounds, Group 2 (GIT) received the guided imagery intervention, and Group 3 served as the control group. Each group consisted of 59 couples.

Aim: This randomized controlled trial aimed to evaluate the effects of listening to angel sounds (fetal heartbeat) and applying the guided imagery technique on prenatal attachment, anxiety, and sleep quality among expectant couples.

Methods: The study included 177 pregnant women and their partners who attended a prenatal education class and met the inclusion criteria. Expectant couples were randomly assigned into three equal groups. In Group 1 (FHS), only fetal heartbeat sounds were listened to. In Group 2 (GIT), the guided imagery technique was applied. Group 3 served as the control group. Each group consisted of 59 couples.

Eligibility Criteria:
Inclusion Criteria:

* Having basic literacy skills,
* Owning a smartphone and having internet access,
* Having a singleton and viable pregnancy,
* Being between the 27th and 38th weeks of gestation,
* Not having any diagnosed pregnancy-related risks (e.g., preeclampsia, diabetes, placenta previa, oligohydramnios),
* Not having any diagnosed fetal health issues (e.g., fetal anomalies, intrauterine growth restriction),
* Pregnant individuals and their spouses with no current or prior psychiatric diagnoses.

Exclusion Criteria:

* Not living with their spouse,
* Spouse working in shifts,
* Pregnancy via assisted reproductive techniques,
* Currently participating in childbirth education programs,
* Presence of communication difficulties or cognitive impairments in either the pregnant individual or the spouse.

Withdrawal Criteria:

* Participated in the intervention for fewer than 3 nights,
* Unable to use the Fetal Heart Rate Monitoring Device (FHRMD),
* Experiencing premature birth or pregnancy loss,
* Incomplete questionnaire data,
* Voluntary withdrawal from the study by the participant or their spouse. -
MRI Staging in Colon Cancer

The main purpose of this study is to investigate whether magnetic ressonance imaging (MRI) can be used in treatment planning with assessment of diagnostic accuracy. With the inclusion of 150 patients the study will investigate whether MRI is useful and better than CT scanning in patients with colon tumors. And also if MRI is useful after neoadjuvant treatment.

Colon cancer is a frequent disease in Denmark with over 3200 new cases and about 1350 deaths per year.

CT scanning is currently the national standard method for determining the stage of disease planning for treatment. CT scan can sufficiently distinct between minor and advanced colon tumors. Prevalence of advanced tumors was well over 40% in the CT study from Vejle Hospital in 2013. Sensitivity and specificity of detection of advanced colon tumors in the CT study was approx. 70% and 80%, respectively. A small MRI pilot study showed higher sensitivity and specificity of 89% and 96%, respectively.

MRI scan is currently performed in most patients with rectal cancer, which has resulted in better treatment planning and increased survival. MRI scan of the rectum is documented with higher accuracy than CT scan. There has been reluctance to introduce MRI scan in patients with colon cancer, as the colon has more peristalsis than the rectum, and movement of the bowel can result in image quality reduction in MRI. However, in recent years MRI has become faster and thereby less sensitive to movements.

MRI scanning may in the future help to select the patients who will benefit from neoadjuvant treatment. In addition, with MRI it is possible to perform MRI diffusion measurements of the tumor, which gives an estimate of the tumor's cell density. It will also be possible to investigate whether this changes the MRI diffusion restriction during the neoadjuvant treatment.

This study is prospective and uses state of the art equipment with a 3 tesla MRI unit.

The main purpose of the study is to investigate whether MRI can be used in treatment planning with assessment of diagnostic accuracy. With the inclusion of 150 patients the study investigates whether MRI is useful and better than CT in patients with colon tumors. And also if MRI is useful after neoadjuvant treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with colon cancer
* 18 years old or older
* Written and verbally informed consent

Exclusion Criteria:

* Pacemakers, implanted medical pumps, and nerve stimulators
* Cochlea implants and cerebral aneurism clips will in some cases be absolute contraindications to MRI examinations.
* Previous treatment with radiation and or chemotherapy
* Serious disease that contraindicates surgical treatment, including severe heart disease
* Any type of cancer other than of the colon (excluding skin cancer, cancer in situ, endometrial cancer, malignant melanoma)
* Any other condition or disease that from the investigator's point of view makes it inappropriate for the patient to participate.