cyrilzakka/clinical-trials huggingface dataset:
Dexmeditomedine as an Adjuvant to Levobupivacaine in Transversus Thoracis Plane Block on the Management of Post-sternotomy Pain in Open-heart Surgeries

the study is to assess the efficacy of dexmeditomedine as an adjuvant to the local anaesthetic levobupivacaine in transversus thoracis plane block given bilaterally on the management of post-sternotomy pain.

the patients will fall into one of two groups using an online randomizer. this study is an assessor-blinded interventional controlled study. the first group will recieve transversus thoracis plane block bilaterally where 15 ml of 0.25% levobupivacaine will be given. and the other group shall also undergo a bilateral transversus thoracis plane block with 15 ml 0.25% levobupivacaine and 0.05 ug/kg dexmeditomedine on each side. the primary aim of the study is the 24 hour post-operative morphine consumption.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients \> 20 years old.
* ASA II to III patients undergoing elective cardiac surgery via a median sternotomy

Exclusion Criteria:

* Patient's refusal.
* Known contraindications to regional blocks, including local skin infections,and coagulopathy.
* Allergies to the local anaesthetics used.
* Patients undergoing complex cardiac procedures.
* Patients with severe chronic obstructive pulmonary disease.
* Patients unable to communicate.
* Patients with chronic pain.
* Patients with severe pulmonary hypertension.
Spices for Cultivating a Healthy Gut Microbiome and Cardiometabolic Profile

Among food products receiving attention for prebiotic functionality, spices represent a flavorful vehicle for cultivating a healthy gut microbiota. As the required doses of spice-derived polyphenols to elicit prebiotic and systemic metabolic effects are not well-characterized, additional research is warranted. Thus, the investigators propose to use a food-first synbiotic (prebiotic + probiotic) approach to examine alterations in the gut microbiota pre- and post-intervention/placebo and their relationship with systemic cardiometabolic effects mediated by short chain fatty acids (SCFA) and gut-derived metabolites.

Study will be conducted as a single blind, randomized crossover design with a 4-week arm (placebo or control) followed by a 2-week washout period and another 4-week arm (placebo or control).

Eligibility Criteria:
Inclusion Criteria:

* post-menopausal women ages 50-69y with a BMI of 18.5 - 34.9 kg/m2

Exclusion Criteria:

* Dx - Diagnosis of cardiovascular disease, type 1 or 2 diabetes, liver disease, cancer, endocrine disorders, or inflammatory condition such as rheumatoid arthritis.
* GI - History of gastrointestinal surgery, irritable bowel syndrome, intestinal bowel disease, or other gastrointestinal distress such as chronic diarrhea, bulimia, anorexia, or frequent laxative use
* Rx or Supplements - Actively taking steroids or antibiotics in the previous two to three months, or currently using tobacco products, \> 10% weight loss or gain in the last 6 months, unwilling to stop taking prebiotic/probiotic or fiber supplements
* Dietary - Adherence to a high fiber/polyphenol rich diet, have an allergy, aversion, or intolerance to food and spices provided in this study
Arthralgia During Anastrozole Therapy for Breast Cancer

The purpose of this study is to describe the joint symptoms and structural joint changes under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Post menopausal woman with a breast cancer and scheduled for an adjuvant treatment with anastrozole
* WHO performance status 0, 1 or 2
* Provision of written informed consent

Exclusion Criteria:

* Recurrence of breast cancer, inflammatory rheumatism
* treatment by chondromodulator, oral glucocorticoid, aromatase inhibitor, anti estrogen, Herceptin
* Diabetes treated by insulin
* Severe renal or hepatic disease
* Known hypersensitivity to anastrozole
Low and Moderete Flow Anaesthesia on Haemodynamics

The study topic investigates the potential advantages of low-flow anesthesia in terms of physiological protection and resource saving.

The study aims to compare the effects of low and normal flow sevoflurane anesthesia on the frontal QRS-T angle and cerebral oxygenation in laparoscopic cholecystectomy surgery. The primary objective was to evaluate the effects of low-flow anesthesia on hemodynamic stability and arrhythmia risk; the secondary objective was to compare the total sevoflurane consumption in both methods.

Eligibility Criteria:
Inclusion Criteria:

* being ASA1-2 status
* between the ages of 18-70
* who are planned for laparoscopic cholecystectomy

Exclusion Criteria:

* Patients who refuse to give informed consent
* Pregnant and breastfeeding patients
* Morbidly obese patients (Body mass index over 40)
* Patients with uncontrolled diabetes mellitus, with serious cardiovascular, pulmonary, renal, hepatic disease, obstructive sleep apnea, with electrolyte imbalance- Those with a history of alcohol or drug abuse, with perioperative hemodynamic instability
* Patients using drugs known to prolong myocardial repolarization
* inability to increase SPO2 above 95 despite necessary intervention
Effects of Bilateral Versus Unilateral Lower Limb Training on Balance and Gait Parameters in Stroke Patients

To determine the effects of bilateral versus unilateral lower limb training on balance and gait parameters in stroke patients

The aim of this study is to compare the effects of bilateral versus unilateral lower limb training on balance and gait parameters in stroke patients. The randomized controlled trial will recruit the stroke patients will be selected and randomly divided into two groups: Group A (unilateral training group (UTG)) and Group B (bilateral training group (BTG)).

Patients in Group A will undergo approach-oriented training using the motor relearning program (MRP) and proprioceptive neuromuscular facilitation (PNF) for the affected side, while those in Group B underwent strength training for the lower-limb muscles using Delorme's principle for the unaffected side and approach-oriented training using the MRP and PNF for the affected side for a period of six weeks, five days per week. A strengthening regimen will designed for the unaffected side, considering the frequency, intensity, time, and type (FITTs) principle provided by the American College of Sports Medicine (ACSM). The static and dynamic balance along with gait parameters will measure using the functional reach test (FRT), one-leg stance test (OLST), Berg balance scale (BBS) Dynamic Gait Index (DGI), gait parameters (stride length, gait velocity, and cadence), and Brunnstrom recovery stages (BRS) at the baseline and post rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Medically stable patients (the diagnosis was made by neurologist).
* Cognitive level is greater than 25 on MMSE.
* Chronic stroke Patients (ischemic and hemorrhagic) (6 months to 2 years).

Exclusion Criteria:

* Transient ischemic attack.
* Patients with other neurological condition, orthopedic problems, and uncontrolled metabolic disease.
* Severe hearing and visual loss.
* Uncontrolled arterial hypertension.
* Recurrent Stroke.
* Patient diagnosed with brainstem stroke and middle cerebral artery stroke.
* Patient with any cardiovascular unstable condition.
Influence of Diabetes Control on Treatment of Diabetic Macular Edema With Ranibizumab

The aim of the prospective randomized study is to investigate whether a intensified diabetic control program leads to better final visual acuity and less frequent diabetic ocular complications in patients with diabetic retinopathy when compared with a normal diabetic treatment.

Patients with diabetic macular edema (DME) will be treated with intravitreal ranibizumab injections and the effect of optimal control of internal factors (eg. glycemia, blood pressure etc) on final functional (best corrected visual acuity-CBVA) and morphological (central retinal thickness-CRT) will be investigated. Patients will be randomized into two groups: Group with intensified diabetic control will be follow and investigated monthly at department of diabetology, endocrinology and nutritional medicine (Campus Benjamin Franklin) in Berlin with aim to reach the optimal glycemic control defined as HbA1c \< 6,5%. Further, triglycerides values \< 140 mg/dl and blood pressure \< 140/90 mmHg will be pursued. Second group of patients will be followed by their general practitioner and in the study center only blood samples will be taken quarterly without active medical intervention.

BCVA, CRT and the number of required ranibizumab injections will we evaluated and compared between both study groups.

Eligibility Criteria:
Inclusion Criteria:

- Patients with diabetic macular edema relevant to visual acuity

* OCT central retinal thickness ≥ 250µm
* HbA1c \> 6,5% at initial visit
* BCVA ≤0.8 and ≥0.05
* Age ≥18 years
* Written patient informed consent given

Exclusion Criteria:

* Previous treatment with intravitreal drugs in last 6 months
* Vitreous hemorrhage as a consequence of proliferative retinopathy
* Pregnancy
* Blood pressure of ≥ 180/100 (or uncontrolled pressures under pharmacological therapy)
* Chronic systemic or ocular inflammatory/autoimmune diseases (e.g. inflammatory bowel disease, Addison´s disease, Cushing Syndrome, Uveitis)
* Systemic cortisone or anti-VEGF therapy
* Acute systemic or ocular infectious diseases
New Foods Take Time, a Curriculum Designed to Promote Tasting and Liking of Fruits and Vegetables

The overall objective of this project is to conduct a preliminary evaluation of the "New Foods Take Time" Intervention in Head Start preschool classrooms.

The overall objective of this project is to conduct a preliminary evaluation of the "New Foods Take Time" Intervention. This curriculum is designed to increase children's preference for and consumption of fruits and vegetables (FV) by encouraging children to try new FV and repeatedly taste these foods.

Eligibility Criteria:
Child Inclusion Criteria:

* Enrolled in a Head Start preschool center
* Between the ages of 2 and 5 years old

Child Exclusion Criteria:

* Food allergy or restriction to foods in the tastings

Parent Inclusion Criteria:

* Parent or primary caregiver of a child enrolled in the study
* Age 18 years or older
* English speaking

Parent Exclusion Criteria:

* None

Teacher Inclusion Criteria:

* Actively employed as an early childhood education provider in the Head Start classroom where the intervention is delivered
* Age 18 years or older

Teacher Exclusion Criteria:

* None
Pain Relief After High Thoracic Eretor Spinae Block

The primary endpoint of this study was to identify if the ESPB in the patients of cervical radiculopathy has the effect of pain relief. The secondary endpoint of this study was to identify the spread level in the craniocaudal direction when performed at the T2 level.

The ESPB requires ultrasound guidance which enables visible local anesthetic spread underneath the erector spinae muscles. The spinalis, longissimus thoracis, and iliocostalis muscles comprise the ES muscles, which run vertically along both sides of the vertebral column from the sacrum up to the skull base (1,10). The ESPB can be performed in the cervical, thoracic, and lumbar regions. Among them, upper or mid thoracic ESPB has been used more widely compared to cervical and lumbar regions.

Previous cadaveric studies on the ESPB at the T5 level using computed tomography (CT) reconstruction or direct dissection demonstrated the extensive craniocaudal distribution of methylene blue ranging from T1 to T8 vertebral segments deep to the ES muscles and variable involvement of epidural, paravertebral, and intercostal spaces. The ESPB performed at the T2 level of the cadaver demonstrated an injected dye distribution ranging from C4 to T10. Also, 36% of cadavers showed the spread of an injected dye to the ventral, dorsal ramus, paravertebral space, and even the contralateral side.

The exact mechanism of action of ESPB remains unclear. A recent study suggested that the analgesic effect of ESPB could be obtained by blocking the ventral and dorsal ramus of the spinal nerves by passing through the costotransverse foramen. However, in clinical practice, we can encounter highly variable clinical outcomes or sensory block after the ESPB. The study of the physical spread of the injected agent can be used to predict the clinical result and elucidate the possible mechanism of action of ESPB.

Eligibility Criteria:
Inclusion Criteria:

* cervical facet joint arthrosis
* cervical foraminal stenosis
* cervical herniated intervertebral disc
* myofascial pain syndrome of upper back muscle

Exclusion Criteria:

* Allergy to local anesthetics or contrast medium
* pregnancy
* prior history of cervical spine surgery
* coagulation abnormality
Cognitive Behavioral Therapy for Adolescents With Bulimia

This pilot study will evaluate the effectiveness of individual cognitive behavioral therapy (CBT) and supportive psychotherapy (SP) in reducing bulimic symptoms among adolescents.

Patients will be randomized to have an equal chance of either receiving CBT or SP. Participants will include both individuals with DSM-IV bulimia nervosa (BN), and patients with sub-threshold BN. Adolescent patients will be treated at the New York State Psychiatric Institute, with a target recruitment of 20 patients completing the study. Participants in both conditions will be assessed prior to treatment and at the end of treatment. This trial is intended to serve as a pilot investigation to determine the feasibility and utility of a larger controlled study in this population.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 12 and 18
2. DSM-IV diagnosis of bulimia nervosa or sub-threshold bulimia nervosa (binge eating and/or purging at least once per week)

Exclusion Criteria:

1. Diagnosis of bipolar disorder
2. Current psychosis
3. Drug or alcohol abuse in the past 3 months
4. Acute Suicidal Risk
5. Major depression producing significant functional impairment
6. Significant medical illness
7. Weight outside of normal weight range (between 85% and 120% of the 50th percentile for age as measured by standard growth charts)
Screening and Secondary Prevention Rheumatic Heart Disease Study

After basic clinical screening including history and physical, Point of care ultrasound will be performed to look at Mitral, Aortic and Tricuspid Valves for regurgitation or stenosis. For patients with confirmed Rheumatic heart disease (RHD), treatment and referral depending on stage of disease. Antibiotic prescription could be shifted to community health workers delivering preventive medications via practical clinical algorithms, diagnostic tools, availability of appropriate antibiotics, and supportive supervision. Patients will have repeat imaging at 2 years and 5 years to look at the outcome of delayed progression of valve disease.

Screening for RHD should be carried out since it is a major health concern that has been shown to have a treatable and detectable latent stage that can be diagnosed using a simple sensitive test (point of care ultrasound) and early treatment (secondary prevention using antibiotic prophylaxis) can provide a better outcome (slow progression of disease) in a cost effective way. The investigators aim to study the Incidence and Prevalence of RHD in community and school settings and aim to intervene depending on the stage the disease is picked up in.

Eligibility Criteria:
Inclusion Criteria:

* Rural communities in Sindh

Exclusion Criteria:

* Refused to participate in the study
The Influence of 11+ on Injury Incidence and FMS-Score in Veteran Soccer Players

According to available data the injury rate in male veteran soccer is high. Interventions to prevent injuries are requested. The 11+ warm-up program was developed by FIFA-experts and consists of several exercises with an overall-length of about 20 min. This study shall investigate the influence of 11+ on injury incidence and Functional Movement Screen (FMS)-Score in male veteran soccer players. Additionally it is to be examined if there is a relationship between FMS-Score and injury incidence. For this purpose the 11+-program is accomplished under supervised conditions over one regular season in a randomized-controlled study design. Injuries are documented via questionnaires in accordance with the FIFA-consensus-statement. FMS-Score is evaluated before and after the interventional period.


Eligibility Criteria:
Inclusion Criteria:

* male veteran soccer players aged 32 and older, who are member of a club veteran team; training and matches on a regular basis

Exclusion Criteria:

* major time-loss injury, chronic inflammatory joint disease
Phase 1 Study of the Effect of Ketoconazole on the PK of Multiple Doses of Cediranib in Patients With Solid Tumours

Phase I, open study to assess the effect of ketoconazole, a marketed drug, on the way the body handles the experimental drug cediranib, in patients with advanced cancer.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Histological or cytological confirmation of advanced solid tumour (with the exception of prostate cancer), which is refractory to standard therapies or for which no standard therapy exists.
* Estimated life expectancy of at least 8 weeks
* WHO performance status (PS) 0-2.

Exclusion Criteria:

* Unstable brain/meningeal metastases
* Biochemistry/haematology results outside of required ranges
* History of significant GI impairment
* Inadequate bone marrow reserve
Mindfulness-based Social Cognition Training for Psychosis (SocialMind): A Feasibility Study

The current investigation has been designed to test the feasibility of a mindfulness-based social cognition training (SocialMind) for people with a first episode of psychosis (AGES-Mind Study, NCT03309475). The intervention has been designed by professionals with both formal training and clinical experience in the field of mindfulness and third generation cognitive-behavioral therapies. Main outcomes are recruitment rate, adverse events and treatment adherence, although therapy effects and adjustment to intervention manual are also explored.

Social functioning is impaired among many patients with a first episode of psychosis, who also show a lower ability to recognize, understand and benefit from social stimuli (i.e., deficits in social cognition) than their pairs. Both deficits underlie the general functional impairment found across non-affective psychotic syndromes. Since currently available pharmacological strategies have not proven themselves effective in addressing this matter, new psychotherapeutic approaches should be developed. This research team developed a mindfulness-based social cognition group training (SocialMind) designed for persons who have suffered a first episode of psychosis within five years prior to their enrollment in the study (AGES-Mind Study, NCT03309475). Although there is enough evidence to support the lack of adverse events derived for mindfulness-based interventions specifically designed for psychotic patients (Cramer et al., 2016), many clinicians express their concerns about the beneficial effects of these approaches. Therefore, and in keeping with international health organisms such as United Kingdom's National Health Service (NHS), this team have proposed a feasibility study. The main hypothesis is that the AGES-Mind study can be carried out in terms of achievement of recruitment rate, lack of adverse events and levels of treatment adherence. Secondary hypothesis states that clinicians will adhere to SocialMind manual. Finally, a positive effect of the intervention is expected, both in participants' satisfaction and in some relevant variables, such as functional outcomes, clinical global impression and social cognition.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old
* Diagnosis of psychotic disorder according to DSM-5 and history of more than five years of psychotic symptoms
* CGI-SCH equal or lower than four points ("moderately ill")
* Informed consent given

Exclusion Criteria:

* Intellectual disability plus impaired global functioning prior to disorder onset
* Generalized development disorder
* Substance related disorders (except for nicotine) according to DSM-5
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III

In this study, a known medicine called 'semaglutide' will be tested in two different tablet versions. The two tablets differ in the way these have been manufactured. The aim of the study is to investigate the amount of active ingredient in the blood after dosing the different tablet versions. Participants will receive one tablet version for 10 days (first treatment period) and the other version for 10 days (second treatment period). The treatment arm participants will be assigned to is decided by chance. The study will last for about 23 weeks for each participant. The study will enroll healthy male participants.


Eligibility Criteria:
Key inclusion criteria:

* Body mass index (BMI) between 22.0 and 31.9 kilograms per meter square (kg/m\^2) (both inclusive) at screening.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Key exclusion criteria:

* Known or suspected hypersensitivity to study intervention(s) or related products.
* Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen, within 14 days before screening.
The Effects Of Discharge Education Program On Recovery And Quality Of Life After Cardiac Surgery

This study aims to build a new discharge education, booklet and mobile application based, and assess it's efffects on recovery and quality of life in cardiac surgery patients. This is a randomised control trial. 12 weeks follow up will be done by phone calls.

Patients following cardiac surgery will be part of the study. Patients will be randomized in control and case groups. Control group receive standart discharge eduation from the nurses of the hospital, they will be interviewed by the researcher to gather general information and also information about recovery and quality of life. Case group will be given a discharge education by the researcher before discharge. After education patients will be given a booklet and a mobile application with the neccasary discharge information. Both groups will be followed for 12 weeks by monthly phone calls. In the last call recovery and quality of life will be reassesed.

Eligibility Criteria:
Inclusion Criteria:

* To agree to participate in the research,
* Open heart surgery patients
* Being 18 years or older,
* Being able to read, write, understand and communicate in Turkish,
* No vision, hearing and perception problems,
* Being conscious, oriented, cooperative and open to communication.

Exclusion Criteria:

• Having surgery other than open heart surgery