cyrilzakka/clinical-trials huggingface dataset:
Protein and Exercise for Postmenopausal Women's Wellbeing

The goal of this clinical trial is to learn if consuming a higher protein diet that includes one serving of beef each day, in combination with resistance exercise, improves wellbeing in postmenopausal women. It will also tell us about how higher protein intake changes body composition and blood values related to health. The main questions it aims to answer are:

* Does higher protein intake combined with resistance training improve mood and sleep in postmenopausal women?
* What other health benefits to postmenopausal women experience when the follow a higher protein diet and participate in resistance exercise?

Researchers will compare three groups 1) postmenopausal women living their daily lives as usual, 2) postmenopausal women consuming a higher protein diet, and 2) postmenopausal women consuming a higher protein diet and participating in resistance training.

Participants will:

* Consume a higher protein diet for 16 weeks
* Participate in an at-home resistance training for 16 weeks
* Keep a diary of their food intake, sleep habits, and mood
* Have health assessments every 4 weeks


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women aged 50 years and older (at least 12 months since last menstrual cycle)
* Participant in physical activity (e.g., 2-4 bouts of physical activity per week (i.e., activities such as brisk walking, yoga, hiking, cycling, gardening, etc.)) -Participants taking hormone replacement therapy (HRT; at least 6 months on HRT), statins, and antihypertensive medications will be allowed to participate.

Exclusion Criteria:

* Food allergies
* Dietary restrictions (e.g., vegan, vegetarian, lactose intolerance, etc.)
* Diet-related conditions that would prevent them from consuming a higher protein dietary intake (e.g., impaired liver function, kidney disease)
* Participants consuming more than 0.8 g protein/kg/body weight per day (determined by 24-hour dietary recall)
* Underweight (BMI \< 18.5)
* Taking nutritional supplements
* Currently smoking or vaping
* Use marijuana
* Drink more than 4 alcoholic beverages a week
* Take medications that may interfere with the primary outcomes of the dietary intervention (e.g., antidepressants, sleep medication, etc.)
* Sleep apnea
* Pittsburgh Sleep Quality Index (PSQI) global score \>5 via or sleep \> 7 hours a night
* Pre-existing health conditions (e.g., diabetes (type I or II), cancer, Parkinson's Disease, Multiple Sclerosis) or conditions that would prevent them from fully participating in all aspects of the study.
Continuous Monitoring of Blood Pressure in Spontaneous Intraparenchimal Cerebral Haemorrhage

Evaluation of blood pressure variability in the acute phase of intraparenchimal cerebral haemorrhage and its consequences to clinical outcome


Eligibility Criteria:
Inclusion Criteria:

* hospitalization only for spontaneous intraparenchimal cerebral haemorrhage
* age over 18 years

Exclusion Criteria:

* cerebral haemorrhage secondary to other causes
Effect of Hormonal Cahanges During Menstrual Cycle on Subcostal Transversus Abdominis Plane Block

Fascial plane blocks are traditionally considered regional anesthesia techniques, where a mixture of local anesthetic (LA) is injected into a plane between two fascial layers, with the aim of spreading along this anatomical plane to block the nerves lying within or passing through it . Various pathophysiological processes that alter the structure and characteristics of fasciae can affect the spread of the local anesthetic and the success of the block. Diabetes, hormonal changes, and cannabinoid use are among these factors. This study aims to investigate the effects of hormonal changes during the menstrual cycle on subcostal TAP block.

Female patients scheduled for laparoscopic cholecystectomy at Adıyaman University Training and Research Hospital, who have been informed about the study and have provided written consent to participate, will be included in the study. The patients who agree to participate will be divided into groups based on the phases of their menstrual cycles. After ensuring airway safety under general anesthesia, a bilateral TAP block using 20 cc of 0.25% bupivacaine with a subcostal approach under ultrasound guidance will be administered to both groups. The study aims to compare the hemodynamic values (arterial blood pressure, heart rate, peripheral oxygen saturation) during the perioperative period, the visual analog scale (VAS) scores postoperatively, and the Quality of Recovery-15 (QoR-15) scores at 24 hours postoperatively between the two groups. This will allow for the investigation of the effects of hormonal changes during the menstrual cycle on the efficacy and success of subcostal TAP blocks.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II, female, Laparoscopic cholecyctectomy, Subcostal TAP , 18-65 years old patient

Exclusion Criteria:

* ASA III-IV
* \<18 , \>65 years old patients
* menstrual disorders
Empirical Mode Decomposition in the Electroencephalogram

Bispectral index (BIS), a standard monitor for perioperative monitor of patient's conscious level, is a noninvasive medical technique for monitoring and recording the electrical activity of brain.

The electroencephalogram and BIS data have lots of information. Fourier transformation to decompose EEG was first applied on the EEG signaling until now. The disadvantages of Fourier transformation is hard to deal with physical signals, which was modulated by autonomic system and factors. The Hilbert-Huang transform (HHT) was proposed to decompose EEG signal into intrinsic mode functions (IMF) since 2004. HHT can obtain instantaneous frequency data and work well for data that is nonstationary and nonlinear. HHT have been applied for wild ranges, not only in the analysis of arrhythmia for medical and public health fields, but also in the earthquake detection and earth physics detection...etc.

The relationship between frontal EEG patterns and general anesthesia remain poorly understood. It can only say that the increase in frontal EEG power and shift power to lower frequencies during general anesthesia from publications. The investigators are going to compare the EEG signal between generations, try to find the difference in aging using empirical mode decomposition method.

Eligibility Criteria:
Inclusion Criteria:

1. 20-40y/o or over 60y/o
2. Scheduled for low risk general anesthesia
3. Suitable for surgery after interviewed by anesthesiologist

Exclusion Criteria:

1. Not suitable for general anesthesia
2. High risk patient
3. Allergic to the EEG sensor
Relationship Between Pressure and Flow Velocity on Coronary Physiology

Subjects are patients who are planned to do percutaneous coronary intervention for coronary stenosis in the left circumflex artery without other stenosis in the left ascending artery and the right coronary artery, or a patient with normal coronary artery. Immediately after coronary angiography or percutaneous coronary intervention, the investigators will evaluate for coronary hemodynamics by distribution of wave intensity which is calcurated by coronary pressure and flow velocity with Combowire in each coronary segment. Also, they will assess coronary morphology by View It in each coronary segment.

Combowire (Volcano Therapeutics Inc., CA, USA) is a 0.014 inch pressure/Doppler sensor-tipped-guidewire which can measure coronary pressure and flow velocity.

View It (Terumo Co., Japan) is a guide catheter with intravascular ultrasound which can measure coronary morphology such as vessel diamter.

Eligibility Criteria:
Inclusion Criteria:

* A patient who are planned to do percutaneous coronary intervention for stenosis in the left circumflex artery without any lesions in other coronary arteries
* Or a patient who is performed coronary angiography without significant stenosis lesion in 3-coronary vessel

Exclusion Criteria:

* A patient with coronary stenosis with LAD
* Hemodialysis
* Acute coronary syndrome
* Congestive heart failure
* A patient with shock vitals
Endotracheal Tube Intracuff Pressure and Leak

We have devised a simple method to continuously measure the endotracheal tube cuff pressure (CP) using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. We have previously confirmed both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement of the IPMS readings with the values obtained from a standard manometer (gold standard). In the current study, we will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery. A secondary outcome measure is the oxygen or nitrous oxygen concentration in the oropharynx.


Eligibility Criteria:
Inclusion Criteria:

* Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation.

Exclusion Criteria:

* Patient who is intubated with an uncuffed endotracheal tube.
* Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine.
Efficiency of Surgical Treatment for Lumbar Spinal Stenosis

Decompression surgery has proved to be effective for Lumbar Spinal Stenosis (LSS) with persistent pain. But the efficiency of the surgery for degenerated LSS remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Patients were randomly allocated to surgical group or a nonoperative group. Because of the procedure , neither patients nor investigators were blinded. The primary outcome is the change of symptom measure by the Oswestry disability index 6, 12, and 24 months after procedure.

This study will use a randomised controlled trial to access the efficiency of the surgery for degenerated LSS. Patients aged 50 years or older, had LSS will be invited to take part. Patients will be randomised divided into 2 arms. The participants in the intervention arm will have decompression surgery ; those randomised to the control arm will receive current standard conservative treatment methods.

Patients were clinically assessed at baseline (the day of surgery or treatment), and at 6,12 and 24 months afterwards. The primary outcome will be the pain release , categorised according to Oswestry disability index.

Eligibility Criteria:
Inclusion Criteria:

* Clinical symptoms: back pain radiation to lower limbs or buttocks; fatigue or loss of sensation in the lower limbs aggravated by walking.
* Persistent pain without progressive neurologic dysfunction
* Duration of symptoms and signs for more than 6 months
* Severity of the disease justifying either surgical or nonoperative treatment

Exclusion Criteria:

* severe LSS with intractable pain and progressive neurologic dysfunction, suggesting forthcoming surgical treatment
* spinal stenosis not caused by degeneration
* lumbar herniated disc diagnosed during the last 12 months
* neurologic disease causing impaired function of the lower limbs
Three Phase Physical Therapy in Children With Relapsed Club Foot After Ponseti Treatment

Clubfoot, or congenital Talipes Equinovarus (CTEV), is a condition where a baby is born with one or both feet twisted inward and downward due to abnormal fetal foot development. Its estimated global prevalence is 1 in 1,000 live births, varying across populations. Relapsed clubfoot, a recurrence after initial correction, may occur due to incomplete treatment, noncompliance, muscle imbalance, or natural growth. Treatment involves surgical and non-surgical interventions, including soft tissue releases, osteotomies, and external fixation devices. The Ponseti method, a non-surgical approach, is commonly used in infants, with post-treatment physiotherapy focusing on three phases to optimize foot function. This holistic approach aims to achieve the best long-term outcomes for children with clubfoot. This 6-month randomized clinical trial at PSRD Hospital aims to assess the effectiveness of three-phase physical therapy versus conventional physiotherapy in treating clubfoot. With a sample size of 19 participants and a 10% attrition rate, the study involves children aged 3-10 previously treated with the Ponseti method. Data collection includes, one-leg standing and sit-to stand tests, Pirani score and the Oxford Ankle Foot Questionnaire. The three-phase therapy consists of joint mobilization, kinesio taping, and functional exercises over three months, with a focus on improving balance and proprioception.


Eligibility Criteria:
Inclusion Criteria:

* Having unilateral and bilateral club foot
* Age between 3-10 year
* Previously treated with Ponseti method
* Children fall under Grade II and III according to classification of relapse pattern

Exclusion Criteria:

* Children who were diagnosed with arthrogryposis multiplex congentia
* Children with spastic Equinovarus
* Children who had multiple surgical operation
Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe

The primary purpose of the protocol is to describe the pharmacokinetics of a single dose of Abatacept 125 mg in Rheumatoid Arthritis patients delivered via the autoinjector device or the approved prefilled syringe.

SC=Subcutaneous

Eligibility Criteria:
Key Inclusion Criteria:

* Subjects ≥18 years of age
* Diagnosis of Rheumatoid Arthritis confirmed by participant's physician
* Disease activity under control

Key Exclusion Criteria:

* Change in disease-modifying antirheumatic drug (DMARD) therapy within 3 months of enrollment
* Exposure to investigational drug within 4 weeks or 5 half lives whichever is longer
* Current or prior use of Rituximab ≤6 months
* Current or prior use of the following within 4 weeks or 5 half lives whichever is longer: biologic DMARDS, Tofacitinib, Cyclophosphamide, Mycophenolate Mofetil \& d-Penicillamine
Evaluate Use of Gravitational Platelet Separation System on Leg Wound Healing in Coronary Bypass Surgery

The aim of platelet rich plasma (PRP) application is to accelerate the healing cascade via application of elevated cytokine concentrations released during platelet degranulation.

This is a prospective randomized study of the effect of autologous platelet concentrate application during surgical closure following a vein harvest during coronary bypass surgery. This prophylactic measure will be compared to standard surgical closure techniques with the primary outcome being the incidence of leg wound infection.

Postoperative wound disturbances, particularly surgical site infection of the chest and leg incision site following cardiac surgery are associated with increased morbidity, mortality, and costs. A recent dissertation from the National hospital in Norway showed a 20% infection rate in wounds after bypass surgery, this is probably representable nation wide. Prophylactic interventions that reduce postoperative wound disturbances and infection would have inherent value in cardiothoracic surgery. Ideally, a specific intervention would demonstrate improved patient outcomes while reducing the output of hospital resources.

The aim of platelet rich plasma (PRP) application is to accelerate the healing cascade via application of elevated cytokine concentrations released during platelet degranulation. It is hypothesized that the elevated cytokine levels will elucidate an accelerated healing response of the affected tissue. PPP application has also been advocated as a tissue sealant for topical hemostasis.

This is a prospective randomized study of the effect of autologous platelet concentrate application during surgical closure following a vein harvest during coronary bypass surgery. This prophylactic measure will be compared to standard surgical closure techniques with the primary outcome being the incidence of leg wound infection.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing a cardiothoracic procedure requiring a leg vein harvest
* Patient signature of informed consent form

Exclusion Criteria:

* Pregnancy
* \< 18 years of age
* History of amenia (hemoglobin \< 11.0)
* History of bleeding disorder
* Un-cooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations
* Hypothyroidism
* History of any blood disorder
* Patient with an active infection
* Patients taking Cox II inhibitors.
* Heparin-induced thrombocytopenia
Treatment of Wounds With a New Adhesive Foam Dressing

This study will look at whether ELECT, a new adhesive foam dressing, can offer an alternative to traditional wound care methods.

Patients will be treated with ELECT for 14 days. Data relating to wound healing, the performance of the dressing and the opinion of the doctor will be collected.

The hypothesis of this study is that the ELECT foam adhesive dressing is 'fit for purpose' and will be effective at treating a variety of wounds.


Eligibility Criteria:
INCLUSION CRITERIA

1. Participants must be ≥1 years old
2. Males and females (females must not be pregnant and must use contraception if of child bearing potential)
3. Participant must have a partial thickness burn, acute or chronic wound that would benefit from the application of an advanced wound dressing to help facilitate moist wound healing
4. Presence of a suitable wound which can be treated with the available sizes of the ELECT Adhesive Foam Dressing (7.5cm x 7.5cm, 12.5cm x 12.5cm, 15cm x 15cm and 17.5cm x 17.5cm)
5. Participant is under the direct observation of the investigator for the duration of the study (i.e the participant's wound must not be treated by another clinician throughout the duration of the study).
6. The participant or the participant's legal representative is able to understand and is willing to consent to the study.

EXCLUSION CRITERIA

1. Participants with a known history of poor compliance with treatment (including if the participant has a known , diagnosed emotional or neurological condition such as mental disorders/illnesses, mental retardation, drug or alcohol abuse, that would pre-empt their ability to understand and consent)
2. Participants who are unable to understand the aims and objectives of the study.
3. Participant is a prisoner.
4. Participants with a known sensitivity to any of the constituents of the evaluation products, including polyester, polyurethane, and acrylic adhesive
5. Participants with facial wounds as the reference wound
6. Participants with confirmed or suspected clinically infected reference wounds (unless wounds are being treated per standard protocol for wound infection)
7. Participant is likely to undergo foreseeable definitive surgery within 2 weeks from screening
8. Participants where a reference wound cannot be treated in isolation from other wounds
9. Participants who have participated in this evaluation previously and closed/100% healed, or have been withdrawn from the study, or any previous studies
10. Participant who are employees of Smith \& Nephew group companies
A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult Participants

This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous (SC) administration with on-body Injector in Healthy Adult Participants.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
* Body weight greater than 40 kg and less than 100 kg at screening.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

Exclusion Criteria:

* Previous exposure to any anti-interleukin-12/23 or anti interleukin-23 treatment for at least one year prior to Screening.
* Intention to perform strenuous exercise to which the participant is unaccustomed within one week prior to administration of first dose of study drug and during the study.
WheezoMeter® Correlation Study

The primary goal of the study is to more firmly establish correlations between WheezeRate(Wz%) and other parameters used to assess wheezing and asthma including spirometry, provider's auscultation, and symptoms at the time of Wz% measurement.


Eligibility Criteria:
Inclusion Criteria:

* Patients \<= 12 years of age who have wheezing at the time of study as confirmed by the physicians' auscultation.

Control:

* Patients \<= 12 years of age without history of asthma or other pulmonary conditions, and who are without wheezing on physical exam.

Exclusion Criteria:

* Medical problems that would contraindicate Wz% measurement.
Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy

Supratentorial craniotomy is one of the most common neurosurgical procedures, with severe perioperative pain. Inadequate perioperative pain relief has been associated with increased blood pressure and intracranial pressure, favoring bleeding and cerebral cerebral hypoperfusion. The ideal analgesia for neurosurgery requires complete pain relief, eliminates the side effects of opioid drugs and no influence for neurological function. Previous studies have proposed a multimodal analgesic strategy, combining analgesics and local anaesthesia, it is expected to achieve the above benefits.

The trial has been designed to analyze the efficacy of local analgesic techniques and dexmedetomidine in the treatment of postoperative acute pain in craniotomy. This randomized clinical trial aims to enroll 2000 patients, which will be randomized to one of 4 groups.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 65 years
* American Society of Anesthesiologists physical status I to III
* Scheduled to undergo elective supratentorial tumor resection

Exclusion Criteria:

* Incision-area skin infection
* A history of previous craniotomy
* Allergy to study medications
* A history of preoperative change in consciousness or cognitive function
* Severe hepatic or renal dysfunction
* Severe bradycardia (heart rate\<40 beats/min)
* Sick sinus syndrome or second- to-third degree atrioventricular block
Early Independent Adaptive Arm and Hand Rehab

The purpose of this study is to test the hypothesis that early independent adaptive bimanual-to-unimanual training of arm and hand movements, assisted with specially designed mechanical devices: the mirrored motion bimanual arm trainer (m2 BAT), will improve motor control and function in patients with post-stroke hemiparesis.

This study will randomly assign individuals admitted to the inpatient stroke rehabilitation unit to receive either conventional occupational therapy (OT) or conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.

Eligibility Criteria:
Inclusion Criteria:

* Ability to follow study instructions
* Ability to likely complete all required visits
* Ability to comply with the therapy protocol as assessed by the investigator
* Must be English speaking
* Subjects must have had a unilateral stroke

Exclusion Criteria:

* Severe upper extremity spasticity suggested by an Ashworth score of ≥3 at any joint, or restriction of full passive range of motion.
* Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition such as psychotic illness or severe depression.
* Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
* History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
* Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease.
* Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol.
* Patients who are cognitively impaired.
* Patients who lack capacity to consent.