cyrilzakka/clinical-trials huggingface dataset:
Prehabilitation in Pancreatic Surgery

The purpose of this study is to use functional studies to study the effectiveness of prehabilitation prior to surgery. The investigators know that stronger patients have better outcomes after surgery compared to weaker patients. This study will help the study team determine if prehabilitation can make patients stronger prior to surgery. It is hoped by learning more about frailty and prehabilitation strategies may be developed to minimize or prevent complications in the future. Participants are being asked to participate in this study because they are going to have a pancreatic procedure.

This study aims to determine if a prehabilitation program can improve three objective frailty metrics and to describe the level of physical activity of pancreatectomy patients prior to their planned resection. Patients undergoing pancreatectomy will undergo routine preoperative work up: Staging PET/CT Chest/Abdomen/Pelvis, and biochemical work up (CBC, CMP, CA 19-9, prealbumin/albumin).

During the initial consultation, the patients' resting vitals (including weight) will be recorded. They will then perform the grip strength, 30s CST, and 6MWT to establish their baseline frailty metrics. Available baseline laboratory values (CBC, CMP including albumin), will also be recorded. Research personnel will then provide them with a fitness tracker, stress ball, and prehabilitation routine to follow at home until the day of surgery. They will also be asked to keep a physical log of their completed physical activities.

The patients will then complete the prehabilitation program during the time between the initial consultation and date of surgery, which typically occurs 3-4 weeks after the initial consultation date.

On the day of surgery, patients will turn in their physical log and their fitness tracker. Data from the fitness tracker will be downloaded onto a Cleveland Clinic encrypted computer. A set of resting vitals will be recorded (again including weight) and the patients will then be asked to perform the three-frailty metrics (grip strength, 30s CST, and 6MWT). After this, the patients will not require any additional testing.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing pancreatic resection over a six-month enrollment

Exclusion Criteria:

* unable to sign a consent
* require a translator in order to sign the consent
* Non-pancreatic resection candidates
Schizophrenia Sensory Gating Deficit With Quetiapine

The purpose of this study is the use of magnetoencephalography or MEG (a machine that measures magnetic activity in your brain) and electroencephalography or EEG (a technique that measures electrical activity in your brain) to study how sounds are processed in individuals with schizophrenia after three months of taking the antipsychotic medication quetiapine.

.Problems with attention and perception are core features of schizophrenia and are hypothesized to result from defects in the filtering or gating of sensory input. Examination of this requires neuoimaging techniques with high temporal resolution. High-density EEG and MEG in combination with structural magnetic resonance imaging (sMRI) are used to map sensory gating. In a number of recent studies patient treated with novel antipsychotics have been shown to have P50 gating ratios resembling those of normal controls rather than that of schizophrenia subjects treatment with conventional antipsychotics. To date, there is no literature on the effects of quetiapine on sensory gating. Subjects who meet all inclusion criteria and have been on a stable dose of quetiapine for three months will receive a clinical interview, an MRI, MEG, and neuropsychological testing to determine if patients with schizophrenia who are treated with quetiapine will demonstrate a sensory gating ratio similar to normal controls, indicating no deficit in sensory gating.

Eligibility Criteria:
Inclusion Criteria:

Patient Population

* Diagnosis of Schizophrenia as determine by the Structured Clinical Interview for DSM-IV
* No comorbid diagnosis of PTSD
* responders to quetiapine, determined by continuous treatment at the same dose of quetiapine and absence of psychiatric hospitalization for at least 3 months
* No history of drug dependency in their lifetime
* No history of alcohol or other substance abuse in the 6 months prior to entry into the study
* No history of head injury with loss of consciousness for more than 5 minutes
* No history of seizure disorder
* No mood stabilizing agents
* Between 18-65 and
* Able to sign informed consent

Normal Controls

* Matched in age and gender to patient population
* No history of psychiatric dysfunction or alcohol or other substance dependence in their lifetime as determine by the SCID
* No history of alcohol or other substance abuse in the previous 6 months
* No family history of psychotic disorder in first degree relatives as assessed by the FH-RDC diagnostic interview
* No history of head injury with loss of consciousness for more than 5 minutes
* No history of seizure disorder
* Between 18-65
* Able to sign informed consent

Exclusion Criteria:

Subjects will be excluded from participating in this study if they:

* Require treatment with a mood stabilizer
* Have had an inpatient hospitalization in the past 3 months
* Have a history of a neurological disorder
* Have any other axis I diagnosis besides schizophrenia
Effect of Local Anesthetic Dose on Interscalene Block

The purpose of this study is to determine if a decrease in the standard volume of local anesthetic used to numb your shoulder area before shoulder arthroscopy will provide adequate anesthesia for the procedure and decrease the amount of time until you are ready for discharge from the hospital.

Traditionally, an interscalene block is done either with nerve stimulator or ultrasound guided using 40-60mL of local anesthetic. The study plans to investigate the difference in hand grip strength post-operatively in patients who will receive interscalene blocks with 40mL versus a lower dose (20mL) of local anesthetic. We suspect the lower dose will achieve adequate surgical anesthesia while creating less motor block and thus, increase patient satisfaction, present fewer complications or adverse affects and decrease time in the recovery room.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 80 years old
* Surgical time \< 2.5 hours
* ASA I, II or III
* Shoulder arthroscopy

Exclusion Criteria:

* Age \< 18 or \> 80 years old
* Chronic pain patients (on narcotics/opioids \> 3 months)
* Open shoulder surgical procedure
* BMI \> 40
* Pre-existing neurological condition
* Patient refusal of interscalene block
* Severe respiratory disease or hemidiaphragmatic dysfunction
* Allergy to any local anesthetics
* Planned general anesthesia
Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma

The purpose of this study is to compare the overall survival (OS) for Orantinib in combination with transcatheter arterial chemoembolization (TACE) versus placebo in combination with TACE in patients with unresectable hepatocellular carcinoma (HCC).

This is a randomized, multi-center, double-blind, placebo-controlled phase III trial of Orantinib administered in combination with TACE in patients with unresectable HCC.

Patients will be randomly assigned (1:1) to receive TACE given in combination with either Orantinib (200 mg orally, twice per day) or placebo.

ORIENTAL:ORantinib InvEstigatioN on TAce combination triaL.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be diagnosed as HCC.
* Patients has no indications for treatment with curative hepatic resection or curative percutaneous local therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
* Patients are able to receive oral medication.
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Bone Mass Among Osteopenic Women

The purpose of this study is to evaluate the efficacy of salmon bone meal in preventing bone loss among perimenopausal women with reduced bone mass density.

The current study is part of a larger project called the CalGo-project. The overall purpose of the study is to use bone meal from salmon to promote skeletal health. Specifically, the effect of salmon bone meal on bone mass density among perimenopausal women (age ≥ 50 years) with osteopenia is investigated over a time period of 2 years. Salmon bone meal is composed of a natural microcrystalline hydroxyapatite form of calcium and phosphorus, collagen type 2. Past literature on mammalian sources of bone meal has indicated that this form of calcium is superior in terms of preserving bone mass density compared to traditional calcium supplements. Preserving bone mass is essential to reduce the risk of future fragility fractures. Osteopenia is a condition of reduced bone mass density and bone quality which can indicate the later onset of clinical osteoporosis. Both are conditions associated with a significant risk of fragility fractures, which are a major global health burden.

Bone mass density is measured using dual-energy X-ray absorptiometry. Markers of bone formation P1NP and CTX-1 will be measured in serum samples of participants. 100 potential participants will be screened for eligibility. Participants who meet the eligibility criteria will be randomized in a double-blind manner to receive 4 capsules daily of salmon bone meal enriched with Vitamin D3 per capsule.

Eligibility Criteria:
Inclusion Criteria:

* Female gender
* ≥ 50 years of age
* DXA T-score of \> -2.5 standard deviations, but ≤ -1 (osteopenic range)
* Steady state body weight 1 month before study commencement date
* No contraindications for intake of the interventional product, including a prior diagnosis of fish allergy.
* Familiar with the Norwegian language, both in writing and orally

Exclusion Criteria:

* A diagnosis of osteoporosis (BMD T-score ≤ -2.5 SD as diagnosed by DXA), or any previously diagnosed fragility fractures on a background of osteoporosis.
* Use of drugs known to affect bone metabolism, including:

  * Glucocorticoids
  * Thyroid hormones
  * Hormone replacement therapy taken continuously for a duration of less than 6 months.
  * Long-term heparin therapy
  * Anti-convulsive drugs
  * Long-term proton pump inhibitor treatment
  * Lithium
  * Anti-osteoporotic drugs
  * Cancer therapy
  * Selective estrogen receptor modulators.
* Any disease or medical condition known to affect bone tissue, including neoplasia with or without metastasis, Paget's disease of bone, Osteomalacia, or any other disease deemed relevant by the PI.
* Gastrointestinal diseases or disturbances potentially affecting absorption of nutrients, including Crohn's disease and Celiac disease.
* Hypersensitivity to ingredients in the interventional product, including fish allergy.
* Not willing to participate in the study.
* Other reasons that the PI deems it necessary to exclude the subject.
In Vivo Detection of Circulating Clots in Patients With Thromboembolism

Subjects with thromboembolic disease or at high-risk for thromboembolic conditions diagnosed with ultrasound or other standard of care techniques will be recruited to estimate the feasibility of a device to detect in vivo CBCs.

There are no current gold standards to detect circulating blood clots. The sensitivity of most current methods to detect CBCs is poor when low numbers are present in the host. A novel method of detecting circulating blood clots, PAFC, may improve detection of CBCs and, if so, ultimately may reduce complications related to previously undetected clots.

Eligibility Criteria:
Inclusion Criteria

* Men and women, 18 years old and older.
* Evidence of current venous or arterial thromboembolic disease diagnosed by standard of care clinical, radiographic, or laboratory testing or acute ischemic stroke.
* Informed consent provided by the subject.

Exclusion Criteria

* Pulmonary embolus with a need for mechanical ventilation or other ventilator support (may be on oxygen delivered by nasal cannula or mask at an FiO2 of ≤ 0.40)
* Acute coronary syndrome (including unstable angina)
* Significant cardiac arrhythmia (may have atrial fibrillation controlled with medication)
* Intracardiac thrombus
* Any embolus or thrombus requiring vascular surgery or interventional radiology to attempt acute embolectomy or thrombectomy
* Sickle cell disease with vaso-occlusive crisis
* Sepsis or life-threatening infection
* Traumatic injury requiring hospitalization (within 30 days prior to enrollment)
* Pregnancy or breastfeeding
* Severe mental illness
* Other conditions deemed by the investigators to put the subject at greater risk
Implementation of an Early Rehabilitation Program for the Patient With Lung Transplantation: From the ICU to Home.

Introduction: Following pulmonary transplantation (PT), peripheral and respiratory muscle weakness, and associated global malfunction are some of the limiting factors in rapid recovery. Effective early implantation pulmonary rehabilitation programs are currently lacking.

Objectives: To introduce an early rehabilitation program in the ICU after PT to see if there is an improvement in functionality, an increase in strength and muscle mass, an improvement in the strength of the respiratory muscles and a shorter hospitalization time in the ICU and in the ward.

Methodology: A single-blind randomized clinical trial will be performed to divide patients with PT into one experimental group and another control group. Prior to the PT, those patients between the ages of 18 and 70 will be recruited, to be admitted to the ICU of Vall Hebron University Hospital, and who have been prescribed pulmonary rehabilitation with onset in the first 15 days after the surgery. The control group receives regular treatment in the ICU, which includes muscle strengthening exercises, passive/assisted or active mobilizations, and respiratory physiotherapy with breathing muscle strengthening in a medium load. The experimental group receives a new early rehabilitation program based on a patient's in-bed cycling that allows controlled and adapted training to the patient's situation, along with coordinated exercise with neuromuscular electrostimulation and respiratory physiotherapy with breathing muscle strengthening in a high load. Improvement will be observed through functional scales (6MWT), muscle dynamometry, manual muscle test (MRC-SumScore), bioimpedanciometry, inspiratory and maximal expiratory pressures, spirometry, frailty and sarcopenia tests and a long-term Cardiopulmonary Exercise Testing.

Expected Outcomes: Patients who perform the experimental group are expected to have an early discharge from the ICU and a reduction of the total hospital admission. Is also expected that the experimental group will improve the functional capacity and muscular strength, and they will have a lower risk of fragility in long term. It is also expected that the patients in the experimental group will soon be able to normalize their oxygen consumption a year after lung transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral lung transplantation.
* Age criteria (From 18 to 70 years old).
* Start the rehabilitation program between the first 15 days after lung transplantation.

Exclusion Criteria:

* Do not meet inclusion criteria.
* Fulfill some criterion of absolute contraindication for the use of electrostimulation in the lower extremities (pacemaker, pregnancy or unstable fracture that requires absolute rest and immobilization.
* Cognitive or psychiatric alteration that does not allow you to participate in the project.
* Not wanting to participate in the study.
A Study To Evaluate The Treatment Pattern Of Moderate-to-Severe Asthma Patients In China

This is a Prospective, Observational, Multicentre Study to describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients in China. Sponsor by Astrazeneca Investment(China) Co., LTD.

This is a prospective, observational, multicentre study. Approximately 500 moderate-to-severe asthma patients from 30 sites across China. Patients will be treated following routine clinical practice. Study measures will be collected at week 0, week 12 and week 24.

The primary objective of PRESENT study is to describe treatment pattern changes of uncontrolled moderate-to-severe asthma patients in China.

Eligibility Criteria:
Inclusion Criteria:

1. Physician-confirmed asthma diagnosis with documented evidence of variable expiratory airflow limitation (e.g., from bronchodilator reversibility testing or other tests)
2. Written informed consent
3. Moderate-to-severe asthma (asthma patients with treatment of GINA Step 3-5)
4. Age 12 years old and above

Exclusion Criteria:

1. Previous diagnosis of chronic obstructive pulmonary disease (COPD) or other clinically relevant chronic respiratory disease other than asthma
2. Received an investigational therapy for asthma, allergy, atopic disease, or eosinophilic disease as part of a clinical trial during the 6 months prior to enrolment. (Once enrolled in the PRESENT Study, patients should not enrol in any investigational trials.)
3. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study
4. Disease or condition other than asthma that requires treatment with systemic or oral steroids
5. Patients with poor inhaler skills and adherence
Effects of Pioglitazone on Insulin Sensitivity in Healthy Overweight and Obese Males (MK-0000-170)

The purpose of this study is to evaluate whether 30 mg of pioglitazone administered once daily for up to 28 days to healthy overweight and obese subjects will lead to a significant change in insulin sensitivity, measured in the setting of a hyperinsulinemic euglycemic clamp


Eligibility Criteria:
Inclusion Criteria:

* Subject has a BMI of greater than 28 kg/m\^2 and less than or equal to 38 kg/m\^2
* Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
* Subject is willing to avoid major dietary changes for the duration of the study

Exclusion Criteria:

* Subject has history of diabetes (Type 1, Type 2 or steroid-induced)
* Subject has a history of hypersensitivity to pioglitazone or other thiazolidinediones
* Subject has a history of liver disease, other than non-alcoholic fatty liver disease or non-alcoholic steatohepatitis
* Subject has a history of congestive heart failure
* Subject has a active or past history of atherosclerotic heart disease, heart failure, osteoporosis, osteopenia, recurrent bone fractures, or anemia
* Subject has a history of stroke, chronic seizures, or major neurological disorder
* Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological or renal abnormalities or diseases
* Subject has a history of neoplastic disease within the past 5 years
ACE and HLA Genotypes Predict Severity and Disease Progression in Danish Sarcoid Patients

Sarcoidosis is a multisystem granulomatous disease of unknown cause histologically characterized by noncaseating granulomas. Genetic factors affect disease course, which is highly variable and difficult to predict.

This study aims to evaluate the predictive value of ACE and HLA genotypes on disease severity and progression in Danish patients with sarcoidosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sarcoidosis
* Signed informed consent

Exclusion Criteria:

* Inability or unwillingness to adhere to the study
* Inability to give informed consent
Trial of High-Dose Vitamin D in the Treatment of Complicated Severe Acute Malnutrition

This double-blind randomized placebo-controlled controlled trial will test the hypothesis that administration of high-dose oral vitamin D supplementation to children in Lahore, Pakistan, who are recovering from complicated severe acute malnutrition will safely accelerate weight gain (primary outcome) and enhance neurodevelopment, muscle mass accumulation, resolution of systemic inflammation and antimicrobial immune function (secondary outcomes).


Eligibility Criteria:
Inclusion Criteria:

* Consent of parent / guardian
* Age 6-59 months at enrolment
* Diagnosis of complicated SAM at the point of hospital admission as defined by the World Health Organisation.
* Medical team managing the child has made the decision to discharge the child from inpatient care

Exclusion Criteria:

* Ingestion of a dose of vitamin D\>200,000 IU (5 mg) in the last 3 months
* Known diagnosis of primary hyperparathyroidism or sarcoidosis (i.e. conditions pre-disposing to vitamin D hypersensitivity)
* Known neurodevelopmental disorder (e.g. cerebral palsy)
* HIV infection
* Taking anti-tuberculosis treatment
* Inability to assess child's developmental status at baseline using the Malawi Development Assessment Tool
* Signs of rickets
* Corrected serum calcium concentration \>2.65 mmol/L on blood sample taken during the current hospital admission
The Effect of Music on Neonatal Stress, Mother's Breastfeeding Success and Comfort

In the literature, music plays an energizing, soothing, stimulating and awakening role for the newborn, and at the same time, music has the potential to wake up a lethargic and withdrawn baby and calm a crying, restless baby. In addition, it is stated that relaxing music in the early postpartum period supports breastfeeding behaviors of mother and baby. It is stated that lullabies positively affect the newborn's relaxation, falling asleep, and mother-baby communication. however, it facilitates sleep due to its monotonous, emotional and repetitive melody structure, slow tempo and relaxing effect. The sound called white noise is a humming, monotonous and constantly used sound that suppresses the disturbing sounds coming from the environment and has a calming feature. In the literature, it has been found that white noise played to infants with colic reduces crying.

The aim of this study is to determine the effects of lullabies and white noise music played during breastfeeding of the newborn on newborn stress, breastfeeding success and mother's comfort. This study was planned as a randomized controlled trial with term newborns 24 hours after birth.

The hypotheses are presented below;

H1- White noise music played during breastfeeding reduces newborn stress compared to the control group.

H2- White noise music played during breastfeeding increases breastfeeding success compared to the control group.

H3- White noise music played during breastfeeding increases comfort of the mother compared to the control group.

H4- Lullaby music played during breastfeeding reduces newborn stress compared to the control group.

H5- Lullaby music played during breastfeeding increases breastfeeding success compared to the control group.

H6- Lullaby music played during breastfeeding increases comfort of the mother compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age,
* Able to speak Turkish,
* Breastfeeding mothers
* Term and healthy newborn (born at 38-42 weeks, weighing 2500-4000 g, born with an APGAR of 7 or more, without any known congenital disease)

Exclusion Criteria:

* mothers who do not agree to participate in the research
* mother has a condition that prevents breastfeeding