cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances

The present study aimed to investigate the cross-sectional effect of Class I AMCOP devices in patients of all possible skeletal types from both vertical skeletal pattern (normodivergent, hyperdivergent, hypodivergent) and sagittal skeletal pattern (skeletal Class I, skeletal Class II, skeletal Class III).

The criterion for choosing patients was determined by the protocol of using these devices, which is to always perform an AMCOP First Class phase with the aim of improving transverse coordination of the arches, Spee's Curve and Wilson's Curve.

This prospective clinical study will investigate the cross-sectional effect of Class I AMCOP (Cranium Occluded Postural Multifunctional Harmonizers, Micerium spa) devices in patients of all possible skeletal types from both vertical skeletal pattern (normodivergent, hyperdivergent, hypodivergent) and sagittal skeletal pattern (skeletal Class I, skeletal Class II, skeletal Class III).

Patients willing to start AMCOP therapy and recruited for the study will be asked to sign the informed consent. Parents will sign the consent for underage patients.

We will recruit patients by following specific inclusion and exclusion criteria during an orthodontic examination.

Diagnostic records will be recorded before treatment (T0) and after 10-12 months of treatment (T1) and included:

* Intraoral and extraoral photographs
* Impressions of the dental arches with digital scanner
* Orthopantomography
* Lateral teleradiography

Changes will be evaluated at T0 and T1 as follows:

* cross-sectional effects will be analyzed on digital models of the upper and lower arch, taking the following linear measurements with OrthoCad program:

  1. upper and lower intermolar distance (taking as reference the top of the mesiovestibular cusp of the upper first molars)
  2. upper and lower intercanine distance (taking as reference the top of the cusp)
* skeletal changes in latero-lateral teleradiography will be analyzed by using "Giannì cephalometric analysis" The expected duration of the first phase of therapy is averaged 10-12 months. During this time, every month patients will be visited and the devices will be activated.

Eligibility Criteria:
Inclusion Criteria:

* patients presenting maxillary transverse deficits (that includes: posterior crossbite monolateral or bilateral; end-to-end occlusal relationships; excessive linguoinclination of lower posterior teeth due to the contraction of maxillary arch; limited permutation space of permanent elements)
* patients with all sagittal and vertical skeletal patterns

Exclusion Criteria:

* syndromic patterns, cleft lip or cleft palate, severe malformations of the maxillae, severe skeletal asymmetry
* physical or psychological limitations
* presence of metallic restorations
* previous orthodontic treatments
COOL-BP Study: Continuous Versus Occasional Blood Pressure Study

The COOL-BP study is part of the Remote Hypertension Program and will investigate the data provided by Aktiia Bracelet (a cuffless Blood Pressure monitor at the wrist) when integrated into the Remote Hypertension Program.

The COOL BP study aims to compare weekly and monthly Blood Pressure averages measured manually by traditional Home Blood Pressure Monitoring to those measured automatically by the Aktiia bracelet.

This is a prospective open-label single arm study. The investigational device of this study is the Aktiia Bracelet device. Aktiia Bracelet is a non-invasive blood pressure (BP) monitor intended to track systolic and diastolic Blood Pressure trends. The Aktiia Bracelet can also measure heart rate.

Participants who consent to participate in COOL-BP will be shipped an Aktiia device to participants' residence.

For 6 months, patient will continue the procedures of the Remote Hypertension Program in parallel to wearing the Aktiia Bracelet. The Remote Hypertension Program is run remotely according to a clinical algorithm, where study navigators contact patients at regular intervals and monitor symptoms by regular phone calls; laboratory tests are obtained to ensure safety of the protocol's prescribed medications. Any symptoms will be evaluated by the program nurse practitioner or physician and managed per standard of care. During the study, the patient completes several surveys to give opinion on Aktiia product versus Home Blood Pressure Monitoring.

Following six months of using the Aktiia.product, the participant's participation in this study will end. Participants continued participation in the Remote Hypertension Program will depend on whether participants have met the blood pressure goals outlined in that program.

Eligibility Criteria:
Inclusion Criteria:

* Fluent in written and spoken English
* Already enrolled in the Remote Hypertension Program
* Average of last 3 office blood pressures \>140/90 mm Hg in last 18 months OR Last office blood pressure \>140/90 mm Hg in last 6 months OR Referred by MD and last 1 blood pressure \>130/80 mm Hg
* Own an iPhone

Exclusion Criteria:

* Tachycardia (heart rate at rest \> 120bpm)
* Atrial fibrillation, persistent
* Severe heart failure (LVEF\<35%)
* Pheochromocytoma
* Raynaud's disease
* Trembling and shivering
* Known pregnancy
* Breastfeeding
* Arteriovenous fistula
* Arm amputation
* Exfoliative skin disease
* Lymphoedema
* Known allergy to silicone
* Not Massachusetts resident
* Last MGB office visit \>3 years
* No-MGB provider
* Terminal medical condition
* CKD 4-5 (eGFR ≤ 30 mL/mn)
Drain vs No Drain After Live Donor Hepatectomy

Prophylactic abdominal drain placement after donor hepatectomy has been a common or even mandatory practice in most transplant centers. This serves to monitor the occurrence of post-operative intra-abdominal bleeding and is used for the detection and drainage of any bile leakage. However prophylactic drain placement is not without complications, like; Increased rates of intraabdominal and wound infection, Increased abdominal pain, Decreased pulmonary function, Bowel injury and Prolonged hospital stay. Comprehensive Complication Index (CCI) is a valuable tool used to assess the overall morbidity of patients after surgical interventions . The CCI score ranges from 0 (no complication) to 100 (death), reflecting the gravity of the overall complication burden on the patient on a continuous scale and is a validated tool for living donor liver transplants. The investigators aim to compare the safety of no drain placement vs abdominal drain placement in LDLT(Live Donor Liver Transplant) by comparing the comprehensive complication index(CCI) between both arms at day of discharge after donor hepatectomy.

* This study will be a randomised controlled, pilot study to compare the safety of no drain placement vs abdominal drain placement in LDLT by comparing the comprehensive complication index(CCI) between both arms at day of discharge after donor hepatectomy.
* Patient admitted for donor hepatectomy will be recruited and further randomised into the Drain and No-Drain arms. Patients in the no drain arm will undergo routine steps in donor hepatectomy. After graft removal, hemostasis and biliostasis will be confirmed, following which abdomen will be closed in layers. For patients in the drain arm, same steps will be followed. At the end of the operation , additionally, 28 Fr abdominal drain will be inserted with tip near cut surface of remnant. Intraoperative and post-operative parameters will be compared between the groups. Comprehensive Complication index will be calculated on day of discharge using online universal CCI calculator application.

Eligibility Criteria:
Inclusion Criteria: Patients undergoing donor hepatectomy -

Exclusion Criteria:

Any patient not consenting to the procedure. Intraoperative need for drain placement in no drain arm due to surgical factors.

Inverted L/ J shaped incision. Laparoscopic donor hepatectomy Robotic donor hepatectomy.

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Tocotrienol as a Nutritional Supplement in Patients With Advanced Lung Cancer

There is a need for improving the effect of first-line chemotherapy for lung cancer patients, preferably by using an approach with none or very few side effects.

In this trial the investigators incorporate δ-tocotrienol/placebo as a nutritional supplement on top of standard chemotherapy for patients with advanced non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed non-small cell lung cancer, including squamous cell carcinomas, adenocarcinomas and non-neuroendocrine large cell carcinomas
* Patients with advanced stages of NSCLC who are candidates to first-line platinum-based doublet chemotherapy
* Measurable disease by RECIST 1.1
* Age ≥ 18 years.
* Performance status 0-2.
* Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):

  * White blood cells (WBC) ≥ 3.0 \* 10\^9/l or neutrophils (ANC) ≥ 1.5 \* 10\^9/l
  * Platelet count ≥ 100 \* 10\^9/l
  * Hemoglobin ≥ 6 mmol/l
  * Serum bilirubin \< 2.0 \* upper level of normal (ULN)
  * Serum transaminase ≤ 2.5 \* ULN
  * Serum creatinine ≤ 1.5 ULN
* Written and orally informed consent.

Exclusion Criteria:

* Other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence.
* Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
* Patients who have received prior chemotherapy for NSCLC
* Patients with NSCLC who are candidates to neoadjuvant chemotherapy or curative chemoradiotherapy
* Underlying disease not adequately treated (diabetes, cardiac disease)
* Allergy to the active substance or any of the auxiliary agents
* Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
* Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment.
Kinesiophobia in Patients Undergoing Total Knee Replacement Surgery

Providing information to the patient before surgery has important effects on the patient's self-care skills regarding the treatment and care process, reducing stress and reducing fears in the postoperative period. The primary aim of this study was to examine the effect of preoperative education on kinesiophobia in patients undergoing total knee replacement surgery. In addition, preoperative anxiety levels, time of first postoperative mobilization, number of steps in the first 24 hours after mobilization and pain levels of the patients will be evaluated as secondary outcomes.

Kinesiophobia is known as the minimization of activities or avoidance of movement due to the fear that the pain caused by movement will negatively affect the person's life and the problem will occur again. It was first defined by Miller, Kopri and Todd in 1990 at the American Pain Society meeting as excessive and unreasonable anxiety against physical movement and pain in the person, which occurs due to the person feeling vulnerable as a result of a painful injury or re-injury. Kinesiophobia is one of the factors that contribute to the chronicization of pain in individuals after surgery; it can lead to negative patient behaviors on the disease in the surgical process. In addition, kinesiophobia can lead to movement limitation and movement limitation can lead to pain. Since this vicious cycle may result in more pain and disability, the importance of the issue is increasing. It has also been shown that patients with high levels of kinesiophobia experience more pain and have a lower quality of life. This research project aims to provide an original approach in a field where studies on preventing or minimizing the effects of kinesiophobia on the surgical process and postoperative recovery process are limited. It is expected that nurses' interventions for kinesiophobia during the operation process will have positive effects on treatment and care. In this study, visual material-supported patient education will be provided to reduce the level of kinesiophobia associated with total knee replacement surgery.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older
* Planned surgery
* Speaking and understanding Turkish
* Being admitted to the hospital at least one day before the surgery

Exclusion Criteria:

* Visual, hearing and speech disabilities,
* Being mentally disabled,
* Having a psychiatric disorder or being in the process of treatment
* Having had knee replacement surgery before
Wellness Education Intervention

Individuals suffering from depression and anxiety have an increased risk of obesity due to multiple factors such as side effects to psychotropic medications, associated appetite dysregulation, disruption of sleep, anergia leading to psychomotor retardation or inactivity, and increased stress hormones through the disruption in the hypothalamic-pituitary-adrenal (HPA) axis. Though not a causal relationship, an intimate bidirectional connection exists between the two conditions, which subsequently impacts the journey of weight loss. The impact mental health can have on weight loss is evident as concurrent depression and anxiety in individuals with obesity predicts poorer outcomes like decreased adherence and less success with weight loss interventions. Here, we will determine if delivery of psychoeducation regarding the primitive brain and model of safety in a group setting to those with obesity seeking weight loss intervention has an impact on not only psychiatric symptoms of depression and anxiety but also weight loss, eating behaviors, sleeping patterns, activity level, and health-related quality of life. This project will improve our understanding of the role of mental health and the stress response in obesity.

This project will recruit subjects seeking weight loss in the Dallas Fort Worth area. A screen consisting of patient's weight and height to calculate a patient's BMI will be completed. Pre-assessment measures of anxiety, depression, eating disorder symptoms, sleep, self-efficacy, quality of life, and weight-wellness related behaviors (sleeping patterns, exercise patterns, eating patterns) will be completed before the intervention using a secure online link to RedCap. Participants will then attend eight weekly sessions of a group psychoeducational intervention. The intervention includes eight modules of various topics including the psychoeducation on the primitive brain model, motivation, goal-setting, affirmations, rewards, promoting autonomy, reducing guilt, and relapse prevention. Participants will complete homework assignments, share their work with the group to elicit feedback, and participate in guided discussions. Post-assessments will be completed 1-4 weeks and 3-5 months after the interventions is completed. These measures will determine (1) if psychological symptoms are responsive to the intervention, and (2) if clinical symptom changes related to weight and quality of life are affected.

Eligibility Criteria:
Inclusion Criteria:

* able to give informed consent
* able to speak English sufficiently to understand study procedures, provide written informed consent for study participation, and complete questionnaires
* BMI \> 25
* appropriate for outpatient care

Exclusion Criteria:

* medically unstable
* inpatient medical
* psychiatric inpatient
* psychiatric residential care
Yoga for Chronic Low Back Pain and Its Mechanism of Action: Impact of Strength and Stretch (YoMA II)

This study is a pilot, randomized controlled trial to provide feasibility and conduct preliminary analyses on physical (strength and stretch) mechanisms associated with a yoga intervention for non-specific chronic low back pain (cLBP). Recent large-scale trials have demonstrated the efficacy of a yoga intervention for cLBP however, many types of yoga classes are available to the public and a specialized yoga protocol for individuals with cLBP is needed. This study's goal is to quantify trunk strength and flexibility to better understand how these potential physical mechanisms specifically lead to improvement in pain-related outcomes including pain and disability. This knowledge will be used to design a large scale trial of mechanisms of yoga for cLBP. For this pilot study, 40 participants will be randomized to either a yoga intervention (N=20) or to a usual care group (N=20) that will receive The Back Pain Helpbook, a mind-body self-care program for better living. The yoga intervention will be offered weekly yoga classes and instructional materials will be provided for home practice.


Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain lasting \> 6 months
* Back pain that is rated at least 3 on a numeric pain rating scale that ranges from 0 to 10 (0-no pain, 10 worst pain imaginable).
* English language fluency

Exclusion Criteria:

* BMI \> 40
* Inability to provide informed consent
* Recent diagnosis of abdominal aneurism
* Recent diagnosis of metastatic cancer
* Recent diagnosis of discitis
* Recent diagnosis of disk disease
* Recent diagnosis of spinal stenosis
* Recent diagnosis of spondylolisthesis
* Recent diagnosis of infectious cause of back pain
* Recent diagnosis of fracture of vertebra
* Recent diagnosis of Fibromyalgia
* Recent diagnosis of rheumatoid arthritis
* Recent diagnosis of ankylosing spondylitis
* Recent diagnosis of paralysis
* Pregnancy
* Prior or planned back surgery
* Blindness or severe vision problems
* Deafness or severe hearing problems
* Bipolar or manic depression and not taking medication
* Major depression
* Psychoses (major)
* a substance abuse condition
* Dementia
* Unable to get up and down from the floor
* Involvement in a lawsuit related to back pain
* Lack of transportation
* Other disabling chronic conditions (e.g., disabling heart or lung disease, diabetic neuropathy, receiving treatment for hepatitis)
* Currently (within the past 3 months) using yoga classes for more than 15 minutes per week
* Inability to be contacted by phone or email
* no computer access
* schedule does not allow for participation in classes/home practice
* planning to move out of town or take a long vacation during the period of the study
Mitochondrial Energy Production in ART (Assisted Reproductive Technology )

Oocyte maturation requires a lot of energy, which is provided by the mitochondria via the synthesis of ATP. The majority of patients with advanced maternal age (AMA) have poor egg quality. One of the reasons depends on oxidative phosphorylation of Pyruvate to undergo maturation; on the contrary, the cells of the cumulus (CC) show great activity glycolytic so that these cells are able to provide ATP(adenosine triphosphate and energy substrates to the oocyte. The goal of this work is to analyze the mitochondrial function and energy production in oocyte donors compared with a group of women of advanced maternal age subject to a same ovarian stimulation Protocol


Eligibility Criteria:
Inclusion Criteria:

* Controls: Women between 18-35 years old who are oocyte donors and fulfill the requirements of the our program of oocyte donation according to the Spanish Law of Human Reproduction
* Cases: infertile women undergoing IVF due to advanced maternal age (\>38 years)

Exclusion criteria:

For controls: Women with antral follicle count \>20 or \<6 follicle per ovary or with pathologies which, in the opinion of the investigator, may interfere with the treatment of ovarian stimulation

* Severe hypersensitivity to drugs of similar structure
* In the case of associated pathologies which can be considered as exclusion criteria on the part of the researcher are endocrine disruption and multi-follicular ovaries with risk of OHSS (Ovarian hyperstimulation syndrome)
* Be positive in serology for syphilis, toxoplasmosis, rubella, gonorrhea, hepatitis B, hepatitis C and HIV and lack of personal history and family of hereditary diseases.

Cases

* Irregular cycles
* Previous Ovarian surgery
* Previous chemotherapy or radiotherapy
Can Point of Care Chest Ultrasound Predicts Pulmonary Complications After Major Surgery?

This study is done to estimate prevalence of the main detectable lung and cardiovascular complications by an ultrasound realized in room of post-interventional supervision at the patients whose duration of general anesthesia is superior at one hour after a surgery to risk


Eligibility Criteria:
Inclusion Criteria:

* Physical status score \> 1
* Anesthesia of duration \> 1 hour
* Visceral, orthopaedic, vascular, thoracic surgery, neurosurgery

Exclusion Criteria:

* Technical incapacity of accessibility to the ultrasound window
* Cardiac or pulmonary transplant
Effect of Levetiracetam on Brain Excitability

This study will examine the effect of the newly developed anti-epileptic drug, levetiracetam, on excitability of the cortex (surface layer) of the brain. Levetiracetam works differently from other anti-seizure drugs, but its mechanism is not well understood. This study may provide insight into a new protection mechanism against seizures as well as the effect of the drug on cortical excitability.

Healthy normal volunteers 18 years of age and older may be eligible for this study. Candidates will have a medical history taken and undergo physical and neurological examinations.

Participants will undergo two different procedures in four separate sessions. One procedure (cortical excitability) involves taking either levetiracetam or placebo (a look-alike inactive substance) and having transcranial magnetic stimulation (TMS). The other procedure (pinch-training related changes) involves taking levetiracetam or placebo, doing a motor exercise called pinch training, and having transcranial magnetic stimulation. For TMS, a very brief electrical current is passed through an insulated coil wire placed on the scalp. The magnetic pulse travels through the scalp and skull, causing small electrical currents in the cortex that may cause muscle, hand, or arm twitching or it may affect movements or reflexes. During the study, subjects may be asked to make movements, do simple tasks or tense muscles. Electrical activity of the muscles will be recorded using electrodes taped to the skin over the muscle. For the pinch training, the subject makes a brief, brisk pinch after each beat of a metronome every two seconds and then completely relaxes the hand until the next beat.

Subjects will be tested on four different days at least 72 hours apart. Each session will last about 3 to 4 hours.

Approximate schedule for cortical excitability testing:

TMS (study 1)

Take levetiracetam or placebo

TMS (study 2) \< 60 minutes after drug or placebo

TMS (study 3) \< 120 minutes after drug or placebo

Approximate schedule for pinch-training related changes:

Take levetiracetam or placebo

TMS and pinch power measurement \< 60 minutes after drug or placebo

Pinch training for 30 minutes

TMS and pinch power measurement

Sample schedule:

Session 1 \< LTC and cortical excitability testing

Session 2 \< Placebo and cortical excitability testing

Session 3 \< LTC and pinch-training related changes

Session 4 \< Placebo and pinch-training related changes

The purpose of this study is to investigate the effect of newly developed antiepileptic drug, levetiracetam, on cortical excitability in humans. This drug may be useful in patients with myoclonus, and its mode of action is not well understood. We plan to determine if oral administration of levetiracetam in therapeutic dosage alters cortical excitability measured by transcranial magnetic stimulation as well as long-term potentiation measured by pinching practice in humans.

Eligibility Criteria:
This study will be done on normal volunteers.

Subjects will be adults older than age 18.

No development of a serious medical condition.

Compliance with protocol evaluations or examinations.