cyrilzakka/clinical-trials huggingface dataset:
Optimization of Parameters of Subthalamic Nucleus Stimulation

Deep brain stimulation of the subthalamic nucleus is an effective treatment for Parkinson's disease. The analysis of cerebral signals of the subthalamic nucleus by local field potentials, provides one of the main electrophysiological markers of the success of the stimulation. This marker can be used to evaluate new paradigms of stimulation. So far, little studied, the temporal characteristics of the stimulation are very important in the effectiveness of the stimulation of the subthalamic nucleus, in Parkinson's disease. The first objective (Study I) is to compare the effectiveness of the stimulation when it is applied with biphasic symmetrical pulses and when applied with the standard pulses applied so far.

The second objective (Study II) is to see if, by applying pseudo-random time intervals between each stimulation pulse, if it would be possible to improve the efficiency and to limit the side effects of the stimulation.

The third objective (Study III) is to evaluate the electrophysiological changes of the subthalamic nucleus caused by the general anesthesia, in the anticipation of the realization of the surgery of the stimulation of the subthalamic nucleus under general anesthesia.

Study I and II: Patients who participate undergo pulse generator change under sedation. Four sets of stimulation parameters will be compared. The efficacy of every set will be measured on induced changes in LFP recorded from the STN electrodes. LFP will be compared between before, during and right after each stimulation conditions. The stimulation order will be randomized. All other stimulation parameters will be the same (macrocontact with most beta-oscillations, 1 minute, 1.5mA) .

Study III: Patients who participate undergo their first pulse generator implantation, performed under general anesthesia because of wire tunnelisation. The depth of anesthesia will be documented, recording the BIS spectral analysis index. The difference in spectral amplitude density of LFP, in particular in beta band oscillations will be correlated with the depth of anesthesia as measured with the BIS index at the time of 2 minutes recordings.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from Parkinson's disease, who must undergo surgery for the replacement of their neurostimulator (under sedation) or for the first positioning of it
* capacity of discernment
* informed signed consent

Exclusion Criteria:

* Health considerations in regard to adding 13' in surgery room (e.g. pain or incomfort).
Combined Colon and Endometrial Cancer Screening in Women With HNPCC

Primary Objectives:

To test the feasibility of combined colon and endometrial cancer screening in women with increased risk for colon and endometrial cancer.

To measure patient satisfaction for the combined procedure.

Women with certain medical conditions have an increased risk for colon and endometrial cancer. Currently, women go through separate screening procedures. Endometrial biopsies are performed at a separate visit to the gynecologist, and patients are not sedated for the procedure. This study will involve performing an endometrial biopsy while you are sedated for your colonoscopy.

Women who are able to have children must have a negative blood or urine pregnancy test before they can take part in this study.

As part of the study, you will be asked about your past experience with endometrial biopsy and colonoscopy. You will be asked about your perception of pain, your expectations, and the benefits and barriers to the combined screening.

You will then be sedated. The colonoscopy will be performed first by a gastroenterologist. This will be followed by the endometrial biopsy, which will be performed by a gynecologic oncologist.

A telephone interview will be performed two weeks after this procedure. The interview will last about 15 minutes. You will be asked about your perception of pain and the benefits and barriers to the combined screening.

This is an investigational study. A total of 50 women will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1) Women with medical indications for colonoscopy and endometrial biopsy.

Exclusion Criteria:

1) Must be 18 years of age and older.
Study of Navtemadlin Plus Pembrolizumab as Maintenance Therapy in Locally Advanced and Metastatic Non-Small Cell Lung Cancer

This study evaluates Navtemadlin (KRT-232) in combination with Pembrolizumab as a maintenance therapy in patients with locally advanced and metastatic non small cell lung cancer.

This is a 2 part, phase 1b/2, maintenance study for patients who have achieved a partial response (PR) or complete response (CR) after completion of up to 4 cycles of a combination platinum-based chemotherapy plus CPI regimen.

Phase 1b is a 3+3 dose escalation design that will be used to determine the maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of navtemadlin in combination with pembrolizumab. A Safety Review Committee (SRC) will review the safety data during the dose escalation to decide on dose escalation and/or exploration of intermediate doses.

Phase 2 will evaluate the efficacy and safety of the RP2D of navtemadlin plus pembrolizumab compared to navtemadlin placebo plus pembrolizumab. Each Arm will have approximately 40 subjects enrolled for a total of approximately 80 subjects. Eligible subjects will be randomized 1:1. This part of the study has a randomized, controlled, double-blind design. A stratified, permuted-block randomization scheme will be used for treatment allocation.

Eligibility Criteria:
Inclusion Criteria:

* ECOG 0-1
* Histologically or cytologically confirmed diagnosis of NSCLC documented as TP53WT
* Locally advanced or metastatic disease; must have completed up to 4 cycles of platinum-based chemo plus CPI and achieved a CR or PR per RECIST V1.1
* Adequate hematologic, hepatic and renal function (within 14 days)

Exclusion Criteria:

* Symptomatic or uncontrolled central nervous system (CNS) metastases
* Prior treatment with a MDM2 inhibitor
* Grade 2 or higher QTc prolongation (\>480 msec per NCI-CTCAE criteria version 5.0)
* History of bleeding diathesis; major hemorrhage or intracranial hemorrhage within 24 weeks
* History of major organ transplant
* Active pneumonitis or known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis
* Prior radiotherapy, cytoreductive therapy, cytokine therapy or any investigational therapy within 28 days
* Medical condition, serious intercurrent illness, psychiatric condition or other circumstance that, in the Investigator's judgment could jeopardize the subject's safety, or that could interfere with study objectives
Intra-operative Inspiratory Oxygen Fraction and Postoperative Respiratory Complications

Respiratory complications represent the second most frequent type of postoperative complications with an incidence estimated to range from 2.0% to 7.9%

It has been shown that intra-operative protective ventilation is associated with a reduced risk of respiratory complications. The effects of intra-operative inspiratory oxygen fraction (FiO2) remain to be investigated.

In this study, the investigators aim to investigate the association between intra-operative FiO2 and respiratory complication as well as surgical site infection and ICU admission in patients undergoing non-cardiothoracic surgery. The investigators primary hypothesis is that high intra-operative FiO2 increases the risk of postoperative respiratory complications independent of predefined risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Non-cardiothoracic surgery at Massachusetts General Hospital between January 2007 and August 2015
* Tracheally intubated at the beginning of the procedure and extubated at the end of the procedure
* above18 years of age

Exclusion Criteria:

* Missing information regarding main characteristics or the exposure variable
Novel Diagnosis of Ectopic Pregnancy

In the project, the investigators aim to determine the Beta- human chorionic gonadotropin (BHCG) value with serial measurements on the same day in the diagnosis of ectopic pregnancy.

Ectopic pregnancy is when the conception material is in a location other than the endometrial cavity. The diagnosis of ectopic pregnancy is basically made by the lack of increase in serum BHCG values as in normal pregnancy. In normal pregnancies, BHCG value increases by 70% or more every 2 days. In ectopic pregnancy, an increase of less than 70% every 2 days is diagnostic. This classical method allows the diagnosis to be made within 2-4 days at the earliest. Most of the time, this period can take 6-10 days.

In the project, the investigators will investigate how to determine the BHCG value with serial measurements on the same day in the diagnosis of ectopic pregnancy. The fact that there is no 70% increase after 2 days in ectopic pregnancy suggests that there may be an irregular increase during the day. The investigators aim to make this diagnosis in a shorter time than long days by measuring BHCG values many times during the day in patients with suspected ectopic pregnancy. The fact that there is no other study on this subject in the literature strengthens the possibility of the project being published as valuable information for the literature, even if a negative result is obtained as a result of this study.

Eligibility Criteria:
Inclusion Criteria:

* Positive bhcg levels

Exclusion Criteria:

* clinically diagnosis of intrauterine pregnancy
Does Perioperative Music Prevent Sleep Disturbances in Hospitalized Surgical Patients

Sleep disturbances are known to be a prevalent problem in hospitalized, surgical patients, which is of importance since sleep disturbances can lead to a range of negative health outcomes. Music interventions have shown potential in improving sleep quality. Unfortunately, the studies on the effect of music on sleep in surgical patient populations are still scarce and of low quality. Therefore, the aim of this study is to study the effect of music on sleep quality in oncological, gastro-intestinal surgical patients in the form of a randomized controlled trial. Participants will be divided in 2 groups, a music group and a control group, where the music group will receive music interventions perioperatively. The researchers will compare both groups to see if there is a difference in sleep quality.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Patients undergoing major elective abdominal surgery for malignant disease, including, but not limited to: Esophageal, gastric, colorectal, hepatic, pancreatic, gynecological and urological surgical procedures.
* Sufficient knowledge of the Dutch language.
* Communicable and able to assess the questionnaires
* Written informed consent acquired from the patient.

Exclusion Criteria:

* Patients with severe hearing impairment (defined as no or barely verbal communication possible).
* The patient is expected to be transferred to another hospital postoperatively.
* Participation in another study that may possibly intervene with the outcome measures. (e.g. in trial use of sleep medication, interventions regarding sleep quality or quantity or similar procedures)
* Assessment of primary outcome is not possible.
* Inability or unwillingness to receive the music intervention.
* Inability to wear the actigraphy device, or inability to perform actigraphy measurement due to paralysis.
Comparison of Liposomal Doxorubicin and Daunorubicin-containing VDCLD Regimen in the Treatment of Adult ALL Patients

This trial is a multicenter prospective, open, non-intervention clinical study. 200 patients with newly diagnosed adult ALL who underwent induction remission with the VDCLD regimen containing PLD and DNR, respectively,were plan to enrolled in this study to evaluate the CR rate and the level of myeloid leukemia stem cells in the first course of chemotherapy with two regimens; and to evaluate the safety of the two induction chemotherapy regimens.

Subjects will receive one of two treatment regimens:

Group A: intravenous drip of liposomal doxorubicin 36 mg/m2, d1、d15，1h； VCR 1.4mg/m2.d d1，d8，d15，d22 iv，CTX 800mg/m2.d d1 ivdrip，L-asp 6000u/m2.d d19～28 ivdrip，Dex10mg.d d1～28 ivdrip，once every 28days.

Group B: intravenous drip of DNR45mg/m2，d d1～3，1h；VCR 1.4mg/m2.d d1，d8，d15，d22 iv，CTX 800mg/m2.d d1 ivdrip，L-asp 6000u/m2.d d19～28 ivdrip，Dex10mg.d d1～28 ivdrip，once every 28days. The primary endpoint is complete remission after the first course treatment of induced remission chemotherapy, to evaluated the ratio of CR patients after the first course of chemotherapy with PLD and DNR VDCLD regimens.The secondary endpoint is to evaluate the changes of myeloid leukemia stem cells in patients before and after induction of VDCLD with PLD and DNR respectively.

Eligibility Criteria:
Inclusion Criteria:

* 1.Male or female, age:14-60 years old; 2.ECOG score 0-2; 3.Subjects had confirmed ALL (WHO classification, primitive cells ≥ 20%); 4.Patients with newly diagnosed ALL who have not previously received chemotherapy (except for dexamethasone, prednisone, hydroxyurea).Blood transfusion, use of hematopoietic growth factors or vitamins are allowed. Some temporary measures such as leukocyte removal, dexamethasone, prednisone, hydroxyurea (0.5-3g daily, over 3 days) are allowed; 5.Flow cytometry was used to detect leukemic stem cells in bone marrow samples before treatment; 6.Informed consent (all studies must be signed patient informed consent).

Exclusion Criteria:

* 1.Mixed AL patients; 2.Active systemic infection; 3.Lactating women, fertile women with positive pregnancy tests for urine or pregnant women who are unwilling to adopt appropriate methods of contraception (such as the use of birth control pills, intrauterine devices, diaphragms, abstinence, condom use) during the study ; 4. Patients currently have a history of cardiac insufficiency (especially congestive heart failure) or previous history of congestive heart failure; 5. Patients with severe liver failure (≥5 times upper limit of normal transaminase, total bilirubin ≥3 mg/dL); 6. Patients had renal insufficiency with creatinine clearance \<30 ml/min and creatinine clearance calculated as follows: Male: Ccr (ml / min) = (140-age) × body weight (kg) / \[0.8136 × serum creatinine (μmol/L)\] women: Ccr (ml/min) = (140-age) × body weight (kg) × 0.85 / \[0.8136 × serum creatinine (μmol/L)\]; 7. Patient is involved in other drugs experimental study within 30 days prior to the trial or within 90 days of the start of the trial; 8. Researchers think it is not suitable for enrolling.
Evaluation of Styloid Chain Calcification to the Patient With the Temporomandibular Joint Disorder

The aim of the study was to evaluate any relation between elongated styloid process (ESP) and type of Temporomandibular Joint Disorders (TMD).

The styloid process (SP) of the temporal bone is a long conical cartilaginous projection lies anterior to the mastoid process. Patients who have ESP or styloid chain calcification are usually asymptomatic, only 4% are symptomatic. Symptoms vary as different syndromes which related affected anatomic structures by calcified process or ligament. Temporomandibular Dysfunction (TMD) describe the temporomandibular joint (TMJ) disfunction that divided three branches according to temporomandibular joint's disc status: non-displacement (ND), displacement with reduction (DWR) and displacement without reduction (DWoR). Since orofacial pain shows similar features in both ESP or styloid chain calcification and TMD, it is possible to confuse and misdiagnosis both of these clinical conditions. This study aimed to investigate the length and calcification pattern of the styloid process in patients with TMD diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Temporomandibular Dysfunction(TMD)
* TMD patients with MR and CBCT images recorded in the digital archive.

Exclusion Criteria:

* operated or treated for any Temporomandibular Joint Diseases
* head and neck trauma
* orthodontic treatment
Rolandic Epilepsy Genomewide Association International Study

We have discovered a small change in the genetic code which increases the risk of the brainwave abnormality that is found in rolandic epilepsy. We now wish to confirm this using a second much larger sample of patients. We will investigate the other genetic changes that cause people with the brainwave abnormality to develop seizures, as well as problems with speech, coordination, attention and learning.

Epilepsy is a common neurological disorder affecting 1% of the population. There are over 30 types of epilepsy, some common, some rare. Most epilepsies arise in childhood and have a genetic cause. Approximately 25% of child patients have "Rolandic Epilepsy" or RE, also known as Benign Epilepsy with Centrotemporal Spikes (BECTS). RE has a complex genetic basis, probably made up of combinations of susceptibility variants in different genes. Children with RE quite often have other symptoms that affect their speech, attention, reading ability or coordination. The goal of this study is to find the genetic basis for susceptibility to seizures and associated comorbidities for RE using genomewide association approaches.

We know that RE has a genetic basis and we recently discovered the genetic cause of the EEG pattern seen in RE. The goal of REGAIN is to now find the genetic basis for susceptibility to seizures and the associated symptoms above. Our hope is to be able to improve diagnosis and understand why each child with RE is different, and perhaps point us towards new treatments that are more effective and have fewer side effects.

We will compare the genetic code of 3,000 children with RE against a similar number of people not affected by epilepsy. With the proposed large sample of participants, we will be able to pinpoint the exact changes that might lead to seizures or attention problems for example. Learning the genetic basis for these problems will deepen our understanding of the mechanisms and lead to new treatments or cures.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Rolandic Epilepsy in accordance with the following international criteria:

   * Age of first afebrile seizure 3-12 years
   * Seizures comprising focal sensorimotor seizures affecting the vocal tract and face, with or without involvement of the arm
   * Predominant sleep-related seizures
   * EEG interictal centro-temporal spikes with normal background
2. Current age 6-25 years

Exclusion Criteria:

1. No history of focal seizure
2. Normal EEG or abnormal background features on EEG
3. Known structural causes (stroke, tuberous sclerosis, infection, post-infectious or metabolic)
4. Primary diagnosis of autism or global learning disability
5. Focal central neurological deficit on clinical exam,
6. Unable to provide informed consent
7. Unable to provide blood sample
Nurse-Provided Care or Standard Care in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer

RATIONALE: Meeting with a nurse to assess symptoms and quality of life may be more effective than standard care in treating patients with breast cancer.

PURPOSE: This clinical trial is studying nurse-provided care to see how well it works compared with standard care in treating patients with stage I, stage II, or stage III breast cancer.

OBJECTIVES:

* To compare the effects of an advanced practice nurse, standardized nursing intervention protocol (SNIP) model vs usual care on overall quality of life and psychological distress of patients with stage I-III breast cancer, from initial treatment to 6 months post diagnosis.
* To compare symptom control in these two groups.
* To compare geriatric assessment outcomes in these two groups.
* To test the effects of the SNIP intervention as compared to the usual care group on resource use by these patients.
* To test the effects of SNIP on patients' and clinicians' satisfaction with care.
* To describe the effects of SNIP on patients' management of transitions from one phase of chronic illness to another.
* To identify subgroups of these patients who benefit most from the SNIP in relation to sociodemographic characteristics, disease/treatment factors, and geriatric assessment predictors.
* To obtain feedback from clinicians regarding interpretation of findings and application to the routine care of breast cancer patients.

OUTLINE: Patients are enrolled sequentially to 1 of 2 groups. Group 1 is enrolled during months 4-21 and group 2 is enrolled during months 25-54.

* Group 1 (usual care): Patient questionnaires are administered at baseline and at 3 and 6 months. The clinicians' satisfaction with care is also evaluated.
* Group 2 (advanced practice nurse \[APN\] intervention): Patients are accrued by an APN. Patients meet with the APN periodically to assess their physical well-being including ambulatory care needed, care of physical symptoms (i.e., pain, fatigue, nausea and vomiting), and psychological well-being. Questionnaires are administered at baseline and at 3 and 6 months.

In both groups, questionnaires include the FACT-Breast, Memorial Symptom Assessment Scale, Psychological Distress Thermometer, Comprehensive Geriatric Assessment, and Patient Satisfaction with Intervention. Clinicians also complete questionnaires. Patients' medical charts are also reviewed.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of stage I, II, or III breast cancer
* Admitted to City of Hope National Medical Center

  * Resides within a 30-mile radius of the medical center
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* No prior cancer

PRIOR CONCURRENT THERAPY:

* Not specified
The Double Exposure Study: The Impact of Job Strain and Marital Cohesion on Blood Pressure

Psychosocial and lifestyle stressors, such as job strain (JS) and marital factors have previously been associated with a sustained increase in blood pressure (BP).

In a one-year longitudinal follow-up to the Baseline Double Exposure cohort study, we, the researchers at Sunnybrook and Women's College Health Sciences Centre, evaluated whether JS and marital cohesion continued to be associated with ambulatory blood pressure (ABP) in subjects enrolled with normal or untreated high BP.

Psychosocial and lifestyle stressors, such as job strain (JS) and marital factors have previously been associated with a sustained increase in blood pressure (BP).

In a one-year longitudinal follow-up to the Baseline Double Exposure cohort study, we evaluated whether JS and marital cohesion continued to be associated with ambulatory blood pressure (ABP) in subjects enrolled with normal or untreated high BP.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-65
* Unmedicated for at least 6 months
* Living with spouse for at least 6 months
* Working for at least 6 months

Exclusion Criteria:

* Working rotating or evening shifts