cyrilzakka/clinical-trials huggingface dataset:
Expired Propofol in Low Back Surgery

Edmon (BBraun, Germany) is a portable, commercially available device for measurement of propofol in exhaled air.

The study will aim at evaluating the sensitivity and specificity of such exhaled propofol values compared with plasma propofol and measures of anaesthetic and antinociceptive effect.

Elective low-back surgery patients will be induced for general intubation anesthesia with propofol and remifentanil.

After induction a 20 min period of stable propofol infusion only will be established before start of surgery. The patients will be monitored for exhaled propofol, plasma propofol (blood samples), continous frontal EEG, Bispectral Index (BIS), skin conductance, estimated (computer based) concentrations of plasma and effect site propofol, and skin conductance.

After start of surgery (with ongoing propofol and restart of remifentanil TCI) the monitoring will continue in order to explore these relationships further.

Eligibility Criteria:
Inclusion Criteria:

* Elective patients scheduled for low-back surgery
* BMI between 20 -32 kg/m2
* ASA I-II
* Written informed concent

Exclusion Criteria:

* Contraindication to propofol TCI
* Use of psychopharmaco or neurologic disease
* Pregnancy or breast feeding
Music During Allogeneic Stem Cell Transplant Hospitalization

The goal of this trial is to develop an Independent Music Listening tool for stem cell transplant patients that have prolonged hospitalizations. The main questions it aims to answer are:

\[primary hypothesis or outcome measure 1\]? \[primary hypothesis or outcome measure 2\]?

Participants will use a self-guided music listening intervention of 1-hour daily music listening during their inpatient hsopitalization and delivered via web-based platform.

To address this clinical and research need in the current project, the primary aim is to (1) assess the feasibility, acceptability, and appropriateness of a self-guided music listening intervention (i.e. Independent Music Listening or "IML") comprised of 1-hour daily music listening during the inpatient hospitalization (e.g., 3-4 weeks) and delivered via web-based platform/smart phone app (e.g., Spotify or Apple music) among 35 HCT patients. Participants will be randomized to IML (n=23) or usual care control group (n=12). The secondary aims are to (2a) explore whether the IML program is associated with improvements on psychosocial self-report measures of patient quality of life, distress, and mindfulness and (2b) whether preliminary psychosocial effects of the IML program are different from a control group of patients completing usual care. In an exploratory aim, the PI will gather qualitative data on patient perceptions and reactions to daily music listening via a daily music diary and post-intervention open-ended questions. Data produced from the current study will help inform development of future interventions to improve quality of life in HCT patients that are based in arts in medicine or creative arts therapy modalities.

Eligibility Criteria:
Inclusion Criteria:

1. Participate patients need to be (a) diagnosed with a disorder that requires an allogeneic stem cell transplant, (b) scheduled for allogeneic stem cell transplant and expected to be admitted for \~3-4 weeks
2. Aged 18 years or older
3. Score ≥1 on the distress thermometer
4. Have access to a smartphone, tablet, or computer with internet capability in order to complete study surveys via Microsoft Forms and to connect to a music streaming platform via website or app
5. Able to provide informed consent.

Exclusion Criteria:

1. Individuals with significant and active cognitive (e.g., major cognitive impairment), psychiatric (e.g., active psychosis), or medical conditions (e.g., untreated significant hearing impairments) that would prevent the ability to provide informed consent or participate in the music listening intervention
2. Individuals without access to music streaming via smartphone, tablet, or computer and have access to internet.
Identification of Genes That Predict Local Recurrence in Samples From Patients With Breast Cancer Treated on NSABP-B-28

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict whether cancer will come back after treatment.

PURPOSE: This research trial is studying genes that may predict local recurrence in samples from patients with breast cancer. treated on NSABP-B-28

OBJECTIVES:

* To evaluate the association between the 21-gene Recurrence Score and risk of local-regional recurrence (LRR) in node-positive, estrogen receptor- (ER) positive (+) patients treated with cyclophosphamide and doxorubicin hydrochloride (AC) with or without paclitaxel in the NSABP-B-28 trial.
* To evaluate the potential for combining the 21-gene Recurrence Score (RS) with traditional clinico-pathologic factors in order to derive an improved algorithm for prediction of LRR risk and in order to identify subgroups of ER-positive patients with 1-3 or 4 or more positive nodes who do/do not need post mastectomy chest wall radiotherapy (XRT) or regional nodal XRT (irrespective of surgical procedure).
* To evaluate whether the 21-gene RS predicts benefit from adding paclitaxel to AC chemotherapy in reducing risk of LRR, and improving disease-free survival (DFS) and overall survival (OS) in node-positive, ER-positive patients from NSABP-B-28.

OUTLINE: RNA extracted from paraffin-embedded tissue samples are analyzed for gene expression profile by Ribogreen assay and RT-PCR. Results are then compared and analyzed with each patient clinical-pathologic factors, including tumor size, patient age, number of positive nodes (1-3, 4+), tumor grade, and surgery type (mastectomy or lumpectomy).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosed with breast cancer and enrolled on NSABP-B-28.

  * Estrogen-receptor positive (ER+)
  * Node-positive disease
* Primary tumor tissue samples available
* Treated with cyclophosphamide and doxorubicin hydrochloride and tamoxifen with or without paclitaxel

PATIENT CHARACTERISTICS:

* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Stria Gravidarum and Olive Oil for Pregnancy Women

The aim of this study was to investigate the clinical efficacy of olive oil on the severity and progression of striae gravidarum. This randomized controlled clinical trial included 156 primipara women who were early third trimester. They were randomly allocated into two groups: an experimental group and a control group. Women in the experimental group applied olive oil to their abdomen twice a day in the morning and evening. The control group had no intervention.

The development of striae is one of the most common skin changes in pregnancy. The aim of this study was to investigate the clinical efficacy of olive oil on the severity and progression of striae gravidarum.

This randomized controlled clinical trial included 156 primipara women who were early third trimester. They were randomly allocated into two groups: an experimental group and a control group. Women in the experimental group applied olive oil to their abdomen twice a day in the morning and evening. The control group had no intervention.Data were collected using maternal information form, Fitzpatrick Skin Type Scale and Davey's Severity Score.

Eligibility Criteria:
Inclusion Criteria:

* being in the age group of 20-30 years, early third trimester (being at the 28th week of gestation), having a singleton pregnancy, being primiparous, and volunteering to participate in the study.

Exclusion Criteria:

* having a chronic disease (such as diabetes or hypertension), having striae (before 28th gestation week), having traces of scar tissue from adolescence, using cortisone cream or another kind of topical cream, having polyhydramnios, having threatened preterm labor or preterm delivery, having any disease of the skin, taking any medication regularly, having a problem preventing communication, using pharmacological or non-pharmacological methods (undergoing pharmacotherapy) to reduce nausea, and undergoing psychiatric treatment (psychotherapy).
Symptom Screening With Targeted Early Palliative Care (STEP) for Patients With Advanced Cancer

Palliative care is defined as multidisciplinary care that increases quality of life (QOL) for patients with a life-threatening illness. Although it is known that patients with the most severe physical and psychological symptoms have the greatest need for palliative care, these patients are often not referred to palliative care services in a timely manner.

We have developed a system called STEP (Symptom screening with Targeted Early Palliative care) that identifies patients with high symptom burden in order to offer them timely access to palliative care. The investigators are conducting a single-arm trial at Princess Margaret Cancer Centre to determine the feasibility of a larger randomized trial of STEP versus usual care and to establish specific parameters for its planning.

Randomized controlled trials (RCTs) have shown when patients with advanced cancer were referred early to specialized palliative care teams, they had improved QOL, symptom control, and greater satisfaction with their cancer care. Such routine specialized palliative care intervention, while effective, may be challenging to enact broadly with widespread shortages of palliative care physicians. STEP systematically identifies patients with the greatest need, using symptom screening at every outpatient visit, with triage and targeted referral to palliative care. This could reduce resource use while directing care to the most vulnerable.

Patients will be recruited from Breast, Lung, Gastrointestinal, Genitourinary, and Gynecology medical oncology clinics. Consenting participants will complete questionnaires measuring outcomes of QOL, symptom control, depression, and satisfaction with care at recruitment, 2, 4 and 6 months. The objectives of the study are to assess the feasibility of conducting a larger phase III trial and to collect information to assist in trial planning and sample size calculation for such a trial. Feasibility criteria are: i) ≥100 patients accrued in 12 months; ii) ≥70% complete screening for ≥70% of visits; iii) ≥60% of those for whom a call is triggered meet at least once with the EPC team; iv) ≥60% complete measures at each endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of stage IV cancer (advanced); hormone-refractory for breast or prostate cancer; stage III or IV for lung cancer and pancreatic cancer; patients with stage III cancer and poor clinical prognosis, e.g. ovarian or esophageal cancer, will be included at the discretion of the oncologist
* ECOG performance status ≤ 2 (estimated by primary oncologist)
* Prognosis of \>6 months (estimated by primary oncologist)
* Patient completes symptom screening in outpatient clinic electronically

Exclusion Criteria:

* Insufficient English literacy to complete questionnaires
* Inability of pass the cognitive screening test (SOMC - Short Orientation Memory Concentration test score \<20 or \>10 errors)
* Receiving specialized palliative care within the last 6 months prior to screening, per chart and patient statement.
tDCS & Auditory Hallucinations in Schizophrenia

The aim of this study is to evaluate tDCS effects on schizophrenia symptoms, particularly on auditory verbal hallucinations. tDCS applied with cathodal (inhibitory) electrode over the left temporal parietal junction and anodal (excitatory) electrode over the left dorsolateral prefrontal cortex.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-60
* Primary diagnosis of Diagnostic and Statistical Manual, fifth edition, schizophrenia
* Persistent auditory verbal hallucinations
* Right handed
* Under stable doses of antipsychotic medication for ≥4 weeks
* Normal hearing by self-report and physical exam
* Use of effective method of birth control for women of childbearing capacity
* Capable to provide informed consent. For patients judged to be incapable to provide informed consent the legal guardian of the patient must agree to participation in the study and provide signed informed consent

Exclusion Criteria:

* Current or past history of substance dependence or abuse (excluding nicotine)
* Other current Axis I disorders
* History of seizure, epilepsy in self or first degree relatives, stoke, brain surgery, head injury, intracranial metal implants, known structural brain lesion, devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
* Frequent and persistent migraines
* History of adverse reaction to neurostimulation
* Participation in study of investigational medication within 6 weeks
* Pregnancy
* Women who are breast-feeding
* Current significant laboratory abnormality
IPACK and Adductor Canal Catheter Patient Outcomes for TKAs?

This study evaluates the addition of the IPACK block to the adductor canal block and catheter in the pain management of total knee arthroplasty. Half of participants will receive the adductor canal block and catheter with the IPACK block, while the other half will receive the adductor canal block and catheter only.

Total knee arthroplasty (TKA) is a surgical procedure that can be associated with significant post-operative pain. Poor pain control in the post-operative period has contributed to delays in early mobility and rehabilitation, an important part of recovery that is best started as soon as possible after surgery. Regional techniques in general have helped manage post-operative pain as well as minimize narcotic use. The application of femoral and sciatic nerve blocks has been shown to decrease opioid use; however, they were associated with adverse events such as quadriceps weakness and falls post-operatively. This led to the development of the adductor canal block (ACB) which has gained favor for providing superior analgesia over opioids alone, and for the added benefit of sparing the quadriceps muscle. Recently, adding local anesthetic to the interspace between the popliteal artery and posterior capsule of the knee (IPACK) blocks have been used to help address pain in the posterior part of the knee that is not well covered by the adductor canal block alone. While the sciatic nerve block is also an option to cover this area, it is associated with foot drop which can hinder early mobility. For patients undergoing TKAs at UCLA, our standard of practice is the ACB. The investigators hope to show with this study that adopting this novel block will help with post-operative pain control, decrease length of hospital stay, and increase distance walked during physical therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing total knee replacement without contraindications to regional blocks

Exclusion Criteria:

* Patients who have contraindications to regional blocks: infection at injection site for the nerve block, allergy to local anesthetics, history of a bleeding disorder
Esophagogastrectomy Versus Extended Gastrectomy in AEG II

Comparison of the oncological outcome of patients who underwent esophagogastrectomy versus extended gastrectomy due to carcinomas of the esophagogastric junction (Siewert type II)

The esophagogastric junction (EGJ) is an anatomical region where different tumour entities which should be treated with different surgical approaches. Carcinomas within this area cause discordance concerning the classification due to the topographical borderland between the esophagus and the stomach. The definition, classification and staging of adenocarcinomas of the esophagogastric junction (AEG) have been inconsistent and are challenging. Siewert provided a system for classifying the tumours into three types based on topographical-anatomical criteria with direct impact on therapeutic strategies and wide acceptance in Europe. Adenocarcinomas of the esophagogastric junction type I involve the distal esophagus and mostly arise in intestinal metaplasia of Barrett's esophagus; AEG type II originates at the anatomical cardia and AEG type III are subcardial gastric carcinomas infiltrating the esophagogastric junction and distal esophagus from below. The mix of esophageal and gastric classification systems and especially, the controversy of the cell of origin of AEG type II present significant difficulties in defining this entity. The 7th edition of the American Joint Committee on Cancer/Union Internationale Contre Cancer (AJCC/UICC) classification presented a new definition of AEG in 2009. A tumour is classified as esophageal as soon as it extends into the esophagus and its epicentre is located within 5cm of the esophagogastric junction. Thus, Tumours with an epicentre in the stomach and distance greater than 5cm from the esophagogastric junction (EGJ) or those within 5cm of the EGJ but without extension into the esophagus are staged as gastric carcinoma. Most of the cardia carcinomas which originally were staged according to the gastric cancer TNM classification are now staged according the esophageal carcinoma TNM classification. Accurate preoperative staging of Siewert type II tumours is a challenge. Apparently, AEG type II show a specific biology with a high rate of lymph node metastases in comparison to distal esophageal carcinomas. The optimal surgical approach ranges from extended gastrectomy to radical esophagogastrectomy. In our opinion, an esophagogastrectomy with colonic interposition could be suggested as an appropriate approach in AEG type II. Therefore, we analyzed the oncological outcome of patients who underwent esophagogastrectomy versus extended gastrectomy due to carcinomas of the esophagogastric junction (Siewert type II).

Eligibility Criteria:
Inclusion Criteria:

* Carcinoma of the esophagogastric junction (AEG type II)
* Age of Minimum 18 years

Exclusion Criteria:

* non
Efficacy of Split Gait in the Treatment of Dynamic Asymmetries in Subjects With Pathologic Claudication

Walking on a split-belt treadmill (each of the two belts running at a different speed) imposes an asymmetrical gait, mimicking limping that has been observed in various pathologic conditions. This walking modality has been proposed as an experimental paradigm to investigate the flexibility of the neural control of gait and as a form of therapeutic exercise for hemi-paretic patients. However, the scarcity of dynamic investigations both for segmental aspects and for the entire body system, represented by the centre of mass, challenges the validity of the available findings on split gait.

Compared with overground gait in hemiplegia, split gait entails an opposite spatial and dynamic asymmetry. The faster leg mimics the paretic limb temporally, but the unimpaired limb from the spatial and dynamic point of view. These differences suggest that a partial shift in perspective may help to clarify the potential of the split gait as a rehabilitation tool.

The aim of the present study is to investigate the dynamic asymmetries of lower limbs in adults with unilateral motor impairments (e.g. hemiplegia post-stroke, Parkinson's disease, multiple sclerosis, unilateral amputation, surgical orthopedic interventions) during adaptation to gait on a split-belt treadmill. The sagittal power provided by the ankle and the total mechanical energy of the centre of mass will be thoroughly studied. The time course of phenomena both during gait when the belts are running at different speed and when the belts are set back to the same speed (i.e. the after-effect) will be investigated.

A greater dynamic symmetry between the lower limbs is expected after split gait. The question whether this symmetry will occur when the pathological limb is on the faster or the lower belt will be disclosed. Some alterations of the motion of the centre of mass during split gait are also expected.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 70 years old;
* ability to walk for at least 20 meters without support;
* ability to wittingly sign the informed consent form;
* ability to understand the instructions and to complete the motor task;
* visual acuity \> 10/20 on the worse side, with optical correction;
* unilateral motor impairments of one lower limb as a consequence of various pathologic conditions, such as (not exhausting list): post-stroke hemiparesis, Parkinson's disease with lateral asymmetry in the motor symptoms, multiple sclerosis with lateral asymmetry in the motor symptoms, unilateral amputation with prosthetic correction, surgical orthopedic interventions, unilateral lesions of peripheral nerves.

Exclusion Criteria:

* systemic neurologic pathologies;
* orthopedic surgical interventions, other than those determining the inclusion criteria;
* symptomatic pathologies of rachis;
* other sensory or neurological pathologies with impact on balance and gait;
* pregnancy.
Effects of Synergy on Nutrient Intake and Acceptability in Phenylketonuria (PKU)

Phenylketonuria (PKU) is a rare inherited metabolic disorder, where subjects are born with a genetic deficiency in the phenylalanine hydroxylase enzyme (PAH), which leaves them unable to convert Phenylalanine (Phe) into Tyrosine (Tyr). Patients with mild PKU or partly responsive to the drug synthetic tetrahydrobiopterin (BH4) (Kuvan®) can change to a more relaxed diet. However due to difficulty to adapt their diet, these patients are at risk of an imbalanced nutritional status and an insufficient intake of specific micronutrients, essential amino acids and DHA (Docosahexaenoic acid). The study product is designed to improve the nutritional status of the patients.

The study investigates if the nutritional status is indeed improved following 24 week use of the study product, and also the study aims to evaluate product acceptability.


Eligibility Criteria:
Inclusion criteria:

1. PKU subjects identified by newborn screening and started low-Phe diet before 3 months of age
2. PKU subjects (with or without current AAM use) with an increased Phe-tolerance/intake due to:

   * Mild PKU phenotype
   * BH4 treatment
3. If treated with BH4, PKU subjects should be on a stable BH4 treatment for at least 26 consecutive weeks up to start test product intake
4. Age≥12 years
5. If subjects (irrespective whether BH4 users or mild PKU) use amino-acid mixture(s; AAM), then a maximum of 25 Protein Equivalents (PE) derived from the AAM per day applies and usage on a daily basis for at least 26 consecutive weeks up to Visit 1
6. If subjects (irrespective whether BH4 users or mild PKU) use AAMs they should be capable and willing to substitute their current AAM(s; maximum of 25 PE per day) with one portion of the test product per day
7. If subjects (irrespective whether BH4 users or mild PKU) use omega-3, antioxidant, and/or vitamin supplements, to stop usage of the supplements and be able and willing to substitute with the test product
8. Willing and able to comply with study procedures
9. Willing and able to provide informed consent (and assent in case of minors if required by local law/regulations)
10. For women of childbearing potential: not to have the intention to become pregnant during the study

Exclusion Criteria:

1. For women: Currently pregnant or lactating
2. Current or prior use of the test product within six weeks prior to entry into the study
3. Concurrent conditions (including renal failure and severe hepatic failure) and medication that could interfere with participation, outcome parameters or safety (as determined by Investigator)
4. Psychotropic medication (i.e. medication affecting the nervous system) and inotropic medication
5. Any condition creating high risk of poor compliance with study
6. Participation in any other studies involving investigational or marketed products concomitantly or within six weeks prior to entry into the study. Except for studies related to Kuvan® (synthetic tetrahydrobiopterin (BH4)) without diagnostic, therapeutic or experimental intervention.