cyrilzakka/clinical-trials huggingface dataset:
Development and Research of an Individualized Intelligent Platform for Rehabilitaion in Parkinson's Disease

The present study aims to compare the clinical efficacy of intelligent POWER therapy, intelligent LSVT-BIG therapy, and the three exercise models currently in clinical use. DCM_IR analysis will also be incorporated into the analysis to develop a personalized and intelligent Parkinson's rehabilitative therapy platform.

Background:

Parkinson's disease is a progressively degenerative disorder. Patients need early screening, therapeutic intervention, and personalized interaction with outpatient rehabilitative treatment. In the past, it had been difficult to meet these goals. Recent advances in bio-sensors technology has enabled collection of bio-metric data. Models of brainwave analysis have also matured. In addition, our ability to analyze vibrational spectrogram had also greatly improved. How to combine these enabling technologies to meet the needs of Parkinson's patients is an urgent topic of research.

Objective:

The present study aims to compare the clinical efficacy of intelligent POWER therapy, intelligent LSVT-BIG therapy, and the three exercise models currently in clinical use. DCM_IR analysis will also be incorporated into the analysis to develop a personalized and intelligent Parkinson's rehabilitative therapy platform.

Method:

Patients will be randomly assigned into three groups, i.e. intelligent POWER, intelligent LSVT-BIG, and current protocol group. Single blind data collection will be used. Patients will be evaluated immediately before treatment, immediately after treatment, and 4 weeks after treatment. Evaluated criteria will include mini-BESTest, Unified Parkinson's disease rating scale, muscle power of lower extremity, time up and go, walk velocity, step length, cadence, and Parkinson's disease questionnaire PDQ-39.

Expected Outcome:

An intelligent rehabilitative therapy platform may be built on the sensor data and neural-network analysis of the data. The platform will enable patients to interact with medical personnel on out-patient basis. If further combined with DCM_IR analysis, personalized therapeutic efficacy indicator may be uncovered, thereby, realizing intelligent personalized rehabilitative therapy.

Eligibility Criteria:
Inclusion Criteria:

1. .Parkinson's disease diagnosis, Hoehn-Yahr level I-III
2. .Stable medicine intake for 2 weeks at least
3. .Able to walk independently for 15 meters
4. .Aged 40-85 years old

Exclusion Criteria:

1. .Cognition deficits(MMSE score\<24)
2. .Combined other neurological disease, such as stork, SCI, and so on.
3. .Pregnant or Breastfeeding
Regorafenib in Subjects With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy

This is an open-label phase III study of regorafenib in patients with metastatic colorectal cancer (mCRC) who have progressed after all approved standard therapy. The purpose of this study is to provide additional information about the safety profile of Regorafenib.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects \>/= 18 years of age
* Life expectancy of at least 3 months
* Histological or cytological documentation of adenocarcinoma of the colon or rectum
* Subjects with metastatic colorectal cancer (Stage IV)
* Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab if KRAS WT (WT: wild-type i.e. no KRAS mutation)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of \</= 1
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements
* Women of childbearing potential and men must agree to use adequate contraception since signing of the inform consent (IC) form until at least 3 months after the last study drug administration

Exclusion Criteria:

* Prior treatment with regorafenib
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug
* Pregnant or breast-feeding subjects
* Congestive heart failure \>/= New York Heart Association (NYHA) class 2
* Myocardial infarction less than 6 months before start of study drug
* Ongoing infection \> Grade 2 Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
* Renal failure requiring hemo-or peritoneal dialysis
Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch

150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. The women will be randomly assigned to one of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of postmenopausal status

Exclusion Criteria:

* Contraindication to estrogen therapy
NLP Headache Speech (NLPH-SPEECH): a Cross-sectional Study on Natural Language Processing Analysing Spoken Monologues by Headache Patients

The research collects spoken descriptions of headache disorders by participants with headache disorders. The speech recordings are analyzed by natural language processing (NLP) tools to analyse linguistic properties of the texts and to obtain insight into the potential of NLP machine learning models for the recognition of headache syndromes of the participants.


Eligibility Criteria:
Inclusion Criteria:

* is a patient of the tertiary headache clinic at Ghent University Hospital
* is 18 years or older
* has Dutch as native speaking language

Exclusion Criteria:

* has difficulties in producing spoken language
* has limited or no knowledge of Dutch
Long-Term Assessment of Quality of Life and Effectiveness of Onabotulinumtoxina Injections in Provoked Vestibulodynia

The study aims to assess and compare the pain in women suffering from provoked vestibulodynia, before treatment with botulinum injections, 3 months after treatment and 18 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Vestibulodynia rated B2 according to 2003 International Society for the Study of Vulvovaginal Disease (ISSVD) classification
* Patients previously treated no later than18 months ago for provoked vestibulodynia with botulinum toxin injections, in the University Hospital of Besançon.

Exclusion Criteria:

* Major psychologic disorders.
Modeling Stress-precipitated Vaping Behavior

The primary aims of this pilot study were to (1) initially validate the applicability of a human laboratory model of relapse initially developed for smokers to e-cigarette users; (2) to use this human laboratory model of lapse behavior to examine the effects of acute psychological stress on vaping-lapse behavior among adults who are experienced, e-cigarette users.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* e-cigarette users
* using ≥1 mL of e-cigarette liquid per day with a nicotine concentration of ≥3mg/ml
* had used an e-cigarette for at least three months

Exclusion Criteria:

* Current smokers
* Psychiatric or medical condition based
* Using a prescription medication other than birth control
Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial.

Low-dose aspirin started in the first-trimester has been associated with a decrease of preeclampsia, fetal growth restriction and preterm birth in high-risk pregnancies. Multiple pregnancies are considered a risk factor for all those adverse outcomes. The main objective of the current trial is to evaluate whether a dose of 80 mg of aspirin is associated with an improvement of birthweight compared to placebo in twin pregnancies.

Twin pregnancies represent approximately 3% of births and are associated with increased risks of complications such as preeclampsia, fetal growth restriction and preterm birth. All of these complications are commonly associated impaired placental function and low birth weight.

Most prophylactic measures tested over the years have failed to prevent these adverse outcomes in twin pregnancies. Since administration of low-dose of aspirin can improve placental function and all these adverse outcomes in high-risk pregnancies, mainly in women with prior adverse outcomes, we suggest that similar benefits could be seen in twins. We are expecting that the administration of low-dose of aspirin starting in the first-trimester in twin pregnancies could lead to an improvement of placental function, a reduction or these adverse perinatal outcomes and therefore to an improvement of birthweight.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 8 0/7 and 13 6/7 weeks
* Twin pregnancy confirmed by ultrasound

Exclusion Criteria:

* One or two negative heart beat
* Previous hypertensive disorder of pregnancy
* Pre-existing hypertension or diastolic blood pressure \>90 mmHg at randomization
* Pre-existing nephropathy
* Pre-existing diabetes (type 1 or 2)
* Anaphylactic allergy to lactose
* Known coagulopathy (antithrombin III deficiency, factor V Leiden, antiphospholipid syndrome, the prothrombin mutation, deficiency of protein S or protein C)
* Use of heparin or other anticoagulants.
* Contre-indications to aspirin
* Discordance of crown-rump length greater than 20%.
* Fetal anomalies (cystic hygroma, nuchal translucency \> 95th percentile, anencephaly, omphalocele, etc.)
* Previous or current gastric ulcer
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease

The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.

IPX066 is intended for chronic treatment of motor symptoms for all stages of PD. This study is designed to enroll subjects who have successfully completed one of the following studies of IPX066:

* IPX066-B08-05 (A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease)
* IPX066-B08-11 (A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa - Levodopa)
* IPX066-B09-02 (A Study to Evaluate the Safety and Efficacy of IPX066 in Advanced Parkinson's Disease)

All participants will be given IPX066 for 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Each subject must meet the following inclusion criteria in order to be enrolled in the study:

  1. Successful completion of studies IPX066-B08-05, IPX066-B08-11, or IPX066-B09-02.
  2. In the opinion of the Investigator, the Parkinson's disease diagnosis is still valid and the subject remains eligible for LD therapy.

Exclusion Criteria:

* Each subject must be free of the following exclusion criteria in order to be enrolled in the study:

  1. Received an investigational medication other than those from an IPX066 trial within 4 weeks prior to the planned start of treatment.
  2. Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation.
  3. Received within 4 weeks prior to Baseline Visit or planning to take during study participation: nonselective monoamine oxidase (MAO) inhibitors (with the exception of rasagiline).
  4. In the opinion of the Investigator, should not participate in the study.
Relationship of Lifestyle Habits and Health Characteristics of Parents and Children

Lifestyle habits and health characteristics (e.g., excess weight) acquired in childhood and adolescence have a good chance of being carried into adulthood. In this sense, seeking to understand which factors can influence these habits and/or characteristics is of paramount importance. One of these factors that can influence the health of children and adolescents are the lifestyle habits and characteristics of these young people's parents. One of the lifestyle habits that appears to be related between parents and children is physical activity. However, most studies analyze the practice of physical activity between parents and children only considering the practice of total physical activity, that is, not considering the different domains of physical activity \[ i) physical efforts carried out in the work environment, occupations in the case of adults and in the school environment in the case of children and adolescents; ii) physical activities carried out during leisure time; iii) physical activities carried out in the form of active commuting\], in addition to there being little information considering the different intensities of physical activity (light, moderate, vigorous and very vigorous). Another gap to be addressed is the relationship between other health variables between parents and children, including unhealthy lifestyle habits, such as smoking, eating disorders and symptoms of anxiety and depression, as well as adverse health conditions, such as the presence of chronic diseases. and overweight, would be different considering the parents' practice of physical activity, for example; whether the possible relationship between excess weight between parents and children would be similar in children of physically active parents when compared to children of insufficiently active parents. Therefore, the objective of the present study will be to verify whether the different domains and intensities of physical activity are related between parents and children, as well as to verify whether other lifestyle habits and health characteristics are related between parents and children, considering the levels of activity. physical status of parents (physically active and insufficiently active).


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescent over 6 years old.

Exclusion Criteria:

-
A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients With AIDS

To compare the efficacy, safety, and tolerance of fluconazole single daily capsule for 14 days versus clotrimazole troche 5 x daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Cimetidine.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Known history of intolerance or allergy to imidazoles or triazoles, or the non-azole components of clotrimazole troches (dextrose, cellulose, povidone, magnesium stearate).
* Moderate or severe liver disease defined by specified lab values.

Concurrent Medication:

Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:

* Barbiturates.
* Phenytoin.
* Coumarin-type anticoagulants.
* Rifampin.
* Oral hypoglycemics.
* Cyclosporin.

Patients with the following are excluded:

* Known history of intolerance or allergy to imidazoles or triazoles, or the non-azole components of clotrimazole troches (dextrose, cellulose, povidone, magnesium stearate).
* Unable to tolerate oral medication.
* Moderate or severe liver disease defined by specified lab values.
* Life expectancy \< 4 weeks.
* Unable or unwilling to be followed at the same center for the conduct of this study.

Prior Medication:

Excluded within 3 days of study entry:

* Other antifungal agents.
* Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:
* Barbiturates.
* Phenytoin.
* Coumarin-type anticoagulants.
* Rifampin.
* Oral hypoglycemics.
* Cyclosporin.

Patients meeting CDC criteria for diagnosis of AIDS, or having serologic or virologic evidence of HIV infection (but without AIDS-defining opportunistic infections as of yet).

* Patients who have given informed consent in writing to their participation in the study.
* Patients with signs of oropharyngeal candidiasis, i.e., with typical white plaques.
Neurophysiological Evaluation of Residual Cognitive Functions in Patients With Severe Alterations of Consciousness

Identify potential markers of recovery through event-related potentials (ERPs) in the evolution of altered consciousness with potential ability to discriminate between different conditions of altered state of consciousness.

Identify potential markers with prognostic value, in order to identify personalized and specific intensive rehabilitation paths based on the outcome indexes obtained.


Eligibility Criteria:
Inclusion Criteria:

* Glasgow Coma Scale (GCS) \> 8;

Level of Cognitive Scale (LCF) = 1-3;

Signature of the consent from the family member and/or guardian.

Exclusion Criteria:

* Failure to sign the consent of the family member and/or legal guardian;

Patients with cranial anatomical alterations that do not allow the correct assembly of the electrodes, caps, etc.;

Patients with absence of neurophysiological responses in visual evoked potentials (VEP) and with absence of peripheral waves (I-II wave) to acoustic potentials (PEA).
Efficacy of Erector Spinae Plane Block for Postoperative Analgesia in Adult Patients Undergoing Thoracoscopy

The erector spinae plane block has been recently described as an effective analgesic postoperative pain treatment in case reports. It consists of injecting local anaesthetics below the erector spinae muscle, at the level of the transverse processes, in order to anaesthetize the thoracic roots coming out from the spinal cord. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore, the objective of this study is to investigate the analgesic benefit of this block on patients scheduled for thoracoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for thoracoscopy
* physical status I-III

Exclusion Criteria:

* allergy to local anaesthetics
* other contraindications to peripheral nerve blocks
* patients suffering from chronic pain condition
Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study

The purpose of this research is to understand cancer related fatigue in patients with non-small cell lung cancer (NSCLC), who are being treated with an immune checkpoint inhibitor.

This is an observational pilot study. The target population includes non-dyad caregivers and adult patients diagnosed with inoperable NSCLC receiving an immune checkpoint inhibitor and report concerns of fatigue to their provider and caregivers. This study will be conducted at Levine Cancer Institute (LCI) and Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AHWFBCCC). This study consists of qualitative interviews at two-time points, the primary, and the follow-up. During the primary interview, patients with NSCLC will be asked to complete the PROMIS® Fatigue-Short Form 7a consisting of seven items and caregivers will be asked to complete the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN) form consisting of 5-items in the caregiving workload subscale. During the follow-up interviews, participants will be asked about any change in their fatigue and views on physical activity.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* ≥ 18 years of age at the time of study entry.
* Patients with inoperable NSCLC confirmed by histologic or cytologic documentation and by clinical assessment.
* Patients have completed at least two cycles of immune checkpoint inhibitors (adjuvant, unresectable, or advanced metastatic disease) as a monotherapy.
* If adjuvant or unresectable, immunotherapy must be planned for at least one year.
* If advanced metastatic NSCLC, immunotherapy must be planned for at least two years.
* Self-reported cancer or treatment related fatigue as noted in the patient's medical record or per treating physician.
* Life expectancy of greater than 6 months.

Caregivers:

* 18 years of age at the time of study entry.
* A family member or friend helping a patient with NSCLC would be eligible for this study in any of the following ways as outlined by the National Cancer Institute:
* Helping with day-to-day activities such as doctor visits or preparing food
* Giving medicines or helping with physical therapy or other clinical tasks
* Helping with tasks of daily living such as using the bathroom or bathing
* Coordinating care and services from a distance by phone or email
* Giving emotional and spiritual support

Exclusion Criteria:

Patients:

* Patients who are currently receiving or have received chemotherapy and/or radiation within the past 1 year.
* Diagnosis of dementia.
* History of clinical depression.
* Current treatment for sarcopenia and anemia or hemoglobin below 10.
* Untreated hypothyroidism.
* Symptomatic heart failure.
* Oxygen dependent lung disease.
* Cognitively unable to complete interviews.

Caregivers:

- Cognitively unable to complete interviews.
Follow-up Strategy for Esophageal Cancer Patients

The recurrence risk of patients with esophageal cancer was stratified by integrating different stages and pathological factors. The risk of recurrence was dynamically estimated for each group of patients, and the optimal follow-up strategy was developed based on the recurrence risk.

Patients with histologically proven, esophageal cancer (EC) patients diagnosed between 2008 and 2018 were recruited. Recursive partition analysis was applied to develop recurrence risk stratification for patients. The follow-up strategies of each stratification were developed based on monthly recurrence probability and validated by bootstrap validation and an external dataset. Markov decision-analytic models were constructed to evaluate the cost-effectiveness of the follow-up strategies.

Eligibility Criteria:
Inclusion Criteria:

(1) Patients aged between 18 and 80 years old; (2) Pathological diagnosis as esophageal squamous cell carcinoma or adenocarcinoma; (3) Patients underwent esophagectomy and received R0 resection.

Exclusion Criteria:

(1) Patients with secondary primary tumor; (2) Patients who died within 30 days after surgery or died of post-operation complications; (3) Patients missing essential clinical information, such as operation record, pathological diagnosis, and follow-up data; (4) Patients with radiologically or histologically confirmed distant metastasis; (5) Patients previously underwent endoscopic mucosal resection or definitive radiochemotherapy as initial treatment.
Timing of Tracheostomy in COVID-19 - Impact on Mortality

How timing of tracheostomy in COVID-19 patients changed and its impact on mortality in patients with severe COVID-19 ARDS


Eligibility Criteria:
Inclusion Criteria:

- Severe COVID-19 infection requiring endotracheal intubation and prolonged invasive ventilation as part of the treatment of severe to moderate acute respiratory distress syndrome.

Exclusion Criteria:

* COVID-19 disease, without the need for endotracheal ventilation.
* COVID-19 disease with need for endotracheal intubation with anticipated short-term invasive ventilation.