cyrilzakka/clinical-trials huggingface dataset:
Tango for Neuropathy Among Breast Cancer Survivors

Group dance classes have been found to improve markers of quality of life and physical health (i.e., balance) among some populations engaged in rehabilitation, such as the elderly and individuals with Parkinson Disease. However, such interventions have yet to be studied among cancer survivors despite the relevance of quality of life and physical health within cancer survivorship. Group dance classes are a promising avenue in that they deliver activity-based medicine in a social context, thus potentially improving physical as well as psychosocial aspects of health. To further this avenue of inquiry, we propose to study the effect of dance-based interventions for cancer survivors.

Participants will be randomized (1:1) to one of two activity intervention arms: Argentine Tango dance or home exercise. Information about neuropathy symptoms, motion, falls incidence, and participant feedback about the interventions will be collected.

Aim1: To evaluate change in postural control over 16 sessions of Tango (exp) vs HEX (control) (n=26 per group) as primary endpoint. As secondary measures, to assess: balance function (i.e., TUG) and patient-reported outcomes (PROs) (i.e., symptoms, pain, fatigue, mood, quality of life) monthly including 1 month post-intervention completion; postural control and symptoms within-session; and falls incidence weekly for 6 months following intervention completion. Hypothesis: At primary endpoint, participants in the experimental group will show more improvement than participants in the control group in measures sensitive to neuropathy disease state (i.e., sway variability and area).

Aim2: To evaluate change in gait variability after 16 sessions of Tango (exp) vs HEX (control) (n=26 per group; 1:1 randomization). As secondary measures, to analyze local and orbital dynamic stability (pre, post, and 1mo post-intervention), PROs (monthly), and falls incidence (weekly) following intervention completion. Hypothesis: At primary endpoint, participants in the experimental group will show more improvement than participants in the control group in measures of gait variability (i.e., stride-to-stride variability in speed).

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer survivor stage I-III
* Symptomatic for neuropathy
* postural control outside 70% CI for adults who are middle-aged without neurotrauma
* having completed taxane-based chemotherapy treatment at least 3 months ago;
* able to understand and comply with directions associated with testing and study treatments.

Exclusion Criteria:

* Pre-existing vestibular deficit;
* poorly controlled diabetes (hgA1C \> 8);
* non-ambulatory or lower extremity amputation (assistive devices allowed);
* use of cytotoxic or immunotherapy during study (endocrine therapy allowed);
* participation in physical therapy during the study;
* contraindication to participate in Tango due to orthopedic issue (e.g., herniated vertebral disc);
Low Sodium Diet in Oligohydramnios Assigned for Conservative Management

The investigators want to examine whether low salt diet can increase the amniotic fluid index in patients diagnosed with oligohydramnios and assigned for conservative management. A randomized controlled trial

Few studies have addressed the changes in maternal diet as affecting the composition and amount of amniotic fluid.

Some articles have shown an increase in amniotic fluid volume as a result of maternal hydration during pregnancy through intravenous fluid infusions and oral fluid intake, the increase was evident in women with amniotic fluid and women with normal amniotic fluid volume. In a mechanism similar to that of liquid hydration, a low-salt diet may lead to an increase in the volume of amniotic fluid.

The investigators would like to examine whether a low-salt diet in women with amniotic fluid is able to significantly increase the amount of amniotic fluid compared with a regular diet.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 24-37 weeks of gestation, single fetus, who were diagnosed with an amniotic fluid index at the 5th percentile or below, according to the current gestational age
* No medical indication for immediate delivery

Exclusion Criteria:

* Refusal to participate in the study
* A medical recommendation for delivery within two weeks of diagnosis
* Fetal malformation or proof of fetal infection that known to cause oligohydramnios (eg CMV).
* Premature rupture of membrane
* Multiple pregnancy
* Medical contraindication to the low-salt diet
Immune Disorder HSCT Protocol

This study hypothesizes that a reduced intensity immunosuppressive preparative regimen will establish engraftment of donor hematopoietic cells with acceptable early and delayed toxicity in patients with immune function disorders. A regimen that maximizes host immune suppression is expected to reduce graft rejection and optimize donor cell engraftment.


Eligibility Criteria:
Inclusion Criteria:

* \</= 28 years of age
* Performance status \>/= 40
* DLCO \>/= 40%
* LVEF \>/=40% or LVSF \>/=26%
* Serum creatinine \< 2x ULN
* Liver enzymes \</= 5x ULN
* Negative pregnancy test
* Suitably matched donor (6/6 matched sib UCB, 8/8 matched sib BM or PBSC, 5-6/6 matched unrelated UCB, 7-8/8 matched unrelated BM, double cord)

Exclusion Criteria:

* Known diagnosis of HIV I/II
* Pregnant or breastfeeding
* Uncontrolled invasive fungal or bacterial infections within 1 month prior to starting alemtuzumab
* Uncontrolled viral infection within 1 week prior to starting alemtuzumab
An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants

The purpose of this study is to describe contemporary, real-world patterns of participant characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with newly diagnosed \[ND\] multiple myeloma (MM) and participants with relapsed/refractory \[R/R\] MM.

This is a prospective, non-interventional, observational study. This study will look at contemporary, real-world patterns of participant characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with MM. Participants will not be asked to change their routine clinical treatment. Participants will have to complete patient reported outcomes (PROs) surveys during on-site routine office visits.

The study will enroll approximately 4200 participants. Participants will be assigned to one of the following cohorts based upon the diagnosis of MM:

* ND MM within 3 months from initiation of treatment
* R/R MM who have received 1 to 3 prior lines of therapy

This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 8 years. Participants will be evaluated and followed-up for a period of at least 5 years, until death, are lost to follow-up, or the end of the study, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

Is 18 years of age or older.

Is experiencing the following:

1. Newly diagnosed MM within 3 months from initiation of treatment with documented month and year of diagnosis, criteria met for diagnosis, stage, and MM-directed treatment history, including duration, or
2. Relapsed/refractory MM who have received 1 to 3 prior lines of therapy with documented data in the medical record regarding diagnosis (month and year), the regimens used in 1st, 2nd, and 3rd line as applicable, whether stem cell transplant was part of 1st, 2nd, and 3rd line of therapy, whether consolidation/maintenance was part of 1st, 2nd, and 3rd line of therapy, also whether investigational therapy/treated on a clinical trial was part of any of these regimens.

Is willing and able to sign informed consent to participate. Is willing and able to complete patient-reported outcomes (PROs) in accordance with local regulatory and data protection requirements.

Exclusion Criteria:

Is reporting to a site in this study for a second opinion (consultation only) or participants whose frequency of consult and follow-up are not adequate for quarterly electronic case report form (eCRF) completion.

Has participated in another study (observational or interventional) that prohibits participation in this study.
Study of Serum Tumor Markers of HBV Associated HCC

In this study, the investigators will detect the expression of four potential HBV-related HCC biomarkers: PGIR,FAM3C,LAMB1 and SDC4 in tumor tissues and peripheral blood, to explore the specific molecular markers for the early diagnosis of HBV-related HCC.

Paired hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) and adjacent liver tissues were selected, and the mRNA and protein expressions of the PGIR,FAM3C,LAMB1 and SDC4 biomarkers in tissues were detected by RT-PCR, western Blot and immunohistochemical analysis. At the same time, healthy subjects were selected as the control group, and mRNA and protein expression levels of the above molecules in blood were detected by RT-PCR and ELISA. At the same time, the correlation between the above biomarkers and the clinical data of patients, such as diagnosis, pathological grading, recurrence, metastasis and survival time was statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* No local or systemic treatment was performed before surgery. The patients were finally diagnosed with HBV-related HCC by examination and imaging examination, and the clinicopathologic data were complete.

Exclusion Criteria:

* Patients with benign liver diseases, such as hepatic cysts and hepatic hemangiomas, or have tumors other than HBV-related HCC.
Home Sleep and Metabolism

Bedtimes and wake-up times vary from person to person. The aim of this research is to examine the associations between sleep habits and metabolism in healthy people. In this study, the investigators will collect information on sleep-wake habits and how the body uses energy.


Eligibility Criteria:
Inclusion Criteria:

* Age: 21-40 years
* Body mass index: 25.0 to 29.9 kg/m2
* Average habitual sleep duration of 6.5 hours or less per night (as confirmed by actigraphy)
* stable sleep habits for the past 6 months

Exclusion Criteria:

* obstructive sleep apnea or history of any other sleep disorder
* night or rotating shift work (current or in the past 2 years)
* habitual daytime naps
* recent (\< 4 week) travel across time zones
* extreme chronotypes
* any acute or chronic medical condition
* diabetes
* prior or current eating or psychiatric disorders
* claustrophobia
* irregular menstrual periods, menopause, pregnancy,
* alcohol abuse, excessive caffeine intake, smoking, illegal drug use
* subjects who are currently following a weight loss regimen or any other special diet or exercise programs
* subjects who have received iv or oral contrast in the past 2 weeks
* use of any prescription medication that can affect sleep or metabolism with the exception of antihypertensive and lipid lowering agents as follows. Subjects who are taking anti-hypertensive medication and/or lipid-lowering agents will be included only if they are well controlled and on a stable regimen (no change in medications in the previous 3 months). However, beta-blockers and thiazide diuretics will not be allowed, as these medications are known to affect insulin sensitivity. Women will be required to not be on hormone replacement therapy.
Heart Rate Variability (HRV) Analysis in Patients With Nocturnal Epileptic Seizures

Epilepsy is disabling and costly to patients and the health service. Nearly 400,000 people in England suffer from epilepsy. About 40% of these patients are known to have seizures predominantly in sleep. All seizures pose risk to the individual both physical and psychological. Nocturnal seizures pose extra risk as the diagnosis may be missed or delayed. Patients with nocturnal seizures are also thought to be at particular risk of sudden unexpected death in epilepsy (SUDEP), especially if their seizures are unobserved. In patients with poor seizure control, the risk of SUDEP has been found to be as high as 9 per 1,000 patient years. Previous studies show that many seizures are associated with changes in the Autonomic Nervous System (ANS) tone. The ANS tone can be assessed using heart rate variability parameters (HRV). A few studies suggest that ANS tone changes tend to precede the onset of epileptic seizure related surface electroencephalographic (EEG) changes, suggesting that ANS tone changes could be used in seizure alarm or intervention systems. This prospective study intends to focus on seizures from sleep and study HRV parameters in the immediate preictal state of the seizure and compare these with resting HRV parameters in the same patient with the aim of finding HRV metrics which could help to identify the presence of seizures in longterm electrocardiographic (ECG) recordings, or help predict seizure occurrence, or provide information about the current risk of seizures. This study will also investigate whether there are differences in the alterations of HRV parameters between different forms of epilepsy and whether seizure lateralisation has an impact on HRV parameters.


Eligibility Criteria:
Inclusion Criteria:

1. Clinically firm diagnosis of epilepsy.
2. 18 years of age
3. Having the capacity to consent to this project.

Exclusion Criteria:

1. Patients who are on medication for cardiac conditions like beta blockers, anti arrhythmic agents, calcium channel blockers.
2. Patients who have other neurological disorders which may be associated with an autonomic neuropathy
3. Patients who have diabetes, renal failure or another general medical disorder associated with autonomic neuropathy.
4. Patients unable to complete self-report measures unaided.
DIEP Flap Surgery and Intraabdominal Pressure

Aim: The primary aim of this study is to test if closure of the abdominal donor site increases the Intraabdominal Pressure (IAP) in women undergoing secondary Deep Inferior epigastric perforator (DIEP) flap breast reconstruction.

Materials and method: By an Unometer, attached to a standard catheter in the bladder, we measured the intravesical pressure as a surrogate marker for the IAP, at baseline, immediate after- and 24 hours after abdominal skin closure, for 13 patients.


Eligibility Criteria:
Inclusion Criteria:

* Females undergoing secondary DIEP flap breast reconstruction.
* Performance status 1-2

Exclusion Criteria:

* Performance status above 2.
* Untreated hypertension or atrial fibrillation

Performance status evalutated using American Society of Anaesthesiologists' (ASA) classification of Physical Health.
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial

The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants.

LVADs are efficacious in improving survival and functional status when used as a bridge to transplantation. The purpose of this study is to evaluate the safety and effectiveness of the VentrAssist LVAD in providing circulatory support in individuals who are awaiting heart transplants.

The VentrAssist LVAD is a centrifugal flow pump. Its small size and mechanical simplicity offers benefits not available with currently approved LVADs, including facilitating a more limited implantation procedure, which could reduce surgical morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:(The following are general criteria; more specific criteria are included in the study protocol):

* Approved and listed for cardiac transplantation.
* Patient for whom LVAD implantation is planned as a clinically indicated bridge to cardiac transplantation.

Exclusion Criteria:(The following are general criteria; more specific criteria are included in the study protocol):

* Presence of heart conditions that would contraindicate LVAD implantation by adversely affecting patient survival or LVAD function.
* Primary coagulopathy or platelet disorder; contraindication to anticoagulant or anti-platelet agents.
* Presence of any mechanical circulatory support other than intra-aortic balloon pump.
* Therapy with an investigational intervention at the time of screening.
Point of Care Ultrasound in Pregnant Women (PoCUS-OB)

Pregnant women with gestational age more than 20 weeks are at risk of developing Obstructive Sleep Apnea (OSA). OSA is a common underdiagnosed comorbid condition in pregnant women associated with adverse maternal and fetal outcomes. It is a severe form of sleep-disordered breathing (SDB), featured with repeated episodes of airflow reduction or cessation during sleep. It exists in different severity among pregnant women and maybe worsen over the course of the pregnancy. If OSA remains untreated, it can complicate the pregnancy by developing heart failure, gestational diabetes, pre-eclampsia, eclampsia, and hypertension. To determine the OSA during pregnancy has become an important issue to reduce the morbidity related to it. Currently, Polysomnography (PSG) remains the gold standard for diagnosing OSA, but scheduling and logistics remain significant impediments to accessibility for pregnant women. Home sleep apnea tests (HST) is a promising alternative but are expensive and not widely available. Point of care ultrasonography (PoCUS) is being increasingly used across specialties. Our preliminary data support the feasibility of PoCUS in the preoperative setting and increasing the diagnostic accuracy and the specificity for moderate to severe OSA (AHI \>15 events per h) when combined with the STOP-Bang questionnaire (cut-off \>5). Given that HST shows high levels of agreement with PSG for the diagnosis of OSA and are significantly less burdensome than PSG, investigators will evaluate the PoCUS airway examination against the HST for the diagnosis of OSA in pregnant women at high risk of OSA.

This project is to define the range of mouth and tongue dimensions and to visualize airway structures by using ultrasound. Given that Home sleep apnea tests (HST) shows high levels of accuracy for the diagnosis of Obstructive sleep apnea (OSA), investigators hypothesize that the Point of care ultrasonography (PoCUS) airway examination against the HST for the diagnosis of OSA in pregnant women at the high-risk can,

1. reliably visualize upper airway structures that are responsible for OSA;
2. objectively measure airway soft tissue thickness and dimensions; and
3. identify pregnant women with moderate-severe OSA.

Eligibility Criteria:
- Inclusion criteria

* Pregnant women ≥ 18 years of age
* at \> 20 weeks of gestation
* ASA physical status I - IV
* With untreated recently diagnosed (within the previous 12 months) OSA or at high risk of OSA will be eligible for inclusion.

High risk of OSA will be defined as outlined by Facco et al. and recommended by recently updated guidelines (i.e., score ≥ 75) (8).

- Exclusion criteria i) past history of oral, head or neck surgery (e.g., corrective surgery for OSA) ii) active head and neck disease (e.g., cancer, infection, radiotherapy etc.) iii) inability to perform HST per instruction iv) patients with diagnosed OSA on CPAP therapy
Treatment Strategy in Patients With High-risk of Postextubation Distress in ICU Based on a Lung Ultrasound Score Versus Standard Strategy

Prospective, randomized clinical multicentric study in ICU during weaning from mechanical ventilation.

Prospective randomized clinical multicentric study on ICU comparing a treatment strategy (nasal humidified high flow therapy and Noninvasive Ventilation) in patients with high-risk of postextubation distress in ICU based on a Lung Ultrasound Score VERSUS standard strategy

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ventilated more than 48 h
* Stable respiratory and hemodynamic conditions for SBT
* Consent of patients
* Arterial line

Exclusion Criteria:

* severe COBP
* Laryngeal dyspnea
* Tracheostomy
* Arrhythmia
* No echogenicity
* Paraplegia \>T8
Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809

To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral drinking solution fasted compared to BI 425809 tablet fasted and tablet fed


Eligibility Criteria:
Inclusion criteria:

* Healthy male subjects
* Age 18 to 45 years (incl.)
* Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.)
* Subject must be able to understand and comply with study requirements

Exclusion criteria:

* Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator
* Repeated measurement of systolic blood pressure \<90 or \>140 mmHg, or diastolic blood pressure \<50 or \>90 mmHg, or pulse rate \<50 or \>90
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
* Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Endoscopic Ultrasonography-guided Double Ethanol Lavage for Pancreatic Cysts: a Prospective Cohort Study

Due to widespread use of cross-sectional imaging modalities, pancreatic cysts are common in abdominal image. These lesions encompass a wide spectrum, ranging from benign to malignant. The diagnosing specific type of cystic lesion is limited in spite of recent advances of diagnostic modalities. Surgical resection is generally recommended for malignant and potentially malignant lesions. However, surgical resection has significant morbidity and sometimes mortality. Recently, a few study of EUS-guided ethanol lavage for cystic tumors of the pancreas reported that complete resolution was achieved in only one-third of patients. Ethanol lavage of pancreatic cysts may be alternative method to surgical resection.

The purpose of this study is the double ethanol lavage is a safe and effective method for treatment in those with the indeterminate pancreas cysts.


Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 and older of any gender, ethnicity and race
* Voluntary enrollment and ability to give written informed consent
* Capable of safely undergoing endoscopy with deep sedation or general anesthesia
* Indeterminate cystic lesion which was diagnosed in cross-sectional image (CT and MRI)
* Pancreatic cystic lesion having uni- or oligo-locular (defined as having 2-6 locules within a cyst) and 2\~4 cm in diameter

Exclusion Criteria:

* Pancreatic cystic lesions which had the typical morphology of serous cystadenomas (i.e., honeycomb appearance) and pseudocysts (i.e., recent history of acute pancreatitis or parenchymal changes)
* Pancreatic cystic lesions having communication between the cystic lesion and the main pancreatic duct according to endoscopic retrograde cholangiopancreatography and magnetic resonance cholangiopancreatography
* Pancreatic cystic lesions having overt evidence of carcinomas, such as peripancreatic invasion
* Patients with a bleeding tendency (prothrombin time \> 1.5 international normalized ratio \[INR\] or platelet count \< 50,000/μL).