cyrilzakka/clinical-trials huggingface dataset:
Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

The purpose of this study is to identify whether sleep-disordered breathing - as measured by overnight polysomnography - is associated with pre-eclampsia and to determine whether use of positive airway pressure can improve nocturnal blood pressure.

Initial enrollment began with only women with a pre-existing diagnosis of pre-eclampsia. Part way through the study, IRB granted approval to expand recruitment to include other hypertensive diagnoses. So, in effect, a more accurate post hoc title would be Study of Positive Airway Pressure to Reduce Blood Pressure in Hypertensive Pregnancies.

Eligibility Criteria:
Inclusion Criteria:

* Women with preeclampsia who receive care at the University of Michigan Hospitals
* No current use of PAP therapy.
* Willing and able to provide informed consent.

Exclusion Criteria:

* Current PAP therapy
* Any medical reason why PAP therapy may not be suitable (e.g., in patients with recent head trauma).
* Cognitively impaired and unable to understand informed consent.
Weight Loss in Obese Kidney Disease Patients After Bariatric Surgery

This study is designed as a prospective, single-center, longitudinal and analytical study on the effect of bariatric surgery in obese patients with chronic kidney disease (CKD).

It is expected to enroll 22 obese subjects with chronic kidney disease (decrease in glomerular filtration and/or albuminuria/proteinuria). After the inclusion in the study patients will remain for six months with a reduced calorie diet until the day of bariatric surgery. Time monitoring of the patient after surgery is 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years (male or female).
* BMI \>35 kg/m2 who meet the following criteria:

  1. GFR 30-60 ml/min and proteinuria\>1g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.
  2. GFR \>60 ml/min and proteinuria \>(3.5) 2.5 g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.
* Patients with BMI\> 40 kg/m2 with a GFR\> 30 ml/min and proteinuria \>(1) 0.5 g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.
* Patients who are able to understand the purpose and risks of the study, which has been fully informed and have finally given the written informed consent according to the ICH-GCP. Patients who can not read or write but who properly understand the verbal information provided by the investigator (or sub-investigator) the consent will be granted orally before their inclusion and an independent witness will signing the informed consent document.

Exclusion Criteria:

* Subjects who are participating or have participated in another clinical trial and/or who are taking or have taken an experimental drug (not registered) in the last 28 days.
* Patients with chronic renal replacement therapy (hemodialysis and/or peritoneal dialysis) and/or renal transplantation.
* Patients with poorly controlled blood pressure (SBP\> 170 mmHg or DBP\> 110 mmHg).
* Patients with a history of cardiovascular events (stroke, ischemic heart disease) in the past six months.
* Patients treated with steroids or other immunosuppressants.
* Patients with a history of renovascular disease, obstructive uropathy, autoimmune diseases, cancer, drug use.
* Patients who are pregnant or lactating.
* Patients who do not sign the informed consent.
* A slight chance of compliance with visits scheduled in the protocol.
Seocalcitol Versus Placebo in Advanced Hepatocellular Carcinoma

The purpose of the study is to determine whether seocalcitol is effective in the treatment of advanced primary liver cancer (hepatocellular carcinoma \[HCC\]).


Eligibility Criteria:
Inclusion Criteria:

* Hospital in- or out-patients
* Either sex
* Aged 18-75 years
* With hepatocellular carcinoma, verified by histology/cytology, which is not amenable to curative treatment or transplantation.
* Patients must have measurable disease, and be classifiable as to Barcelona Clinic Liver Cancer (BCLC) stage 0, as described in Llovet JM et al. Hepatology 1999;29:62-67.

Exclusion Criteria:

* Patients treated with chemotherapy or other anti-cancer therapy within 4 weeks before visit 1
* Patients with another primary tumor, except for basocellular carcinoma of the skin or in situ carcinoma of the cervix, within the last 2 years
* A history of renal stone(s)
* A life expectancy of \< 3 months
* World Health Organization (WHO) performance status 3 or 4
* Okuda stage III.
* Patients with hypercalcemia, or other clinically important laboratory abnormalities
* Patients with previous/current calcium metabolic disease, taking calcium-lowering therapy, or medication known to affect systemic calcium metabolism are also excluded.
* All patients must give their signed informed consent to join the study.
Long Term Prognosis of MRI Diagnosed Partial Thickness Tears of the Rotator Cuff

Patients diagnosed with partial thickness tears of the rotator cuff are sometimes surgically repaired, while other cases are not. It is unknown how patients fare over time without electing surgical repair and how outcomes differ by type of injury.

We plan to conduct a retrospective cohort study to assemble a research database of all patients with shoulder pain from 1/1/02-12/31/06 presenting at the Hershey Medical Center. Participants will be identified using billing codes in the medical records office, with inclusion/exclusion criteria as described above. Data extraction will include medical record number, demographic data (age, race/ethnicity, sex, insurance type), pre-fracture functional status, pre-admission residence, medical co-morbidities, prior hospitalization within 30 days, abnormal clinical findings on admission, shoulder score, pain score, range of motion score, type of diagnosis (partial tear, full thickness tear, tendonitis, shoulder pain), occupation, past medical history, physical therapy and duration of physical therapy, cigarette/cigar use, drug use, alcohol use, treatment protocols (anti-inflammatory medication, injections, etc.), and complaints by patient of pain status.

Eligibility Criteria:
Inclusion Criteria:

* Patients examined at the Hershey Medical Center from 1/1/02-12/31/06 with a documented MRI report of a partial thickness tear of the rotator cuff that was treated non-operatively.

Exclusion Criteria:

* Full thickness tear of the rotator cuff, surgically repaired rotator cuff, and patients who do not fit criteria listed in inclusion criteria.
Pharmacokinetics of BIBR 277 in Hypertensive Patients

The pharmacokinetic profile of BIBR 277 single dose given in capsule form to hypertensives was evaluated. The results of the present study are to be used in the Japanese population pharmacokinetics analysis


Eligibility Criteria:
Inclusion Criteria:

* Age: \>=20 years
* Sex: Either male or female
* Patient status: Either inpatient or outpatient, provided that the patient was available for hospitalisation from the day before the trial medication administration until the morning of the day after administration
* BP: Sitting systolic and diastolic blood pressures (SBP and DBP) taken the day before administration should be \>= 150 mmHg and \>= 90 mmHg, respectively. Patients undergoing treatment with other antihypertensives were not excluded provided the above criteria were satisfied.

Exclusion Criteria:

* Malignant hypertension
* Renovascular hypertension
* Severe heart failure (NYHA functional class III - IV), unstable angina pectoris, or history of myocardial infarction (within 6 months of onset)
* Atrioventricular conduction disturbance (degree II to III), atrial fibrillation, or serious arrhythmia
* Symptoms of cerebrovascular disorder
* Serious hepatic dysfunction
* Renal function disorder (serum creatinine \>= 4.0 mg/dL)
* Known hypersensitivity to angiotensin II receptor antagonists
* Hyperkalaemia (potassium \>= 5.5 milliequivalents per liter (mEq/L))
* Treatment with the other investigational drug within 6 months of initiation of the present study
* Pregnant, breast feeding, possibly pregnant or planning to become pregnant during this study
* Previous treatment with the trial medication of the present study
* Otherwise judged ineligible by the investigator
The Impact of Gender Stereotypes on Fiberoptic Intubation Performance

Gender bias and stereotypes have been recognized as pervasive factors influencing various aspects of society, including professional settings. Within the realm of medical practice, understanding the potential impacts of such biases on performance is of paramount importance. Anesthesiology, a field that demands technical precision, teamwork, and rapid decision-making, is not immune to the potential effects of gender stereotypes on performance outcomes. This study aims to explore the potential influence of gender stereotype manipulation and stereotype threat on the fiber-optic intubation (FOE) performance of female anesthesiology residents.

Stereotype threat refers to the apprehension individuals experience when their actions or abilities are evaluated within the context of negative stereotypes associated with their social group. Such threat has been shown to adversely affect cognitive and motor performance in various domains. In medical education, where skills are honed through training, understanding the role of stereotype threat is crucial to fostering equitable learning environments and ensuring patient safety.


Eligibility Criteria:
Inclusion Criteria:

1.Residents in the Department of Anesthesiology and Reanimation at Hacettepe University Faculty of Medicine, who have completed their initial year of residency and have prior experience in FOE.

Exclusion Criteria:

1. Not meeting the above criteria
2. Not willing to participate in the study
Adult MDW Dual Cut-Off Accuracy Study

This study will establish the clinical performance of the Monocyte Distribution Width (MDW) parameter on the DxH 900/ DxH 690T hematology analyzers to aid in the detection and risk assessment of patients in the Emergency Department (ED) for progression to sepsis.

The objective of this study is to validate the MDW dual cut-off values established during characterization and demonstrate the performance of MDW to detect sepsis in a multi-center study of adults presenting to the ED who have CBC w/diff ordered within 12 hours of presentation.

This study is designed to enroll all-comers from selected sites that currently have a DxH 900 in use as part of routine testing in the ED. All subjects who meet the Inclusion Criteria will be included in the study, without enrichment. Data from all subjects meeting the Inclusion Criteria will be provided to a panel of independent adjudicators. Adjudicators will be blinded to the MDW result and any sepsis diagnostic determinations which may or may not be in the original medical record.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 to 89 years) of all races and ethnicities presenting to the ED
* Whole Blood venous samples collected in K2EDTA while the patient was in the ED
* First CBC w/diff test ordered within 12 hours of presentation to ED as part of their standard medical care
* CBC w/diff tested within 2 hours of specimen collection
* Subjects with at least ≥12 hours of follow-up in the ED (or inpatient, if admitted) from presentation

Exclusion Criteria:

* CBC w/diff test ordered after 12 hours of presentation to ED
* Subjects previously enrolled in this study (i.e. subjects may not be enrolled more than once in this study)
* Subjects discharged from ED \<12 hours from ED presentation
* ED Transfer Patients

Data Exclusions Post Enrollment:

* Samples that have a system generated flag from the Standard of Care (SOC) CBC w/diff testing will be excluded.
* Samples with instrument flags, including vote outs and review flags for MDW will also be excluded (i.e. invalid MDW results).
* Subjects' data collected with Instrument Quality Control failure(s).
Effect of Calcium Chloride on Recovery From Neuromuscular Blockade

The purpose of this study is to evaluate the effect of calcium chloride against residual neuromuscular blockade at the end of general anesthesia

During general anesthesia, neuromuscular blocking agent is administered to facilitate endotracheal intubation and the view of operative field. The neuromuscular blockade should be reversed at the end of anesthesia to recover spontaneous breathing of the patient.

Residual neuromuscular blockade (RNMB) is defined as train of-four ratio \< 0.9. RNMB is a risk factor for postoperative pulmonary complication and increases postoperative mortality. Neostigmine is acetylcholinesterase inhibitor routinely used at the end of anesthesia to prevent RNMB. A meta-analysis, however, showed that 40 percent of patients who received intermediate-acting neuromuscular blocking agent during anesthesia showed RNMB in PACU.

Calcium triggers the release of acetylcholine from the motor nerve terminal and enhances excitation-contraction coupling in muscle. Increasing calcium concentrations decreased the sensitivity to dTc and pancuronium in an animal muscle-nerve model. The effect of calcium chloride on residual neuromuscular blockade is not studied yet.

The purpose of this study is to evaluate the effect of calcium chloride on residual neuromuscular blockade at the end of general anesthesia

Eligibility Criteria:
Inclusion Criteria:

* 18-65 yr
* Body mass index 15.0-25.0 kg/m2
* American Society of Anesthesiologists physical status I-III
* Scheduled for elective surgery with an expected duration of more than 60 min under general anesthesia with endotracheal intubation

Exclusion Criteria:

* Suspected difficulty airway
* Bronchial asthma, chronic obstructive pulmonary disease
* Neuromuscular disease
* Hepatic or renal dysfunction.
* Taking medications that might influence the effect of neuromuscular blocking agents
* Allergy to the medication that used in this trial
* Pregnant, or breastfeeding state
* Suspected malignant hyperthermia
* Contraindication to the medication that used in this trial
* Hypercalcemia
Feasibility Trial Self-Acupuncture for Chemotherapy Cancer Patients

The proposed study will employ a pragmatic mixed methods randomised parallel-group exploratory design to determine the feasibility of delivering self-acupuncture within an NHS cancer care setting. The trial will explore the feasibility and acceptability of all aspects of a definitive clinical trial of teaching cancer patients to self-administer acupuncture to alleviate symptoms of cancer and the side effects of conventional chemotherapy treatment. In addition the feasibility trial will provide preliminary data on effectiveness to inform the sample size calculation for a controlled clinical trial. Patients will be randomly allocated to receive either: 1) self-acupuncture in addition to standard care or 2) standard care alone. Participants randomised to the self-acupuncture arm will be asked to attend a 1.5 hour group workshop delivered by an experienced practitioners and teachers of self-acupuncture. Participants allocated to standard care will be offered training in self-acupuncture once the trial is complete to address any ongoing side effects from their cancer and its treatment. Patients will be recruited at the initiation of their chemotherapy cancer treatment from UCH Macmillan Cancer Centre. Participants will complete baseline outcome measures and be asked to complete follow up outcomes measures at the end of chemotherapy treatment, and 3 months post chemotherapy treatment. At the end of chemotherapy treatment participants will also be asked to take part in a qualitative telephone interview to explore their views on the design of the study and if allocated to self-acupuncture their views on the intervention. At 3 months post chemotherapy treatment those allocated to self-acupuncture will be invited to participate in a second qualitative interview to explore the long-term practice and effects of self-acupuncture. Qualitative interviews will also be conducted with stakeholders (acupuncturists delivering workshops and UCH Macmillan Cancer Centre staff) to explore their views on the feasibility of teaching cancer patients self-acupuncture.


Eligibility Criteria:
Inclusion Criteria:

* Patients due to receive radical (curative) intravenous chemotherapy (any chemotherapy regime).
* Patients of either gender and older than 16 years old.
* Patients with any cancer diagnosis.
* Patients willing to participate in the study and be randomised to one of the two treatment arms.
* Patients willing to attend the self-acupuncture workshop, and self-administer acupuncture, if assigned to the intervention.

Exclusion Criteria:

* Palliative patients.
* Patients unwilling to participate (for instance due to needle phobia).
* Patients currently receiving acupuncture.
* Patients with a platelet count \<20 000mm.
* Patients with a white blood cell count \<1000mm.
* Patients with severe clotting dysfunction or who bruise spontaneously.
* Patients unable to complete the questionnaires as judged by the investigators.
Genetic Variation - The Need for Opioids During Surgery

The purpose of this study is to find out if the tetanic noxious stimuli and the measured skin conductance response can be used as a test in patients before surgery to have an indication about what amount of analgesics the patient will need during surgery.

Skin Conductance (SC) shows the emotional state as reflected in changes in the sympathetic nervous system. During sleep or other states of low basic sympathetic activity, activation of the sympathetic nervous system results in filling of the palmar and plantar sweat glands, and the SC increases transiently before the sweat is removed and the SC decreases again. When a short lasting outgoing sympathetic nervous burst occurs, fluctuations of SC will follow. An increase in the number of SC fluctuations (NSCF) can therefore be interpreted as increased activity in this part of the sympathetic nervous system. When remifentanil, an opioid analgetic is given, NSCF is reduced.

Genetic variation influences the pharmacokinetics and the pharmacodynamics of analgesics like morphine derivates and remifentanil. 50 female patients will therefore be blood tested to study if they are Val/Val or Met/Met for the COMT gene, or if they are homozygous or heterozygous for the 118G allele and the 118A allele.

This study will show if skin conductance can be used to measure noxious stimulation response before surgery (by giving a tetanic stimuli), and then predict what level of analgesic a patient will need during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Women in American Society of Anesthesiologists (ASA) group 1-2 and with body mass index between 20 and 30 and going through laparoscopic surgery at the Gynecological Department, Ullevål University Hospital.
* Normal renal and hepar function (serum albumin and serum creatinine should be within the normal limit).

Exclusion Criteria:

* Chronic pain in the last 6 months or recent use and abuse of analgesics.
Esophageal Cancer Multimodal Prehabilitation Study

The goal of this research study is to investigate the feasibility of implementing a prehabilitation program that aims to improve a patient's physical, nutritional, and sleep health before surgery in an older, at-risk group with esophageal cancer.

This research study is to test whether a novel, 4-week surgical multimodal prehabilitation protocol is feasible in at-risk older adult patients who have previously undergone neoadjuvant chemotherapy or radiotherapy and are scheduled for surgical removal of esophageal cancer.

Research study procedures include screening for eligibility, clinic visits, questionnaires, blood tests, and Computed Tomography (CT) scans.

Participation in this research study is expected to last 7 months.

It is expected about 30 patients will participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age and over
* Adult male or non-pregnant female volunteers
* Completed neoadjuvant chemotherapy or radiotherapy for esophageal cancer
* At least four weeks to esophageal cancer surgery
* Without skin conditions that preclude wearing sensors
* Able to speak English and consent

Exclusion Criteria:

* Participants in any other interventional study that may bias results or limit study adherence during our study
* Dietary restrictions that prevent consumption of nutritional supplements
* Women who are pregnant, nursing, or at risk of becoming pregnant
* Profound physical disability (for example, quadriplegia) that precludes participation in any aerobic or strength training.
Cognitive Muscular Therapy for Patients With Long-COVID and Breathing Pattern Disorder

The aim of the study is to test a treatment known as "Cognitive Muscular Therapy (CMT)" for reducing breathlessness and improving autonomic function in patients with long-COVID.

A key symptom of long-COVID is dysfunctional breathing, characterised by an alteration in the muscular and mechanical control of breathing, such as altered movement/coordination of diaphragm and ribs. Long-COVID patients also experience symptoms such as dizziness and fatigue, which have been linked to dysautonomia (dysfunction of the nervous system controlling automatic body functions). Importantly, dysautonomia is connected to alterations in breathing mechanics. Specifically, rapid breathing, high in the chest, is associated with increased activity in the fight-or-flight system and decreased activity in the rest-and-repair system. Given this link, interventions capable of improving breathing mechanics could alleviate many long-COVID symptoms. However, current breathing retraining methods lack visualisation of breathing mechanics and do not integrate a whole-body approach to improving postural control.

We have developed a clinical system which can visualise breathing mechanics in real-time, providing patients with a "window into their body". We propose to integrate this system within a new intervention, known as Cognitive Muscular Therapy (CMT). CMT integrates psychological informed physiotherapy with training to reduce overactivation of postural muscles which can interfere with the mechanics of breathing. We propose to test this combined intervention on 20 people with Long-COVD to understand if we can improve respiratory function and symptoms associated with dysautonomia. If successful, this pilot study could pave the way for large-scale studies in long-COVID

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old
* Experience moderate/severe breathlessness, quantified using the Modified COVID-19 Yorkshire Rehabilitation Scale (C19-YRSm) scale.
* Speak and understand English sufficiently to read the information sheet and sign the consent form
* Ability to stand without any assistive device for at least 20 minutes (to ensure sufficient capacity to complete the intervention)

Exclusion Criteria:

* Dementia or other major cognitive impairment
* BMI \>32 (as increased subcutaneous fat prevents use of breathing measurement system)
* Current smoker or smoked regularly within last 6 months
* Any cardiorespiratory disease that requires medical intervention (except asthma management)
* Currently receiving physiotherapy-based treatment for LC or breathing pattern disorder
* Significant respiratory co-morbidity (e.g. COPD, uncontrolled Asthma)
Traditional Versus ScvO2 Guided Perioperative Fluid Therapy

Perioperative goal directed fluid therapy by means of an esophageal doppler has been shown to reduce morbidity and length of stay. In this study patients undergoing elective bowel surgery will be randomised to traditional fluid therapy with crystalloids versus fluid boluses guided by central venous oxygen saturation. The primary outcome will be complications after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Elective bowel surgery,
* Able to give informed consent

Exclusion Criteria:

* Coagulation defect,
* Renal failure,
* Valvular stenosis