cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Guided Versus Land-mark Method for Spinal Anesthesia in Super Obesity Parturients

This study will investigate whether an ultrasound-assisted technique is better than a classical land-mark technique to facilitate spinal anesthesia in the sitting position in super obese pregnant women with BMI ≥ 50 who will undergo elective cesarean section.

The primary objective of this study is the rate of successful dural puncture at the first attempt. It was assumed that ultrasound could facilitate neuraxial blockade in super obese (BMI ≥ 50 kg/m2), pregnant women, according to the Who classification, whose topographic anatomy is difficult.

Spinal anesthesia is the most commonly used anesthesia method for elective cesarean deliveries. Anesthesiologists may struggle to determine the poorly palpable surface landmarks in super obese (BMI ≥ 50 kg/m2) pregnant women.

The manual palpation technique, preferred in neuraxial anesthesia, may be very difficult in super obese pregnant women due to difficulty identifying bone landmarks. Neuraxial ultrasound examination before spinal anesthesia may help spinal anesthesia performance and decrease the number of attempts in obese parturients.

This study will be a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective cesarean will be screened for enrollment in the study. The anesthetist administering spinal anesthesia and evaluating the data were blind to the distribution of patient groups. Ultrasonographic examinations were performed by a single investigator trained in this technique who performed more than 60 ultrasound-guided neuraxial blocks.

Eligibility Criteria:
Inclusion Criteria:

* Parturient who will receive selective cesarean delivery under spinal anesthesia
* ASA 3 scheduled for elective sections
* BMI≥50 kg/m2
* Normal singleton pregnancy

  * 37 weeks of gestation

Exclusion Criteria:

* Multiple gestations
* Emergency C-section
* Exist contraindications of spinal anesthesia
* Local anesthetics allergy
* BMI\<50 kg/m2
* History of lumbar spinal diseases and lumbar surgery
* Parturient refusal
Combined Effects of Simultaneous Variety and Portion Size on Meal Intake of Women

The primary purpose of this study is to investigate the combined effects of simultaneous meal variety and portion size on food intake at a meal. Additionally, other individual characteristics will be examined for their influence on the effects of simultaneous variety and portion size on meal intake.


Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to travel to Penn State University Park campus weekly for meals
* Be fully vaccinated against COVID-19
* Be a woman 20 - 65 years old
* Regularly eat 3 meals/day
* Be willing to refrain from drinking alcohol the day before and during test days
* Have a body mass index between 18.0 and 35.0 kg/m\*m
* Be willing to refrain from eating after 10 pm the evening before test sessions
* Be willing to participate in all study procedures

Exclusion Criteria:

* Must not be a smoker
* Must not be an athlete in training
* Must not be pregnant or breastfeeding at the time of screening
* Must not have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months
* Must not dislike or be unable to eat the test foods (because of allergies, intolerance, or dietary restrictions)
* Must not have a high variability in liking of the test foods
* Must not be currently dieting to gain or lose weight
* Must not have a health condition that affects appetite
* Must not have participated in a similar study in our lab in the past year
* Must not be a student, faculty, or staff member in nutritional sciences or psychology
Effectiveness Study of the BioVac Direct Suction Device in Upper Gastrointestinal Bleeding

Upper endoscopy is performed for upper gastrointestinal bleeding (bleeding in the esophagus, stomach, or part of the duodenum) to identify and potentially treat the cause of bleeding. However, blood clots often make visualization difficult during endoscopy. The current practice is to try to wash off and suction up these blood clots with the endoscope. However, this is often not successful due to blood clots blocking the suction channel.

A new device has been approved by Health Canada that attaches to the endoscope and helps prevent blockage. It is believed that this device will help doctors suck out blood clots and potentially improve visualization, identification of the cause of bleeding, and possibly health outcomes, although this has never been proven. The purpose of the this clinical trial is to test whether the device works and whether it can help patients with this type of bleeding.

STUDY DESIGN:

This is a randomized double blind clinical trial of the BioVac suction device versus standard endoscopy suction for UGIB. The study will be performed at London Health Sciences Center Victoria Campus and University Campus with an anticipated recruitment period of 2.5 years.

STUDY POPULATION:

All patients over the age of 18 admitted to hospital with a diagnosis of UGIB will be considered for recruitment. Patients already admitted to hospital with another diagnosis who develop UGIB will also be included.

INTERVENTION:

Patients will undergo EGD for UGIB as per standard clinical practice. If the bleeding source is not found within the first 5 minutes (timer starts once EGD passes upper esophageal sphincter) due to blood clots, the patient may benefit from additional suctioning. The patient will be randomized in blocks of 2-6 stratified by site to either the BioVac device or endoscopy suction. Those randomized to the BioVac device will use it to irrigate and suction as much blood as possible until the bleeding source is found or until the endoscopist feels that additional time would not help. Those randomized to endoscopy suction will do the same without the BioVac device. Due to the suctioning power of the study device, a placebo is not possible. Our original intention was to record the endoscopy video to blindly assess the outcome. Unfortunately, this ended up not being possible for technical reasons.

Eligibility Criteria:
Inclusion Criteria

1. Patients presenting with fresh blood hematemesis, coffee ground emesis, or melena
2. Patients with hematochezia and hypotension (systolic blood pressure \< 90 mm Hg) or tachycardia (heart rate \> 110 beats per minute)

Exclusion Criteria

1. Identification of a bleeding source within the first 5 minutes of the upper endoscopy or no blood seen in the upper GI tract as these patients do not require additional suctioning.
2. Age \< 18.
3. No endoscopy was performed.
4. Endoscopy previously performed for current episode of UGIB.
5. Patients unable to consent and who do not have a substitute decision maker.
Effects of Fast-tracking Geriatric Hip Fracture Patients

The purpose of this study is to determine whether fast-tracking hip fracture patients to geriatric medicine wards, as opposed to standard care at the emergency room, results in less complications and shorter hospitalization for the patients.

Each year about 18000 persons in Sweden suffer from a hip fracture. These people are often among the oldest and have many complicating diseases. The one-year mortality after hip fracture is 20%. Due to the complexity including many comorbidities in these patients, it is of great value that the care of these patients is optimal.

Today, most of the patients with suspected hip fracture in the catchment area of Sahlgrenska University hospital, Gothenburg, are transported directly to the radiology unit. Thereafter, the patient waits in the emergency room (ER) for an othopedic examination before being admitted to primarily a geriatric medicine ward where they wait for the operation. The average waiting time in the ER is today around four hours. The current scientific evidence for fast-tracking hipfracture patients is limited. The aim of our randomized controlled trial is to determine the effect of fast-tracking hip fracture patients at geraitric medicine wards compared to standard care regarding complication rate (primary endpoint), lenght of hospital stay and time to operation (secondary outcomes).

Eligibility Criteria:
Inclusion Criteria:

* patients with low energy trauma with pain at the hip and/or groin AND
* respiratory frequency: 8-25/minute AND
* saturation: 90% or higher on air AND
* pulse: 50-119 beats per minute AND
* systolic blood pressure: \>90 mmHg AND
* level of consciousness: Reaction level scale (RLS) 1 or Glasgow Coma Scale (GCS) 14-15 AND
* plasma-glucose: 3,0-25 mmol/l

Exclusion Criteria:

We will exclude patients based on the following criteria:

* distal status affected
* suspicion of other simultaneous fracture
* suspicion of head trauma or affected consciousness
* suspicion of acute cardiac disease
* signs of acute cardiac ischemia in electrocardiogram
* generalized symtoms, except for pain in the hip
Study of Salirasib to Treat Non-Small Cell Lung Cancer

The purpose of this study is to determine whether Salirasib is effective to shrink or prevent the growth of the tumors associated with non-small cell lung cancer in both patients who are newly diagnosed or have recurrent disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Non-Small Cell Lung Cancer not amenable to curative therapy with surgery or radiation
* Measurable disease
* Adenocarinoma of the lung, have not received prior chemotherapy for the malignancy and has a ≥ 15 pack year history of smoking; OR previously treated with recurrent disease and documented KRAS mutation
* Last dose of radiotherapy \> 3 weeks prior to study entry and recovered from all acute toxicities associated with the prior therapy
* No history of another malignancy in the past 5 years except treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix
* Karnofsky Performance status of 70 or greater
* Body Weight \> 50 kg
* Life expectancy ≥ 3 months
* Serum Creatinine ≤2.0 mg/dL, total bilirubin ≤ 2.0 mg/dL, ALT and AST ≤ 3x ULN, alkaline phosphatase ≤ 5x ULN, WBC \> 3000/mm³, ANC ≥ 1500/mm³, platelets ≥ 100,000/mm³, hemoglobin ≥ 10g/dL.
* No coexisting cardiac or medical problems that would limit compliance in the study
* Willing to undergo blood sampling for pharmacokinetic analysis
* Negative pregnancy test, if applicable

Exclusion Criteria:

* Evidence of active heart disease including myocardial infarction within previous 3 months
* Active infectious process
* Active central nervous system metastases (requiring increasing doses of corticosteroids over the prior month, known progressing lesions)
* Pregnant or lactating
* Major surgery without full recovery or major surgery within 3 weeks prior to treatment start
* QTc Interval \> 470 msec
* Gastrointestinal tract disease resulting in inability to take or absorb oral medications
The Use of the USCOM Device in Addition to Cardiac Ultrasound in Patients Undergoing Treatment for Undifferentiated Shock

Currently, bedside ultrasound (US) is performed routinely in emergency department (ED) patients with undifferentiated shock to help guide resuscitation. Previously, it has never been possible to measure cardiac output on patients in the ED. Our clinical question looks at whether the USCOM device gives clinically relevant information in addition to ED cardiac US in patients with shock.


Eligibility Criteria:
Inclusion Criteria:

* Patients in shock, as defined by systolic blood pressure less than 95 mmHg or shock index (heart rate/systolic blood pressure) greater than 0.9

Exclusion Criteria:

* less than 18 years old
* Pregnant
* Patients in shock due to trauma
Chinese Adolescent Registry for Diabetes (CARD) Study

The CARD study is a observational study which includes Chinese adolescents with diabetes aged 18-30. The study aims to explore the status of disease treatment, self-management, the relationship between disease treatment and disease outcome in Chinese adolescents with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed diabetes
* aged 14-30
* signed the informed consent

Exclusion Criteria:

* taking part in other drug research
* gestational diabetes
* diagnosed with tumor or cardiovascular disease
The Postero-superior Contact and Rotator Cuff Lesion

The possibility of physiological contact between the deep surface of the tendon of the supraspinatus muscle and the labrum and/or posterior superior glenoidal rim during an armed movement of the arm (abduction and external rotation or ABER position) has been described for many years. The physiological hypotheses put forward to explain this contact are first of all that the intrinsic mobility of the scapulohumeral joint is limited by these 2 structures, that an anterior instability or micro-instability induces an abnormal anterior translation when performing an abduction and lateral rotation movement, or finally that there is a decrease in humeral retroversion. When this contact becomes symptomatic, it is called a posterior superior conflict. This pathology is mainly found in throwing athletes or athletes repeating maximum external rotation in the abducted position of the arm. This conflict is also described among some manual workers, and is then observed in an older age group.


Eligibility Criteria:
Inclusion criteria:

* Major subject ((≥18 years old)
* Operated subject (at the HUS between 01/01/2012 and 31/12/2013) under arthroscopy of anterior instability, of an unruptured tendinopathy of the rotator cuff, or of an extra-articular pathology.
* Subject not expressing opposition to the use of his data for research purposes

Exclusion criteria:

* Subject having expressed his opposition to participating in the study
* Patient under safeguard of justice
* Subject under guardianship or curatorship
Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia

The purpose of this study is to assess the safety and efficacy of MediTate Temporary Implantable Nitinol Device (TIND) used to alleviate symptoms of Bladder Outlet Obstruction (BOO) secondary to Benign Prostate Hyperplasia (BPH).The TIND is inserted in the bladder neck and prostatic urethra under local anesthesia for few days and taken out some 5 days later in the doctors office.


Eligibility Criteria:
Inclusion Criteria:

Main IC:

* Subject signed informed consent prior to the performance of any study procedures.
* Male with BPH, who are at least 50 years of age and that were diagnosed with BOO.
* IPSS symptom severity score ≥ 10.
* Peak urinary flow of \< 12 ml/sec
* No pathology found with kidney US
* Prostatic urethra length \< 30 mm
* Prostate volume \< 35 cc
* Normal Urinalysis and urine culture.

Exclusion Criteria:

Main EC:

* Any prior prostate treatment
* Suspected or proved carcinoma of prostate
* Urethral stricture
* Urinary bladder stones
* Serum prostate specific antigen level \> 4 ng/ml (unless proved to be carcinoma free by biopsy).
* Active urinary tract infection as determined by positive culture, bacterial prostatitis within the past year documented by positive culture.
* Median prostatic lobe enlargement or a prominent obstructing "ball valve" prostatic lobe.
* Subject has an interest in future fertility and is not willing to undergo fertility treatments whatsoever.
* Any serious medical condition likely to impede successful completion of the study

Intraoperative EC:

* Irregular findings by the implanting physician during the implantation procedure by the cystoscopy that to the best of the implanting physician are exerting non compliance with the exclusion or inclusion criteria and that were not noticed previously during screening
Exercise-based Rehabilitation to Treat Persistent Chemotherapy Induced Peripheral Neuropathy (CIPN)

The goal of this clinical trial is to learn if the EX-CIPN exercise-based intervention is feasible, acceptable, and safe in participants with persistent chemotherapy-induced peripheral neuropathy (CIPN). It will also give insight on the effectiveness of the exercise intervention in treating CIPN symptoms. The main questions it aims to answer are:

* Is EX-CIPN safe, acceptable, and feasible in cancer survivors experiencing persistent CIPN?
* Are the study design and methods feasible (recruitment and retention rates, feasibility of data collection and procedures)?

Researchers will provide all participants with the exercise-based intervention.

Participants will:

* Complete assessments at baseline, immediately post-intervention, and 3-months post-intervention
* Complete a 10-week remote, individualized exercise program
* Receive health coaching calls on weeks 2, 3, 4, 6, and 8 of the intervention
* Wear a FitBit throughout the study to track physical activity and promote behaviour change


Eligibility Criteria:
Inclusion Criteria:

* Received a diagnosis of any cancer and treated with curative intent (no minimum dose) including Stage 3 \& 4 gynecologic malignancies, treated in the platinum-sensitive setting
* Are \> 6 months post-completion of chemotherapy (ie no other chemotherapeutic agents since completing of the chemotherapy regimen)
* Report \> Grade 1 on the Patient Reported NCI Common Terminology Criteria for Adverse Events version 5.0 grading scale (numbness and tingling severity item) and neuropathic pain \>3 on the Neuropathic Pain 4 (DN4) (interview) (0-7)
* The presence of peripheral neuropathy due to chemotherapy (following onset of chemotherapy), as established via clinical assessment
* May be on maintenance oncologic therapies (ie endocrine therapy, Poly (ADP-ribose) polymerase (PARP) inhibitors) not known to cause neuropathy
* No current plans for chemotherapy in the next 6 months
* Currently engaging in \< 90min per week of planned moderate-intensity aerobic exercise
* Independent with ambulation and transfers with or without ambulatory assistance (EGOG 0-2)
* Able to communicate sufficiently in English to complete intervention, questionnaires, and consent
* Willing to participate in the intervention and attend in-person physical assessments
* Have access to and are able to operate videoconferencing.

Exclusion Criteria:

* Known neurological conditions influencing cognition and preventing safe or appropriate engagement with self-management and exercise recommendations
* Pre-existing neuropathy prior to the start of chemotherapy
* Are currently enrolled in other cancer rehabilitation or exercise-based programs/interventions.
* Are currently taking ado-trastuzumab emtansine (TDM1) (ex. Kadcyla)
Drug Interaction Study Between Dorzagliatin and Sitagliptin

This is a Phase 1, open-label, sequential, multiple-dose, drug interaction study of glucokinase activator dorzagliatin and sitagliptin in subjects with T2DM. Pharmacokinetics and pharmacodynamics when dorzagliatin and sitagliptin given alone and in combination will be studied.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects diagnosed with T2DM within at least 3 months prior to screening
2. Male and/or female subjects between the ages of 30 and 65 years, inclusive;
3. Body Mass Index (BMI) of 19 to 38 kg/m2, inclusive;
4. Fasting C-peptide test result \>0.3 nmol/L (\>0.90 ng/mL);
5. HbA1c ≥7% and ≤10.5%;

Exclusion Criteria:

1. Fasting blood glucose at screening or Day -1 ≤110 or ≥270 mg/dL;
2. Type 1 diabetes mellitus;
3. Reported incidence of severe or serious hypoglycemia within 3 months prior to screening;
4. Known contraindications to sitagliptin;
5. Clinically significant gastrointestinal disorder;
6. History or symptoms of clinically significant cardiovascular disease within one year prior to screening;
7. History of more than three urinary tract infections and/or more than three genital fungal infections in the last 12 months;
8. Reported history of clinically significant central nervous system disease;
9. Reported history of liver disease;
10. Reported history of clinically significant renal disease;
11. Estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73m2;
12. Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
13. Known or suspected malignancy;
14. Any reported hypersensitivity or intolerance to sitagliptin;
15. Antidiabetic treatment with insulin, sulfonylureas, thiazolidinediones or GLP-1 agonist within 3 months prior to screening;
16. Systolic blood pressure \<90 or \>160 mmHg or diastolic blood pressure \<60 or \>100 mmHg at screening;
17. A hospital admission or major surgery within 90 days prior to screening;
18. Uncontrolled hypertriglyceridemia \>500 mg/dL;
19. Positive blood screen for HIV, hHBsAg, or hepatitis C antibody;
20. Positive pregnancy test result;
21. Female is breast-feeding or planning to become pregnant;
22. Treated with any investigational drugs within 6 weeks prior to screening;
23. Reported history of prescription drug abuse;
24. Reported history of alcohol abuse;
25. Reported history of donation or or acute loss of blood during the 90 days prior to screening;
Development & Validation of Utilities for Health States Relevant to Cervical Cancer Patients

Purposes of this study: 1) To define comprehensive set of descriptive health states related to treatment of cervical cancer (e.g. radical hysterectomy, whole pelvic radiation, brachytherapy, chemoradiation) 2) To define set of descriptive health states related to adverse events associated w treatment of cervical cancer (i.e. bladder dysfunction, pain, enteritis, fistula formation) \& 3) To derive, using a validated method, a set of QoL related utility scores corresponding to these health states.

Subjects will valuate cervical cancer-related health states using the visual analog score (VAS) and TTO (TTO) methods. The subject will be asked to read a pertinent health state description and listen while it is read aloud. She will first be asked to place the state on a continuum (VAS) from zero to 100, with 100 presenting perfect health and zero presenting death. The TTO interview will then be administered. The subject will be asked to assume a remaining life expectancy of 30 years, and to choose between 30 years in the health state described or 29 years in a state of perfect health. The utility of the health state, a number between zero and one, is calculated as the minimum number of years the patient would accept divided by 30. Each subject will be asked to review and valuate 20 health states over the course of 60-90 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Any member of public over age of 18 and without the diagnosis of cervical cancer can participate in this study.
* Patients over the age of 18 with the diagnosis of cervical cancer are eligible to participate in this study.

Exclusion Criteria:

* Any member of public under the age of 18 or with a prior diagnosis of cervical cancer is excluded from this study.
* Any cervical cancer patient younger than 18 is excluded from this study.
Phase 3 /Seroquel SR Acute Mania Monotherapy - US

The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3 weeks.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Documented diagnosis of Bipolar Disorder, with most recent episode being manic or mixed
* Inpatient hospital admission for the first 4 days of study treatment

Exclusion Criteria:

* \>8 mood episodes within the last 12 months
* Use of prohibited medication
* Substance or alcohol abuse or dependence
* Current suicide risk or suicide attempt within last 6 months.