cyrilzakka/clinical-trials huggingface dataset:
ArteVu Blood Pressure Accuracy Study

A continuous noninvasive blood pressure monitoring digital fingertip clip device, the ArteVu, will be compared against the reference arterial catheter during operation. The device safety and its blood pressure accuracy will be examined in the study.

ArteVu is a non-invasive and continuous blood pressure monitor. It detects the arterial pressure waveform with a force sensor that detects the arterial pulsation that produces changes in pressure transmitted through the subcutaneous tissue overlying or adjacent to the digital arteries. The data is transmitted to a parameter module to display noninvasive and continuous blood pressure in a hospital setting. The primary objective of this study is to validate ArteVu's blood pressure and heart rate measurement accuracy by comparing its values simultaneously with the corresponding values obtained from an invasive radial arterial line. The secondary objective is to evaluate the effectiveness of utilizing ArteVu for continuous blood pressure measurements. The study population includes 50 patients undergoing surgery who requires general anesthesia and continuous blood pressure measurement with a radial arterial line. Blood pressure values measured from the arterial line will be recorded simultaneously during ArteVu's measurements.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 20 years
2. Requiring general anesthesia and continuous blood pressure measurement with a radial arterial line
3. Limb circumference is within 22 cm - 32 cm
4. The width of the first knuckle of the index/middle/Ring finger is less than 19.8 mm
5. Ease of access to the finger and arm used for ArteVu
6. Able to provide written informed consent for participation in the study

Exclusion Criteria:

1. Pregnant patients
2. Medical or surgical condition that prevents the ability to apply the ArteVu device on an upper extremity finger or the ipsilateral arm such as impaired skin integrity
3. Operations involving the upper extremities or the blood vessels of the upper extremities
4. Arthritis or severe deformities of the hand and fingers
5. Prosthetic devices or jewelry that cannot be removed from the finger or the ipsilateral arm to be used for the ArteVu device
6. History of malignant hyperthermia
7. Raynaud's disease affecting the fingers or hands
8. Topical allergy to Acrylonitrile Butadiene Styrene(ABS), Polycarbonate(PC), or silicone
9. Swelling, edema or lymphedema of the upper extremity
10. Participants with upper extremity occlusive peripheral vascular diseases
11. Inability of the patient to provide written informed consent
A Study to Evaluate Safety and Effectiveness of Bevacizumab in Combination With Paclitaxel and Cisplatin/Carboplatin or Toptecan in Participants With Advanced Cervical Cancer

This study will evaluate the safety of bevacizumab (Avastin®) combined with standard chemotherapy in participant with advanced cervical cancer, with special focus on the incidence of gastrointestinal (GI) and genitourinary (GU) fistulas and GI perforations in the common practice setting.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Diagnosis of primary stage IVB, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy
* Retrospective clinical decision made to initiate therapy with bevacizumab (Avastin®) combined with standard chemotherapy (cisplatin or carboplatin or topotecan and paclitaxel) between 01 January 2015 and 01 January 2016
* All participants must have received at least one dose of bevacizumab combined with standard chemotherapy between 01 January 2015 and 01 January 2016 AND have at least 12 months of documented follow up, from treatment start, unless died or lost to follow up within the minimum study entry follow up period
* Availability of documentation of for advanced cervical cancer (including prior treatment as applicable) and follow up in the participant's medical records

Exclusion Criteria:

* Participation during the study period in an interventional clinical trial or any other interventional study that may impact advanced cervical cancer outcome
* Participants who have received prior therapy with any anti-VEGF drug, including bevacizumab
Categorized PT for Non-arthritic Hip and Groin Pain

There is currently limited literature on a categorized physical therapy protocol for management of hip pain. Only a handful of studies have looked at the treatment of osteoarthritis of the hip with a standardized physical therapy treatment, primarily looking at manual therapy versus exercise therapy protocols. However, there are no studies observing the effect of a standardized physical therapy program on patients presenting with non-arthritic hip and groin pain. Based on the gap in the literature, this study will aim to assess the effect of matrix-based standard of care therapy in patients presenting with non-arthritic hip and groin pain.


Eligibility Criteria:
Inclusion Criteria:

* New patient presenting with non-arthritic hip impingement, hip pain, and groin pain (Tonnis 0-1)
* 18-60 years old

Exclusion Criteria:

* Arthritic hip pain (Tonnis 2+)
* \<18 and \>60 years old
* History of spinal fusion surgery
* History of low back pain with radicular pain
* History of hip arthroscopy
* History of inflammatory conditions, and other concurrent problems interfering with hip therapy (i.e., concurrent back/knee/foot/ankle/shoulder issues)
* Patients currently taking TNF-alpha inhibitors for inflammatory conditions
* History of prior knee osteotomy
* Non-English speakers
Progression of Atrial Fibrillation in the Young

The purpose of this study is to investigate the presence and magnitude of structural changes of the heart and their long-term development in young patients with atrial Fibrillation (AF), studied by echocardiographic measurements and plasma biomarkers and their association to AF burden, studied using long-term ECG

100 patients with symptomatic Atrial Fibrillation diagnosis are included. Diagnosis is set either at the index visit or within 12 months before inclusion. . The follow up period is 5 years. Patients presenting with AF in connection with acute infection, acute cardiac ischemia, surgery or thyroid disease are excluded. Further, AF patients with cardiomyopathies, known genetic diseases and congenital cardiac abnormalities are also excluded.

At inclusion patients undergo an in-depth interview regarding comorbidities, medication, previous treatments related to the AF diagnosis. In addition, baseline data for weight and height are collected.

In connection to inclusion the patients are asked leave venous bloodwork (Na, K, Creatinine, plasma Glucose and NTproB-Type Natriuretic Peptide). An echocardiographic exam is performed according to a prespecified protocol with special emphasis on the left atrial function and anatomy. This is followed by a continuous ECG recording for 14 days using BioTel ePatch. The ECG patch is later returned to a core facility by mail.

The patients´ are followed for five years and are asked to leave bloodwork and perform a 14-day ECG recording yearly. After these exams, a follow up phone call is placed to the patient aimed at documenting clinical progress related to symptoms, treatment and interventions. After 5 years follow up patients undergo a follow up echocardiographic exam in addition to yearly bloodwork and ECG recording. The patients´ clinical symptoms are treated at the clinician´s discretion according to current guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Atrial fibrillation
* Diagnosis of atrial fibrillation within one year of inclusion

Exclusion Criteria:

* Duration of atrial fibrillation over one year.
* Acute stressor for atrial fibrillation such as: acute ischemic heart disease or infection
Safety and Performance of PEEK Anchors in Extremities

Safety and performance of the study devices in extremities up to 12 months post-surgery


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have undergone extremity joint repair using the study devices.
* Subjects aged 18 years and older at the time of surgery.

Exclusion Criteria:

* Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
* Subjects who are \< 3 months post-operative
Improving Acute Hypertension Management Through Emergency Department Checklist

The investigators hypothesize that the implementation of a checklist in acute severe hypertension would result in improving short and long-term outcomes of patients with acute severe hypertension treated in the emergency department (ED). The investigators hypothesize that in the short-term, a checklist would improve the diagnosis and management of end-organ damage as well as reduce the length of stay of acute severe hypertensive patients in the ED. The investigators hypothesize that the checklist will result in better compliance with anti-hypertensive medications than without the checklist at six-month post-discharge.

Hypertension is a global public health issue and results in over 10 million deaths every year. The disease affects one-third of people living in low- and middle-income countries (LMICs) and contributes to half of all productivity losses in LMICs due to non-communicable diseases. Though hypertension often presents as a chronic asymptomatic illness, hypertension-related emergencies represent a significant burden to the health care system. Acute severe hypertension \[i.e., systolic blood pressure (SBP) ≥ 180 mmHg or diastolic blood pressure (DBP) ≥ 110 mmHg\] make up to 5% of all emergency admission. One-third of these patients present with end-organ damage; a condition called a hypertensive crisis. More worrisome is the fact that a number of ED visits, as a result, severe acute hypertension and hypertensive crises have almost tripled between 2006 and 2013 in the US. Treatment approaches to managing acute severe hypertension (\~5% of ED patients) are largely unclear and only 6% of ED patients with acute severe hypertension receive appropriate work-up for the end-organ damage, indicating a huge care gap. One approach, which has been used successfully in managing other complex and critical conditions, is the use of checklists. Checklists are a listing of actions to be performed in a given clinical setting with the aim of improving adherence to standards, reducing errors and thus improving patient outcomes. The investigators hypothesize that the use of a Checklist, if appropriately implemented, can lead to an improvement in the care of patients presenting with hypertensive crisis. During this study, the investigators will measure the prevalence of acute severe hypertension and assess the current quality of care for these patients. This will be followed by the development of a checklist for the management of the hypertensive crises in the ED. The investigators will follow these patients to see the impact of the checklist on the quality of care and long-term outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adults who visit the Aga Khan University Hospital Emergency Department with acute severe hypertension
* able to provide consent to participate
* Age \>25 years of age
* Meeting the criteria of acute severe hypertension (SBP\>180 and DBP\>110).

Exclusion Criteria:

* Patients not providing consent or are unconscious are excluded from participation.
MT2021-27 FT538 Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

To determine the maximum tolerated dose (MTD) of FT538 monotherapy when administered via intraperitoneal (IP) catheter and in combination with intravenous (IV) enoblituzumab in patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer meeting one of the following minimal prior treatment requirements (no limit to the maximum number of prior treatments).
* Platinum Resistant: may receive FT538 as 2nd line (as 1st salvage therapy).
* At least 18 years of age at the time of consent.
* GOG Performance Status 0, 1, or 2 (refer to Appendix I).
* Adequate organ function within 14 days (28 days for pulmonary and cardiac) of study treatment (CY/Flu or enoblituzumab) start
* Pulmonary Function: Oxygen saturation ≥ 90% on room air; PFTs are performed only if known history or as medically indicated - if done, must have pulmonary function \>50% corrected DLCO and FEV1.
* Cardiac Function: LVEF ≥ 40% by echocardiography, MUGA, or cardiac MRI; no clinically significant cardiovascular disease including any of the following: stroke or myocardial infarction within 6 months prior to first study treatment; unstable angina or congestive heart failure of New York Heart Association (NYHA) Grade 2 or higher (Appendix I).

Exclusion Criteria:

* Pregnant or breastfeeding or planning on becoming pregnant in the next 6 months.
* Currently receiving or likely to require systemic immunosuppressive therapy
* Active autoimmune disease requiring systemic immunosuppressive therapy.
* History of severe asthma and currently on chronic systemic medications.
* Uncontrolled bacterial, fungal or viral infections with progression of clinical symptoms despite therapy.
* Receipt of any biological therapy, chemotherapy, or radiation therapy (except palliative RT), within 2 weeks prior to the first dose of FT538
* Live vaccine within 6 weeks prior to start of lympho-conditioning.
* Known allergy to the following FT538 components: albumin (human) or dimethyl sulfoxide (DMSO).
* Prior enoblituzumab.
* Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment. (Refer to Section 5.1.8 regarding history of brain metastases.)
* Known history of HIV positivity or active hepatitis C or B - chronic asymptomatic viral hepatitis is allowed.
* Presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to patient.
* Any medical condition or clinical laboratory abnormality that, per investigator judgement, precludes safe participation in and completion of the study or that could affect compliance with protocol conduct or interpretation of results.
Influence of Protein Source on Satiety and Metabolism

Dietary protein is the more satiating nutrient, however it is not clear whether satiety may be influenced by the nature of the protein. This study was designed to assess potential differences between protein sources on satiety and their relationship with digestive and metabolic kinetics.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 30

Exclusion Criteria:

* allergy to milk proteins
A-priori Versus Provisional Heparin on Radial Artery Occlusion After Transradial Coronary Angiography and Patent Hemostasis

The Provisional Heparin TherApy on Radial Artery Occlusion after transradial coronary angiography and patent Hemostasis (PHARAOH) study compares the strategy of standard a-priori heparin use in patients undergoing transradial coronary angiography to a strategy of provisional heparin administration only if patent hemostasis is not achievable.

Transradial access use for coronary angiography and intervention is increasing. Its efficacy in lowering access site complications, as well as increased patient comfort, has been proven unequivocally. One of the complications of transradial access is radial artery occlusion (RAO) that occurs with a variable incidence. It is population specific, with a higher prevalence in subsets, such as women, and patient's with small radial arteries. RAO is also known to be higher at hospital discharge and radial recanalization may spontaneously occur at later times. It is usually asymptomatic. Its main adverse impact is by limiting future transradial access from that radial artery. Since most of the patient's with atherosclerotic vascular disease may undergo several invasive procedures during their lifetime, prevention of RAO is of paramount importance.

Heparinization, during the procedure, has been shown to be of benefit in lowering the incidence of RAO. Maintaining patency of the radial artery during hemostasis, has also been shown to be effective in prevention of RAO following transradial access. As maintenance of flow has potent antithrombotic effect, it is unclear whether systemic anticoagulation is still required in all cases.

In some cases, it would be preferable to avoid heparin administration prior to coronary angiography. It is currently unknown whether it would be safe to refrain from heparin administration in case of transradial catheterization and patent hemostasis technique.

Eligibility Criteria:
Inclusion Criteria:

* all diagnostic cardiac cath patients

Exclusion Criteria:

* warfarin therapy
* previous ipsilateral TRA
* lack of consent
* abnormal (type D) Barbeau test
* scleroderma
* thrombocytopenia
* or other contraindications to heparin
Gamma-linolenic Acid Supplementation Study

Weight regain following weight loss is common. In rodent models of obesity and pilot studies in humans, increasing membrane arachidonic acid content improves fuel partitioning and prevents weight regain. This study aims to understand the effect of gamma-linolenic acid (GLA) supplementation on weight loss maintenance in Virta Health patients.

The primary purpose of this research is to determine if GLA supplementation reduces weight regain over 24 months in Virta Health patients.

The secondary purpose is to determine the effect of GLA supplementation on diabetes-related outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 yrs
* Patients referred to Virta Health by employers or insurers
* Weight loss greater than or equal to 7% of initial weight and current BMI \> 25 kg/m2
* Willing to take 3 supplement capsules daily
* Able to understand study procedures and willing to provide informed consent
* English-speaking

Exclusion Criteria:

* Patients who are pregnant or lactating
* Patients who are taking or are prescribed orlistat
Water-only Versus Water-CO2 (Hybrid) Colonoscopy Insertion Technique

The colonoscopy procedure involves insertion of a thin, flexible tube with a tiny camera inside (colonoscope) passed inside the bowel. To allow passage of the colonoscope and adequate visualisation of the lining of the bowel wall a range of techniques can be used. During colonoscopy, you can distend the colon with water, CO2 and air.

Air is no longer recommended for gas insufflation during colonoscopy as it causes pain and excess bowel distention. So the options are water and/or CO2 but it is not entirely clear which combination is the best and at what point during the colonoscopy.

In practice, a hybrid technique where both CO2 and water are used during the colonoscopy in used. Here, water is exclusively used to help navigate the sigmoid colon with air pockets suctioned and turbid water exchanged with clean water. From splenic flexure to caecum a mixture of water and CO2 is used.

The aim of this study is to assess procedure comfort and efficiency of two different colonoscopy insertion techniques: water-alone insertion of the colonoscope (gas insufflation not allowed on insertion; water exchange technique) versus water-CO2 hybrid insertion (water used predominately to splenic flexure with water/CO2 used to caecum; modified water immersion technique).


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Capacity to consent

Exclusion Criteria:

* Pregnancy
* Previous bowel surgery
* Unable to consent
Extension of a Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen

This study is an extension to younger patients of the currently ongoing national, multicenter, open-label, randomized phase III HAPLOMUDELDERLY which evaluates elderly patients with hematological malignancies, justifying an allo-HSCT from an alternative donor when a MRD has not been identified. It will extend the investigation of these two modalities of allo-HSCT to younger patients which are eligible to RIC.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hematological malignancy
* Age\<55 years
* HCT-CI score ≥ 3 or non-eligible for myeloablative regimen
* Patients without a matched related donor
* Patients eligible for an allogeneic HSCT from an alternative donor
* Able to comply with the protocol
* Written informed consent
* Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen

Exclusion Criteria:

* Clinical or biological contraindication to allogeneic HSCT
* Pregnant or breast-feeding women.
* Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
* Severe concomitant disease
Acellular Dermal Matrix Versus Tenting Technique in Peri-implant Soft Tissue Augmentation and Crestal Bone Stability

This study looks at two ways to make gums thicker and bones stable around dental implants for people with thin gums. It compares two methods in 40 people: one method uses a special graft, and the other uses a technique called tenting. The goal is to see which method might work better for making the gums and bones around implants healthier. The check-ups are planned when the implant is put in and again after one year. The study focuses on how these methods are done without talking about what the results are.

The study's protocol entails a randomized comparison between acellular dermal matrix grafting and the tenting technique, aimed at enhancing gum thickness and bone stability around dental implants in individuals with thin gum profiles. Forty participants are systematically assigned to one of the two methods under investigation. The study is structured to evaluate the interventions' potential in improving conditions conducive to the success of dental implants, specifically targeting soft tissue thickness and crestal bone level stability. The comprehensive investigation is designed to explore effective approaches for managing patients with particular soft tissue challenges, focusing on the clinical application and procedural aspects without presenting any results or conclusions.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between 18-75 years old.
* Physical and psychological capacity to undergo implant therapy (ASA I or II).
* Fully healed single mandibular posterior treatment sites (premolars or molars) being edentulous for at least 3 months.
* Minimum of 6 mm width and 8 mm height native bone ridge.
* No requirement for concomitant or a history of regenerative treatments.
* Minimum of 4mm keratinized mucosa at the implant site (2 mm buccal and 2mm lingual).
* Healthy non-inflamed keratinized soft tissues with a maximum soft tissue thickness height of 2 mm measured at crestal buccal and lingual aspects.
* Periodontally healthy by fulfilling all of the following criteria: Full-mouth bleeding score (FMBS) \< 20%, Full-mouth plaque score (FMPS) \< 15%, Community Periodontal Index of Treatment Needs (CPITN) \< 2.

Exclusion Criteria:

* Patients with a history of periodontitis.
* Poor oral hygiene after Oral Hygiene Instructions (OHI).
* Pregnant or lactating.
* Uncontrolled concomitant medical diseases, e.g., diabetes.
* Receiving or having received pharmacological treatment affecting wound healing within 3 months prior to the study-related intervention.