cyrilzakka/clinical-trials huggingface dataset:
A Multicenter Observational Study on the Development and Health Effects of Premature Ovarian Insufficiency

Premature ovarian insufficiency (POI) refers to the occurrence of ovarian hypofunction in women before the age of 40, which seriously affects women's overall health and quality of life. However, there is currently insufficient understanding of the risk factors, pathogenesis, short-term and long-term health effects of POI, and the health effects of the disease, and there is a lack of high-quality evidence to support clinical diagnosis and treatment decisions. This study intends to construct a hospital-based multi-center POI case-control and prospective special disease cohort, after baseline assessment and follow-up monitoring, collect disease characteristics, lifestyle, social psychology, environmental and occupational exposure, biological samples and other data, aiming to observe POI The natural occurrence, progression and health impact of POI, clarify the risk factors of POI, evaluate the impact of POI on women's health and disease risk, and discuss the benefits, risks and options of HRT for POI patients. The results of this study will deepen and expand the understanding of the occurrence and development of POI and its short-term and long-term health effects, provide high-level evidence for optimizing POI prevention, diagnosis and treatment strategies, and establish a long-term management system, laying the foundation for interventional research.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-39 years old
* Meet POI diagnostic criteria
* Volunteer to participate in this study and willing to cooperate with the investigation

Exclusion Criteria:

* Reproductive endocrine disease
* Those receiving hormone supplementation and other steroid-containing drug therapy now or within half a year
* Chromosomal abnormalities
* Pregnancy and breastfeeding women
* Uncontrolled endocrine system diseases
* Uncontrolled cardiovascular system diseases
* Uncontrolled autoimmune related diseases
* Abnormal liver function
* Abnormal kidney function
* Abnormal coagulation function
* Severe anemia
* History of malignant tumors
* History of radiotherapy
* History of chemotherapy
* Mental impairment
* Cognitive impairment
Titanium Mesh Versus Collagen Membrane for Closure of Window in Maxillary Sinus Elevation With Implant Placement

Evaluation the amount of bone height gained when using titanium mesh in closing the lateral window of the sinus compared to collagen membrane.Evaluation the quality of new bone gained when using of the titanium mesh to close the lateral window of the maxillary sinus as a new option for tenting compared to collagen membrane.

this study is aimed to review the bone height, quality and closure of lateral osteotomy used for maxillary sinus floor lifting comparing titanium mesh to collagen membrane.

Eligibility Criteria:
Inclusion Criteria:

* no signs of sinus pathology non or light smokers less than 20 cigarettes per day no systemic disease that may affect normal healing no pscychiatric problems no history of neoplasms or radiation therapy to the head and neck no previous bone augmentation to implant site

Exclusion Criteria:

* Sinus pathology. Heavy smokers more than 20 cigarettes per day Patients with systemic disease that may affect normal healing. Psychiatric problems Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
Nitrite Effects on Cardiac Muscle in CABG

The purpose of this study is to test whether sodium nitrite affects the expression of cellular proteins important for metabolic and vascular function in vascular offcuts and cardiac biopsies taken from patients undergoing coronary artery bypass grafting (CABG) surgery.

Nitrite has been shown in recent studies to improve cardiac performance, particularly in patients with heart failure. These improvements were demonstrated in measures that are independent of cardiac loading conditions, implying improved contractility via effects at a cellular level. In humans, coronary artery bypass graft (CABG) surgery presents an opportunity to safely obtain cardiac muscle biopsies and vascular tissue in order to investigate changes at a cellular level in these tissues.

The aim of this study is to investigate whether sodium nitrite affects the expression of cellular proteins important for heart muscle metabolism and vascular function when infused prior to routine CABG surgery. Patients undergoing CABG surgery who provide written informed consent will receive intravenous sodium nitrite 24hours prior to surgery, 30 minutes prior to surgery, or placebo. As Type 2 Diabetes Mellitus is common in patients undergoing CABG surgery, and itself has profound effects on metabolism, these patients will be sub-grouped into a diabetic cohort for interpretation of the molecular biology results. The 24hours prior to surgery vs. placebo arm will take place first, followed by the 30minutes prior to surgery vs. placebo arm. The data from this study will provide important information on the effects of nitrite on heart muscle and blood vessel tissues, and inform larger clinical trials in patients with cardiovascular disease.

Eligibility Criteria:
Inclusion Criteria:

Males or females aged \>18years scheduled to undergo coronary artery bypass grafting.

Exclusion Criteria:

Inability to read and understand the consent form and patient information leaflet Pregnancy and any woman of child bearing potential Patients with Type I diabetes Significant medical, surgical or psychiatric disease that in the opinion of the patient's attending physician would affect subject safety and participation in the trial including severe heart failure (NYHAIII-IV and EF\<40%) and severe renal impairment (requiring dialysis).

Unstable coronary syndrome (within 2 weeks) Known glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD deficiency measured at screening in males of African, Asian or Mediterranean decent.

Receipt of an investigational drug or biological agent within the 4 weeks prior to study entry or 5 times the drug half-life, whichever is the longer.

Intended heart valve surgery or additional surgery or redo-CABG surgery.
MHealth Effect on Multiple Sclerosis Patients' Quality of Life and Self-care Practices

The goal of this clinical trial is to learn if an Arabic mobile application for multiple sclerosis patients will improve self-care practice and the quality of life of patients or not. The main question it aims to answer is:

Does the Arabic mobile application for MS patients will improve their self-care and quality of life?

Participants will:

Use the developed application or usual care without using the application for 3 months Be followed up during the 12 week period and asked to follow the instructions in the application

This study aims to build and test a culturally appropriate mobile application in Arabic for MS (multiple sclerosis) patients in Egypt. It will focus on self-care practices and quality of life enhancement via educational material provision, symptom tracking as well as medication adherence reminders among other possible functions depending on user preferences. The study shall evaluate how effective the developed app is in promoting self-care practices and improving the quality of life for MS patients compared to a control group who do not use the app.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed clinically with multiple sclerosis.
* From 18 to 50 years old (adult).
* With smartphones.
* Willing to participate in the study and use the mobile application.

Exclusion Criteria:

* Patients who are bedridden or in a wheelchair
* Illiterate patients.
Obesity Alters Lung Mechanics in Robotic Surgery

Intraoperative lung protective ventilation strategies using standardized tidal volumes based on predicted body weight have proven beneficial, but attempts to standardize positive end expiratory pressure (PEEP) settings have not robustly accounted for body habitus or dynamic surgical conditions. Laparoscopic abdominal surgery in Trendelenburg (head-down) is an increasingly common surgical modality that presents a unique physiological challenge to the pulmonary system. In order to delineate the impact of body habitus, pneumoperitoneum, and surgical positioning on intraoperative pulmonary mechanics we conducted an observational study of patients undergoing robotic assisted laparoscopic abdominal surgery in Trendelenburg position. Using esophageal manometry, we partitioned the mechanical properties of the respiratory system into its lung and chest wall components and evaluated the effects of pneumoperitoneum, surgical position, and body mass index (BMI) on transpulmonary pressures, airway and transpulmonary driving pressures, and lung elastance. We hypothesized that increasing BMI would be associated with evidence of increasing atelectasis, increased driving pressures, and elevated lung elastance and that these changes would be exacerbated by pneumoperitoneum and Trendelenburg positioning.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were presentation for robotic assisted laparoscopic abdominal surgery in the supine position, age ≥ 18 years, and ability to provide informed consent

Exclusion Criteria:

* Exclusion criteria included intrinsic lung disease, ≥ 20 pack year smoking history, reactive airways disease, home oxygen requirement, inability to provide informed consent, emergent surgery, or esophageal pathology (i.e., strictures, varices, history of esophageal dilatation or surgery).
Analysis of Patients Treated for Chronic Granulomatous Disease Since January 1, 1995

This study is a longitudinal and cross-sectional evaluation of patients with Chronic Granulomatous Disease (CGD) who received or are receiving hematopoietic cell transplantation (HCT) for their disease under a variety of protocols used by participating institutions compared to a control non-HCT group receiving standard care. Investigators at multiple centers caring for patients with CGD in North America and 3 centers in Europe will participate. Patients with CGD will have been treated according to institutional practice and protocols. Investigators will enroll these patients as subjects in this protocol. This study will investigate which patients benefit most from HCT, and what types of transplants are optimal for patients with CGD, in the context of overall outcomes in CGD patients with and without transplant.

This study is a longitudinal and cross-sectional evaluation of patients with Chronic Granulomatous Disease (CGD) who received or are receiving hematopoietic cell transplantation (HCT) for their disease under a variety of protocols used by participating institutions compared to a control non-HCT group receiving standard care. Investigators at multiple centers caring for patients with CGD in North America and 3 centers in Europe will participate. Patients with CGD will have been treated according to institutional practice and protocols. Investigators will enroll these patients as subjects in this protocol. This study will investigate which patients benefit most from HCT, and what types of transplants are optimal for patients with CGD, in the context of overall outcomes in CGD patients with and without transplant.

Eligibility Criteria:
* Both HCT and non-HCT subjects must be over the age of 2 and actively enrolled and receiving treatment under a CGD protocol at NIAID.
Effect of CPAP on Postoperative Delirium

Patients with a medical condition known as obstructive sleep apnea may be at increased risk of delirium following surgery. This study loans autotitrating CPAP machines to randomly-selected patients who are at high-risk for obstructive sleep apnea with the goal of preventing post-operative delirium.

Patients undergoing elective knee and hip replacements will be prospectively enrolled. These surgical procedures all have an expected length of stay \> 3 days. Immediately following enrollment, patients will be randomized to receive CPAP or routine peri-operative care. Patients in the CPAP group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.

Eligibility Criteria:
Inclusion Criteria:

* Age 50 and above
* Scheduled for an elective knee or hip replacement
* Ability to speak English and give informed consent
* At risk for obstructive sleep apnea as defined by a STOP-BANG score \> 2

Exclusion Criteria:

* History of psychiatric or neurologic illness that would confound delirium assessment
* Severe tracheal or lung disease
* Contraindications to face-mask CPAP
* Treated OSA
Ability of Near Infrared Spectroscopy to Isolate Compartments of the Extremity

Near infrared spectroscopy (NIRS) provides a non-invasive means of continuously monitoring tissue oxygenation, which may be useful for diagnosis of acute compartment syndrome (ACS). Placement of these sensor pads on the surface of the skin must be such that light penetrates the intended compartment without inadvertently obtaining measurements of an adjacent compartment. The objective of this study is to examine whether the NIRS measurements of each compartment truly represent the tissue perfusion of the intended compartment, as indicated by the predictable decrease in muscle oxygenation of a given compartment in response to muscle fatigue. The investigators hypothesize that the tissue oxygenation values of the stimulated compartment will significantly decrease following muscle stimulation, indicating that the intended muscle compartment was successfully isolated. Additionally, the investigators hypothesize that NIRS values of unstimulated muscle compartments will not change from baseline.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* no current extremity injuries
* willing to provide written informed consent

Exclusion Criteria:

* history of any anatomy-altering surgery to the extremity in question
* history of peripheral vascular disease
* history of pulmonary disease
Capability Assessment for Diet and Activity (CADA) Model for Diabetes

This study investigates the capabilities related to diet, physical activity, screening, and knowledge among diabetic adults with or without a history of hospital admissions in Central Florida. The hypothesis is that enhancing these capabilities, based on the Capability Approach framework, can significantly reduce hospital readmissions and improve diabetes management outcomes.

Managing diabetes effectively requires a comprehensive understanding of various capabilities, including diet, physical activity, regular screening, and diabetes-related knowledge. For diabetic adults with a history of hospital admissions, these capabilities are critical in preventing readmissions and improving overall health outcomes.

The objective of this study is to extend the investigation of feasible opportunities for managing diabetes by including measures of screening practices and knowledge alongside diet and physical activity. By employing the Capability Approach, this research aims to provide a comprehensive assessment of how these capabilities interact with individual and environmental factors to affect diabetes management. This approach will enrich existing knowledge by highlighting the interplay between diet, activity, screening, and knowledge, and how these factors collectively impact health outcomes. It will also inform targeted interventions that address both personal and environmental determinants of diabetes management, contributing to more effective public health strategies.

The study uses a survey instrument to collect data from diabetic adults who have experienced hospital admissions in Central Florida and those who don't. The data will be analyzed using Structural Equation Modeling (SEM) to explore the relationships and potential causal pathways between the capabilities assessed (diet, activity, screening, knowledge) and health outcomes. This approach, grounded in the Capability Approach framework, will help identify how each capability contributes to the management of diabetes and highlight areas for targeted interventions.

This study is available in English and Spanish.

Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 18.
* Persons diagnosed with diabetes
* Have an email account with access to a reliable internet connection or smartphone

Exclusion Criteria:

* Minors , ages under 18
* Adults not diagnosed with diabetes
* Adults who are unable to provide consent.
Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients

Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels.

Secondary Objectives: To demonstrate that use of glucose-sparing Peritoneal Dialysis solutions (D-E-N versus Dianeal only) in diabetic (Type 1 and Type 2) CAPD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female patients 18 years of age or older
2. Diagnosis of ESRD \[Glomerular Filtration Rate (GFR) ≤ 15 mL/min\]
3. CAPD using only Dianeal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time
4. Diabetes Mellitus (Type 1 and 2)
5. HbA1c \> 6.0% but ≤ 12.0%
6. Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL
7. Total Kt/V ≥ 1.7

Exclusion Criteria:

1. Blood Urea Nitrogen (BUN) \> 95 mg/dL
2. Exposure to Extraneal within 60 days of Screening
3. Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP \< 77mm Hg) at Screening
4. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days
5. Cardiovascular event within the last 30 days
6. Ongoing clinically significant congestive heart failure \[New York Heart Association (NYHA) class III or IV\]
7. Allergy to starch-based polymers, glycogen storage disease or isomaltose/maltose intolerance
8. Receiving rosiglitazone maleate
Efficacy of Physiotherapist-supervised Rehabilitation After Proximal Humerus Fracture

This study investigates the efficacy of physiotherapist-supervised training once per week during 10 weeks compared to home-based training during 10 weeks, after proksimal humerus fracture.

Proximal humerus fracture is the third most common fracture in elderly people after hip and colles fracture, and are often caused by fall and osteoporosis. These fractures are highly related to morbidity and mortality among elderly people and consumes considerably health care resources. More than 70% of the proximal humerus fracture patients are over 60 years of age and 75% are female.

Only sparse evidence reveals to what extend the patients need rehabilitation and how it should be implemented in the treatment strategy.

In Denmark as well as in Finland the rehabilitation after proximal humerus fractures takes place in local centers in the municipalities, and the rehabilitation offered to the patients varies significantly. Currently in Denmark there are no national clinical guidelines to support the rehabilitation strategy.

Eligibility Criteria:
Inclusion Criteria:

•Low energy proximal humeral displaced (more than 5mm or 30 degrees) two-part fracture where fracture line emerges through the surgical (or anatomical) neck, treated non-operatively

Exclusion Criteria:

* Refuse to participate in the study
* Younger than 60 years old
* Non-independent
* Demented
* Does no understand written and spoken guidance in local language
* Pathological fracture or previous fracture in the same proximal humerus
* Other operational injuries in the same upper limb
* Major nerve injury (e.g. Complete radialis- or delta palsy)
* Open fracture
* Multi-trauma patient
* Fracture dislocation or head splitting fracture
* Undisplaced fracture
* Isolated tuberculum fracture
* Fracture has no precondition to ossify by conservative treatment (no bony contact between fracture parts or the humeral shaft is in contact with the articular surface)
* Treating surgeon considers patient unsuitable to attend the study on medical basis
Accelerated Immunosenescence and Chronic Kidney Disease

The aim of this study is to investigate the impact of renal function and dialysis techniques on the percentage of senescent T lymphocytes.

The immunosenescence is a complex and profound remodeling of the immune system during life. It is mainly due to thymic involution and repeated antigenic stimulation. Kidney disease is associated with a decrease in adaptive immunity as evidenced by the decrease in vaccine response and increased susceptibility to infections, similar to those observed in the elderly population.

However, data on aging of the immune system in chronic kidney disease remains incomplete. Furthermore, the determinants of immunosenescence are not also not known. It is possible that "uremic" factors help explain the phenotypic and functional changes of lymphocytes, as antigenic stimuli associated with repeated bio-compatible materials used in dialysis contact.

The purpose of this study is to describe the phenotypes of the immune system of renal and analyze the determinants of these changes.

Eligibility Criteria:
Inclusion Criteria:

* Patient able to understand the reason of the study
* Patient not opposed to the conservation of biological samples for scientific research

Exclusion Criteria:

* Patient suffering from psychotic illness
* Any history of immunosuppressive therapy (except steroids up to 5mg/day)
* History of cancer (except skin cancer) or treated hematological malignancy
* Infectious episode required hospitalization not older 3 months
* Hepatitis B or C infection
* HIV infection, active or inactive
* For dialysis patients: renal failure on dialysis for less than 3 months and/or have benefited from two techniques for renal replacement therapy in the last 6 months