cyrilzakka/clinical-trials huggingface dataset:
GOTHA - The Early Arthritis and Psoriasis Study of Region Västra Götaland, Sweden

GÖTHA- The early arthritis and psoriasis study of Region Västra Götaland, Sweden - is a longitudinal observational study, which will prospectively and in parallel follow patients with newly diagnosed rheumatoid arthritis (RA, N=1000), psoriatic arthritis (PsA, N=500) and undifferentiated arthritis (N=100), together with patients with psoriasis (N=500). The study will also recruit healthy controls from the general population (N=3000).

The aims of the study are to define predictors for disease course and severity, treatment response, comorbidities, health related quality of life (HRQoL) and health economy.

The study is a collaboration between the department of Rheumatology and the department of Dermatology at Sahlgrenska University Hospital in Gothenburg, and the departments of Rheumatology at the hospitals of Alingsås, Borås, Uddevalla and Skövde, in the west of Sweden.

All patients with newly diagnosed RA, PsA and undifferentiated arthritis at the Rheumatology centers are eligible for inclusion. Patients with psoriasis will be recruited from the Department of dermatology at Sahlgrenska University Hospital.

The patients will be examined at baseline and at one, three, five and ten years. The assessments will include physical examination with evaluation of joints, entheses and skin and validated questionnaires regarding medical history, comorbidities, lifestyle, disease activity, bodily function, socioeconomic factors and HRQoL. Blood samples will be collected. The patients with arthritis will also undergo radiography of the lung, hands and feet, and Cone Beam Computed Tomography (CBCT) of hands and feet.


Eligibility Criteria:
Inclusion Criteria:

* Patients with rheumatoid arthritis (RA) meeting the classification criteria of American College of Rheumatology (ACR) and/or European League Against Rheumatism (EULAR) från 2010
* Patients with psoriatic arthritis (PsA) meeting the classification criteria of Classification for Psoriatic Arthritis (CASPAR) PsA
* Patients with undifferentiated arthritis defined as a patients with a clear arthritis, but not meeting with established classifications criteria of any now known rheumatic disease
* Patients with psoriasis diagnosed at a dermatology department. The patients should not have any history of joint complaints with a duration of more than 6 weeks
* General population controls, matched for age, sex and residence of living to the included patients.

Exclusion Criteria:

* Inability to follow study protocol
* Swedish language difficulties
* Having other concomitant rheumatic diagnose (Sjögrens syndrome is not an exclusion criteria)
Satellite-supplementation of Medical Outreach Clinics: a Feasibility Study

Much of the basic general medical care and chronic disease management in rural Honduras comes from groups of volunteers setting up temporary clinics run by volunteers. These clinics, also known as brigades, or medical missions, are often criticized for their lack of quality and the lack of follow-up, both of which stem, in part, from understaffing with volunteer physicians. This study is designed to assess if it is feasible, safe, and acceptable to treat patients in short-term mobile medical clinics in rural Honduras using US physicians connected with patients by videoconference.


Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* Non-emergent medical complaints
* At least 18 yrs in age

Exclusion Criteria:

* Pregnancy
* Mental Disability
Bottle PEP in Cystic Fibrosis

The study aims to investigate the sustainability of Bottle-PEP in patients with cystic fibrosis


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cystic fibrosis
* Acute exacerbation

Exclusion Criteria:

* Any contraindication using the Bottle - PEP such as the presence of pneumothorax
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.

To assess the safety and tolerability of multiple subcutaneous doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 18 and 34 kg/m2
* Normal physical and neurological examination, clinical laboratory values and ECG
* Ulcerative Colitis Disease Activity Index (UCDAI, aka Mayo score) score of 4 to 10 (inclusive), with a minimum sigmoidoscopy score of 1; (for subjects with ulcerative colitis)
* Crohn's Disease Activity Index (CDAI) score of \>150 and \< 450 at screening (for subjects with Crohn's disease)
* Additional inclusion criteria apply

Exclusion Criteria:

* History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluations, procedures or completion
* History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers within the past 5 years
* Underlying condition(s) that predisposes the subject to infections
* Disease limited to the rectum, i.e. within 10 cm of the anal verge (for subjects with ulcerative colitis)
* Evidence of severe disease (as evidenced by an Hb concentration less or equal to 10g/dL; toxic megacolon, or an UCDAI score greater than 10) (for subjects with ulcerative colitis)
* Subject has short bowel syndrome (for subjects with Crohn's disease)
* Presence of an ostomy (for subjects with Crohn's disease)
* Presence of a fistula (for subjects with Crohn's disease)
* Additional exclusion criteria apply
Methods of Pancreatic Stump Closure for Distal Pancreatectomy

The aim of this study is to conduct a retrospective analysis of patients who underwent distal pancreatectomy in our hospital, aiming to evaluate the safety and feasibility of two methods for closure of the pancreatic remnant: simple closure with a closure device and closure combined with electrocoagulation.

The aim of this study is to conduct a retrospective analysis of patients who underwent distal pancreatectomy in our hospital, aiming to evaluate the safety and feasibility of two methods for closure of the pancreatic remnant: simple closure with a closure device and closure combined with electrocoagulation. This study aims to determine which method is safer and more feasible, with the potential to reduce postoperative complications, improve outcomes, facilitate better patient recovery, and thereby provide better guidance for clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent distal pancreatectomy performed by Director Jin Gang's team at Changhai Hospital affiliated with Naval Medical University between January 2019 and January 2023.
* Patients who underwent closure of the pancreatic remnant using either simple closure or closure combined with electrocoagulation during surgery.

Exclusion Criteria:

* Patients undergoing surgeries by other primary clinical teams during the same period.
* Patients undergoing closure of the pancreatic remnant using methods other than those mentioned.
* Patients who violate the requirements of the study protocol.
* Patients with incomplete data collection in the hospital's diagnostic and treatment system.
A Trial of a Hospital Policy of Tranexamic Acid Use to Reduce Transfusion in Major Non-cardiac Surgery

A Phase IV trial of a hospital policy of Tranexamic acid to reduce transfusion in major non-cardiac surgery.

The TRACTION Trial is a national multi-centre Phase IV randomized cluster-crossover trial of Tranexamic acid versus placebo. Over the duration of the study, participating centres will be centrally and randomly allocated to receive either TXA or matching placebo at 1-month intervals for a total of 8 months. As our pragmatic trial is designed to define practice, we have selected co-primary outcomes that evaluate effectiveness in the context of safety.

Our co-primary outcomes are the:

1. Proportion of patients transfused RBCs
2. Incidence of DVT or PE (collectively called venous thromboembolism (VTE) within 90 days of surgery.

Eligibility Criteria:
Cluster-level inclusion criteria:

Hospital sites will be included in the trial if anesthesia and hospital leadership agree to manage patients as per the policy being implemented and evaluated in the trial.

Patient-level inclusion criteria:

* Patients \>/= 18 years of age undergoing major non-cardiac surgery (a state of hyperfibrinolysis)
* Inpatient surgeries with an estimated \>/= 5% risk of RBC transfusion, including open surgeries or laparoscopic surgeries with an estimated duration of \>/= 3 hours

Examples of eligible surgeries could include (but are not limited to):

1. General surgery (esophagectomy, gastrectomy, gastric repair, small bowel repair or resection, ostomy formation, colon/rectum repair or resection, colostomy, splenectomy, hepatectomy, pancreatectomy, resection of abdominal mass)
2. Orthopedics (hip fracture repair, pelvic fixation, femur repair / fixation, shoulder / humerus open reduction internal fixation, lower extremity amputation)
3. Spine (vertebrectomy, surgery involving \>/= 3 levels)
4. Otolaryngology (glossectomy, mandibulectomy, radical laryngectomy)
5. Thoracic (lung resection or decortication)
6. Vascular (arterial bypass / endarterectomy / aneurysmorrhaphy involving the aorta or proximal vessels off the aorta)
7. Gynecology (hysterectomy)
8. Urology (nephrectomy, cystectomy, prostatectomy, pelvic exenteration)
9. Plastic surgery (large neoplasm resections, burns or debridements)
10. Surgeries anticipated to be associated with 5% or greater risk of RBC transfusion in hospital as per the surgical team.

Exclusion Criteria:

* Active thromboembolic disease (ie, patient is anticoagulated for thromboembolic disease prior to admission)
* Pregnancy
* Cardiac surgery and hip and knee arthroplasty where TXA is standard-of-care
* Surgeries with free flap reconstruction
* Trauma surgeries where TXA was administered within the previous 3 hours.
The Effect of Isotretinoin on the Etonogestrel Contraceptive Implant

This exploratory study will fill a knowledge gap regarding the pharmacokinetic effects of isotretinoin on the etonogestrel (ENG) contraceptive implant.

The Investigators will enroll only women with an etonogestrel contraceptive implant in place who are initiating isotretinoin therapy through their dermatologist. The Investigators will monitor the subjects serum etonogestrel concentration during isotretinoin therapy but no medications will be provided through this study. No medical devices will be inserted as part of this study either.

Eligibility Criteria:
Inclusion Criteria:

* Have a secondary form of non-hormonal contraception or abstain during isotretinoin therapy and four weeks afterwards
* Have at least two negative pregnancy tests at least 19 days apart prior to initiating isotretinoin therapy
* Have normal baseline laboratory evaluation including liver function tests, basic metabolic panel, and complete blood count
* Willing to abstain from taking any Vitamin A supplement during the study period
* Have a Body Mass Index (BMI) \>= 18.5

Exclusion Criteria:

* Currently breastfeeding
* Known contraindications to isotretinoin
* Currently taking any known cytochrome P-450 3A4 enzyme inducers or inhibitors
Role of Color Doppler Ultrasonography in Assessment of Vascular Access Surveillance in Hemodialysis Patients.

The aim of this study is to provide an overview of the possible applications of DUS during the maturation and postoperative follow-up of vascular access, with particular emphasis to establish a relationship between doppler Ultrasound parameters including:

1. Flow volume.
2. Outflow vein diameter.
3. Outflow vein depth.
4. Resistive index.


Eligibility Criteria:
Inclusion Criteria:

* ESRD patients on dialysis with heamodialysis vascular access with adult age group (18 years and above).

Exclusion Criteria:

* Patients with chronically occluded vascular access with failed surgical or interventional attempts.
HRT Versus MOS for Endometrial Preparation Prior to FET in Non PCOS Patients

Evaluation of endometrial preparation using either hormonal therapy or ovarian stimulation prior to frozen-thawed embryo transfer (FET) in patients without polycystic ovarian syndrome (PCOS)

Women will be randomly divided into two groups; one will be subjected to endometrial preparation by hormone replacement therapy (HRT) and the other will be subjected to minimal ovarian stimulation (MOS). Women in the HRT group will be given estradiol valerate 4 mg daily from day 2 to day 12 of the cycle then the endometrial thickness will be assessed on day 13 by transvaginal sonography (TVS). If the endometrium is ≥ 8 mm and of moderate echogenicity, luteal phase support (using progesterone supplements) will be started but if the endometrium is \< 8 mm, estradiol valerate will be continued until reaching appropriate endometrial thickness and echogenicity then the luteal phase support will be started. Women in the MOS group will be given clomiphene citrate in dose of 100-150 mg daily for 5 days (from day 2 to day 6 of the cycle) then switched to low dose gonadotropin (75-150 IU daily) followed by monitoring of the follicular growth (folliculometry) ); starting from day 10 of the stimulation cycle and repeated every 2 days. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle \> 18 mm in diameter followed by luteal phase support (using progesterone supplements) after 48 hours. In both groups, FET will be planned in the appropriate day according to the stage that the embryos have been cryopreserved in it.

Eligibility Criteria:
Inclusion Criteria:

* Women without PCOS as defined by the Rotterdam criteria.
* Presence of at least 2 cryopreserved good quality cleavage-stage embryo (good quality cleavage-stage embryos display stage-specific cell division, have blastomeres of fairly equal size with few to no cytoplasmic fragments).

Exclusion Criteria:

* PCOS or polycystic ovary on ultrasound scan.
* Moderate or severe endometriosis.
* Hydrosalpinx.
* Uterine abnormalities or myoma.
* Previous uterine surgery.
GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults

The primary objective is to estimate the size of the GR270773 treatment effect on 28-day all-cause mortality for two doses of GR270773 versus placebo in adult subjects with suspected or confirmed Gram-negative severe sepsis. GR270773 will be administered as a three-day continuous intravenous infusion.


Eligibility Criteria:
Inclusion criteria:

* Receiving parenteral antibiotic therapy for a suspected or confirmed Gram-negative infection.
* Have at least one new hypoperfusion abnormality or at least one new onset organ failure resulting from the current septic episode.
* Must be available and able to receive the first dose of study medication no more than 12 hours after the confirmation of a new hypoperfusion abnormality or new onset organ failure and within 36 hours after the initiation of new parenteral antibacterial therapy for the suspected or confirmed Gram-negative infection believed to be responsible for this episode of sepsis.

Exclusion criteria:

* Subject is unlikely to remain in hospital for a minimum of three days (72 hours) following enrollment.
* Subject has neutropenia (e.g., subject recently receiving cytotoxic chemotherapy with absolute neutrophil count \<500/mcL or expected to decline to \<500/mcL in the next 3 days).
* Subject has known active hemolytic disease, immune hemolytic anemias, hemoglobinopathies (sickle cell anemia and thalassemia major).
* Subject has a known bone marrow disorder of inadequate red cell production (eg, aplastic anemia, myelodysplasia).
* Subject is at increased risk of complications from GR270773-related hemolysis due to the inability to increase cardiac function sufficiently to meet the demands for oxygen delivery.
* Subject has a baseline hemoglobin (measured after adequate volume resuscitation) \<9.0 g/dL (5.59 mmol/L).
* Subject is currently being treated with XIGRIS (Drotrecogin alfa (activated)) or its use is considered imminent (ie., a decision to treat with XIGRIS has been made).
* Subject has a history of allergic reaction to eggs (or egg products), soybeans, INTRALIPID, or any component of GR270773.
* Subject has been designated as 'not full support do not resuscitate' (DNR), or other equivalent status which prohibits the use of life supporting interventions (e.g., mechanical ventilation, dialysis/hemofiltration, or others) thereby limiting the treatment options available.

Note: Subjects with advanced directives prohibiting only chest compression (CPR) are eligible for the study.

* Subject has preexisting severe liver disease such as cirrhosis, primary biliary cirrhosis or known preexisting Child-Pugh class B or C liver dysfunction.
* Subject is moribund (a state in which death is perceived to be imminent) or has a life expectancy of less than 3 months due to an underlying disease.
* Subject is currently receiving one of the following prohibited concomitant medications; parenteral nutrition supplements containing lipid emulsions (e.g., INTRALIPID), amphotericin, liposomal amphotericin, or amphotericin B lipid complex.
Cerebral Blood Flow Changes in People With Obesity After Glucose Consumption

This study evaluates the hypothesis that a meal constituted of only glucose produces differences in the brain blood flow in people with obesity that are not observed in people without obesity. These changes, at least in part, could explain the mechanisms involved in maintenance or development of obesity.


Eligibility Criteria:
Inclusion Criteria:

* Live in Ribeirão Preto, São Paulo - Brazil.
* Age between 18 and 40 years old.
* Female gender.
* Regular menses.
* Weight inferior than 120 Kg and body mass index (BMI) between 30 and 40 kg/m2, for the group with obesity.
* BMI between 18,5 and 24,9 kg/m2, for the group without obesity.

Exclusion Criteria:

* High blood pressure, diabetes, glucose intolerance or impaired fasting glycemia, metabolic syndrome, hypothyroidism and any kidney, liver, heart or neurologic disease.
* Psychiatric disorders, alcoholism, smoking or illicit drug abuse.
* Pregnancy or desire to be pregnant
* Use of medications, excluding contraceptives.
* Contraindication for magnetic resonance imaging.
* Be in treatment for obesity.
Oral Health Awareness and Oral Hygiene in Insulin Dependent Diabetes Mellitus

This study is designed to evaluate the effect of oral health educational program on the awareness and oral health status of children with Insulin Dependent Diabetes Mellitus.

First visit: (baseline)

1. Awareness questionnaire is given to parent or caregiver to fill.
2. Child information will be recorded in the diagnosis chart of Pediatric Dentistry and Public Health Department
3. Intra-oral and extra-oral examination to all children included and recording Oral Hygiene Index simplified.
4. Intervention group will receive:

   * Supra-gingival scaling
   * Oral Health Educational Program through life demonstration of tooth brushing on a model, power point presentation and a poster.
   * Package containing tooth brush, tooth paste, poster and follow-up chart.

Second and third visits: (every month)

1. Oral hygiene index simplified will be recorded for both groups.
2. Follow-up chart is collected from intervention group.

Forth visit: (final visit)

1. Awareness questionnaire is given for parents of both groups.
2. Oral Hygiene Index simplified is recorded for both groups.
3. Follow up charts is collected from intervention
4. Control group will receive the same program after collection all data.

Number of visits \& follow up period:

* Four visits, time interval between each visit is one month and the follow up period is three months

Eligibility Criteria:
Inclusion Criteria:

1. Children aged 6-8 years old.
2. Cooperative children.
3. Both genders.
4. Insulin Dependent Diabetes Mellitus children

Exclusion Criteria:

1. Children with any other medical condition.
2. Children undergoing orthodontic treatment.
3. Parents unable to give informed consent
The Effect of L-Citrulline Malate on Ankle Brachial Index Among Patients With Coronary Heart Disease

In this randomized clinical trial before and after study we will assess the effect of L-citrulline malate on brachial index in patients with coronary heart disease based on their smoking history. Twenty patients with coronary heart disease with no history of diabetes or other chronic diseases and with no history of myocardial infarction in the last 6 months will participate in our trial.A written well-versed permission was attained from all patients. We will measure the brachial index tow times once before giving L-Citrulline malate and the other time after 2 weeks giving it.Patients receiving L-Citrulline malate as a 1 gram dry powder agent twice a day, that should in use with 250 mg dilute water .The patients will followed after 2 weeks by measuring brachial index which is our primary outcome measurement in this trial.We assumed that the brachial index in both smoker and non-smoker group of patients with coronary heart disease would change to normal or close to normal after giving 1 gram L-citrulline malate twice a day for 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

1- patients with coronary heart disease without history of diabetes or any chronic disease 2- no myocardial infarction in last 6 months 3-ejection fraction more than 50% 4- please to recruit in the trial 5-no uncontrolled blood pressure 6- with stable condition when come to the clinic

Exclusion Criteria:

1- those who refuse to being in the trial 2- those which their total condition become worse 3- CCU admission as a result of being unstable 4- patients with chronic heart failure(CHF)
Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops

This study was designed to compare the difference of using atropine eyedrops alone from atropine combined with the stimulation of auricular acupoints therapy in reducing myopia progression.

A total of 64 school-aged children with myopia, fulfilling eligibility criteria, were recruited. They were randomly assigned to three arms:

1. 21 treated with the 0.25 % atropine each night (0.25A).
2. 20 treated with the 0.5 % atropine each night (0.5A).
3. 23 treated with 0.25 % atropine each night together with stimulation of auricular acupoints(0.25A+E).

This protocol was proceeded for at least 6 months.The differences in post-treatment effects of these three groups were statistically accessed.

Eligibility Criteria:
Inclusion Criteria:

* all included patients, age from 6 to 15 years, had myopia (spherical equivalent \> -0.5 D) after cycloplegic refraction,
* The astigmatism and anisometropia were less than 2.0 D,
* IOP was less than 21 mmHg.

Exclusion Criteria:

* the presence of related disease such as infection, ulceration, eyelid disease, ocular and auricular disorders,
* individuals with amblyopia or strabismus,
* individuals received any other therapies in the period of study,
* individuals suffering some sort of haemostasis disorder,
* individuals did not follow the treatment (eyedrops and/or stimulation of auricular acupoints) over seven days