cyrilzakka/clinical-trials huggingface dataset:
Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer

This phase II trial is studying fulvestrant to see how well it works in treating patients with recurrent, persistent, or metastatic endometrial cancer. Estrogen can stimulate the growth of cancer cells. Hormone therapy using fulvestrant may fight cancer by blocking the uptake of estrogen by the tumor cells.

PRIMARY OBJECTIVES:

I. Compare the probability of clinical response in estrogen receptor (ER)-positive vs ER-negative patients with recurrent, persistent, or metastatic endometrial cancer treated with fulvestrant.

II. Compare the relationship between response rate and intensity of receptor expression in patients treated with this drug.

III. Determine the frequency and intensity of toxicity of this drug in these patients.

OUTLINE:

Patients receive fulvestrant intramuscularly on day 1. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria:
Criteria:

* Histologically confirmed recurrent, persistent, or metastatic endometrial cancer that is not curable with surgery or radiotherapy
* Estrogen receptor (ER) and progesterone receptor status known by immunohistochemistry

  * ER positive or negative allowed
* Measurable disease:

  * At least 1 target lesion not within a previously irradiated field OR irradiated target lesion with clear disease progression
  * At least 20 mm by conventional techniques, including palpation, x-ray, CT scan, MRI, OR at least 10 mm by spiral CT scan
* Performance status:

  * GOG 0-1
* Hematopoietic:

  * Absolute neutrophil count \>= 1,500/mm\^3
  * Platelet count \>= 100,000/mm\^3
  * No prior bleeding diathesis (disseminated intravascular coagulation, clotting factor deficiency, or requirement for anticoagulants)
* Hepatic:

  * Bilirubin =\< 1.5 times upper limit of normal (ULN)
  * SGOT =\< 3 times ULN
  * Alkaline phosphatase =\< 3 times ULN
* Renal:

  * Creatinine =\< 2 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No hypersensitivity to castor oil
* No other concurrent malignancy except nonmelanoma skin cancer
* No other prior malignancy within past 5 years
* No prior chemotherapy for persistent, recurrent, or metastatic endometrial cancer
* No more than 1 prior chemotherapy regimen for newly diagnosed endometrial cancer that has subsequently recurred
* At least 3 weeks since prior hormonal therapy and recovered
* At least 3 weeks since prior radiotherapy and recovered
* At least 3 weeks since prior surgery and recovered
Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine

A non randomized study to validate the MATHYS Scale in a population of in and outpatients greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and treated with olanzapine.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) disease diagnostic criteria for Bipolar Disorder

   * currently or most recently in a Manic Episode (Single Manic Episode or Most Recent Episode Manic) or
   * currently or most recently in a Hypomanic Episode or
   * currently or most recently in a Mixed Episode or
   * currently or most recently in a Major Depressive Episode
   * and confirmed by the module D of the SCID (Semi-Structured Interview).
2. Patients must be more than 18 of age at Visit 0.

Exclusion Criteria:

1. A valid current or lifetime DSM-IV-TR Axis I or II diagnosis which could interfere, at the investigator's opinion, with the evaluation.
2. Patients on antidepressant or mood stabilizer therapy one week (four weeks with fluoxetine) prior to Visit 1, with the exception of mood stabilizer therapy considered in the opinion of the investigator as an efficient treatment for at least one year prior to the study.
Platform Trial For Cryptococcal Meningitis

Cryptococcal meningitis is a fungal infection that causes a severe syndrome of meningitis that is 100% fatal without antifungal therapy. Even with antifungal therapy, mortality rates remain high, especially in low and middle income countries where the ongoing HIV/AIDS pandemic increases the risk of cryptococcosis among persons living with HIV infection. The combination of amphotericin and flucytosine (5-FC) has been the mainstay of therapy for the initial management of cryptococcal meningitis for 4 decades. Indeed, the effective delivery of these first line therapy in Africa can lower mortality to 25%. However, several challenges exist. First, even while 5-FC is included on the WHO list of essential medicines, the availability of 5-FC worldwide is limited. Second, liposomal amphotericin (Ambisome ®) is currently available from a single source supplier, creating risk. Third, current therapies have substantial toxicity. Lastly, with widespread agricultural fungicide use of azoles, the median fluconazole minimum inhibitory concentration (MIC50 ) for Cryptococcus has doubled since 2013. Globally, new or improved antifungals are needed for cryptococcal meningitis, particularly those which have less toxicity, greater efficacy, a prolonged half-life, and minimal drug-drug interactions. As multiple new antifungal medicines are on the horizon, this platform trial utilizes a master protocol to investigate, multiple regimens using standardized eligibility criteria, standardized study schedule of events, and standardized contemporary endpoints.


Eligibility Criteria:
Inclusion Criteria:

* CSF cryptococcal antigen (CrAg) positive meningitis
* HIV positive
* Ability and willingness to provide informed consent
* Willing to receive protocol-specified lumbar punctures
* Age \>= 18 years
* Female participants of childbearing potential who are participating in sexual activity that could lead to pregnancy must agree to use reliable forms of contraception (duration will be indicated in each Trial Appendix).

Exclusion Criteria:

* Received \>= 3 doses of antifungal therapy for meningitis treatment or \> 6mg/kg of liposomal amphotericin B cumulatively within prior 30 days
* Inability to take enteral (oral or nasogastric) medicine
* Cannot or unlikely to attend regular clinic visits
* Receiving chemotherapy or corticosteroids
* Receiving hemodialysis or known liver cirrhosis
* Suspected Paradoxical immune reconstitution inflammatory syndrome (IRIS)
* Pregnancy or breastfeeding
* Previous administration of investigational study drug
* Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments
* Trial Appendix study-drug specific eligibility criteria
Blood Levels of Local Anaesthetic in Hip Arthroplasty

The primary goal is to evaluate ropivacaine blood concentrations during and after local anaesthetic (ropivacaine) infiltration - the Caledonian technique - for total hip replacement surgery. The investigators plan to measure these levels by testing blood samples taken over a timed period.

This will allow us to confirm whether the current regimen of local anaesthetic use is within safe limits.

Local anaesthetic (LA) toxicity may occur when the blood levels of a drug become particularly high. There is a need to confirm that the technique is safe to use. In addition, journal case reports may only describe serious side-effects of toxicity such as abnormal heart rhythms whilst more subtle clinical signs are rarely reported.

The investigators would like to study whether or not toxic levels may be approached in some patients or whether more subtle toxicity symptoms and signs are missed. For example, irregular heartbeat, low blood pressure or confusion/agitation.

Therefore, the investigators intend to study ropivacaine blood levels in patients receiving a total hip replacement in the Golden Jubilee National Hospital. A series of timed samples will be taken during the perioperative period. The anaesthesia and surgery will be performed as routine and no new treatment will be involved. Patient demographics, ropivacaine blood levels and clinical observations following LA administration will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients greater than 65 years of age

Exclusion Criteria:

* Patients with a known sensitivity/allergy to ropivacaine or amide-type local anaesthetics
* Patients who are not suitable for the Caledonian technique
* Patients who refuse or are unable to give consent
* Patients undergoing bilateral hip replacements
* Patients with known heart, liver or kidney failure
Complications in Minimally Invasive Aesthetic Dermatological Procedures in Switzerland

The aim of this retrospective study is to describe cases of complications from minimally invasive aesthetic procedures treated at a university reference centre in Switzerland between 2021 and 2024.

During the past decade, a steady increase in aesthetic procedures has been observed. Over the last four years, non-surgical procedures have grown by 40%. The five most popular treatments are botulinum toxin, hyaluronic acid, hair removal, chemical peels, and nonsurgical fat reduction.

With the increase in aesthetic procedures, adverse effects have also increased. Contributing factors include weak regulations, unlicensed practice, and individuals with little or no formal training administering botulinum toxins and dermal fillers.

This study aims to analyze unexpected and often unfavorable outcomes, referred to as complications, arising from minimally invasive procedures-both non-injectable (e.g., laser treatments, chemical peels) and injectable (e.g., botulinum toxin, fillers). The complications are categorized based on their severity and ethiology. This retrospective case series is conducted at a university reference center in Switzerland (Margarethenklinik of the University Hospital Basel) between January 2021 and December 2024.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and older of all genders, ethnic and social demographic background that have signed the General consent and the Photo-Informed Consent Form.

Exclusion Criteria:

* Patients who didn't sign the general consent.
* Patients under 18 years old.
Nitrous Oxide Vasodilation Healthy Adult Volunteers

Nitrous oxide (N2O) is a gas that is normally used to take away pain and anxiety during painful medical procedures. However, one of its effects is to also make veins appear larger and more visible. This is useful when there is a patient who needs to have an intravenous (IV) needle put in their skin to give them medicine or ﬂuids, but may have veins that are very hard to see or feel. The mechanism of this observed effect is not entirely clear. The purpose of this study is to use an ultrasound to directly measure whether there is an actual change size of veins or change in blood flow in healthy adult volunteers when you give them 50% nitrous oxide, and see whether or not this change in size, or change in flow, is what causes the changes in visibility or palpability of the vein.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers.
* 19 years or older (inclusive)
* English speaking.

Exclusion Criteria:

* ASA class III or greater;
* History of, or suspected, difﬁcult airway based on physical exam, facial dysmorphism or syndrome
* Any condition in which air may be trapped in a body cavity. These include, but are not limited to:

Pneumothorax or chest injury, concurrent acute asthma exacerbation, middle ear occlusion, intestinal obstruction, ileus, or abdominal distension, sinusitis or maxillofacial injuries with potential for trapped gas, recent intraocular surgery or penetrating globe injury, air embolus, severe bullous emphysema (consider in patients with cystic ﬁbrosis), history of craniotomy in previous three weeks

* Pregnancy (1st and 2nd trimester)
* Increased intracranial pressure, impaired level of consciousness, or head injury
* Known Vitamin B12 deﬁciency
* Known MTHFR Deﬁciency (Inborn error of metabolism)
* History of bleomycin administration (note that the oxygen component of N2O administration is what interacts with bleomycin to cause pulmonary toxicity)
* Intoxication with alcohol or other drugs
* Any condition in which patient may be catecholamine-depleted (e.g. septic shock)
* Recent history of altered mental status
* Pulmonary hypertension
* Congestive heart failure.
* Trainees, including students, residents, and fellows, working in the pediatric emergency department.
The Effect of a Gastric Bypass on Type 2 Diabetes in the Morbidly Obese Patient

Proof of concept, of RYGBP and its capabilities to cure type 2 diabetes (DM 2) and sleep apnea has already been recognized in the reports on weight loss surgery.

The investigators project aims to prove that RYGBP also recovers the beta cell function (BCF) Clamp tests, the gold standard for testing IS and BCF, will be performed preoperative and early postoperatively.

Aims \& methodology:

Analysis of the short-term effect of gastric bypass and sleeve gastrectomy on insulin sensitivity and beta cell function.

Preoperative baseline insulin sensitivity and beta cell function will be assessed with euglycemic and hyperglycemic clamp tests. These results will be compared with the results of the same tests carried out 3 weeks postoperative.

To determine if the duodenal exclusion is causing this effect. The results of the clamp tests 3 weeks postoperative will be compared


Eligibility Criteria:
Inclusion Criteria:

* Female or male subjects aged 18 to 65
* BMI \> 35 kg/m2
* Subject is capable and willing to give informed consent.
* In the surgical groups indication for surgery is approved by the local multidisciplinary obesity workgroup following the NIH guidelines of 199112.
* Patient suffers from type 2 diabetes necessitating insulin therapy.
* Subject is a non-smoker for at least 6 months prior to study start.
* Female patients of child bearing potential must use oral, injected or implanted hormonal methods of contraception from at least the commencement of their last normal period prior to the screening visit. Patients using hormonal contraception should use a barrier method in addition from screening visit until their next normal period following the end of the study.
* Female patients of non-child bearing potential defined as:

  * Post-menopausal females, being amenorrhoeic for at least 1 year
  * Pre-menopausal females with a documented hysterectomy or bilateral oophorectomy.

Exclusion Criteria:

* Female patient is pregnant or breastfeeding.
* BMI \< 35 kg/m2
* Patient suffers from an endocrine disease, besides diabetes and thyroid disease, such as Cushing's disease, Addison's disease, hypothalamic tumor...)
* Patient suffers from type 1 diabetes, MODY or LADA
* Patient has undergone previous surgical procedure for weight loss
* Patient is considered ASA 4 or more according to the ASA physical status classification system of the American Society of Anesthesiologists.
* Patient suffers from liver cirrhosis
* Patient uses steroids
* Patient uses cyclosporin
* Recent (\<30 days) or simultaneous participation in another clinical trial.
* Any situation that can compromise the study, including serious illness or a predictable lack of cooperation from the subject.
Efficacy of Tranexamic Acid in Brain Tumor Resections

The purpose of this study is to determine whether Tranexamic Acid is effective or not in the reduction of intraoperative bleeding loss in brain tumors resections.

Brain tumor resection has been associated with increased blood loss and a significant increase in the incidence of Intravascular disseminated coagulopathy. The development of coagulopathy in the context of tumor resection is associated with poor results. Transfusion decision during the course of neurosurgical surgery offers benefits such as increased oxygen carrying capacity but may increase the risk associated with transfusions such as blood infections, hemolysis, lung injury and immunosuppression. The information available on tranexamic acid used in neurosurgery is little, therefore this opens up new alternatives in the techniques of reducing intraoperative bleeding.

Tranexamic acid is an antifibrinolytic agent that blocks the binding of plasminogen to the fibrin surface. It has been used to reduce blood loss during coronary revascularization, liver resection, obstetrics and orthopedic procedures. Tranexamic acid intraoperatively has been shown to reduce blood loss up to 45%. The primary concern when administering an antifibrinolytic drug is the potential increased incidence of thromboembolic events. There is no actual data on the utility of tranexamic acid to reduce blood loss in brain tumors resection surgery.

We want to compare Tranexamic Acid to Saline solution(Placebo) to see whether Tranexamic ACid Administration will reduce blood loss during brain tumor resection. Reduction in transfusion requirements will lead to reduced costs and possible reduction in complications of blood transfusion and perioperative incidents.

Eligibility Criteria:
Inclusion Criteria:

* Patients who agree to participate by giving informed consent
* Eligible previously untreated patients with resectable brain tumor.

Exclusion Criteria:

* Patients with previous thromboembolic events.
* Patients with coagulopathy or anticoagulation therapy. (Abnormal PT, PTT)
* Patients with impaired renal function (Creatinine \>1.1mg/dl)
* Patients with known contraindications to fibrinolytic treatment.
* Patients receiving rejection therapy.
* Patients with abnormal liver function.
* Known allergies to Tranexamic Acid.
Soluble Fibre Supplementation in NAFLD

The FIND study will look at the effect of a nutritional mixed fibre supplement, oligofructose and inulin (OF+INU), on children with non-alcoholic fatty liver disease. In this randomized, double- blind controlled trial, subjects will be given a supplement, in the form of oral pills, and will have bloodwork performed, their diets analyzed, and liver fat measured at several timepoints. Liver fat will be measured by using a specialized MRI device located at St. Joseph's Hospital. Subjects will be recruited from the Children's Exercise and Nutrition Clinic.

The FIND (Fibre in Non-Alcoholic Fatty Liver Disease) study will be a single-centre, randomized, double-blind placebo-controlled trial comparing the effects of 6 months of mixed oligofructose and inulin (OF+INU) supplementation vs placebo on hepatic fat content, hepatic stiffness, metabolic outcomes, and body composition in children ages 8-17 years old.

Assessments such as MRI measurements of hepatic fat and hepatic stiffness, anthropometry and pubertal status questionnaires, and other investigations such as body composition via dual energy X-ray absorptiometry (DXA), fasting lipids, liver enzymes, blood glucose and oral-glucose tolerance (OGTT) tests will be performed; and randomization will be conducted via REDCap software.

Eighty participants will be enrolled for baseline evaluation in order to randomize sixty participants for the intervention phase (i.e. thirty participants per study group). Participants will consume one packet (4g) of OF+INU or placebo (Maltodextrin) daily. If tolerated, this will increase to one packet twice daily. Several strategies will be implemented to increase compliance, including text message reminders (daily for first week, then weekly), study calls to assess compliance and tolerability, and check-ins with participants at each clinic visit. These interactions will allow the study team to assess challenges and offer prompt support. Compliance will be assessed at each study visit by counting empty and unused sachets. Treatment with OF+INU or placebo will occur for 6 months, with study visits being conducted at baseline evaluation, 3 months and 6 months

Eligibility Criteria:
Inclusion Criteria:

* Children ages 8-17 years
* Diagnosed with obesity (BMI ≥2 standard deviations above WHO reference median)
* Enrolled in GHWM Clinic
* Clinical evidence of NAFLD (elevation of ALT, greater than 2x upper-limit-of-normal (ULN) \[ALT\>80 IU/L for 8-17 years of age\], and hepatic steatosis measured as part of clinic enrolment).

Exclusion Criteria:

* Type 1, Type 2 diabetes mellitus (T1DM, T2DM)
* Contraindications to having MRI (claustrophobia, metal implant, recent tattoo, weight \> 300lbs)
* Concomitant use of other fibre supplements
* Medications known to affect hepatic fat content, taken within the past year (i.e., glucocorticoids, anabolic steroids, tetracycline, anticonvulsants, antipsychotics, glucose- lowering medications)
* Presence of another known cause of liver disease
* Known allergy or hypersensitivity to OF-INU supplementation
* Self-reported alcohol intake \>7 drinks/week or 3 drinks/day
Insertion Time Over Fiberoptic Bronchoscope of Double Lumen Tube and Single Lumen Tube

One lung ventilation (OLV) is required during thoracic procedures such as lung and esophagus surgery. three technique can be employed. (1) placement of a double-lumen bronchial tube (DLT); (2) use of a single-lumen tracheal tube (SLT) in conjunction with a bronchial blocker; (3) insertion of a conventional SLT into a main bronchus. Flexible fiberoptic intubation with SLT is well established technique for anticipated or unexpected difficult intubation. But, little is known about flexible fiberoptic intubation with DLT.

The investigators compared insertion time over fiberoptic bronchoscope between SLT with bronchial blocker and DLT in patients undergoing thoracic surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing thoracic surgery and one lung ventilation American Society of Anesthesiology Physical status 1,2

Exclusion Criteria:

* abnormality of upper airway, gastroesophageal disease, risk of aspiration, BMI \> 35
Quality of Life in Adult Patients With Severe Haemophilia in Turkey

The primary aim of this study is to evaluate the overall quality of life in adult patients with severe haemophilia (an inherited bleeding disorder affecting mainly men) in Turkey and to assess the impact of certain disease and drug related factors (treatment modality, presence of viral disease, inhibitor, etc.) on the quality of life.

Haemophilia is an inherited bleeding disorder affecting one in 10000 male births worldwide. People with severe haemophilia usually suffer from recurrent life threatening bleeds (e.g. into the brain, digestive system or abdomen) and/or disabling degenerative disease of weight bearing joints (e.g. knees, elbows and ankles)resulting from haemorrhage into the joints. Daily activities of people with haemophilia has been shown to be dramatically hampered by the resultant joint damage. Evaluation of quality of life issues in people with severe haemophilia would help to create awareness of their problems and limitations. This would also set up the scene for developing policies to improve the treatment options/facilities and social life of the patients. Current study aims to assess the quality of life of adult patients with severe haemophilia in a developing country (Turkey) by using a validated Quality of Life Questionnaire (Turkish version of Haem-A-QoL).

Eligibility Criteria:
Inclusion Criteria:

* age equal or greater than 18 years
* male gender
* factor VIII or IX level equal or below 1%
* patients that are willing to participate and have given a written consent

Exclusion Criteria:

* age less than 18 years
* females
* factor levels above 1%