cyrilzakka/clinical-trials huggingface dataset:
12-month Study of AMG 073 in Renal Osteodystrophy

4 doses of AMG 073 or placebo over 52 weeks after a 30-day screening period. Throughout the study, labs will be drawn to measure analytes such as iPTH and corrected calcium. In addition, a bone biopsy will be performed at screening and at the end of study.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age of greater
* Using effective contraceptive measures
* iPTH greater than or equal to 300 pg/mL
* Serum Calcium greater than or equal to 8.4 mg/dL; Hemoglobin greater than 9
* Stable hemodialysis for 1 month prior to day 1

Exclusion Criteria:

* Any unstable medical condition
* Pregnant or nursing women Recent parathyroidectomy
* Change in Vitamin D therapy
* Recent MI, Seizure, Malignancy, GI Disorder
* Inability to swallow tablets
A Study of Risperidone in Combination With Lorazepam Compared With Standard Therapy for Emergency Treatment of Schizophrenic Patients

The purpose of the study is to show that risperidone (an antipsychotic medication) combined with lorazepam (an anti-anxiety medication) is more effective than conventional therapy administered by intramuscular injection for emergency treatment of patients with schizophrenia.

Patients with acute schizophrenia are often anxious and uncertain because of the psychotic symptoms they are experiencing. These patients are in need of rapid help and symptom relief. Risperidone, a widely used antipsychotic medication, is effective against positive and negative symptoms of schizophrenia, has a rapid onset of action, a low incidence of extrapyramidal symptoms, and, in general, mild adverse events. This is an open-label trial of 2 mg dose of an oral formulation of risperidone in combination with 2 to 2.5 mg of oral lorazepam compared with standard care, which consists of a conventional neuroleptic drug administered via an intramuscular injection, with or without lorazepam. Patients requiring emergency care are offered a choice of these two therapies and are monitored for 24 hours after initial treatment. Optional follow up may be performed after 2, 3, and 7 days. The primary measure of effectiveness is the success of the treatment 2 hours after the drug is administered, as indicated by the patient being asleep or by showing improvement on the Clinical Global Impression (CGI) Improvement subscale. Additional effectiveness assessments include an evaluation of hostility and agitation, as assessed by Brief Psychiatric Rating Scale (BPRS), the degree of sedation, and the ability of the patient to interact with the physician at 1, 2, and 24 hours after the start of treatment. Safety assessments include the incidence of adverse events throughout the treatment and follow up periods. The study hypothesis is that oral risperidone combined with lorazepam is more effective than therapy with conventional neuroleptic intramuscular agents, with or without lorazepam, for emergency treatment of patients with schizophrenia. Single, oral 2 mg dose of risperidone and a single, oral 2 to 2.5 mg dose of lorazepam; further dosing during the 24 hour period at investigator's discretion. Comparator drug of choice (with or without lorazepam) administered intramuscularly according to product labeling.

Eligibility Criteria:
Inclusion Criteria:

* Psychotic patients with schizophrenia who require rapid intervention
* experiencing symptoms of a psychotic disorder
* capable of choosing to be treated

Exclusion Criteria:

* Patients with a known hypersensitivity to the study drugs
* have participated in an investigational drug trial within 30 days of study initiation
* known to be unresponsive to treatment with risperidone or the comparator drug
* known to have benzodiazepine dependence (addiction to this class of anti-anxiety drugs)
Drug-Drug Interaction Study of Casdatifan in Healthy Adult Participants (ARC-29)

The purpose of the study is to assess the effects of multiple doses of itraconazole (a strong CYP3A4 inhibitor) on single dose PK of casdatifan in healthy adults and to assess the effects of multiple doses of phenytoin (a strong CYP3A4 inducer) on single dose PK of casdatifan in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult, male or female 18-55 years of age, inclusive, at the screening visit.
* Male participants must be vasectomized
* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting.
* BMI ≥ 18.0 and ≤ 32.0 kg/m2 and body weight ≥ 45 kg, at the screening visit
* Able to swallow multiple tablets and/or capsules.

Exclusion Criteria:

* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
* History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
* History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
* History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
* History of asthma or chronic obstructive pulmonary disease (including childhood), clinically significant food allergies or anaphylaxis, as deemed by PI or designee.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Bendamustine, Wkly Bortezomib, Lenalidomide and Dexamethasone for Multiple Myeloma

The purpose of the study is to determine the safety and efficacy of the use of bendamustine in combination with a commonly used combination chemotherapy to treat relapsed and refractory multiple myeloma. The study will be conducted in two phases. Participants in phase I will receive 1 of 4 escalating doses of bendamustine. Once the maximum tolerated dose of bendamustine is determined, phase II of this trial will begin. Participants in phase II will receive the maximum tolerated dose of bendamustine in combination with standard of care chemotherapy.

Multiple myeloma is a multi-organ neoplastic disorder caused by the clonal proliferation of plasma cells. It has an incidence of about 4.5/100,000 per year in the U.S., making it the second most common hematologic malignancy. For many years, alkylating agents have been the backbone of treatment. The combination of melphalan and prednisone was, for many years, the standard of care for patients who were not candidates for autologous transplantation. Melphalan continues to be the primary conditioning agent for autologous transplant,and cyclophosphamide has also gained a foothold in the treatment of this disease.

The introduction of novel agents has fundamentally changed the landscape of treating this disease, although the true effects on survival are not yet known. Immunomodulatory agents and proteosome inhibitors, including thalidomide, lenalidomide and bortezomib have been used in both newly diagnosed and relapsed patients. Currently, there is intense clinical research on the optimal way to combine these novel agents with the traditional backbones of treatment - including alkylators, with one another and, eventually, with the subsequent iterations of these classes of drugs. However, despite the therapeutic excitement surrounding this disease, most patients will relapse and a cure remains an elusive goal.

Eligibility Criteria:
Inclusion Criteria:

* Adults with relapsed and/or refractory myeloma who have received between 1-4 prior lines of therapy
* Must have adequate liver and renal function
* Zubrod Performance Status (ZPS) of 2 or better
* Must have measurable disease

Exclusion Criteria:

* Peripheral neuropathy of grade II or higher
* Thrombocytopenia (platelets less than 50,000/uL)
* Neutropenia (ANC\<1000/uL)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.4 X ULN
* Total bilirubin \>1.5 X upper limit of normal (ULN)
* Creatinine clearance of less than 45 milliliters per minute (mL/min)
* Patients with HIV
* Patients with active hepatitis
* Pregnant or lactating women
* Individuals of child-bearing potential not using adequate contraception
* Individuals unable to provide informed consent
Comparison of Deferasirox and Desferoxamine in Patients of β-Thalassemia Major With Iron Overload

This study was planned to compare deferasirox and desferrioxamine in terms of mean serum ferritin levels in patients of β-thalassemia major having Iron overload. Choosing an effective iron chelator is crucial to increasing iron chelation therapy compliance. Not much local data exists in Pakistan comparing the effectiveness of deferasirox (DFX) and desferrioxamine (DFO), so, this study would be helpful in providing baseline data and formulating new protocols for iron chelation therapy, in which DFX may be a useful oral alternative to parenteral DFO.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of β-thalassemia major (as per medical record or confirmed by hemoglobin electrophoresis)
* Iron overload (serum ferritin level above 1000 µg/L)

Exclusion Criteria:

* Patients with other transfusion-dependent anemias
* Thalassemia major with cardiomyopathy or arrhythmia.
* Chronic renal failure
* Chronic liver disease (ALT \>200 IU)
* Hhypersensitivity to deferasirox or desferrioxamine
* Patients already on combined chelation therapy
Ultraviolet-A and Riboflavin Treatment for Infectious Keratitis

This study is to evaluate the efficacy of ultraviolet-A (UVA) and riboflavin application (also often referred to as corneal collagen crosslinking) as a method to enhance treatment of infectious keratitis.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be 18 years of age or older.
2. Ability to provide written informed consent.
3. Likely to complete all study visits.
4. Subjects must have one eye that with a diagnosis of infectious keratitis.

Exclusion Criteria:

1. A corneal perforation.
2. Descemetocele.
3. Pregnancy or breastfeeding.
4. Active Herpes corneal disease.
5. Patient is unwilling or unable to comply with a medication regimen and follow up appointments.
Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy

The aim of this study was to evaluated the advantages of routine application of the anterior approach in patients scheduled to right hepatectomy or extended right hepatectomy, without infiltration of segment 1, inferior vena cava or main bile duct.

Mobilization of the liver during right hepatectomy with classic approach is performed before parenchymal transection. In this phase severe bleeding may occur due to laceration of the inferior vena cava (IVC) wall, rupture or ligation falling off the hepatic short vein (HSV) or bleeding from the right liver attachments. Besides, the twisting of the portal pedicle during mobilization can render the left hepatic lobe ischemic for transient interruption of the hepatopetal flow. These events are more frequent in case of large hepatic lesions (mainly HCC) that involves surrounding structures (such as diaphragm). Two of the most important factors that affect the postoperative course of patients undergoing liver resections are indeed intraoperative bleeding and postoperative liver dysfunction. For these reasons Lai et al proposed anterior approach as alternative to classic right hepatectomy. In this case liver mobilization is performed only at the end of parenchymal transection, when all vascular connections are already interrupted. Liu et al published the results of a retrospective study in which 54 patients with, right sided HCC greater than 5 cm underwent right hepatectomy using the anterior approach technique. The anterior approach group had significantly less intraoperative blood loss, less need of blood transfusion and a lower hospital mortality rate. The same group reported results of a prospective randomized controlled study analyzing 120 patients with large (\>5 cm) right liver HCC. The overall operative blood loss, morbidity, and duration of hospital stay were comparable in both groups. However, a higher number of patients in classic approach group experienced mayor operative blood loss (\> 2000 cc) and required blood transfusions (8.3% vs. 28.3%).

Eligibility Criteria:
Inclusion Criteria:

* patients between 18 and 80 years
* patients scheduled to right hepatectomy or extended right hepatectomy
* the future remnant liver (FRL) ≥ 25% in patients with a normal liver or ≥ 30% in those with chronic liver disease
* indocyanine green retention rate (ICG) at 15 minutes ≤ 10% in cirrhotic patients

Exclusion Criteria:

* resection of S1
* resection of bile duct
* infiltration of inferior vena cava
* America Society of Anesthesiologists (ASA) grade IV
* Emergency surgery
A Drug-drug Interaction (DDI) Study of Morphothiadine Mesilate/Ritonavir in Healthy Subjects

The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of Morphothiadine Mesilate/Ritonavir combined with Entecavir or Tenofovir Disoproxil Fumarate in healthy subjects

This is a 2-part study with each part is an open-label, crossover study in healthy adult subjects.

Total 56 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 28 subjects in each part. Part A is to evaluate the drug-interaction between GLS4/RTV and ETV, Part B is to evaluate the drug-interaction between GLS4/RTV and TDF. With each part, the subject will be split into two groups and receive study drug per the defined treatment periods of Day 1, Day 11-20 and Day 21.

Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions
* Be able to complete the study according to the trail protocol
* Subjects (including partners) have no pregnancy plan within 1 year after the last dose of study drug and voluntarily take effective contraceptive measures
* Male subjects and must be 18 to 45 years of age inclusive
* Body weight ≥ 50 kg and body mass index（BMI）between 18 and 28 kg / m2, inclusive
* Physical examination and vital signs without clinically significant abnormalities.

Exclusion Criteria:

* Use of \>5 cigarettes per day during the past 3 months
* Known history of allergy to study drugs，or allergies constitution ( multiple drug and food allergies)
* History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine)
* Donation or loss of blood over 450 mL within 3 months prior to screening
* 12-lead ECG with clinically significant
* Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis
* Subjects deemed unsuitable by the investigator for any other reason.
Intermittent Theta-Burst Stimulation to Target Irritability in Adults With ASD

This study aims to demonstrate the feasibility, tolerability, safety and preliminary efficacy of 6 weeks of fMRI-guided iTBS delivered to personalized regions of the prefrontal cortex (PFC) in adults with ASD in reducing irritability in adults with ASD.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of ASD or Asperger's based on DSM-5 criteria as confirmed by a qualified clinician (including Dr. Fung), and if necessary the administration of Autism Diagnostic Interview-Revised (ADI-R) and/or Autism Diagnostic Observation Schedule-Generic (ADOS-G)
2. Age 22 to 55.
3. Adults who are physically healthy.
4. No significant current psychosocial stressors per history.
5. Full scale IQ \> 50.
6. ABC-I score of 18 or greater.
7. if the participant is taking medication, they must be stable on this medication regiment for at least 4 weeks prior to baseline and agree to stay on these medications for the duration of the trial

Exclusion Criteria:

(f) Pre-term birth (\<34 weeks' gestation) (g) Low birth weight (\<2000 g). (h) DSM-5 diagnosis of other severe psychiatric disorder such as bipolar disorder or schizophrenia.

(i) Current use of benzodiazepines. (j) Use of other medications that modulate the GABA(A) receptor within 4 weeks of scanning (8 weeks for fluoxetine).

(k) History of alcoholism or substance abuse. (l) Active medical problems such as unstable seizures, congenital heart disease, endocrine disorders.

(m) Significant sensory impairments such as blindness or deafness. (n) Contraindication for MRI. (o) Pregnancy. (p) evidence of genetic syndrome.
Providing Resources to Enhance Patients' Readiness to Make Decisions About Kidney Disease: The PREPARE NOW Study

This study evaluates the effectiveness of patient educational materials (a book and DVD) to help patients with chronic kidney disease make early, shared, and informed decisions about kidney replacement therapy. Half of the participants will receive the educational materials and half will receive usual care from their doctors.

The investigators will study the effectiveness of patient educational materials (a book and DVD, called the PREPARED materials) to help patients with chronic kidney disease make early, shared, and informed decisions about kidney replacement therapy. Half of the participants will receive the PREPARED materials and half will receive usual care from their doctors. PREPARED materials feature patients and their families discussing the pros and cons of different treatment options for kidney failure. The investigators will randomly assign patients already under the care of a nephrologist to receive the video and book or to receive their usual nephrology care. They will measure the degree to which patients in either study arm are prepared for kidney failure treatment at follow up.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* English speaking
* Advanced kidney disease defined as an eGFR \< 20 mL/min/1.73m2 at their last clinical appointment with their nephrologist
* Have not initiated a Renal Replacement Therapy

Exclusion Criteria:

* Cannot speak English
* Have initiated Renal Replacement Therapy
Physical Exercise Cardiovascular Adaptation Monitoring in Pregnancy (PE-CAMP Study)

The main theme of this study focuses on providing evidence of the impact of antenatal physical activity on maternal/foetal cardiovascular changes during pregnancy and maternal cardiovascular adaptations during the early postpartum period.

Overwhelming research supports the general benefit of antenatal physical activity (APA) for pregnant women, but there is a lack of knowledge about the influence of exercise on cardiovascular physiology in healthy and overweight pregnant women and their foetuses. Also some research supports the theory of foetal programming; which establish that maternal habits during pregnancy will impact in-utero environment, so if this maternal habits are healthy ones they could improve foetal health.

Cardio vascular disease (CVD) was the top cause of death all over the world in 2015. In Wales CVD as cause of death is still one of the top ones. However, these statistics could be improved if people adopt healthier lifestyle habits, since 54% and 45% of Welsh women are overweight/obese or sedentary respectively. Pregnancy seems to be a teachable moment for women and the starting point of adopting healthy life-style habits. Therefore, by introducing Welsh pregnant women to exercise, there is the potential to improve their health and of their foetuses an also exert an exponential impact on future generations.

The main theme of this study focuses on providing evidence of the impact of APA on maternal/foetal cardiovascular changes during pregnancy and maternal cardiovascular adaptations during the early postpartum period.

This is a 3-year study carried out in Swansea University, Singleton Hospital.

The project leading to this application has received funding from the European Union's Horizon 2020 research and innovation programme under the Marie Sklodowska-Curie grant agreement No 663830.

Healthy pregnant women with no contraindications for exercise will be eligible for the study and those who want to participate in the project will be allocated into an exercise group (EG) or a control group (CG). EG participants will receive an intervention based on an APA during 20-24weeks, CG participants will follow their standard health care during pregnancy.

All participants must attend three cardiovascular assessment protocols (18-22 weeks \& 32-36weeks during pregnancy, 12weeks postpartum). These protocols will involve maternal/foetal electrocardiograph and echocardiograph evaluation, heart-rate monitoring and moderate physical exercise (walking).

Eligibility Criteria:
Inclusion Criteria:

1. Women with healthy pregnancy
2. Aged 18-40 years
3. Single pregnancy
4. Pregnancy stage \<= 16 weeks' gestation at the point of consent.
5. Two or fewer previous term pregnancies (as physiology can be altered by multiple pregnancies).

Exclusion Criteria:

1. Known complications of pregnancy
2. Known contraindications for physical exercise
3. Known major cardiovascular or respiratory pathology
4. Three or more previous term pregnancies
5. Inability to communicate in English or Welsh.
Evaluation of Acute Post-thrombectomy Complications for Stroke

Retrospective study to assess the incidence of acute complications after thrombectomy for stoke.

Research in the computerized medical file of patients admitted to intensive care unit (ICU) in the last 5 years for a stroke.

Searching for acute complications during the ICU stay. Looking for hemorrhagic, acute renal failure, hemodynamic support, neurologic degradation.

Eligibility Criteria:
Inclusion Criteria:

* \>18 year old
* ICU admitted patient for stroke and received thrombectomy

Exclusion Criteria:

* missing data
Different Abbreviated MRI for Hepatocellular Carcinoma Diagnosis

Abbreviated MRI (AMRI) could improve the diagnostic performance of hepatocellular carcinoma (HCC), but it lacks analysis in different subgroups and effective validation. The investigators aimed to compare and validate the diagnostic performance of different AMRI protocols in diagnosing early-stage HCC.

This retrospective study enrolled untreated patients at risk for developing HCC who underwent gadoxetic acid-enhanced MRI from three independent cohorts from January 2020 to December 2022. Three AMRI protocols were extracted from the complete liver MRI protocol, including non-contrast (NC-AMRI), hepatobiliary phase (HBP-AMRI); and dynamic contrast-enhanced (DCE-AMRI). Two readers at each cohort independently interpreted each AMRI based on ancillary and main features from the Liver Imaging Reporting and Data System (LI-RADS) version 2018. For DCE-AMRI, two established algorithms were employed: modified LI-RADS (DCE-AMRIm) and LI-RADS v2018 (DCE-AMRIv2018). Non-HCCs were ascertained based on histologic and clinical follow-up data, while early-stage HCCs were confirmed post-operatively. Patient-level performance metrics were compared using bootstrap resampling and generalized estimating equations.

Eligibility Criteria:
Inclusion Criteria:

* no previous history of HCC treatment
* no history of any other underlying malignancy besides HCC.

Exclusion Criteria:

* For HCC group: (a) without preoperative MRI within 3 months; (b) without postoperative pathological confirmation; (c) liver cirrhosis without histopathologic proof or radiologic evidence; (d) the size of HCC smaller than 1cm; (e) outside of Milan Criteria; and (f) suboptimal imaging quality.
* For non-HCC group: 1) lost follow-up, 2) insufficient follow-up period, or 3) suboptimal imaging quality.