cyrilzakka/clinical-trials huggingface dataset:
Study of SANGUINATE™ In the Treatment of Sickle Cell Disease Patients With Vaso-Occlusive Crisis

Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis

Patients who are experiencing a vaso-occlusive crisis will report to the clinic for treatment and screening into the SGSC-005 study. Patients who meet all inclusion/exclusion criteria will be randomized to receive either SANGUINATE 320 mg/kg or placebo (saline) over a 2 hour infusion period. Assessments of vital signs, ECGs, safety labs, adverse events as well as patient and physician questionnaires will be completed up to 6 hours after the start of the infusion. Patients will then be assessed for discharge either to home or admitted to the hospital for further treatment depending on their disease severity. Follow-up phone calls will be completed 24 hours and 7 days after initiation of treatment . A follow-up visit will be completed in the clinic at 72 hours after initiation of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years,
2. Sickle Cell Disease (all genotypes),
3. Diagnosis of a severe vaso-occlusive crisis (VOC), based on the clinical judgement of the Investigator,
4. Participant needs to be admitted to the ambulatory site for treatment of VOC requiring IV pain medication,
5. Able to provide written consent,
6. Able to receive IV infusion of study drug.

Exclusion Criteria:

1. In the judgment of the Investigator, the participant is not a good candidate for the study,
2. An acute severe complication of SCD beyond VOC,
3. Pregnant or actively trying to become pregnant, or breastfeeding,
4. Participant had \> 6 urgent visits for SCD complications in the prior 3 months,
5. Fewer than 30 days since any prior treatment with IV pain medication for VOC,
6. Onset of current acute painful crisis \> 3 days prior to dosing,
7. Evidence of moderate to severe renal insufficiency (CrCl \< 50 mL/min) or chronic kidney disease, or of moderate to severe hepatic disease (LFTs \> 2 x ULN) based on past medical history,
8. Concurrent or prior treatment within 90 days with an investigational medication,
9. Abnormal ECG due to cardiac ischemia and/or atrial fibrillation of acute onset, in the opinion of the Investigator.
Prospective Observation of Cardiac Safety With Proteasome Inhibition

The purpose of this study is to better define and understand potential cardiac toxicities of proteasome inhibitors and to understand optimal management strategies to treat and prevent cardiovascular events.

Cancer treatments, using proteasome inhibitors, have the potential in induce cardiac toxicities including heart failure (HF), hypertension, arrhythmias and ischemic heart disease. While the presence of cardiac events may be a class effect of proteasome inhibitors (PI), the effect may be more profound with the irreversible inhibition of carfilzomib compared with reversible inhibition with bortezomib. Data available from currently published clinical trials may be inadequate to fully understand the incidence and severity of cardiac injury in patients treated with proteasome inhibitors because the trials were not designed to fully assess cardiac events. The purpose of this study is to better define and understand potential cardiac toxicity and begin to understand optimal management strategies.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed multiple myeloma at any time-point in treatment course and planning to start a proteasome inhibitor-based therapy as part of standard care
* Received at least one prior line of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy)
* Males and females ≥ 18 years of age
* Able to provide written informed consent in accordance with federal, local, and institutional guidelines

Exclusion Criteria:

* POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
* Known or suspected AL amyloidosis, secondary amyloidosis or cardiac amyloidosis
* Plasma cell leukemia (\> 2.0 × 109/L circulating plasma cells by standard differential)
* Waldenström Macroglobulinemia
* Myelodysplastic syndrome
* History of MI within the last 3 months
* Symptomatic unstable cardiac arrhythmia requiring treatment in the past 3 months
* Class 3 or 4 New York Heart Association Heart Failure in the past 3 months
* Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
A Drug-Drug Interaction Study of Warfarin and PA21

The purpose of this study is to determine if Warfarin is affected by PA21.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Written informed consent

Exclusion Criteria:

* No significant medical conditions
* Pregnancy
A Study to Evaluate Efficacy and Safety of VX-864 in Participants With the PiZZ Genotype

The purpose of this study is to evaluate the efficacy and safety of VX-864 in participants with the PiZZ genotype over 48 weeks.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants must have a PiZZ genotype confirmed at screening
* Plasma AAT levels indicating severe deficiency at screening

Key Exclusion Criteria:

* History of a medical condition that could negatively impact the ability to complete the study
* Solid organ, or hematological transplantation or is currently on a transplant list
* History of use of gene therapy or Ribonucleic acid interference (RNAi) therapy at any time previously
* Participants for whom discontinuation of augmentation therapy is not considered to be in their best interest, based on the clinical judgement of the treating physician

Other protocol defined Inclusion/Exclusion criteria may apply.
Prophylactic Irradiation of the Para-Aortic Lymph Nodes and Supraclavicular Lymph Nodes in Locally Advanced Uterine Cervical Cancer

This study is an open-label, randomized study, which is designed to investigate the efficacy of Extended-field irradiation (EFI) on reducing recurrences at the para-aortic lymph node (PAN) and supraclavicular lymph nodes, and also on improving disease-free survival of locally advanced uterine cervical cancer. This study includes a translational research component in that all the primary tumors and lymph node are stained with Sema4c, before randomization. According to the investigators study result, patients with more pelvic lymph node metastasis are more likely to develop distant metastasis including the recurrences at PAN and supraclavicular lymph node. Primary cervical cancer tissues and lymph nodes are examined for expression of Sema4c just after registration, and before the patients are randomized to each arm (pelvis only vs. EFI). The investigators expect a higher benefit of EFI in patients with Sema4c-positive lymph node.


Eligibility Criteria:
Inclusion Criteria:

* Patients (who have been adequately clinically staged) with primary, untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, FIGO stage IB1 with pelvic lymph node metastasis, IB2, IIA(≥4cm in tumor size, or pelvic LN metastasis), IIB, IIIA, IIIB? with only unilateral pelvic wall extension
* Patients with negative, para-aortic lymphadenopathy determined by pelvic MRI and/or PET/CT scan.
* Patients with adequate bone marrow function: ANC greater than or equal to 1,500/ul, platelets greater than or equal to 100,000/ul at the beginning.
* Patients with adequate renal function: creatinine equal to or less than 2.0 mg/dL.
* Patients who have signed an approved informed consent and authorization
* Patients with ECOG Performance Status of 0, 1, 2 and Karnofsky Performance Scale of 100, 90, 80, 70, 60, 50
* Age: 18≤age≤80

Exclusion Criteria:

* Stage IIIb with bilateral pelvic wall extension and stage IVB lesions are not eligible.
* Patients with histology other than squamous, adeno, adenosquamous cell carcinoma
* Patients who have received prior radiotherapy of pelvis or total hysterectomy Patients who have diagnosis of other malignant tumors other than non-malignant melanoma skin cancer or stage I. II papillary, follicular thyroid cancer.
BOOST: Study of Increased Dosage of Lopinavir/Ritonavir (LPV/r)

This study will look to see if increasing the standard dose of Kaletra is tolerated and if it will lower viral loads to undetectable levels. This study will also look at the pharmacokinetic data (amount of Kaletra in blood at different times).

There are several reasons for low level viremia in patients on Kaletra (LPV/r), including poor adherence, incomplete absorption, cellular drug pumps or resistance mutations. Increasing exposure to protease inhibitors via boosting with ritonavir increases minimum blood concentrations, and is a strategy which has been shown to improve suppression of virologic replication. Little is known about the pharmacokinetics (PK), tolerability and safety of increased doses of LPV/r. The objectives of this 24-week single arm pilot study are to assess the PK parameters, safety, tolerability, change in viral load and CD4 counts on increased dose (600/150 and 800/200 mg) LPV/r in participants with low level viremia on standard dose LPV/r-based ART. Participants will undergo six PK samplings over 12 hours on standard dose LPV/r. The dose will be increased to 3 tabs (600/150) BID and blood will be sampled for PK after two weeks. If tolerated at 8 weeks, the dose will be increased to 4 tabs (800/200 mg) BID and final PK sampling will be performed after two weeks. There will be a one time, optional, optimization of background regimen of NRTIs two weeks after the first dose escalation.

Major Eligibility Criteria:

* CD4 count: \> 50
* Viral load: 200-75,000 on two most recent measures
* Current treatment: \> 16 weeks standard dose (400/100mg BID) LPV/r-based ART (no other PI or NNRTI allowed
* Prior treatment experience and resistance profile: Up to 20-fold resistance to LPV/r

Eligibility Criteria:
Inclusion Criteria:

* CD4 Count \>50
* Viral load 200-75,000 on two most recent measures
* More than 16 weeks on standard dose Kaletra (LPV/r)
* May be initial PI regimen or prior PI usage
* Up to 50-fold resistance to LPV/r

Exclusion Criteria:

* Age \< 18 years old
Effect of Screen Time Exposure on Eating Behaviour and Health Related Quality of Life

The goal of this observational study is to learn the effect of screen time exposure on eating behaviour and health related quality of life in normal preschool children.

Screen media devices have become an integral to daily life, especially for preschool children due to emerging technologies, increased marketing , widespread familial and societal use , and easy access to or ownership for young children. Common screen activities include watching television, digital video discs and videos, playing video games, and using apps . However ,excessive screen time, non-educational screen content, unsupervised and early screen exposure can have numerous potential negative effects on children's health .

Screen time can significantly affect quality of life in various ways, both positively and negatively. Regarding cognitive development, screens have the potential to enhance education and learning. However, studies have shown that excessive screen time can negatively affect executive functioning, sensorimotor development, and academic outcomes. Early screen exposure has been associated with lower cognitive abilities and academic performance in later years. Language development is also affected by screen time, as it diminishes the quantity and quality of interactions between children and caregivers. Excessive screen usage can also lead to problems in social-emotional development, including obesity, sleep disturbances, depression, and anxiety. It can impair emotional comprehension, promote aggressive behavior, and hinder social and emotional competence .

Eligibility Criteria:
Inclusion Criteria

1. Chronological age range 5 :6
2. Both genders will be included
3. According to score of screen dependency scale children stratified into Two Groups:

   * Group A children score more than 24.5
   * Group B children score less than 24.5

Exclusion Criteria:Any children has one or more from the following criteria:

1. Any surgical intervention in mouth.
2. Any congenital anomaly in the mouth as cleft lips or cleft palate.
3. Oral disorders
Comprehensive Study of Social Representation of Platelet Transfusion in Patients Followed for Advanced Hematological Malignancies (R-PLQ)

Limited data is available for end of life care in hematologic malignancies, moreover with thrombocytopenic patients. Thrombopenia is a frequent complication, specific of bone marrow involvement in those diseases or its treatments. Yet, a few studies was interested in, whereas platelet transfusion is the only treatment indicated. As it represent a scarce, limited resource, the ethical principles are in conflict in this setting and there's a lack of recommendation. The final decision is take by the clinician and his patient, but no study exist in representation of the two parts. We provide a qualitative study to understand what this decision is made of.


Eligibility Criteria:
Inclusion Criteria:

* major patient
* patient with advanced hematological malignancies
* patient transfused in platelet regularly (3 time at least in last month)
* medical practioner, hematologist, prescribing platelet transfusion at least one per week.
* nurse working in hematology, practicing platelet transfusion at lest one peer week.

Exclusion Criteria:

* minor patient
* non communicant patient
* non transfused platelet patient
* non voluntary patient or hematologist or nurses
* non graduated hematologist
Impact of Additional Resistance Training During Rehabilitation Therapy in Patients With Heart Failure

The impact of moderate- or low-intensity resistance training will be investigated additional to endurance training in heart failure patients following rehabilitation. The aim is to optimize intensity of resistance training in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of heart failure and participation in cardiac rehabilitation

Exclusion Criteria:

* Orthopedic disorders, neurological disorders affecting muscle strength, cognitive disorders, heart or arterial surgery (percutaneous coronary intervention, bypass, heart valve surgery) in the last year, acute myocardial infarction in the last 6 months, participation in another intervention
Cost- Effectiveness Study of Brief Interventions for Mood and Anxiety Disorders

This study compares both clinical effectiveness and cost-effectiveness of a brief, intensified therapy and diagnostic method for patients with mood and/or anxiety disorders with Treatment As Usual (TAU) at five outpatient Mental Healthcare Centers in the Netherlands.


Eligibility Criteria:
Inclusion Criteria:

* Male of female adolescents
* Adolescents aged between 18 to 65 year
* Adolescents main complaint: Mild to moderate anxiety and/or mood disorders with or without psychiatric and/or somatic co-morbidity
* Adolescents with proper understanding of the Dutch language.

Exclusion Criteria:

* Adolescents with current psychotic or bipolar traits,
* Adolescents with homicidal or suicidal risk
* Adolescents with severe social disfunctioning
* No proper understanding of the Dutch language
A Drug-Drug Interaction Study To Investigate The Ginkgolides Meglumine Injection To Alter The Pharmacokinetics Of Midazolam

This is an open label, randomized, Parallel Assignment, placebo-controlled study. One of the purposes of this study is to investigate the multiple dosing Ginkgolides Meglumine Injection to alter the pharmacokinetics of Midazolam, the other is to calculate the pharmacokinetic parameters after Single and multiple dosing of Ginkgolides Meglumine Injection.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-40.
* Male.
* Subjects have standard weight( generally not less than 50 kg), and body mass index (BMI) within 19-25.
* All physical examinations( including ECG, kidney function, liver function, blood routine, urine routines, etc) are normal.
* Subjects have no history of significant diseases, allergy or orthostatic hypotension.
* All subjects sign the informed consent after being informed all possible adverse drug reaction and .are able to complete all examination defined.

Exclusion Criteria:

* Subjects who cannot communicate with medical staff, and subjects with cerebral insufficiency or psychological problem.
* Partner of subjects have plan to pregnant.
* Subject have primary disease in vital organ.
* Subjects have a history of drug dependence or psychosis in last 2 years.
* Subjects with severe blood loss or blood donation more than 200 mL in the prior 3 months.
* Subjects who have participated in another clinical trial within the prior 3 months.
* Known or suspected to have a history of alcohol or drug abuse.
* Subjects who have abnormal clinical significance after checking preclinical laboratory data and physical examinations.
* Known allergy to pharmaceutical ingredient of Ginkgolides Meglumine Injection or allergy sufferers who are allergic to more than two kinds of food or drugs in the past.
* Subjects who have used any drugs in the prior 2 weeks.
* Subjects have unexplained infections.
* The subjects could not complete the study in the opinion of the Principal Investigator due to any reason.
* Subjects who test positive at screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV) , hepatitis B surface antigen (HbsAg), etc.
Clomiphene in Males With Prolactinomas and Persistent Hypogonadism

Prolactinomas are usually associated with hypogonadotropic hypogonadism in both sexes. Clomiphene citrate is a well known selective estrogen receptor modulator that increases gonadotropin secretion via hypothalamic-pituitary action. We conducted a prospective, open label clinical trial of CC to evaluate its effects in reverting persistent HH in male patients with prolactinomas under dopaminergic agonist treatment.


Eligibility Criteria:
Inclusion Criteria:

* a minimum follow-up of 6 months under DA therapy with normal serum prolactin or with maximum DA dose (3.5 mg/week of cabergoline or 10 mg/day of bromocriptine for at least 2 months)
* serum total testosterone less than 300ng/dl with normal or low LH and FSH levels after discontinuing testosterone replacement for at least 2 months.

Exclusion Criteria:

* impossibility to attend scheduled visits and irregular compliance to DA treatment.
Platelet Inhibition and Bleeding in Patients Undergoing Non-Cardiac Surgery

The aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing non-cardiac surgery during dual antiplatelet therapy.


Eligibility Criteria:
Inclusion Criteria:

* intake of Clopidogrel, Prasugrel, or Ticagrelor within the last 7 days
* spontaneous bleeding or impeding surgery (major vascular surgery, intraperitoneal or intrathoracic surgery, ENT-surgery, orthopedic or trauma surgery, prostatic surgery)

Exclusion Criteria:

* concomitant medication with warfarin
* renal insufficiency needing dialysis
* concomitant therapy with GPIIB/IIIA Antagonists
* expected duration of operation \>30min
A Telemedicine Solution for Remote Support of Rehabilitation, for Patients Undergoing, Total Hip Arthroplasty Surgery

The RRS project is a Randomized Clinical Trial documenting the effect of Remote Rehabilitation and Support via a telemedicine solution for patients undergoing an optimized fast-track orthopedic surgery procedure with the implementation of a total hip arthroplasty. With the telemedicine solution the investigators will support and try to motivate the patient to be discharged after only one day of hospitalization.

This PhD study evaluates the effect of an information technology solution containing RRS. The way it supports, informs and educates the patient and support person, provides an opportunity for communication between the patient and the surgeons, physiotherapists and nurses at the hospital.

The parameters evaluated will be: Length of stay, health-related quality-of-life (HRQOL), functional outcome, pain, anxiety, complications and an evaluation of the socio-economic effect.

The aim of the study generates the following hypotheses and focus for publication

* Length of stay is lower for the intervention group compared to the control group.
* The average quality of life measured with EQ-5D will either be the same or higher when comparing the intervention group with the control group.
* Compared to the control group the functional outcome of the intervention group measured with Oxford Hip Score (OHS) and Timed Up and Go (TUG) will be the same or better.
* Complications measured as luxations, infections, and reoperations are the same or lower in the intervention group compared to the control group.
* There will be a correlation between patients with the highest level of psychological problems and symptoms of psychopathology measured with Symptom Checklist-90-R, and the postoperative outcome measured with EQ5D, anxiety and TUG.
* There will be a correlation between support persons with the highest level of psychological problems and symptoms of psychopathology measured with Symptom Checklist-90-R, and the postoperative outcome measured with EQ5D, anxiety and TUG for the patient they are related to.
* The socio-economic costs will be lower for the intervention group compared to the control group based on self reported data and data collected from official databases. This study will be conducted as a piggy back to the RCT.

Eligibility Criteria:
Inclusion Criteria:

* Patients qualified to go trough at joint-care procedure after the guidelines from Regionshospitalet Silkeborg.

Exclusion Criteria:

* Previous hip surgery with the implantation of a total hip arthroplasty.
* Patients living more than approximately 60 kilometers from the Regionshospitalet Silkeborg.
* Patients with no 3G tele-net at their home address.
* Patients with the need of Danish interpretation.
Prognostic and Predictive Biomarkers in Ovarian Cancers

The investigators therefore propose to conduct a biological study of prospectively collected patient tumour samples, ascites, blood and other residual samples (feces, urine, vaginal smear) throughout the disease course where markers (at diagnosis and their change with treatment) will be correlated to outcome in order to investigate how genetic diversity in OC prior to treatment and adaptation following treatment contribute to chemotherapy resistance. In addition freshly collected ascitic samples (and tumour samples) will be subjected to ex vivo DNA repair functional assays and isolated in primary culture (and established as xenografts) for target validation experiments.


Eligibility Criteria:
Inclusion Criteria:

1. New patient with a diagnosis of OC, or
2. Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center presenting with progressive disease, and consenting to CT guided biopsy of relapsed disease, or
3. Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center scheduled for surgery for relapsed disease.
4. Signed informed consent
5. Age ≥ 18
6. Patient affiliated to a social security regimen or beneficiary of the same

Exclusion Criteria:

1. Patients who do not fit the inclusion criteria and those who refuse an antitumoral treatment;
2. Coagulation abnormalities that contra-indicates the biopsy