cyrilzakka/clinical-trials huggingface dataset:
An Open Trial of Cysteamine Treatment in Schizophrenia

The purpose of this study is to determine the tolerability of the medication cysteamine bitartrate on schizophrenia patients and to evaluate the effect of the medication on the symptoms of schizophrenia.

Despite the availability of numerous antipsychotics, the treatment of schizophrenia is very unsatisfactory. Many patients have persistent positive psychotic symptoms or negative symptoms despite treatment, and any improvement in cognitive function is small. New approaches to the pharmacotherapy of schizophrenia that are not based primarily on dopaminergic blockade are needed.

The rationale for a trial of cysteamine comes from the evidence that cysteamine increases brain concentrations of brain-derived neurotrophic factor.

We will conduct an open-label study of tolerability and efficacy of cysteamine as an adjunct to second-generation antipsychotics in schizophrenia and schizoaffective subjects with partially responsive symptoms.

Our objectives are to determine the safety and tolerability of cysteamine administered as an adjunct to second-generation antipsychotic drugs in adult outpatients with partially-responsive schizophrenia. Additionally, we are evaluating the effect of cysteamine on the positive and negative symptoms of schizophrenia as measured by changes in the Positive and Negative Symptom Scale (PANSS), and on cognitive impairment as measured by the Brief Assessment of Cognition in Schizophrenia (BACS).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* 18-60 years of age
* Residual symptoms, as defined by both 1 \& 2:

  1. At least one PANSS positive symptom item score \> 4, or at least two items with a score \> 3
  2. At least one PANSS negative symptom item score \> 4, or at two items with a score \> 3
* No clinically significant change in symptoms for at least one month
* On the same psychotropic medication(s) \> 2 weeks
* Taking a second-generation antipsychotic (olanzapine, risperidone, quetiapine, ziprasidone, aripiprazole, or clozapine)
* Provision of written informed consent

Exclusion Criteria:

* Meets criteria for current major depressive disorder
* Abnormal hepatic function (AST or ALT \> 2.5 X the upper limit of normal, or bilirubin \> 1.5 X the upper limit of normal)
* Abnormal renal function (BUN or creatinine \> 1.5 X the upper limit of normal)
* Presence of any unstable or untreated medical disorder
* Any history of seizure disorder, HIV, or diagnosis of AIDS
* Any abnormal lab test result that is judged to be clinically significant by the investigators
* Pregnancy, breast feeding, or female and of child-bearing potential who is not using any contraceptive method
* Present danger to self or others
Long-Circulating Liposomal Prednisolone Versus Pulse Intramuscular Methylprednisolone in Patients With Active Rheumatoid Arthritis

Trial to study the safety of a single, intravenous administration of long-circulating liposomal prednisolone disodium phosphate in patients with active rheumatoid arthritis.

A proof of concept, dose-escalating trial to study the safety of a single, intravenous administration of long-circulating liposomal prednisolone disodium phosphate in patients with active rheumatoid arthritis.

Secondary goals: To compare the therapeutic effect of this intervention with that of a single intramuscular administration of 120 mg methylprednisolone (Depo-Medrol, Pharmacia). The latter is commonly used in the clinics as bridging therapy. To assess the effect of these interventions at the synovial tissue level.

On the longer term, the goal of liposomal corticosteroids is to achieve an increased efficacy/safety ratio compared to standard treatment with free corticosteroids.

Eligibility Criteria:
Inclusion Criteria:

In order to be enrolled in the study a patient must:

Be aged 18 years or older Fulfill the revised 1987 ARA criteria for the classification of RA Have an active RA as defined by a Modified Disease Activity Score (DAS28) of more than 3.2 Have been on stable treatment with disease modifying anti-rheumatic drugs within 12 weeks prior to trial initiation Be able and willing to give voluntary written informed consent The indication for bridging therapy with systemic corticosteroids has been established by the caring rheumatologist -

Exclusion Criteria:

The patient must not Have been treated with oral corticosteroids within 2 weeks prior to baseline or with intraarticular or intramuscular corticosteroids within 8 weeks prior to baseline Have diabetes mellitus or abnormal renal, liver or haematological tests Have a clinically severe or unstable medical condition involving cardiac, pulmonary, liver and endocrine disorders or malignancies Have a previous history of bleeding or infectious disorders Be currently pregnant or breastfeeding

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Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis

Partial response or loss of response to golimumab is observed in a significant proportion of patients started on golimumab for active ulcerative colitis. The current dosing regimen in European Union is based on patients' body weight as maintenance treatment for patients with ≥ 80 kg is 100 mg q4 weeks and for patients with \<80 kg 50 mg q4 weeks. The investigators recent observations in a golimumab pharmacokinetics study of 24 patients however, show large interindividual variations in golimumab trough concentrations. Furthermore, it seems that patients with continuous response have higher golimumab trough levels at several time points during treatment compared to patients who lose response. Higher induction/maintenance dose of golimumab increases golimumab trough levels, therefore it is likely that higher induction/maintenance dose of golimumab would increase efficacy of golimumab treatment.

Partial response or loss of response to golimumab is observed in a significant proportion of patients started on golimumab for active ulcerative colitis. The current dosing regimen in European Union is based on patients' body weight as maintenance treatment for patients with ≥ 80 kg is 100 mg q4 weeks and for patients with \<80 kg 50 mg q4 weeks. The investigators recent observations in a golimumab pharmacokinetics study of 24 patients however, show large interindividual variations in golimumab trough concentrations. Furthermore, it seems that patients with continuous response have higher golimumab trough levels at several time points during treatment compared to patients who lose response. Higher induction/maintenance dose of golimumab increases golimumab trough levels, therefore it is likely that higher induction/maintenance dose of golimumab would increase efficacy of golimumab treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed ulcerative colitis

Exclusion Criteria:

* Active tuberculosis or other opportunistic bacterial, viral and fungal infections
* History of moderate to severe heart failure (NYHA III/IV), and potential risk of congestive heart failure
* Pregnancy
* History of allergic reactions to sorbitol (E420), L-histidine, L-histidine monohydrochloride monohydrate, polysorbate80, water for injections.
Kanagawa Combination Anti-hypertensive Therapy (K-CAT)

The purpose of this study is to compare the effect and safety of the antihypertensive combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.

The combination therapy with multiple antihypertensive drugs is recommended in the patients who are uncontrolled with monotherapy. Diuretics increase the activities of renin-angiotensin-aldosterone system (RAS), and angiotensin receptor blockers (ARB) depress blood pressure potently in the state of increased RAS activities. Thus, the combination therapy with ARB and diuretics is expected to lower the blood pressure synergistically. This combination therapy is also expected to reduce the side effects of each drug. In this study, we will compare the effect and safety of the combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.

Eligibility Criteria:
Inclusion Criteria:

* Under treatment of hypertension with ARB monotherapy for more than one month.
* systolic blood pressure more than 140mmHg and less than 160mmHg or diastolic blood pressure more than 90mmHg and less than 100mmHg in sitting position.
* In diabetic or CKD patients, systolic blood pressure more than 130mmHg and less than 160mmHg or diastolic blood pressure more than 80mmHg and less than 100mmHg in sitting position.

Exclusion Criteria:

* uncontrolled hypertension (diastolic blood pressure \>120mmHg)
* uncontrolled diabetes mellitus (HbA1c\>9.0%)
* Acute myocardial infarction, stroke and other cardiovascular events within six months
* The history of gout, or uric acid\>8.0mg/dl
* Serum creatinine\>2.0mg/dl
* sever liver dysfunction
* Bilateral renovascular stenosis
* secondary hypertension
* malignant hypertension
* uncontrolled arrhythmia
* pregnancy or possibility of pregnancy
* hypersensitivity to trial drug
Comparative Study of Alternative Antiandrogen (AA) Therapy and Early Initiating of Enzalutamide for Castration-resistant Prostate Cancer (CRPC) After Combined Androgen Blockade (CAB) Therapy.

The objective of this study is to compare the efficacy and safety of enzalutamide or alternative AA therapy in CRPC participants who were previously treated with a combined androgen blockade therapy which included bicalutamide (Bic-CAB). Efficacy and safety of enzalutamide and alternative AA therapy will be evaluated, and effective therapy against CRPC after treatment with Bic-CAB will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Testosterone of less than 50 ng/dL
* Participants who was detected of disease progression on image or relapse of PSA (All PSA values measured 3 time at least one week interval are consecutively increased and final value is 2 ng/mL or more. If third value is not higher than second one, fourth measurement will be undertaken and its value must be higher than second one.)
* Participants who relapsed after CAB with bicalutamide
* Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1
* Aged 20 years or older
* Participants who provided written informed consent

Exclusion Criteria:

* Any prior treatment with enzalutamide, flutamide, abiraterone or chemotherapy, except for neoadjuvant therapy
* With active double cancer
* Any prior treatment with bicalutamide within 6 weeks
* Participants who received systemic biological therapy (except for existing approved drug for bone or treatment with luteinizing hormone-releasing hormone (LHRH) analogue) or received treatment with other antitumor agent for prostate cancer
* With serious complication
* History of hypersensitivity to enzalutamide or any other excipient of enzalutamide
* History of hypersensitivity to flutamide-containing agent
* With liver dysfunction
* Participants who are considered as inadequate by the investigator
Preventative Osteopathic Manipulative Treatment (OMT) and the Nursing Home Patient

This pilot research study will investigate the possible benefit that elderly nursing home patients may receive from regular Osteopathic Manipulative Medicine (OMM) care during the winter months. The study is based on the osteopathic philosophies that structure and function are interrelated and that the body has self-healing mechanisms. The body is expected to have optimized ability to heal itself "when all its parts are in place" (AT Still). This study is looking at subject population for whom their ability to take care of themselves is diminished by their underlying diseases. Based on the osteopathic philosophies, optimization of the nursing home patient's physical structure through osteopathic manipulative treatment (OMT) should enhance their body's homeostatic mechanisms. This study is assessing the validity of these philosophies by looking at the effect of OMT on the global health of these individuals.

This study will randomly assign 36 nursing home patients from two Kirksville nursing homes into three groups of twelve subjects: 1) treatment as usual (TAU) control group; 2) light touch (LT) group, and 3) standard OMT group.

This study will begin with rolling admission of volunteer nursing home patients starting in October 2009. Subjects in the LT and OMT group would receive focused musculoskeletal evaluations twice a month for 5 months (10 visits). The OMT group would also receive an OMT protocol each visit that would specifically address optimization of homeostatic mechanisms - balancing autonomic nervous system and improving lymphatic drainage- along with OMT that would specifically target somatic dysfunction found on that day's evaluation. The LT group subjects would receive a light touch protocol meant to simulate OMT. The TAU group will receive no intervention. The protocol period will end for all subjects by March 2010. All osteopathic examinations, assessments, and treatments will be performed at the participating nursing homes.

Throughout the protocol period, at the end of the winter (March 2010), and three months later (June 2010), retrospective chart reviews will be conducted on all subjects. All cause morbidity and mortality for all subjects will be assessed by monitoring their medications, health history changes, and hospitalizations.

Eligibility Criteria:
Inclusion Criteria:

* Resident of Participating Nursing Home
* Life Expectancy of at Least 6 Months

Exclusion Criteria:

* Diagnosis of Terminal Cancer
* Diagnosis of Active Tuberculosis
* Diagnosis of Metabolic Bone Disease or Condition That Would Place Patient at Risk for Pathological Fracture
* Unable to Cooperate
* Unable to Tolerate OMT
* OMT is Contraindicated
Mostafa Maged Maneuver in Comparison With Bimanual Uterine Compression to Control Post-partum Hemorrhage

The current study aimed to investigate the effectiveness of the Mostafa Maged maneuver compared to Bimanual uterine compression in controlling postpartum hemorrhage during vaginal delivery.

The study subjects were categorized into two groups. The first group was managed by the Mostafa Maged maneuver , whereas the second group was managed by routine bimanual uterine compression.

investigators attempted to determine the duration of each maneuver required until the investigator became exhausted, as well as whether or not oxytocin was administered later in each maneuver .


Eligibility Criteria:
Inclusion Criteria:

- female and pregnant

Exclusion Criteria:

* hematological diseases morbid obese smoking
Prognostic Value of Lactate Levels in Patients With STEMI Undergoing Primary PCI

To assess the prognostic value of systemic arterial lactate levels in patients with ST segment elevation myocardial infarction undergoing primary PCI and correlate with the results of primary PCI and 30 days MACE follow up.

* Study Population: STEMI patients treated with primary PCI.
* Study period: over 6 months.
* Sample Size: 300 patients.

All patients received the standard care for acute STEMI patients which is the primary percutaneous intervention in addition to medications.

Hyperlactemia is defined as elevated lactic acid level in the blood. The normal blood lactate level is (0.5-1 mmol/L).

All subjects were subjected to

1. Careful history taking
2. Full cardiac examination
3. Investigations include:

   1. 12 lead surface ECG.
   2. Lactate level and full labs
   3. Pre-discharge echocardiography
   4. Peri-procedural details of primary PCI

the investigators assessed the relation between hyperlactemia and coronary flow, peak cardiac enzymes, hemodynamic parameters and MACE in 30 days follow up

Eligibility Criteria:
Inclusion Criteria:

* Patient with ST-segment elevation myocardial infarction for the first time.
* Patients undergoing primary PCI.
* Adult patients ≥ 18 years old.

Exclusion criteria:

* Hemodynamically unstable patients.
* Patients with renal impairment (creatinine clearance \< 30 ml/min).
* Patients who developed flow limiting coronary dissection or mechanical complication during the procedure.
* Patients presenting \> 24 hours after symptoms onset.
Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

This study will look at the feasibility of using magnetic resonance fingerprinting (MRF) in children, adolescents and young adults (AYA) with and without brain tumors. This study will also look at subjects with and without neurofibromatosis type 1(NF1), a genetic disorder that affects the growth of nervous system cells. Further, it will explore potential ways of using of MRF signal measurements in children, adolescents, and young adults with brain tumors, including tissue characterization, looking at whether the treatment was effective, and finding metastasized tumors of unknown origin (occult tumors). To explore the feasibility and potential applications of MRF, this study will recruit up to 80 subjects but will stop once 10 subjects have usable data in each of six groups.

Specific Aim 1: Demonstrate the feasibility of magnetic resonance fingerprinting (MRF) in children, adolescents and young adults (AYA) with and without brain tumors.

Specific Aim 2: Characterize the MRF signature of low-grade gliomas

Specific Aim 3: Determine whether MRF can identify occult tumor in subjects with low-grade glioma.

Specific Aim 4: Determine whether MRF can identify treatment effects in low-grade gliomas.

Specific Aim 5: Explore whether common brain tumors can be differentiated by comparing pre-operative MRF signature with pathologic diagnosis.

Outline: This study will examine the feasibility of MRF in children and AYA and determine whether quantitative measures of T1 and T2 relaxation times can be derived in subjects \<35 years of age. Approximately 80 subjects will be evaluated and include subgroups where MRF may be of particular utility, including children and AYA subjects with brain tumors and subjects with neurofibromatosis type 1 (NF1). Additional aims will investigate the utility of MRF in these groups.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing MRI evaluation of the brain
* NF1 status will be determined by clinical exam or genetic testing
* NF1-associated Optic Pathway Glioma (OPG) will be defined as radiographic evidence of glioma along the optic nerve, chiasm, tract or radiation in a child with NF1
* Untreated low grade gliomas will be imaging-defined gliomas that have not yet been exposed to radiation or systemic chemotherapy. Those exposed to therapy will have had radiation and/or systemic chemotherapy more than 1 month prior to scans

Exclusion Criteria:

* History of mental retardation unrelated to brain tumor
* Presence of a genetic disorder other than NF1 that effects cognition or is associated with MR imaging abnormalities (e.g. tuberous sclerosis)
* History of cerebrovascular accident (stroke)
* Birth weight below five pounds, premature birth prior to 36 weeks of gestation, or ischemic episode at birth
* Major psychiatric diagnosis prior to neuro-oncological diagnosis
UNITy-BasED MR-Linac Adaptive Simultaneous Integrated Hypofractionated Boost Trial for High Grade Glioma in the Elderly

The usual standard of care for patients over 65 diagnosed with glioblastoma ("GBM") or Grade 4 astrocytoma, IDH-mutant is a 3-week course of radiotherapy, with concurrent and adjuvant temozolomide (TMZ). This radiation dose and length of treatment are less than what would be given for younger patients, primarily due to unclear survival benefits from randomized trials. However, survival remains dismal, and may be partially due to the reduced radiation dose. Recent studies investigating this have found that increased radiation dose (to the equivalent of what is normally given over 6 weeks in younger patients) over 3 weeks is well-tolerated and has improved survival rates.

Additionally, with the advent of novel technology such as the MR-Linac, adaptive radiotherapy with this regimen using reduced radiation margins is possible. Use of the MR-Linac allows for daily MRI scans to be done prior to treatment, so plans can be adapted to tumour dynamics and anatomical deformations. In this trial, we will examine the outcomes of increased radiation dose, combined with reduced-margin adaptive radiotherapy in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥ 65 years
* Histopathologically confirmed, based on biopsy or surgical resection, glioblastoma or WHO grade 4 astrocytoma, IDH-mutant
* Biopsy or surgical resection performed ≤ 6 weeks prior to study entry
* Deemed suitable by the treating physicians for 15 daily fractions of radiation, delivered daily over 3 weeks, with concurrent temozolomide chemotherapy
* Expected survival ≥ 12 weeks
* ECOG performance status of 0, 1 or 2
* Able (sufficiently fluent in English) and willing to complete QOL questionnaires; however, inability to complete the questionnaires will not make the patient ineligible for the study
* Sufficient estimated glomerular filtration rate (eGFR) of ≥ 30 mL/min/1.73 m2 to allow administration of gadolinium-based contrast agent; patients with eGFR \< 30 mL/min/1.73 m2 not on dialysis may be allowed on the study after discussion of risks and benefits and approval by study neuroradiologist(s)
* Completed written informed consent
* Patient must be accessible for treatment and follow-up

Exclusion Criteria:

* Contraindications to MRI as per standard MRI screening policy
* Contraindication to Gadolinium-based contrast media
* Inability to lie flat in a supine position for at least 90 minutes
* Inability to tolerate immobilization in a head thermoplastic mask
* Patients \> 140 kg and/or a circumference \> 60 cm
* Prior dose-limiting cranial irradiation
* T1w post-gadolinium enhancing disease involving the brainstem
* Leptomeningeal dissemination of disease
* Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol
Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating

To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after exercise compared to the full coverage observed prior to exercise.


Eligibility Criteria:
Inclusion Criteria:

* Subjects may be male or female, of an age of 18-55 years inclusive.
* Subjects must be capable of understanding and providing written informed consent.
* Subjects must sign a written confidentiality agreement including a photography release form.
* Subjects must be in good general health as judged by a specified licensed physician, who will indicate their suitability to participate in this study.
* Female subjects must be willing to take a rapid screen pregnancy test prior to each exercise session.
* Subjects must be willing to follow study instructions as set forth in the protocol.
* Subjects must not have facial piercing(s).
* Subjects must be Fitzpatrick Skin Type I, II, or III.

Exclusion Criteria:

* Subjects must not have received or used an Investigational New Drug within the last 30 days.
* Subjects must not have been active participants in another clinical or subjective TP performance study within the last 30 days unless authorized by this Sponsor.
* Subjects must not have a known physical or medical condition that would preclude vigorous exercise
* Subjects must not have a five-minute resting pulse rate greater than 80 bpm.
* Subjects must not take any chronic medication other than vitamins, hormone replacement therapy, low-dose aspirin, or oral contraceptives.
* Subjects must not have applied prescription or over-the-counter medicines to their face at least 96 hours prior to exercise session
* Subjects must not have a known allergy or sensitivity to sunscreen products or Cetaphil cleanser.
* Female subjects must not be pregnant (self-reported) or test positive using an on-site pregnancy test.
* Female subjects must not be nursing a child.
* Subjects must not have smoked cigarettes, pipes, or cigars in the last 60 days.
* Subjects who in the judgment of the Investigator have any condition that would make study participation inappropriate.
* Subjects must not be a member or relative of the clinical trial staff or the Sponsor directly involved in the study.