cyrilzakka/clinical-trials huggingface dataset:
A Study to Find the Minimum Inhibitory Concentration of KAE609 in Adult Male Patients With P. Falciparum Monoinfection

This study aims to determine the Minimum Inhibitory Concentration of KAE609 in adult male patients with acute, uncomplicated malaria due to P.falciparum monoinfection after single dosing with KAE609

There will be a total of approximately 45 patients recruited into this study and six doses of KAE609 and will be investigated.The dose groups will run in sequence. Patient will be given a single dose of KAE609 and be followed up for 42 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Monoinfection with P. falciparum confirmed by microscopy
* Asexual P. falciparum parasitemia count of 5,000 to 50,000/µL
* Axillary temperature ≥37.5 ºC or oral/tympanic/rectal temperature ≥38 ºC; or similar documented temperature during the previous 24 hours
* Body weight between 40 to 90 kg

Key Exclusion Criteria:

* Signs and symptoms of severe malaria according to World Health Organization (WHO) 2010 criteria
* Mixed Plasmodium infection, i.e. infection with more than one species of malaria parasites
* Use of other investigational drugs within 30 days or within 5 half-lives of enrollment, whichever is longer
* History of antimalarial use within 2 months of screening
* Use of any antibiotics with antimalarial activity or other prohibited medication within 14 days of screening
* Long QT syndrome or QTc using Fridericia's formula \>430 msec
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
* Hemoglobin level \<10 g/dL
* Liver disease or injury as indicated by elevated liver tests such as SGPT (ALT) or SGOT (AST) \>2 times the upper limit of normal
* Renal dysfunction as indicated by serum creatinine \>2 times the upper limit of normal in the absence of dehydration; in case of dehydration, serum creatinine should be \<2 times the upper limit of normal after oral or parental rehydration
* Known to be immunocompromised (including HIV infection) or are receiving immunosuppressive therapy at the time or enrollment; HIV testing is not required
* Known history of hepatitis B or C; testing is not required
* Febrile condition due to diseases other than malaria (e.g. acute lower respiratory tract infection), known underlying chronic or severe disease (e.g. cardiac, hepatic, renal, gastrointestinal, neurologic, or psychiatric disease), or any condition precluding enrollment into this study according to the investigator
* Severe vomiting defined as \>3 times during the previous 24 hours or inability to tolerate oral medication; severe diarrhea defined as ≥3 watery stools during the previous 24 hours
* Severe malnutrition defined by a body mass index (BMI) \<18.5 kg/m2 or unintentional loss of weight ≥10% with evidence of suboptimal intake resulting in loss of subcutaneous fat and/or severe muscle wasting
* Active tuberculosis or history of taking anti-tuberculosis medications within 24 months prior to screening
A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)

This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26. All patients will receive stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. The treatment period is planned for 48 weeks (until primary analysis) and then participants will enter the open label phase until the drug is commercialized. Target sample size is 1000.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, ≥ 18 years of age
* Rheumatoid arthritis for at least 3 months
* Inadequate response to previous or current treatment with at least one anti-TNF-alpha agent
* Receiving either leflunomide or methotrexate for ≥ 12 weeks, with a stable dose for the last 4 weeks
* Swollen joint count (SJC) ≥ 4 (66 joint count) and tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline.
* CRP ≥ 0.6 mg/dL using a high-sensitivity assay.
* Positive rheumatoid factor or positive anti-CCP antibody or both.

Exclusion Criteria:

* Rheumatic autoimmune disease or inflammatory joint disease, other than RA
* Any surgical procedure in past 12 weeks,or planned within 48 weeks of baseline
MR-guided Focused Ultrasound Plus GCase

The goal of this study is to establish safety and feasibility of intracerebral delivery of GCase via MRgFUS. This technique may offer potential benefits given the exposure of the putamen to GCase in animal models has been shown to be efficacious in improving Parkinson's disease pathology and phenotype.

This is a two-arm, open-label, intervention only phase I/II clinical study. One arm of the study will enroll seven (7) GBA PD patients and the other arm seven (7) idiopathic PD patients. During the intervention phase, the first four subjects of each arm will receive three transcranial bilateral putamenal GCase at 30 IU/kg IV every two weeks, followed by 60 IU/kg in the next three subjects. Following three treatments in this study, the subjects will be followed for twelve months.

Eligibility Criteria:
Inclusion Criteria:

* Men or women between age 35 and 80 years, inclusive.
* Able and willing to give informed consent.
* Diagnosis of PD satisfying MDS Clinical Diagnostic Criteria for PD
* At least 2 years from initial diagnosis
* Hoehn and Yahr Stage 1-3 on PD medication
* Dopaminergic deficit by a positive DAT SPECT scan
* On stable regimen of PD medications for at least 90 days prior to the study
* American Society of Anesthesiologists (ASA) score 1-3
* Harbor at least one GBA mutation if enrolled in the GBA PD arm or two wild-type GBA alleles if enrolled in the idiopathic PD arm

Exclusion Criteria:

* Positive pregnancy test (for pre-menopausal women).
* Contraindication to DEFINITY ultrasound contrast agent or perflutren (e.g. hypersensitivity, known left or bidirectional cardiac shunt)
* Contraindication to MRI or gadolinium-DTPA (e.g. incompatible device, hypersensitivity)
* Insulin-dependent diabetes mellitus that is not well-controlled or that in the Investigator's opinion precludes participation in the study.
* Severely impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2 and/or on dialysis.
* Currently participating in another clinical therapeutic trial
* Patient receiving bevacizumab (Avastin) therapy
* Subjects with evidence of cranial or systemic infection.
* Cerebral or systemic vasculopathy.
* Documented cerebral infarction within the past 12 months or TIA in the past 1 month.
* Contraindication to GCase enzyme therapy, specifically previous hypersensitivity reaction to GCase enzyme therapy
* Parkinsonism plus symptoms, secondary parkinsonism
* Previous neurosurgical procedure for PD
Community-Based Trial of Screening for Chlamydia Trachomatis to Prevent Pelvic Inflammatory Disease

Chlamydial infection is a common, sexually transmitted disease which women can have without knowing. Untreated, it can lead to an infection of the womb and fallopian tubes called pelvic inflammatory disease (PID), which can cause infertility. There has been only one trial of chlamydia screening and this was in American women in 1992 and used outdated tests. We now need to see if screening using modern tests and self-taken swabs works in a high risk, young, multiethnic female population in the United Kingdom (UK).

The study is a randomised trial. It will involve asking women students in college bars to complete confidential questionnaires on sexual health and to provide self-administered vaginal swabs. We have successfully done this in a small pilot study. Participants will be told that the tests are for research purposes only and that if they think they may have been at risk of a sexually transmitted infection they should get checked at a clinic. If the trial shows that chlamydia screening using these new methods prevents PID, extending this community-based intervention nationwide could improve women's reproductive health and wellbeing and might prevent some women from becoming infertile

Background: Pelvic inflammatory disease (PID) is common and can lead to infertility, ectopic pregnancy or chronic pelvic pain.

Objectives: To see if screening and treatment of chlamydial infection reduces the incidence of PID over 12 months, and to investigate the natural history of chlamydial infection and the role of bacterial vaginosis (BV) in the development of chlamydia associated PID.

Design: Randomised trial over one year

Setting: Common rooms, bars and lecture theatres at universities and colleges in London, UK.

Participants: 2500 sexually active female students aged \<28 years will be asked to complete a questionnaire on sexual health and to provide a self-administered vaginal swab and smear with follow up after a year.

Intervention: Following randomisation, vaginal swabs from intervention women will be tested for chlamydia by PCR and those infected referred for treatment. Vaginal swabs from control women will be stored and analysed after a year. Vaginal smears will be Gram stained and analysed for BV.

Main outcome measure: Incidence of clinical PID over 12 months in intervention and control groups.

Possible cases of PID will be identified from questionnaires and record searches. Confirmation of the diagnosis will be done by detailed review of medical records by two independent researchers blind to whether the woman is in the intervention or control group.

Eligibility Criteria:
Inclusion Criteria:

* Sexually active

Exclusion Criteria:

* Never been sexually active
* Tested for chlamydia in past 3 months and no new sexual partner since then
* Pregnant
Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

This study is examining the safety and effectiveness of two medications, ketamine and riluzole, in treating patients with treatment resistant major depressive disorder. This study will also examine the effectiveness of an FDA approved drug called lamotrigine in decreasing the potential side effects associated with ketamine.

This research proposal will investigate a glutamate-modulating agent, riluzole, in treatment-resistant patients who exhibit an acute, sustained response to a single dose of intravenous (IV) racemic ketamine. Fifty ketamine-responders will be randomized to riluzole or placebo in a 4-week, randomized, double-blind, continuation-phase study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients, 21- 70 years of age
2. Subjects have a history of at least one previous episode of depression prior to the current episode (recurrent major depressive disorder) or have chronic major depressive disorder (at least two years' duration)
3. Subjects have not responded to an adequate trial of one antidepressant in the current episode

Exclusion Criteria:

1. Female subjects who are either pregnant or nursing
2. Serious, unstable illnesses
3. Any previous use or treatment with ketamine, or riluzole
4. Past intolerance to lamotrigine, including drug rash
Preoperative Frailty Assessment With Ultrasound in Elderly Patients

In this study, the investigators aim to evaluate the prediction accuracy of the thickness measured with point-of-care ultrasound of the rectus abdominis, biceps brachii muscles of frailty.


Eligibility Criteria:
Inclusion Criteria:

* Patients 60 years old or older scheduled for total knee arthroplasty

Exclusion Criteria:

* Unable to communicate with the patient or the patient's guardian
* Myopathy
* History of injury of rectus abdominis, biceps brachii or quadriceps femoris muscle.
* History of total knee arthroplasty in the recent 3 months prior to surgery
Cohort Study of Blood Biomarkers for TES

In this study, high-throughput screening and multi-omics (transcriptomics and proteomics) joint analysis technology will be employed to explore potential CTE/TES biomarkers (RNA and protein) in blood and its exosomes. Thereafter, these biomarkers will be combined with the reported TBI biomarkers to create a novel set of CTE/TES molecular diagnostic signatures. The findings may open a new avenue for the clinical diagnosis of the disease and the future research on its therapeutic strategy.


Eligibility Criteria:
Inclusion Criteria:

1. Athletes and patients with traumatic brain injury

   * Age ≥ 18 and ≤ 80 years old with independent behavior ability or authorized legal representative.
   * Have a clear history of repetitive mild TBI, concussion or subconcussion.
   * The most recent head injury occurred 3 months ago.
2. Healthy Volunteers

   * Age ≥ 18 and ≤ 80 years old with independent behavior ability.
   * No history of repetitive mild TBI, concussion or subconcussion.
   * Fully understands the nature of the study, and voluntarily participates and signs the informed consent.

Exclusion Criteria:

1. Athletes and patients with traumatic brain injury

   * Pregnant or lactating women.
   * History of other neurological diseases.
   * History of tumors, hematological diseases, severe cardiopulmonary diseases, hepatic failure or renal failure.
   * Have participated in clinical trials in the past four weeks.
   * The investigator believes that not appropriate for inclusion.
2. Healthy Volunteers

   * Pregnant or lactating women.
   * History of TBI or other neurological diseases.
   * History of tumors, hematological diseases, severe cardiopulmonary diseases, hepatic failure or renal failure.
   * Have participated in clinical trials in the past four weeks.
   * The investigator believe that not appropriate for inclusion.
An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder

The purpose of the study is to evaluate the efficacy of saredutant in the treatment of Major Depressive Disorder in elderly patients.To evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.To evaluate safety and tolerability of 24 weeks of additional treatment in patients completing the initial 8-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive disorder, recurrent, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI).

Exclusion Criteria:

* Total score of less than 23 on the MADRS.
* HAM-D total score less than 17.
* Duration of the current depressive episode less than 1 month or greater than 2 years.
* Patients with an Mini Mental State Examination score of less than 23.
* Patients with a history or presence of bipolar disorders or psychotic disorders.
* Patients with alcohol/substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
* Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, monoamine oxidase inhibitors within 4 weeks, other antidepressants, or mood-stabilizer (lithium, anticonvulsants) within 1 week.

The investigator will evaluate whether there are other reasons why a patient may not participate
Impact of Cytomegalovirus (CMV) Replication Over Hepatitis C Recurrence in Liver Transplant Recipients

The relationship between cytomegalovirus infection and recurrence of hepatitis C in liver transplant recipients remains controversial. Although some studies (Teixeira et al., 2000; Singh et al., 2005)have not found an association between recurrence of hepatitis C and CMV infection, studies such as Rosen et al. show that 50% of patients with CMV infection suffered cirrhosis durig follow-up period, while between not-infected patients the rate was 11%. To clarify this question, a non-interventional study will be carried out in order to assess if CMV replication is a risk factor for graft dysfunction in liver transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Men or women who underwent liver transplantation after hepatopathy caused by HCV, confirmed by pre-transplantation detection of HCV RNA
* Age \> 18 years old

Exclusion Criteria:

* Patients co-infected with HBV or HIV
* Patients who show other causes of liver disease
Spectral Dynamic Imaging of Cognitive Functions in Epileptic Patients Explored Stereoelectroencephalography

This prospective research aims to develop the use of Spectral Imaging in addition Dynamics of cortical electrical stimulation to identify major anatomical and functional networks in epileptic patients candidates for surgery and explored by stereoencephalography, to minimize risk of post-surgical cognitive deficits.

Cognitive deficits after epilepsy surgery are poorly known particularly because the tools used to evaluate them. In addition, the prevention of certain postoperative deficits, is extremely difficult because of the lack of robust markers to anticipate. The various examinations conventionally used for this purpose (neuropsychological testing, functional MRI and cortical stimulation) does indeed provide insufficient information or difficult to interpret, so the development of improved methods appears as an imperative in the field of the epilepsy surgery.

SID appears as such particularly adapted to the case of epileptic patients explored SEEG to provide individualized cognitive map millimeter thereof without requiring, for additional invasive act, or risk of inducing unintended crisis. In practice, this clinical research project should lead to the definition of several simple cognitive tasks which, together, could be achieved by each volunteer patient in two or three hours, and then analyzed in a similar time to provide fast, even the patient is still explored SEEG and even before cortical electrical stimulation, a list of brain regions involved in most major cognitive functions.

Eligibility Criteria:
Inclusion Criteria:

* Drug-resistant partial epilepsy justifying a SEEG exploration
* Intellectual capacities compatible with the award of cognitive tasks

Exclusion Criteria:

* Pregnant or lactating women
* Patient deprived of liberty by a judicial or administrative
* Major patient subject to a measure of legal protection
Study of Multiple Oral Doses of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus

This is a Phase 1, randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open study of PF-07081532. Study participants will receive the investigational product or placebo every day for 42 days.

The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of multiple oral doses of PF-07081532 in participants with inadequately controlled type 2 diabetes mellitus, on metformin and optionally in non-diabetic participants with obesity.


Eligibility Criteria:
Inclusion Criteria:

* Females of non childbearing potential;
* Patients with T2DM, inadequately controlled with metformin;
* HbA1c ≥7.0% to ≤10.5% (for T2DM); HbA1c \<6.5% (for non-diabetic obese, if enrolled)
* Total body weight \>50 kg (110 lbs)
* BMI ≥24.5 to ≤45.5 kg/m2 (T2DM), BMI \>30.5 to ≤45.5 kg/m2 (for non-diabetic obese)

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, neurological, dermatological, or allergic disease;
* Medical history of T2DM (for non-diabetic obese participants, if enrolled);
* Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes;
* Evidence or history of clinically significant cardiovascular disease;
* Any malignancy not considered cured;
* Acute pancreatitis or history of chronic pancreatitis;
* Acute gallbladder disease;
* Any condition possibly affecting drug absorption;
* Personal or family history of MTC or MEN2;
* Medical or psychiatric condition that may increase the risk of study participation;
* Any vaccination within the 1 week prior to admission to the CRU;
* Previous administration with an investigational drug within 30 days or 5 half-lives preceding first dose;
* Known prior participation in a trial involving PF-07081532;
* A positive urine drug screen at screening or admission;
* Positive testing at screening for HIV, HBsAg, HBcAb, HBsAb or HCVAb;
* Positive COVID-19 test at screening or admission;
* Supine BP ≥160 mm Hg (systolic) or ≥100 mm Hg (diastolic);
* 12-lead ECG clinically relevant abnormalities that may affect participant safety or interpretation of study results;
* Participants with ANY of the following abnormalities in clinical laboratory tests: \*AST or ALT level ≥1.5x ULN;

  * Total bilirubin level ≥1.5x ULN;
  * TSH\> ULN;
  * Fasting C-peptide \<0.8 ng/mL;
  * Serum calcitonin \> ULN;
  * Amylase \> ULN;
  * Lipase \> ULN;
  * eGFR \<60 mL/min/1.73m2 (per MDRD equation);
  * FPG \>270 mg/dL
* History of alcohol abuse, binge drinking and/or any illicit drug use or dependence within 6 months of Screening;
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing;
* History of sensitivity to heparin or heparin induced thrombocytopenia;
* Known intolerance to any GLP-1R agonist.
Development of a Neuronal Microscope

Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and is a leading cause of cancer-related death worldwide. The prognosis of HCC remains poor, with a 5-year survival rate of 18%. Risk factors for HCC include viral infection, autoimmune hepatitis, chronic alcohol use or metabolic fatty liver disease, obesity, and diabetes mellitus.

Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and is a leading cause of cancer-related death worldwide. The prognosis of HCC remains poor, with a 5-year survival rate of 18%. Risk factors for HCC include viral infection, autoimmune hepatitis, chronic alcohol use or metabolic fatty liver disease, obesity, and diabetes mellitus. Furthermore, alterations and chronic inflammation of the microenvironment can facilitate the transformation of normal liver stem cells into precancerous tumor stem cells. All these underlying pathogenic stimuli can induce a spectrum of genetic and epigenetic modifications, which are involved in the cell cycle, cell growth and regulation of adhesion. Therefore, heterogeneity and tumor priming potential arise from a combination of both endogenous and exogenous factors. However, current in vitro models, based on conventional hepatoma and hepatocarcinoma cell lines, fail to recapitulate key characteristics of tumor tissue such as three-dimensional tissue architecture, cellular heterogeneity, and cell-cell interactions. Organoids, which are 3D cellular structures generated from induced pluripotent stem cells and adult tissue-resident stem cells, have recently been exploited to overcome the limitations of 2D cell culture systems, emerging as powerful tools for studying human diseases. Therefore, organoid structures stably preserve the genetic information of autologous tissue by mimicking the pathological state of the tissue itself.

Eligibility Criteria:
Inclusion Criteria:

Patients aged \>18 years:

* undergoing surgical cholecystectomy, liver resection for hepatocellular carcinoma (both intra-tumoral and extra-tumoral tissues) or whole liver explants;
* who have given consent to participate in the study.

Exclusion Criteria:

• positivity for chronic viral hepatitis (HCV-RNA and HBsAg).