cyrilzakka/clinical-trials huggingface dataset:
Hydroxyurea and EPO in Sickle Cell Disease

The proposed study is a Phase 1/2 multi-center study evaluating the safety and efficacy of erythropoietin (EPO) in combination with hydroxyurea in the treatment of chronic anemia in patients with sickle cell disease (SCD).

Sickle cell disease (SCD) is a devastating inherited hemoglobin disorder characterized by recurrent episodes of pain and chronic hemolytic anemia. Chronic anemia contributes to multi-organ damage and decreased life expectancy in SCD. However, there are limited treatment options for anemia in SCD. Erythropoietin (EPO) is the standard of care for treatment of anemia related to chronic kidney disease (CKD) and is also used ad hoc in patients with SCD. However, there is limited data on the safety and efficacy of EPO in patients with SCD, especially in combination with hydroxyurea. Therefore, this study aims to treat patients on stable hydroxyurea therapy with subcutaneous EPO, with the goal of assessing the safety of EPO therapy and its effect on chronic anemia in SCD.

(Note: Outcome measure changes were in place prior to study initiation.)

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Confirmed diagnosis of SCD (HbSS or HbS/β0-thalassemia genotypes)
* Screening Hb ≤ 9.0 g/dL
* Screening transferrin saturation ≥ 20% and ferritin ≥ 50 ng/mL
* Must be on stable-dose hydroxyurea treatment (i.e., no changes in dose within 60 days prior to start of study drug) and plan to continue taking hydroxyurea at the same dose and schedule during the study
* If receiving L-glutamine or crizanlizumab, must have been receiving the drug at a stable dose for at least 60 days prior to screening and plan to continue taking the drug at the same dose and schedule during the study

Exclusion Criteria:

* Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and/or planning on undergoing an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted, but participant should not have received a blood transfusion within 60 days of start of study drug
* Received voxelotor or EPO within 30 days of start of study drug
* Untreated iron deficiency, or had initiation or change in dose of supplemental iron within 30 days of start of study drug
* Ongoing acute illness, infection, or VOC within 2 weeks of start of study drug
* Arterial or venous thrombosis within 180 days of start of study drug
* Grade 3 hypertension (defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; medical intervention indicated; more than one drug or more intensive therapy than previously used indicated) on two consecutive measurements
* Unstable angina, uncontrolled seizure disorder, or active malignancy
* End-stage renal disease requiring hemodialysis
* Current pregnancy or breastfeeding
* Received active treatment on another investigational trial within 30 days (or 5 half-lives of that agent, whichever is greater) prior to start of study drug or plans to participate in another investigational drug trial
Study of N-homocysteinylation of Key Proteins in Alzheimer's Disease (HO-MA)

Alzheimer's disease (AD) is the leading cause of dementia in France. It is a multifactorial pathology, combining genetic and environmental risk factors. Homocysteine, a sulfur-containing amino acid belonging to the methionine-monocarbon cycle, has frequently been found at high levels in neurodegenerative diseases, and in AD in particular. It has been shown on human brain sections that the interaction of homocysteine with tau and MAP1, two key AD proteins, was significantly higher in AD patients than in controls, and corresponded to an N-homocysteinylation type interaction.

This is a prospective study, the main objective of which is to compare MAP1 N-homocysteinylation levels in fibroblasts from individuals with AD versus disease-free cell lines.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* Age of onset of AD \< 75 years
* Person with AD with positive CSF biomarkers
* Person who has previously benefited from an analysis of AD genetic characteristics (APP, PSEN1, PSEN2, TREM2, ABCA7, SORL1 genes and ApoE status) and an analysis of monocarbon metabolism genes in the case of biochemical abnormalities by clinical exome, targeted panel or complete exome, and for whom the data set is already available.

Exclusion Criteria:

* Pregnant, parturient or breast-feeding women
* Minor (not emancipated)
* Person of legal age (subject to a legal protection measure)
* Adult unable to give consent
A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007)

Researchers are looking for a new way to treat people with non-segmental vitiligo (NSV). The goal of this study is to learn about the safety of MK-6194 and how well people tolerate it. Researchers also want to learn if people who take MK-6194 have more of a decrease in the amount of vitiligo on their face compared to people who take placebo.


Eligibility Criteria:
Inclusion Criteria:

* Has a clinical diagnosis of non-segmental vitiligo
* Has non-segmental vitiligo with disease duration of at least 6 months
* Has depigmentation contributing to Facial Vitiligo Area Scoring Index (F-VASI) ≥ 0.3 at screening and baseline
* Has depigmented facial body surface area (BSA) ≥0.3% at screening and baseline
* Has Total Vitiligo Area Scoring Index (T-VASI) ≥4 at screening and baseline
* Has total body vitiligo area ≥4% at screening and baseline excluding hands and feet involvement

Exclusion Criteria:

* Has segmental vitiligo
* Has ≥50% leukotrichia on face or body
* Has any other dermatological diseases that would interfere with vitiligo assessments
* Has history of or current inflammatory condition other than vitiligo that, in the opinion of the investigator, could interfere with the evaluation of vitiligo
* Has a known systemic hypersensitivity to interleukin 2 (IL-2), or modified IL-2 including MK-6194, or its inactive ingredients
* Has an active or clinically significant infection requiring hospitalization or treatment with IV anti-infectives within 4 weeks prior to Randomization, or oral/intramuscular anti-infective therapy within 2 weeks prior to Randomization
* Has symptomatic heart failure (New York Heart Association class III or IV) or myocardial infarction or unstable angina pectoris within 6 months prior to Screening
* Has a severe chronic pulmonary disease requiring oxygen therapy
* Has a transplanted organ, which requires continued immunosuppression
* Has a history of any malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix
* Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB
* Has confirmed or suspected COVID-19 infection
* Has history of drug or alcohol abuse within 6 months prior to Screening
* Has had major surgery within 3 months prior to Screening OR has a major surgery planned during the study
* Has had an inadequate response (as evaluated by a dermatologist or local physician specialist equivalent) to previous treatment with a Janus kinase inhibitor (JAKi) after an appropriate treatment duration (eg, ≥12 weeks)
* Has received prohibited medications within protocol-specified timeframes prior to Randomization
* Has participated in another investigational clinical study within 4 weeks prior to Randomization
* Has donated or lost ≥1 unit of blood (approximately 500 mL) within 4 weeks prior to the Screening Visit
* Has received cosmetic or other procedures that could interfere with evaluation of vitiligo during the study
Cerebellar rTMS for Essential Tremor

Essential tremor (ET) is a low-mortality, though truly burdensome and debilitating condition which is known to be the second most common movement disorder of the adult population only after restless legs syndrome. The prevalence of the disorder in all age groups has been estimated to be 0.9%. Repetitive transcranial magnetic stimulation (rTMS) is an almost safe technique which has been used in diagnosis and treatment of many neurologic and psychiatric conditions. Recent studies have shown that cerebellum has a significant role in development of ET and that rTMS could exert therapeutic effects on its motor symptoms. In this study researchers will recruit at least 30 subjects among patients visiting at the Specialty Clinic of Mashhad Medical University according to researchers exclusion and inclusion criteria and after signing a written informed consent, will randomly be assigned to either real or sham rTMS. On the real rTMS arm, patients will be treated with 900 pulses of 1 Hz rTMS on 90% of resting motor threshold (RMT) delivered over each cerebellar hemisphere for 5 consecutive days and sham treatment will be performed with the same protocol using a small device placed on the TMS coil (not visible to the patients) producing electrical stimulation (less than 3 mili amperes), to simulate the sensation of real TMS. Subject's ear will be protected with earplugs during both real and sham stimulations. After 2 months of follow-up, patients will undergo crossover and receive the other treatment as described above. Patients would be assessed using Fahn-Tolosa-Marin scale at the baseline and again on days 5, 12, and 30 after each real or sham treatment session by a blinded researcher. Data will be analysed by another researcher who is also blind.


Eligibility Criteria:
Inclusion Criteria:

* having a diagnosis of essential tremor (ET) based on Movement Disorder Society criteria, involving at least one hand.
* 18 years or above
* cognitively eligible to give informed consent of participation in the trial.

Exclusion Criteria:

* Cardiac pace-maker or other implanted magnetic device or having other contraindications of performing a routine non-contrast MRI
* skin defect at the occipital area preventing placement of a coil
* Currently pregnant or plan for pregnancy in the next 6 months
* History of seizure
* Other comorbid medical conditions capable of producing or enhancing tremor
* advanced cardiac, renal, hepatic or other disabling conditions making patient physical unable to participate in examination and receiving the intervention
* Use of new drugs with potential effect on tremor
The Evaluation of Erector Spinae Plane Block for the Pain Control of Thoracic Postherpetic Neuralgia

Erector spinae plane block is new interfascial plane block, and can be applied to management of thoracic neuropathic pain syndromes. The target of needle is deeper(or anterior) to the erector spinae muscle. So it is more safe and simple technique than prior technique, thoracic paravertebral block. The aim of this study is the evaluation of erector spinae plane block comparison to prevertebra block.

This study is single-blind because it is not possible to blind the practitioner performing the injection.

Subjects were randomly assigned to the erector spinae plane block group (group E) and the thoracic paravertebral block group (group P) by a random random number table, and the possibilities for belonging to any group were all the same and can not be artificially controlled by researchers.

Before the procedure, a resident who does not know of this study records the patient's pain and painDETECT. and on follow-up four weeks visits, PGIC scale is checked.

The erector spinae plane block or thoracic paravertebral block should be performed after receiving the informed consent of the patient.

Because of the large difference between the skilled and unskilled patients, the procedure in this study is performed by only one skilled practitioner.

Eligibility Criteria:
Inclusion Criteria:

1. Inclusion criteria were patients who had chest wall post herpetic neuralgia, with moderate and severe pain and received appropriate antiviral therapy.

Exclusion Criteria:

1. Patient refusal
2. Patients who did not receive appropriate antiviral therapy
3. Patients with mild pain
4. Heavy skin eruption (no healthy area for needle entry) and infection at site of injection.
5. Patients with history of renal, hepatic diseases, coagulopathy, diabetes
6. Patients taking chemotherapy and/or radiotherapy
7. Patients with history of steroid therapy
8. Patients taking narcotic analgesics
9. Patient who does not understand the study because of illiteracy or language problems.
10. Abnormal findings in peripheral blood test (CBC, ESR, CRP, PT/aPTT)
Effect of W-3 Polyunsaturated Fatty Acids on Serum Albumin Concentration in Patients With Acute Heart Failure, Hypoalbuminemia, and High Inflammatory Activity

Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in serum albumin

Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in serum albumin

Assess the effect of high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity on:

* Inflammatory activity (C-reactive protein)
* The development of biomarkers (NTproBNP).
* The prognosis of patients evaluated by the combined event of death from any cause or readmission for heart failure within three months after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or olders hospitalized for acute heart failure, chronic decompensated or new onset of any etiology, presenting hypoalbuminemia (serum albumin ?3,4 g / dl) and high inflammatory activity (CRP ?2,5 mg / dl).

Exclusion Criteria:

* Impending doom
* Participating in other clinical trials
* Treatment with ?-3 acids in the last month prior to admission
* Percutaneous or surgical treatment of the cause of heart failure during hospitalization.
* Pregnant women.
* Renal failure on dialysis.
* Chronic liver disease Child-Pugh B or C.
* Acute infectious process.
* Active malignant neoplasia.
Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Ocular hypertension or primary open-angle glaucoma in each eye
* Requires treatment with IOP-lowering medication in both eyes

Exclusion Criteria:

* Required chronic use of ocular medications during the study other than study medication
* Use of any corticosteroids within 30 days
* History of any traumatic eye surgeries
* Cataract surgery in the past 6 months
* Anticipated wearing of contact lenses during the study
Personalised Program for Women Treated for Hodgkin Disease

After treatment for Hodgkin disease, secondary cancer, in particular breast cancer induced by treatment, are the first cause of death.

The investigators will estimate the risk to develop breast cancer in this population of women treated for hodgkin disease, and will propose women at high rish to participate in an intensive screening program based on an annual detection based on mammography, echography, and RMI.


Eligibility Criteria:
Inclusion Criteria:

* women \> 18 years
* treated for Hodgkin disease
* signed informed consent
* high risk of breast cancer

Exclusion Criteria:

* patients unable to have a regular follow-up
Repetitive Transcranial Magnetic Stimulation and Multi-modality Aphasia Therapy for Post-stroke Non-fluent Aphasia

Many stroke survivors experience aphasia, a loss or impairment of language affecting the production or understanding of speech. One common type of aphasia is known as non-fluent aphasia. Patients with non-fluent aphasia have difficulty formulating grammatical sentences, often producing short word fragments despite having a good understanding of what others are trying to communicate to them. Speech language pathologists (SLPs) play a central role rehabilitating persons with aphasia and administer therapy in an attempt to improve communication skills. Despite standard therapy, approximately 50% of individuals who experience aphasia acutely continue to have language deficits more than 6 months post-stroke.

In most people, Broca's area is dominant in the left side of the brain. Following a left-sided stroke, the right-sided homologue of Broca's area (the pars triangularis), may adopt language function. Unfortunately, reorganizing language to the right side of the brain seems to be less effective than restoring function to the left hemisphere. Repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, can be used to suppress activity of specific regions in the right side of the brain to promote recovery of function in the perilesional area. Despite preliminary success in existing studies using rTMS in post-stroke aphasia, there is much work to be done to better understand the mechanisms underlying recovery. Responses to rTMS have been positive, yet heterogenous, which may be related to timing of treatments following stroke.


Eligibility Criteria:
Inclusion Criteria:

* Isolated left middle cerebral artery (MCA) stroke within past 6 months (sub-acute) or more than 6 months ago (chronic)
* Stroke type: Ischemic or hemorrhagic
* Non-fluent aphasia as determined by the Western Aphasia Battery (Fluency \< 5)
* English is first or primary language
* Ability to follow 3-step commands

Exclusion Criteria:

* Prior stroke to the right frontal lobe
* Current diagnosis of moderate to severe depression
* Diagnosis of any other psychiatric condition
* History of other neurologic disorders (e.g., epilepsy, brain tumor)
* Contraindication to MRI or TMS (metal in the head or any implanted electrical device)
* Has received intensive speech therapy within the past 6 months (\>8 hours per week)
* Enrolled in another interventional study
Drug Interaction Study With Proton Pump Inhibitor

The purpose of this clinical research study is to assess the effect of omeprazole at 20 mg on the pharmacokinetics of atazanavir administered as atazanavir with ritonavir relative to atazanavir or atazanavir/ritonavir in the absence of omeprazole in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between the ages of 18 to 50 years old with BMI 18 to 32 kg/m2
A Research Study of a New Medicine NNC0113-6856 in Healthy Males

In this study NN0113-6856 will be given to humans for the first time. We will be looking into how safe different single doses of the new investigational product NNC0113-6856 is and we will measure its amount as well as the amount of specific parts of the new investigational product in blood. The study will look at the effects of different single doses of NNC0113-6856. This could either be as an oral dose (cohort 1 to 5) or one injection into the vein (intravenous \[IV\]-cohort). Participant will get the investigational product either as one or two tablets (oral dose in cohort 1 to 5) or as injection into the vein (IV cohort). The study will last for about 6-10 weeks (up to 14 weeks in case of rescheduling for stand-by participants).


Eligibility Criteria:
Inclusion Criteria:

* Male.
* Aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body mass index between 20.0 and 27.0 kilogram per meter square (kg/m\^2)(both inclusive).

Exclusion Criteria:

* Glycated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percent (%) (48 millimoles per moles \[mmol/mol\]) at screening.
* Use of tobacco and nicotine products, defined as any of the below:

  * Smoking more than 5 cigarettes or the equivalent per day.
  * Not willing to refrain from smoking and use of nicotine substitute products during the inpatient periods.
* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
* History of major surgical procedures involving the stomach potentially affecting absorption of trial products (example: subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant
* Presence or history of pancreatitis (acute or chronic).
* Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
* Any of the below laboratory safety parameters at screening outside the below laboratory range, see "Log of laboratory ranges used for laboratory parameter exclusion criterion" for specific values:

  * Alanine Aminotransferase (ALT) greater than (\>) upper normal limit (UNL)
  * Aspartate aminotransferase (AST) \> UNL
  * Bilirubin \> UNL
  * Creatinine \> UNL
  * International normalized ratio (INR) \> UNL
* Precence or history of hepatitis
Isolated Oligohydramnios Less Favorable Delivery and Neonatal Outcomes

Oligohydramnios happens in 1-5% of term pregnancies. The clinical significance of isolated oligohydramnios been a matter of debate. We aimed in this study to investigate the impact of isolated oligohydramnios on the mode of delivery and risk of adverse perinatal outcome.

Retrospective study conducted in Armed Forces Hospitals of Southern Region, comparing cases with oligohydramnios (amniotic fluid level index \<5) to normal amniotic fluid cases (amniotic fluid level index ≥ 8). Primary outcomes are the mode of delivery and adverse perinatal outcomes (including mortality, NICU admission, low Apgar score and sepsis)

Eligibility Criteria:
Inclusion Criteria:

1. Third trimester pregnancy
2. Isolated oligohydramnios

Exclusion Criteria:

1. Multiple pregnancy
2. less than 32 weeks
3. medical disorders like DM HPN
4. Fetal jeopardy