cyrilzakka/clinical-trials huggingface dataset:
Thrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis

Pulmonary embolism, the second leading cause of death in cancer patients, is effectively treated with anticoagulants. In patients with cancer-associated thrombosis (CAT), the use of anticoagulants is associated with 10 to 15% of bleeding in the first 6 months. Most of the guidelines propose to integrate the bleeding risk in the choice of therapies. Thrombin generation assay (TGA) reflects an overall hemostatic response and could be a useful biomarker. Proven on the thrombotic side in the CAT population, useful in the assessment of the bleeding risk of hemophiliac patients, the TGA is emerging as a tool. The investigators to measure TGA in cancer patients included prospectively, having recently developed a CAT and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment.

Pulmonary embolism, the second leading cause of death in cancer patients, is effectively treated with anticoagulants. In patients with cancer-associated thrombosis (CAT), the use of anticoagulants is associated with 10 to 15% of bleeding in the first 6 months. Most of the guidelines propose to integrate the bleeding risk in the choice of therapies. Existing models for predicting anticoagulant associated bleeding risk applied to the CAT patients are not very predictive (AUC\<0.60). Thrombin generation assay (TGA) reflects an overall hemostatic response and could be a useful biomarker. Proven on the thrombotic side in the CAT population, useful in the assessment of the bleeding risk of hemophiliac patients, the TGA is emerging as a tool. The investigators wish to measure TGA in cancer patients included prospectively, having recently developed a CAT and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with active cancer, as defined by current French recommendations (Mahé I et al Rev Mal Respir 2021)
* Presenting acute proximal deep vein thrombosis of the lower limb (DVT) and/or proximal pulmonary embolism (PE), confirmed by objective tests (Doppler ultrasound in the event of DVT; lung scintigraphy or CT scan in the event of PE)
* No contraindication for anticoagulant treatment at a curative dose at the time of inclusion

Exclusion Criteria:

* Patients participating in a therapeutic clinical trial with blinded therapy will be excluded.
* Patients already on anticoagulant at a curative dose for valvular or rhythmic embolic disease or a history of venous thromboembolic disease
* Hematological malignancies
* Patients with a contraindication to anticoagulant treatment on inclusion
* Patient whose relay by DOAC has already been carried out.
Ticagrelor Therapy for RefrACTORy Migraine Study

This is a prospective, open-label, single-arm pilot study treating 40 subjects to assess the hypothesis that P2Y, G protein-coupled 12 (P2Y12) inhibition with Brilinta/ticagrelor (90 mg by mouth (PO) twice a day) reduces episodic and/or chronic migraine headache symptoms in patients with right to left shunt. Headache frequency while on Brilinta/ticagrelor will be compared with the documented baseline for each subject. If the Brilinta/ticagrelor therapy was effective (\> 50% reduction in monthly headache days), the subject could elect to continue therapy for an additional two months (56 days), while continuing to complete daily headache logs.

Migraine headaches are poorly understood, and can be severely debilitating. Many types of drugs have been tried in migraine sufferers including anti-depressants, anti-seizure medications, blood pressure medicines and others. The investigators have shown that in a small number of patients, a certain type of blood thinner (Clopidogrel) can reduce or eliminate migraine headaches in patients who also have a hole in the heart wall that allows flow from the right side of the heart to the left. Ticagrelor is a blood thinning drug which works in the same way as the clopidogrel, but is broken down by the body differently and thus allows everyone to use it. The investigators wish to test this medication to see if it works as well, or better than the clopidogrel.

Eligibility Criteria:
Inclusion Criteria:

* At least one year history of Episodic or Chronic migraine headache symptoms
* At least 6 headache days per month
* Subject able to complete online daily headache log

Exclusion Criteria:

* Inability to understand the study or history of non-compliance with medical advice
* Currently taking a P2Y12 inhibitor
* Known hypersensitivity to Brilinta/ticagrelor
* History of stroke/transient ischemic attack (TIA) in the previous 6 months
* Active bleeding from any site
* Active peptic ulcer disease or upper gastrointestinal (GI) bleeding within six (6) months
* Migraine onset after 50 years of age
* Renal impairment: Creatinine Clearance \< 60 cc/min
* Severe hepatic impairment with total bilirubin \> 3.0 mg/dL
* Thrombocytopenia with platelet count \< 100,000 / ul
* History of intracranial hemorrhage
* Contraindications to blood thinner therapy or history of major bleeding episode while taking blood thinner therapy
* Need for chronic oral anti-coagulation therapy (i.e. Atrial Fibrillation)
* Need for chronic anti-platelet therapy (i.e. drug-eluting (DE) Stent), including daily aspirin use
* Need for daily nonsteroidal anti-inflammatory drug (NSAID) use
* Need for daily carbamazepine therapy or other strong CYP3A inhibitors or potent CYP3A inducers
* Need for simvastatin or lovastatin greater than 40 mg daily
* Symptomatic bradycardia or syncope
* Pregnancy or currently breast-feeding, or plan to become pregnant during the study period
* Planned surgery during the study time-frame
* Previously implanted patent foramen ovale (PFO), atrial septal defect (ASD), pacemaker, inferior vena cava filter, or left atrial appendage closure device
Ipragliflozin Add-on Long-term Study in Japanese Participants With Type 2 Diabetes Mellitus on Sitagliptin (MK-0431J-849)

This is a study to assess the safety and efficacy of the addition of ipragliflozin to sitagliptin in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy.


Eligibility Criteria:
Inclusion Criteria:

* Has Type 2 diabetes mellitus
* Has inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy
* Hemoglobin A1C (HbA1c) ≥7.0% and ≤10.0% before study participation

Exclusion Criteria:

* History of type 1 diabetes mellitus or a history of ketoacidosis
* History of any of the following medications: Thiazolidinediones (TZD) and/or insulin within 12 weeks prior to study participation, sodium glucose cotransporter 2 (SGLT2) inhibitors anytime
* Currently has a urinary tract infection or genital infection with subjective symptom
Transcranial Magnetic Stimulation for the Treatment of Parkinson's Disease

The problems in motor activity associated with Parkinson's disease are still poorly understood. Patients with Parkinson's disease often suffer from extremely slow movements (bradykinesia) which result in the inability to perform complex physical acts.

Imaging studies of the brain have provided researchers with information about the specific areas in the brain associated with these motor difficulties. One particular area involved is the surface of the brain called the cerebral cortex.

Transcranial Magnetic Stimulation (TMS) is a non-invasive technique that can be used to stimulate brain activity and gather information about brain function. It is very useful when studying the areas of the brain related to motor activity (motor cortex, corticospinal tract, and corpus callosum). Repetitive transcranial magnetic stimulation (rTMS) involves the placement of a cooled electromagnet with a figure-eight coil on the patient's scalp and rapidly turning on and off the magnetic flux. This permits non-invasive, relatively localized stimulation of the surface of the brain (cerebral cortex). The effect of magnetic stimulation varies, depending upon the location, intensity and frequency of the magnetic pulses.

Researchers plan to study the therapeutic effects of repetitive transcranial magnetic stimulation (rTMS) on complex motor behavior of patients with Parkinson's disease. In order to measure its effectiveness, patients will be asked to perform complex tasks, such as playing the piano while receiving transcranial magnetic stimulation.

The physiology of the motor disturbance in Parkinson's disease is not completely understood. One of the major and perhaps most disabling manifestations of PD is bradykinesia. It is particularly difficult for these patients to perform simultaneous, sequential and complex motor acts. Imaging studies have recently provided important information in reference to the brain regions associated with performance of these motor sequences in normal volunteers and in PD patients. These studies helped us to identify the brain regions active in association with task performance. It has been suggested that cortical regions, and particularly the SMA are less active in patients with PD than in controls in association with motor performance.

We plan to study the effects of subthreshold rTMS delivered to SMA and primary motor cortex in patients with PD "on" and "off" medication. From this study, we expect to learn if stimulation of the scalp overlying primary motor cortex and SMA can ameliorate performance of simple and complex motor sequences in PD.

Subthreshold rTMS has been proposed as a therapeutic tool in psychiatric disorders. In the motor domain, subthreshold rTMS delivered to primary motor cortex improves reaction times and motor performance in patients with Parkinson's disease. The mechanisms underlying this beneficial effect are not known. However, they may be related with subthreshold rTMS replacing the missing excitatory drive on the motor cortex.

Eligibility Criteria:
Patients with PD.

No epilepsy.

No seizures.

No metal in the head.
Interactive Mobile Health Intervention to Improve Early Postpartum Modern Contraceptive Method Uptake

The main aim of this study is to determine effectiveness of mobile health intervention to improve early postpartum modern contraceptive service uptake among postpartum women in Dessie and Kombolcha town zones, North east Ethiopia. This study will be conducted in Dessie and Kombolcha zones in Amhara region, North east Ethiopia. The largest sample size will be taken and total sample size will be 784.

The main aim of this study is to determine effectiveness of mobile health intervention to improve early postpartum modern contraceptive service uptake among postpartum women in Dessie and Kombolcha town zones, North east Ethiopia. This study will be conducted in Dessie and Kombolcha zones in Amhara region, North east Ethiopia. The largest sample size will be taken and total sample size will be 784.

Cluster randomized control trial behavioral intervention sampling technique will be deployed. First participants will be grouped in to two arms based on randomization of clusters. The intervention arm will take the new mobile health intervention with existed health care practice and the control arm will take the existed current health care practice. Intervention mobile health messages will be developed from family planning behavior change framework and national guidelines. Data will be collected by using pre-tested interviewer administered structured questionnaires. Data will be collected in four different phases. Open data kit (ODK) will be used for data collection. Duration of intervention will be 4 months. Descriptive analyses will be made by computing proportions and summary statistics. Statistical package to social science (SPSS.26) and STATA.15 soft wares will be used to do analysis. Structural Equation Modeling (SEM) or path analysis will be done to identify the fitted components to determine latent variables.

Eligibility Criteria:
Inclusion Criteria:

All mothers who will be 24-28 week of gestation and have access to mobile phone in the study area will be recruited to this study.

Exclusion Criteria:

* Pregnant women, who will be assumed to have serious medical problems, will be excluded.
Evaluation of the Efficacy of Vertistop® D and Vertistop® L in the Prevention of BPPV Recurrence

The study involves the evaluation of 3 groups of subjects (3-arm study). Patients diagnosed with BPPV and "sufficient" serum concentrations of Vitamin D (\>30 ng/mL, \>75 nmol/L) at baseline may be treated with 2 tablets per day (morning and evening) of Vertistop® L ( Alpha-lipoic acid, carnosine, zinc and curcumin) or untreated, on the basis of the randomization criterion to which they will be assigned. Patients with Vitamin D "deficiency" (\<20 ng/mL, \<50 nmol/L) or Vitamin D "insufficient" (20-30 ng/mL, 50-75 nmol/L) at baseline, or subsequent follow-up, they will be treated for 2 months with Vertistop® D (alpha-lipoic acid, carnosine and zinc, vitamin D3 and vitamins of the B complex) taking 1 tablet a day (before meals).

The main purpose of the study is to evaluate, over a period of 6 months, the efficacy of Vertistop® D and Vertistop® L supplementation in preventing recurrences of BPPV (Benign Paroxysmal Positional Vertigo), in relation to blood levels of Vitamin D.

Patients will be assigned to one of the three study groups following a randomization list with reference to groups 1 and 2 and according to the serum concentrations of 25(OH) Vitamin D, evaluated at the baseline visit, with reference to group 3.

The determination of the Vitamin D concentration will be requested by the Investigating physician and the report will be evaluated during the randomisation visit (V1), Visit 2, (after 2 months from enrollment/start of treatment), Visit 3 (Follow-up visit up to 4 months from enrollment) and finally Visit 4 (Follow-up visit 6 months after enrollment).

The blood sample and the Vitamin D dosage will be carried out the week before the day of the visit agreed with the Investigator, in a trusted laboratory of the patient, provided that it has the legal authorizations and the analytical methodology satisfactory the measurement intervals reported in Protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes, aged between 18 and 85 years, diagnosed with primary BPPV.
2. Patients who have BPPV of the posterior semicircular canal (SPC) geo and apo, lateral semicircular canal (SLC) geo and apo (single-canal, multi-canal).
3. Patients with relapsing BPPV, defined as two or more episodes in the past six months, or three or more episodes in the last 12 months.
4. Patients able to understand and follow the requirements of the Study Protocol and to provide their informed consent.

Exclusion Criteria:

1. Patients under the age of 18.
2. Secondary BPPV. Other causes of possible high recurrence BPPV and/or massive otolithic detachment:

   * Migraine;
   * Meniere's or delayed endolymphatic hydrops;
   * Lindsay Hemenway syndrome;
   * Otological and/or dental implant surgery in the last 3 months;
   * Conclusion within 30 days.
3. Patients with Vitamin D values exceeding 100 ng/mL (\>250 nmol/L).
4. Pregnant or lactating women, as reported by the patient.
Prehospital Resuscitation Intranasal Cooling Effectiveness Survival Study 2

The aim of this clinical trial is to study the impact of ultra-early transnasal evaporative cooling after cardiac arrest and subsequent hypothermia at hospital, on survival with complete neurologic recovery, compared to currently recommended normothermia. The study population will consist of patients 18-79 years old, with out-of-hospital cardiac arrest with initial shockable rhythm.

The main research question it aims to answer is whether there is a difference in survival with complete neurologic recovery at 90 days after cardiac arrest between the group of patients that received ultra-early cooling, compared to the group that was treated with normothermia.

Participants will be randomized to two groups. One group (the intervention group) will receive ultra-early trans-nasal evaporative cooling initiated by EMS personnel at the scene of the cardiac arrest, and subsequent systemic hypothermia for 24 hours at hospital arrival. The other group (the control group), will receive standard of care (advanced cardiac life support and normal body temperature (normothermia)).


Eligibility Criteria:
INCLUSION CRITERIA:

Patients ≥18 years that meet all of the following inclusion criteria:

1. Adult out-of-hospital cardiac arrest patients with initial shockable rhythm
2. Unconsciousness defined as Glasgow Coma Scale \< 8
3. Inclusion within 20 minutes from EMS arrival

EXCLUSION CRITERIA:

Patients are not eligible if they meet one or more of the following criteria:

1. Age ≥ 80 years
2. Obvious non-cardiac causes to cardiac arrest
3. Obvious already hypothermic
4. Obvious barrier to placing intra nasal catheters
5. Have a known Do Not Attempt to Resuscitate (DNAR) order or other limitations in care
6. Have a known terminal disease
7. Known or clinically apparent pregnancy
Muscle Glycogen Synthesis When Caffeine and Protein is Co-Ingested With Carbohydrates

The aim of the present study is to investigate the effect of added protein+leucine or caffeine to 1.2 g/kg/h CHO on the rate of post-exercise muscle glycogen re-synthesis in healthy, recreational athletes.

The investigators hypothesize that both interventions (the addition of caffeine or protein+leucine) will lead to higher glycogen re-synthesis compared to the ingestion of CHO only, and that the co-ingestion of protein and leucine will result in the highest muscle glycogen synthesis rates.


Eligibility Criteria:
Inclusion Criteria:

* male cyclists
* healthy
* BMI \< 25

Exclusion Criteria:

* female
* use of medication
* non cycling
* BMI \> 25
Treating Violence-related PTSD and Substance Risk in Low-income, Urban Adolescents

This project will provide initial feasibility and efficacy data for the implementation of Narrative Exposure Therapy (NET) to urban, at-risk youth. Posttraumatic stress and substance use outcomes, as well as participant responses to the intervention, will be examined.

The goal of the proposed study is to gather preliminary feasibility and efficacy data for an innovative intervention (Narrative Exposure Therapy: NET) to promote adolescent mental health related to interpersonal trauma (IPT). Among those at highest risk for interpersonal violence and its sequelae are youth from urban, low-resourced neighborhoods. Post-traumatic stress disorder (PTSD) is a common outcome associated with IPT. Substance misuse (SUB) is a frequent concomitant of PTSD. NET is a promising intervention to reduce PTSD symptoms and associated psychological distress, via the supported reconstruction (narrative telling) of the traumas. NET has a critical advantage over existing PTSD treatments in that it can be delivered in a brief format, in community settings where at-risk adolescents are likely to be found. Despite its promise in treating adolescent distress, NET has yet to be tested as an intervention for those who have interpersonal trauma-related PTSD. Further NET's influence on SUB has not been examined.

Accordingly, the objective of this project is to conduct a pilot study (N=30) to estimate NET treatment effects on PTSD symptoms and SUB in IPT-exposed urban adolescents (ages 16-21). Both feasibility and preliminary efficacy data will be collected to serve as pilot work for a larger-scale NIH proposal. Recruitment and intervention will be set within community partners where the adolescents already are connected and are receiving social or psychological services. Outcome data will be collected at: (T0) Baseline, and at 1(T1), and 3 months (T2) follow-up assessments. Participant responses to the intervention will be assessed post-intervention. Change in PTSD, SUB will be estimated with effect sizes and inferential tests. Preliminary evidence of efficacy and feasibility will pave the way for further NET development to offer a patient-oriented, community-based, intervention that will promote adolescent mental health for those at greatest risk for health access and outcomes disparities.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents (ages 16-25),
* Positive PTSD diagnosis (CAPS diagnosis)
* Positive lifetime incidence of interpersonal violence-related trauma.

Exclusion Criteria:

* Actively suicidal with an immediate referral to the community agency crisis staff
* Severe cognitive delay
* Active psychosis
Genetic Basis for Variation in the Renal Elimination of Metformin

The current study is part of a large multi-investigator grant to look at the pharmacogenetics of a number of membrane transporters. We will study individuals with particular genotypes of the human organic cation transporter, (hOCT2), to test the hypothesis that genetic variation in hOCT2 is associated with variation in the renal clearance of the antidiabetic agent, metformin.

The drug, which is used in the treatment of Type II diabetes, has a narrow therapeutic range. Its net renal clearance by secretion (i.e., renal clearance minus filtration clearance) ranges from approximately 100 ml/min to 800ml/min in normal, healthy subjects. Although many factors may contribute to inter-individual variation in renal secretory clearance, initial estimates of heritability (greater than 0.6) suggest that genetic factors play an important role in the renal secretion of metformin. Available evidence supports the idea that hOCT2 is the primary transporter involved in the first-step of renal secretion of metformin, i.e., uptake from the blood to the tubule cell across the basolateral membrane. In particular, (a) hOCT2 is the primary organic cation transporter on the basolateral membrane of the human kidney; and (b) metformin interacts with and is translocated by hOCT2 in heterologous expression systems.

In recent studies, we identified four variants (M165I, A270S, R400C, and K432Q) with ethnic-specific allele frequencies ≥1% \[6\] that have altered function in studies in heterologous expression systems. In addition, we identified a common haplotype of hOCT2 and one haplotype that contain the non-synonymous cSNP, A270S. We will determine whether variability in the renal secretory clearance of the model organic cation, metformin, in healthy individuals is associated with genetic variation in hOCT2. In particular, we will determine whether the renal clearance of metformin differs in individuals who are homozygous for the common haplotype of OCT2 (OCT2\*1) and those who are heterozygous for the less common haplotype OCT2\*3D, which we have identified in a comprehensive screen of ethnically identified DNA samples. We will also determine whether individuals who are heterozygous for the less common OCT2 variants, M165I, R400C and K432Q, have reduced renal clearances of metformin.

Eligibility Criteria:
Inclusion Criteria:

* Subjects have previously participated in the Study Of Pharmacogenetics In Ethnically Diverse Populations (SOPHIE) study.
* 18-40 years old
* Possess a pre-specified genotype for OCT2

Exclusion Criteria:

* Taking any regular medications other than vitamins.
* Individuals with anemia (hemoglobin \< 12 g/dL), an elevation in liver enzymes to higher than double the respective normal value, or elevated creatinine concentrations (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL)
* Pregnant or breastfeeding