cyrilzakka/clinical-trials huggingface dataset:
Integrative Analysis of Tumor Microenvironment and Optimization of Immunotherapy Duration in NSCL Cancer Patients

Non-comparative multicentric randomized study to assess long-term benefit of PD-1 inhibition in NSCLC patients who experienced a response between 6 and 12 months after initiation of ICI (immune checkpoint inhibitor PD1/PDL-1 blockade therapy)

Two-arm, non-comparative, prospective, multicentric, randomized study for early discontinuation of immune checkpoint inhibitor PD1/PDL-1 blockade therapy in non-small cell lung cancer patients who achieved objective response between 6 and 12 months after treatment onset.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed non-small cell lung carcinoma (squamous or non squamous).
2. Locally advanced/unresectable or metastatic disease.
3. For non-squamous histology, tumor with no oncogenic addiction: no activating EGFR mutation, no ALK or ROS1 rearrangement,
4. Treatment with ICI (immune checkpoint inhibitor PD1/PDL-1 blockade therapy):

   1. in first or second-line treatment as per market authorization. For patients in first line, ICI alone or ICI + chemotherapy,
   2. start of ICI treatment 6 to 12 months (+/- 2 weeks) before registration.
5. At least one measurable lesion according to the RECIST v1.1 criteria before ICI treatment onset and confirmed by centralized review (lesion in previously irradiated filed can be considered as measurable if progressive at inclusion according to RECIST v1.1). At least one site of disease must be uni-dimensionally ≥ 10 mm.
6. Patient with objective response according to RECIST v1.1 criteria at 6 months or more and less than 12 months after ICI treatment onset. Response must be confirmed by centralized review
7. At least one lesion that can be biopsied for research purpose.
8. Age ≥ 18.
9. Performance status \< 2.
10. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration.
11. Patient with a social security in compliance with the French law (Loi Jardé).
12. Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
13. Voluntarily signed and dated written informed consent prior to any study specific procedure.

Exclusion Criteria:

1. Female who is pregnant or breast-feeding.
2. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
3. Hypersensitivity to one of the active substances or to one of the excipients
4. Any contraindication to pursue ICI treatment as per investigator judgement.
5. Previous enrolment in the present study.
6. Individual deprived of liberty or placed under legal guardianship.
Computed Tomography Angiography Prediction Score for Side Branch Occlusion

Lesions involving coronary bifurcations account for approximately 20% of all percutaneous coronary interventions (PCI). Revascularization within bifurcation sites remains technically challenging. While the most optimal interventional treatment strategy for bifurcation lesions is still debatable, side branch (SB) occlusion is one of the most serious procedural complications with prevalence rates over 7%.

Numerous mechanisms of the SB occlusion (e.g. plaque or carina shift, coronary artery dissection, thromboembolism, coronary artery spasm, etc) have been postulated. Regardless of the cause, loss of the SB is associated with increased risk of periprocedural mortality and myocardial infarction. Therefore, PCI involving coronary bifurcation mandates consideration of the risk of SB compromise. The CT-PRECISION (Computed Tomography angiography PREdiCtIon score for SIde branch Occlusion in coronary bifurcation interventioN) registry was designed to evaluate the application of coronary computed tomography angiography (coronary CTA) for the prediction of SB occlusion during percutaneous revascularization of bifurcation lesions. The main purpose of this single-center study is to develop a noninvasive CTA-based prediction tool to determine the procedural outcome of PCI in bifurcation lesions.

Coronary CTA allows for precise and noninvasive evaluation of coronary bifurcation lesions. Pre-procedural planning for coronary revascularization using CTA provides detailed characterization of bifurcation anatomy and morphology including the spatial distribution of coronary plaque. To date there has been no compiled CTA-based prediction model for SB occlusion in coronary bifurcation intervention.

The CT-PRECISION registry is a retrospective observational cohort study of patients undergoing preprocedural coronary CTA before PCI involving coronary bifurcation lesions between January 2010 and July 2018. The study is designed to enroll 400 consecutive patients undergoing elective main vessel stenting with a provisional approach to the SB at a single high-volume PCI center.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for attempted PCI of a bifurcation lesion with a significant SB as part of their standard of care
* Initial stenting of the main branch with a provisional approach to the SB
* Performance of dual-source coronary CTA within 30 days before attempted PCI

Exclusion Criteria:

* Age \<18 years
Illness Perception and Coping in Kidney Transplant Recipients: a Mixed Research Based on Common Sense Model

The goal of this observational study is to learn about the current status of illness perception and the distribution of coping styles in kidney transplant recipients. The main question clarifies the current status and experience of illness perception in post-transplant patients with different coping styles, and aims to provide a reference basis for intervention of illness perception in kidney transplant patients, with the aim of improving their current status of illness perception, optimizing their awareness of treatment management and self-care behaviors, and perfecting the modern medical service system. Participants will describe the main tasks participants will be asked to do.

Aims:This study explores the current status of illness perception and the distribution of coping styles in kidney transplant recipients, clarifies the current status and experience of illness perception in post-transplant patients with different coping styles, and aims to provide a reference basis for intervention of illness perception in kidney transplant patients, with the aim of improving their current status of illness perception, optimizing their awareness of treatment management and self-care behaviors, and perfecting the modern medical service system.Methods:This study is based on the Common Sense Model (CSM), which is the most widely used theory for explaining and predicting disease adaptation and patient self-management behaviors.This study utilizes a mixed-methods research design, specifically the interpretive sequence design, consisting of two phases. The first phase is a quantitative study that employs a questionnaire to investigate the current state of illness perception and the distribution of coping styles in kidney transplant recipients, and to explore the differences in illness perception between positive coping and negative coping patients after kidney transplantation; The second phase involves a descriptive qualitative study that utilizes face-to-face, semi-structured, in-depth interviews to investigate the causes of differences in illness perceptions of different coping styles in kidney transplant recipients who experience idiosyncrasies.

Eligibility Criteria:
Inclusion Criteria:

Patients between the ages of 18 and 55 who have received a kidney transplant and have been discharged from the hospital for at least 3 months. Patients must have basic communication skills and be willing to participate in the survey voluntarily by signing the informed consent form.

Exclusion Criteria:

(i) Patients with a history of other malignant tumors; (ii) patients who are participating in other clinical trials or related treatments; (iii) patients with other serious physical diseases; and (iv) kidney transplant patients with psychiatric disorders, serious cognitive impairment, or speech defects that prevent them from cooperating.
Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase I/II trial to study the effectiveness of topotecan plus sargramostim in treating patients who have advanced cancer.

OBJECTIVES: I. Identify a priming schedule of sargramostim (GM-CSF) that reduces the percentage of progenitor cells in cycle at the time of chemotherapy administration in patients with advanced malignancies. II. Determine the maximum tolerated dose and toxic effects of topotecan when administered with sargramostim in these patients. III. Conduct a preliminary assessment of the activity of this topotecan regimen in these patients.

OUTLINE: This is a dose escalation study of topotecan. Patients receive priming with sargramostim (GM-CSF) on days -4 through -2. On day 0, topotecan IV is administered over 30 minutes. Cohorts of 6 patients receive escalating doses of topotecan. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity (DLT). Sargramostim resumes on day 1 following topotecan, and continues for 5 days or until sufficient hematologic recovery. The next course of topotecan is given 48 hours later. Treatment repeats every 6 weeks for 4 courses. Patients are followed every 3 months for the first year, then every 6 months thereafter.

PROJECTED ACCRUAL: 15-25 patients will be accrued for the duration of 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven malignancy for which no alternative treatment exists

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1500/mm3 Hepatic: Total bilirubin no greater than 2.0 mg/dL Renal: Creatinine clearance at least 50 mL/min Other: No active infections HIV negative No other concurrent medical condition

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: No prior wide field radiotherapy No prior radiotherapy to greater than 20% of bone marrow Surgery: Recovered from prior surgery
Intermittent Preventive Treatment of Malaria in Schoolchildren

This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary objective of the study is to compare the efficacy of different combination antimalarial regimens, including amodiaquine + sulfadoxine-pyrimethamine (AQ+SP), dihydroartemisinin-piperaquine (DP), and placebo, to SP for intermittent preventive treatment (IPT) in schoolchildren, as measured by risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up. This will assess both the efficacy for treatment of asymptomatic infections and the efficacy for prevention of new infections.

The study will be carried out among children aged ≥ 8 to \< 14 years (boys) and ≥ 8 to \< 12 years (girls) attending primary schools in Tororo district. Schools will be selected using convenience sampling with the assistance of the district and the education sector. The target population includes children attending primary schools in Uganda. The accessible population includes the children attending the participating primary schools in classes 3-7 in Tororo district. Children who meet the selection criteria for participation in the study will be randomized to treatment with one of the four study regimens and will be followed for 42 days. Repeat evaluations will be performed on days 1, 2, 3, 7, 14, 28, and 42 (and any unscheduled day that a student is ill) and will include assessment for the occurrence of adverse events. Treatment efficacy outcomes will be assessed using revised WHO outcome classification criteria. Acceptability of treatment regimens will be assessed using a questionnaire administered to participating students on day 7. The primary outcome measure is risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 8 to \< 14 years (boys), ≥ 8 to \< 12 years (girls)
* Student enrolled at participating school in classes 3-7
* Provision of informed consent from parent or guardian
* Provision of assent by student

Exclusion Criteria:

* Known allergy or history of adverse reaction to study medications
* Onset of menstruation (girls)
* Fever (≥ 37.5°C axillary) or history of fever in the previous 24 hours
* Evidence of severe malaria or danger signs
* Haemoglobin \< 7.0 gm/dL
* Parasite density \> 10,000/ul
Sleep Therapy for Insomnia and Depression

In this study we are testing 2 different forms of sleep therapy to help people with insomnia and depression. As part of the study, you receive 1 of these 2 sleep therapies. We want to see how these sleep therapies help insomnia in people with depression.

The first group is the sleep hygiene group. If you are assigned to the sleep hygiene group you have 1 session with a clinician to learn about different things you can do to improve your sleep.

The second group is the intensive sleep retraining group. If you are in this group you will spend about 1 day at our sleep lab, starting around your usual bedtime and ending the following day. Over a 20 hour period you will complete a sleep retraining session, which involves an opportunity to fall asleep every 30 minutes; we will wake you after a few minutes if you fall asleep.

For both groups, after the treatment session, you will complete questionnaires online and talk with a study clinician who will ask you questions about your mood every two weeks for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Experiencing depression
* Experiencing chronic insomnia
* Have been taking an antidepressant medication at a stable dose for at least 8 weeks, and willing to stay on a stable dose for the duration of the study. This medication must be prescribed by a doctor at the University of Michigan. OR not taking any antidepressants and you do not plan to start taking any antidepressants over the next 9 weeks.

Exclusion Criteria:

* Have psychiatric conditions or sleep disorders other than depression or insomnia
* Have a chronic medical condition that could negatively affect your sleep or mood
* Are currently receiving treatment for insomnia (such as prescription or over-the-counter medications, or other therapies)
Expression of PARP-1 in Multiple Sclerosis Patients

This study will explore the expression of PARP-1 in optic neuritis of multiple sclerosis patients.

The data will be collected from Sohag University hospital in the period from the start of August 2021 to the end of December 2021.

The study protocol will be approved by the Scientific Research Ethical Committee, Faculty of Medicine, Sohag University.


Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple sclerosis with or without optic neuritis Multiple sclerosis will be diagnosed according to the McDonald criteria

Exclusion Criteria:

* • Isolated optic neuritis.
To Compare "Balloon Occluded Thrombolysis" With "Conventional Catheter Directed Thrombolysis" in Thrombotically Occluded DIPSS Stent in Patients of Budd- Chiari Syndrome.

DIPSS has become a widely accepted treatment for complications of portal hypertension. Shunt or hepatic vein stenosis are common short and mid term complications of the procedure. When identified early, shunt stenosis or occlusion may be treated before recurrence of the symptoms for which DIPSS was done at the first place. Present day endovascular DIPSS revision techniques have significantly improved the primary assisted patency rates.

The purpose of this study is to understand the newer technique of Combined balloon occlusion thrombolysis and intra stent balloon sweeping being practiced at our institute and compare it with the widely used conventional thrombolytic methods.

Primary objective:

1. To study the outcome of combined technique of Balloon occluded thrombolysis, Balloon sweeping and maceration of thrombus in Blocked DIPSS stent and compare it with Conventional catheter directed thrombolysis and angioplasty.

   Secondary objective:
2. Study DIPSS stent patency and re-occlusion rates at 1 month followup

Methodology:

Study population: Patients with Budd -Chiari syndrome who underwent DIPSS revision till February 2021

Study design: Single center retrospective cohort study

Study period: 1year

Sample size: All eligible patients according to inclusion and exclusion criteria who underwent TIPS/DIPS revision will be included in thestudy.

Intervention: DIPSS Revision

Monitoring andassessment:

The following parameters to be evaluated over a period at least 1 month after DIPSS revision and compare with pre revisionvalues

Clinical parameters:

Status of ascites Urine output Recurrence of UGI/LGI bleed

Laboratory parameters:

ALBI Score,LFT, KFT

DOPPLER PARAMETERS:

Mid stent velocity, velocity at hepatic venous end Main portal vein velocity Direction of flow in intrahepatic portal vein branches

Stopping rule: Not applicable.

Expected outcome of the project: Balloon Occluded thrombolytic infusion alongwith intratsent balloon sweeping gives faster and better patency as compared to conventional pharmaco-mechanicalthrombolytic methods

Eligibility Criteria:
Inclusion Criteria:

1. Patients of Budd- Chiari syndrome who underwent DIPSS revision for blocked stent till February 2021

Exclusion Criteria:

1. Patients who underwent DIPSS revision more than one time using both the techniques were excluded.
2. Failure to cannulate existing shunt.
Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Chronic Kidney Disease

Impaired renal function is associated with reduced responsiveness to clopidogrel. There are no studies which have shown a means by which to overcome platelet hyporesponsiveness in patients with chronic kidney disease (CKD). The purpose of this study was to determine the functional impact of cilostazol in patients with CKD undergoing hemodialysis.

The aims of this study is to evaluate the effects of platelet responsiveness to clopidogrel or cilostazol in CKD patients undergoing hemodialysis. The differences in platelet activation markers are also evaluated before and after clopidogrel or cilostazol administration. The investigators will perform a prospective, randomized study to compare the degree of platelet inhibition and platelet activation markers by adjunctive cilostazol (100 mg twice daily) compared to clopidogrel (75 or 150 mg/day) in CKD patients undergoing hemodialysis.

Eligibility Criteria:
Inclusion Criteria:

* CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease

Exclusion Criteria:

* known allergies to aspirin, clopidogrel, or cilostazol thienopyridine use before enrollment
* concomitant use of other anti-thrombotic drugs (oral anticoagulants and dipyridamole)
* platelet count \<100 x 106/μL
* hematocrit \< 25%
* liver disease (bilirubin \> 2 mg/dl)
* active bleeding or bleeding diathesis
* gastrointestinal bleeding within the last 6 months
* hemodynamic instability
* acute coronary or cerebrovascular event within 3 months
* malignancy
* concomitant use of a cytochrome P450 inhibitor or a non-steroidal anti-inflammatory drug
* recent treatment (\<30 days) with a glycoprotein IIb/IIIa antagonist.
A Single-Group Study to Examine the Efficacy of a Melatonin Lotion With Magnesium to Improve Sleep Quality and Quantity

This study will evaluate the efficacy of Asutra's 'Dream the night away' nighttime lotion with melatonin and magnesium on sleep health in terms of quantity, quality, ease of falling asleep or falling back asleep after waking in the night, and grogginess upon waking. The study will be conducted as a virtual single-group trial in which all 35 participants will use the test product. This study will last 3 weeks, and participants will use the product daily (each night 30 minutes before bedtime for 20 nights). Participants will use a sleep tracker to monitor their sleep for a week at Baseline (before commencing the trial) and nightly throughout the trial. Participants will complete study-specific questionnaires at Baseline, and after first use, 3 days, 1 week, 2 weeks, and 3 weeks, in which they will also record the results from their sleep tracker.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-59.
* Must agree to not use any other sleep aids including prescriptions, supplements, or melatonin products during the study or 28 days prior to Baseline.
* Has favorable sleep conditions (a dark, quiet room to sleep in and is not woken up regularly throughout the night due to personal circumstances e.g. by a baby).
* Willing to maintain their standard sleep pattern and activity level for the duration of the study.
* Be generally healthy and not living with any uncontrolled chronic disease. Willing and able to supply and use their own sleep tracking device.

Exclusion Criteria:

* Diagnosed with any chronic sleep condition including insomnia, narcolepsy, or sleep apnea.
* Has extremely sensitive/irritable skin or diagnosed skin conditions.
* Has poor sleep hygiene as a result of specific personal circumstances e.g. new mothers.
* Women who are pregnant, breastfeeding, or attempting to become pregnant.
* Anyone unwilling or unable to follow the study protocol.
* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Is currently undergoing, or planning to to undergo any sleep-related procedures in the next three weeks.
* A history of severe allergic reactions including but not limited to any of the product's ingredients.
* Heavy drinkers or drug users. A heavy drinker is considered to be a woman who drinks 8 or more alcoholic drinks per week or a man who drinks 15 or more alcoholic drinks per week.