cyrilzakka/clinical-trials huggingface dataset:
ELobectomy for NSCLC by VATS Versus Thoracotomy (ECTOP-1007)

This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1007). The goal of this study is to determine video-assisted thoracoscopic surgery is non-inferior to thoracotomy in terms of disease-free survival for solid clinical stage T1N0M0 NSCLC.

It is a randomized clinical trial comparing video-assisted thoracoscopic surgery (VATS) with thoracotomy for solid clinical stage T1N0M0 NSCLC. The primary objective of the study is to determine that VATS is non-inferior to thoracotomy in terms of disease-free survival (DFS). Secondary objectives are to compare VATS and thoracotomy for overall survival (OS), perioperative complications, pain levels and quality of life.

Although there are numerous retrospective studies have indicated feasibility and effectiveness of VATS, no data has been reported from those prospective and randomized clinical trials with prognostic indicators as the primary objective. Whether VATS is non-inferior to thoracotomy in terms of survival is still unclear. Therefore, we design this trial by recruiting patients in clinical stage T1N0M0 with solid mass on computed tomography (CT). To determine the clinical stage, CT scans will be performed routinely and PET-CT/EBUS-TBNA/mediastinoscopy will be conducted in patients with suspected positive mediastinum lymph node or distant metastases. Detailed inclusion criteria include clinical stage T1N0M0 and surgical resectable, solid appearance on CT, age 18 to 75 year and signed informed consent. Exclusion criteria includes not NSCLC in pathologic analysis, no lobectomy or sublobar resection, history of other malignant tumors within 5 years, history of thoracic surgery or unsuitable for VATS and previous radiation or chemotherapy.

In our previous data, the 3-year DFS for cT1N0M0 patients with solid mass who were subjected to thoracotomy (lobectomy or sublobar resection) was 77.9%. If the 3-year DFS of VATS arm is not less than 70.9%, the VATS arm will be regarded to be non-inferior to thoracotomy. A sample size of at least 1086 participants is required for performance equal to 80%, α-level equal to 0.025, 1:1 recruitment and considering a dropout rate of 10%. Participants will be randomly assigned to either group using a random table.

Lobectomy or sublobar resection will be conducted by standard procedures at the discretion of the surgeon. Each participating surgeon will be evaluated by the trial committee to ensure proper surgical technique. If the VATS is diverted to thoracotomy intraoperartively, the reason will be recorded, and the cause will still be analyzed in an intention-to-treat analysis. Patients will be follow-up every 6 months to 3 years after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Clinical stage T1N0M0 and surgical resectable.
* Solid appearance on computed tomography scan.
* Age 18 to 75 year.
* Signed the informed consent form.

Exclusion Criteria:

* Not NSCLC in pathological analysis.
* Not lobectomy or sublobar resection.
* History of other malignant tumors within 5 years.
* History of thoracic surgery or unsuitable for VATS.
* Previous radiation or chemotherapy.
Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol (THC) and the Ability to Drive in Chronic or Occasional Cannabis Users

Study of the effects of smoked cannabis consumption on performance on a driving simulator and reaction time. The study aims to explore the relationship between concentrations of cannabis in the blood, driving performance and reaction time.

This study will examine:

* The relationship between THC blood levels and driving performance measured on a York Driving simulator
* The relationship between THC blood levels and reaction times as measured on the psychomotor vigilance test (PVT)
* the pharmacokinetics of THC in occasional and chronic cannabis consumers
* Determine the minimum blood concentration level of THC and 11-OH-THC, below which no effect of cannabis is observed
* Determine whether the polymorphism of CYP2C9 (\* 3) is associated with the AUC, Cmax, and higher THC T1/2
* Determine if the polymorphism of CYP2C9 (\* 3) is associated with different pharmacodynamic effects at a given THC level on performance measured by driving simulation

Eligibility Criteria:
Inclusion criteria:

* Healthy volunteer of male gender from 18 to 25 years
* Normal medical examination
* Driving license owner
* BMI between 18.5 and 25
* moderate tobacco consumption
* moderate consumption of coffee, tea, cola (≤ 225mg caffeine per day)
* Cannabis user for at least 1 year
* Occasional (1-2 joints per week) or chronic (1-2 joints per day) cannabis consumers
* Availability during the study
* Signed consent

Exclusion criteria:

* Participation in another clinical study
* Having taken any psychotropic medication in the past one month
* Having taken any narcotic (alcohol, psychotropic drugs, other narcotics) other than THC in the past 3 days (negative urinary test at inclusion)
* Alcohol blood level positive at inclusion
* Excessive alcohol consumption (AUDIT score \> 7)
* Dependence, present or past, to any psychotropic product (alcohol, psychoactive drugs, other narcotic)
* Depression
* Sleep disorders
* Any psychiatric history, including psychosis
* Deprived of their liberty by judicial or administrative decision
* Lack of medical insurance
* Professional use of motorized vehicles
mHealth Mood Management Tool (Actify) to Improve Population-Level Smoking Cessation

This phase I trial investigates a new smartphone application (called Actify) for improving population-level smoking cessation and mood management. Actify delivers behavioral activation therapy for depression as part of a smoking cessation intervention and will be compared to another smoking cessation smartphone application that is based on current clinical practice guidelines. Participants will be randomly assigned to receive one of two smartphone applications and accompanying text notifications to help with quitting smoking and improved mood.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.

ARM II: Participants use United States (US) Clinical Practice Guidelines (USCPG) app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.

After completion of study, participants are followed up at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Current smoker, averaging at least 5 cigarettes/day for the last 30 days
* Interested in quitting smoking in the next 30 days
* Experience downloading and using one or more apps on their smartphone
* Either screens negative (Patient Health Questionnaire - 9 Item \[PHQ-9\] score 0-4) for depression or screens positive for mild to moderate current depressive symptoms (PHQ-9 score 5-19)
* Willing and able to complete all study activities
* Comfortable reading and writing in English
* Have a mobile data plan and/or access to WiFi to support the use of the Actify app
* Reside in the US
* Have a smartphone either an iPhone (running iOS version 11 or higher) or an Android phone (running version 5.0 or higher)

Exclusion Criteria:

* Currently receiving behavioral treatment for depression (e.g., psychotherapy)
* Current use of a depression app
* Severe depression (PHQ-9 \>= 20)
* Receiving other treatment for smoking cessation
* Previous use of the QuitGuide app
* Current or recent (within the past year) enrollment in a Fred Hutch smoking cessation study
* Employees/family of investigator or study center
* Member of the same household as another participant
* Woman who is pregnant or breastfeeding, or planning to become pregnant
* Currently incarcerated
* Is ineligible per fraud prevention protocol
Misoprostol Prior to Intrauterine Device Insertion

The intrauterine device (IUD) is a reliable, safe, long acting, and effective contraceptive method . In spite of that, the pain associated with IUD insertion can be a cause against its insertion. Many researches have been conducted aiming to decrease the degree of pain during IUD insertion; these studies included medical and also technical methods.

The physicians usually prefer to insert the IUD during women's menses because the women are very unlikely to be pregnant and the insertion is easier and the pain is lower The easiness of IUD insertion is a very important issue that can increase women's satisfaction and decrease insertion pain.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-45 years
* Non-pregnant women
* Women who will come when there are non-menstruating.

Exclusion Criteria:

* Women received any analgesics or misoprostol in the 24 hours prior to insertion
* Women with any contraindications for IUD insertion
* Nulliparous women
* Women refuse to participate.
* Women have any contraindication of misoprostol.
Neurodevelopmental Therapy-Bobath Approach in The Early Term of Stroke; Safe and Effective

Early term rehabilitation initiated after stroke should be based on motor learning principles and neural plasticity. To achieve motor learning and neural plasticity, exercises consisting of intense and repetitive training should be given according to the patients' functional level. The neurodevelopmental treatment-Bobath (NDT_B) approach is based on motor learning principles. In literature, studies that show the early term effects of NDT-B on functional recovery are inadequate. The aim of this study was to investigate the effects NDT-B applied in the early term of stroke, on postural control, functional movement, balance and activities of daily living.

When literature is examined, it can be seen that evidence is limited. Studies investigating the effects of the Bobath Approach in the early term in stroke, state that NDT-B is reliable and feasible. However none of these studies have examined the effects of NDT-B in acute term stroke on functionality and daily living. Additionally, in all of these studies it was also stated that further studies should be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age
* Systolic blood pressure between 120 and 220 mmHg
* Oxygen saturation \>92% (with or without O2 support)
* A heart rate of 40 to 100 beats/min
* A body temperature of \<38.5°C
* A disability level of ≤4 according to the Modified Rankin Scale
* Those who could respond to verbal commands

Exclusion Criteria:

* A history of previous stroke
* Concomitant progressive neurological disturbances
* Acute coronary disease
* Severe heart failure
* Concomitant rheumatologic diseases
* A fracture or an acute orthopedic disorder that would prevent mobilization
Phase II Study of Bevacizumab, Pemetrexed and Carboplatin as First-Line Therapy in Malignant Pleural Mesothelioma

The primary objective is to assess antitumor activity of the combination of bevacizumab, pemetrexed and carboplatin, in terms of time to progression.

Secondary endpoints are to evaluate:

* the objective response rate (RR) of the combination;
* the toxicity and the safety profile of the combination;
* the duration of response (RD) and time to treatment failure (TTF);
* the overall survival (OS)
* RR, TTP and OS according to baseline plasma VEGF levels (introduced with Amendment 1 dated 8/11/2007)

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven malignant pleural mesothelioma, inoperable, non previously treated with chemotherapy including intracavitary administration
* PS 0-1
* Measurable and/or evaluable lesions according to RECIST criteria
* Adequate organ function

Exclusion Criteria:

* Uncontrolled hypertension
* Evidence of bleeding diathesis or coagulopathy
* Pregnancy or breast-feeding
TRanslesIonal Assessment of Gradients During Endovascular Therapy

Primary objective: To document change in translesional pressure gradients (TLPGs) and ratios (fractional flow reserve) using the NAVVUS RXi catheter following endovascular treatment for symptomatic lower extremity peripheral arterial disease.

Secondary objectives:

* Evaluation of correlation of the ABI and TBI and TLPGs at baseline and following endovascular therapy
* Evaluation of the correlation between the change in WIQ, TCOMs, wound size and change in TLPGS
* Evaluation of correlation between lesion severity by QVA (MLD, % diameter stenosis) and TLPGs
* Evaluation of baseline MLA, MLD, plaque burden by intravascular ultrasound (optional) and TLPGs

There are a lack of tools available for the intraprocedural assessment of endovascular procedures for lower extremity peripheral arterial disease. The present study will use the NAVVUS RXi catheter to document changes in translesional hemodynamics obtained with and without hyperemia in patients undergoing directional atherectomy, angioplasty, and/or stenting of femoropopliteal and infrapoplieal lesions.

Eligibility Criteria:
Inclusions:

* Age \>18 y/o, undergoing clinically indicated endovascular therapy (balloon angioplasty, stenting, atherectomy or combination) for lower extremity peripheral artery disease (PAD) and claudication or critical limb ischemia (CLI). Rutherford Category 2-6.
* Includes iliac lesions, common femoral, superficial femoral artery, popliteal artery and tibial vessels
* A subject can be enrolled more than once (up to a maximum of two total times) for treatment of a staged lesion but must wait at least 6 weeks from the completion of the last study enrollment.

Exclusions:

* No pregnant females
* No vulnerable populations (dementia, prisoners, children)
* Baseline bradycardia (heart rate \<50 beats/min) or hypotension (systolic blood pressure \<90 mm Hg) will be excluded from receiving adenosine
Feasibility Study of a Modified Yoga Program for Elders

The purpose of this study is to determine whether a modified yoga program helps improve pain and function in elders age 65 years or older living in an assisted living community. Participation in regular physical activity, such as yoga, may improve strength and mobility and decrease pain. This study was developed to ascertain whether a modified yoga program improves pain and function in assisted-living elders, age 65 years and older.

Chronic pain is costly and debilitating, affecting an estimated 100 million Americans and costing about $600 billion a year in indirect and direct medical costs. Managing chronic pain is difficult, requiring an array of pharmacologic and non-pharmacologic approaches to address not only pain, but relevant and intertwined domains of life such as sleep, energy, and mood. One such non-pharmacologic therapy is yoga. Systematic reviews of yoga clinical trials have shown that yoga is effective in managing low back and neck pain. However, these studies utilized younger populations, and no studies have characterized the effects of yoga for pain in the elderly. Given the rapidly growing aged population, the growing popularity of yoga, and the high prevalence of pain conditions among elderly individuals, studies that examine the effect of yoga on acute and chronic pain in the elderly are warranted. Thus the purpose of this proposal is to perform a pilot study to assess the feasibility and efficacy of yoga for managing chronic pain in elderly adults. This study will characterize whether such an intervention is feasible, assess whether a gentle yoga intervention improves subjective symptoms of pain, and investigate whether this yoga interventions decreases use of as needed pain relievers among elderly adults. This pilot study will characterize these effects in a sample of 60 elderly adults in at the United Methodist Retirement community in Chelsea, Michigan. The results of this study will be immediately translatable to members of this community in the short term, and nationwide in the long term.

Eligibility Criteria:
Inclusion Criteria:

* Report chronic (\>3months) clinically relevant pain, defined as a score of ≥3 on a 0-10 numeric pain scale, at least 3 of 7 days per week
* Must be current resident of the United Methodist Retirement Community or Silver Maples Assisted Living Community with medical record availability regarding medication use over the previous 10 weeks

Exclusion Criteria:

* Persons who have not lived at the facility long enough to analyze their medical records
* Having any medical condition or lack of physical capability that would prohibit safe participation in yoga exercise
* No regular yoga practice (regular yoga practice defined as ≥1 practice session/week)
* Cannot provide informed consent for study
Exploratory Prospective of Experienced by Patients in the Surgery of Skin Cancers of the Face in Interventional Dermatology Department

Surgery is the first-line treatment of localized skin cancers. Knowledge on the patient's psychological experience is limited. Therefore, the psychological impact on patients before, during and after surgery can be underestimated. Moreover, the diagnosis of cancer disturbs the patient's entire life and the onset of anxiety disorders is frequent following this announcement.

The main objective of the study is to explore patients' experience assessing anxiety before, during and away from surgery. The investigators will distinguish the anxiety related to the surgical act itself and the anxiety related to the announcement of the disease.

The secondary objective is to assess the impact of surgery on quality of life, self-image and aesthetic satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 year-old
* Skin cancer on the face ((malignant lentigo, basal cell carcinoma and squamous cell carcinoma) for which a surgical treatment is proposed and will be performed in the Dermatology unit of the University Hospital (CHU) de Bordeaux
* Surgical procedure under local anesthesia
* Patient affiliated to Health Insurance
* Patients will sign consent after reading the information sheet explaining the objectives of the study.

Exclusion Criteria:

* Patients not able to complete the self-assessment questionnaires (difficulties for understanding or reading)
* Patient for whom there was no pre-op consultation in the center
* Patient for whom follow-up will not be possible in the center (because of remoteness for example)
Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus

This is a prospective multicenter randomized controlled trial with a total duration of 36 months aiming to evaluate the effectiveness and the safety of low protein diet on top of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and renin-angiotensin-aldosterone inhibitors (RAASi) in reducing the progression of chronic kidney disease in patients with type 2 Diabetes Mellitus

The KDIGO Diabetes in CKD Guideline (2020) recommends the use of SGLT2i (level 1A) and suggests (level 2C) the prescription of plant protein-based low-protein diet in patients with chronic kidney disease (CKD) and diabetes mellitus (DM). Both interventions have shown synergistic nephroprotective effects, slowing the progression of chronic kidney disease by reducing glomerular hyperfiltration and proteinuria, thus resulting the hypothesis that by combining these two interventions it could be possible to achieve a superior control over the progression of diabetic kidney disease.

The nutritional intervention will consist in a mild protein restriction (0.6 g/kg dry ideal body weight) and a total recommended energy intake of 30-35 kcal/kg of ideal dry body weight per day in all patients. The protein intake will be checked through the food diary and calculated based on urea from 24 hours urine collection.

The efficacy and safety parameters will be evaluated during follow-up visits at month 1,2,3,6,12 and 18.

Eligibility Criteria:
Inclusion Criteria:

* age\>18 years old
* confirmed chronic kidney disease (with eGFR between 60 and 20 ml/min/1.73 m2 and/or proteinuria \>500 mg/g urinary creatinine) and confirmed type 2 Diabetes Mellitus
* stable kidney function for at least 12 weeks before enrollment (defined as decrease in eGFR \< 5 ml/min/1.73 m2/year according to KDIGO 2012 guideline)
* treatment with ACE/ARBs and/or MRAs for at least 3 months
* no previous treatment with SGLT2i
* good nutritional status
* declared and anticipated good compliance with the prescribed diet
* signed informed consent

Exclusion Criteria:

* eGFR \< 25 ml/min/1.73 m2
* poorly controlled arterial blood pressure (mean BP≥145/85 mm Hg)
* class IV NYHA heart failure, recent MACE (less than 6 months)
* relevant comorbid conditions (active infections (HBV, HCV, HIV), active neoplasia, digestive diseases with malabsorption, active autoimmune diseases/ immunosuppressive therapy)
* ADPKD
* kidney transplantation with functional graft
* malnutrition: BMI\<18 kg/me, eight loss \>10% during the last 6 months, serum albumin \<3 g/dL
* feeding inability (anorexia, nausea)
Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C

Pegylation of interferon prolongs the medication half-life which has resulted in Pegylated Interferon (PEG-IFN) as the new modality for treatment of chronic hepatitis C. We current this clinical trial to assess the efficacy and safety of domestic PEG-IFN alpha-2a (Pegaferon®) in the patients with chronic hepatitis C.

We enroll 50 patients in to the study. The patients receive Pegaferon® 180 micgr per week plus ribavirin 10-15mg/kg per day. The patients are visited every 4 weeks with biochemistry lab tests. They are checked with quantitative HCV PCR on the third month after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the six month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.

Eligibility Criteria:
Inclusion Criteria:

* HCV RNA: Positive
* Biopsy approved in genotype 1
* Age older than 18 yrs

Exclusion Criteria:

* ongoing pregnancy or breast feeding
* Hx of hemochromatosis
* Hx of metabolic liver dis.
* Hx of HCC
* Hx of autoimmune hepatitis
* Hx of alcoholic liver dis.
* Hx of bleeding from esophageal varices
* ongoing systemic anti-viral or anti-neoplasmic treatment
* Hx of treatment with an anti-depressant medication at therapeutic doses for at least 3 months at any pervious time
* Hx of treatment with an tranquilizer at therapeutic doses for psychosis for at least 3 months at any pervious time
* Hx of hospitalization for psychiatric dis.
* Hx of suicidal attempt
* Hx of IBD
* Hx of SLE
* Hx of scleroderma
* Hx of rheumatoid arthritis
* Hx of ITP
* Hx of autoimmune hemolytic anemia
* Hx of severe psoriasis
* Hx of chronic pulmonary dis. associated with functional limitation
* Hx of MI or unstable angina
* Hx of arrhythmia requiring ongoing treatment
* Hx of functional class III or IV
* Hx of severe seizure dis. or current anti-convulsant use
* Hx of organ transplantation with existing functional graft
* Hx of severe retinopathy
* Hx of Thalassemia
* Hx of spherocytosis
* Hx of cerebrovascular dis.