cyrilzakka/clinical-trials huggingface dataset:
Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation

The goal of this study is to evaluate the effects of a smoking cessation intervention combining behavioral treatment with low nicotine cigarettes on neuroimaging measures of reward function and smoking cessation outcomes. The results of this study will provide information about mechanisms contributing to smoking and smoking cessation and will help to guide future treatment studies.

Smokers who are interested in quitting will be randomly assigned to one of two treatment conditions. In the BA +VLNC condition (n = 16) smokers will switch to smoking very low nicotine cigarettes (VLNCs) while wearing a 21 mg/d nicotine patch for 5 weeks prior to their quit date. They will also participate in weekly behavioral activation (BA) treatment sessions. Smokers in the VLNC Only group (n = 19) will undergo the same pharmacological pretreatment but will undergo standard counseling and health education instead of BA. Following the quit date, both groups will receive standard nicotine replacement therapy. At baseline and pre-quit, BOLD response to smoking and non-smoking rewards will be measured using fMRI after 24 hr abstinence. Latency to relapse will serve as a continuous clinical outcome measure. Participants will also receive follow-up phone calls at 6 months and 12 months post-quit to assess smoking status.

Eligibility Criteria:
Inclusion Criteria:

* generally healthy
* intact intellectual functioning (K-BIT2 \>79)
* smoking at least 5 cigarettes per day
* expired CO concentration of at least 8 ppm or urinary cotinine \> 100 ng/mL
* interested in quitting smoking

Exclusion Criteria:

* inability to attend all experimental sessions
* report of significant health problems
* use of psychoactive medications or current participation in psychotherapy
* current unstable psychiatric illness as assessed by clinical diagnostic interview
* suicidal ideation with plan or intent
* regular use of smokeless tobacco
* current alcohol or drug abuse
* use of illegal drugs (excluding marijuana) as measured by urine drug screen
* current use of nicotine replacement therapy or other smoking cessation treatment
* presence of contraindications for nicotine replacement therapy
* left-handed
* presence of conditions that would make MRI unsafe
* claustrophobia
* history of fainting
* pregnant, trying to become pregnant, or breastfeeding
A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber

This study will compare the effectiveness of QAV680 against placebo in treating the symptoms of seasonal allergic rhinitis in an Environmental Exposure Chamber.


Eligibility Criteria:
Inclusion Criteria:

* Positive skin prick test to ragweed allergen
* FEV1 must be ≥80% predicted value at screening and prior to entry into EEC on Day -2.
* Patients must weigh at least 50 kg, and must have a body mass index (BMI) within the range of 18 to 35 kg/m2.
* Non-smokers and ex-smokers (≤10 pack years and \>6 months of smoking abstinence).
* Understand and sign the written informed consent

Exclusion Criteria:

* Patients requiring a change in the use of any prescription drugs within four (4) weeks prior to initial dosing.
* Participation in any clinical investigation within four (4) weeks prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.
* Significant illness within two (2) weeks prior to initial dosing.
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

Other protocol-defined inclusion/exclusion criteria may apply
Photodynamic Diagnosis of Upper Tract Urothelial Carcinoma Using Fluorescence Endoscopy and Oral 5-ALA

This study is evaluating whether a medication called 5-aminolevulinic acid (5-ALA), approved by the FDA for use in brain surgery, can help improve the visibility of upper tract urothelial tumors during surgery. Patients undergoing ureteroscopic tumor resection will receive 5-ALA prior to surgery, and surgeons will use special blue light to help identify abnormal tissue that might not be seen under standard white light. The goal is to assess whether this technique can enhance tumor detection and removal.

This is a prospective, single-arm feasibility study investigating the use of 5-aminolevulinic acid (5-ALA, Gleolan) to enhance intraoperative tumor visualization in patients undergoing ureteroscopic resection for suspected upper tract urothelial carcinoma (UTUC). 5-ALA is an FDA-approved oral agent used in glioma surgery to promote fluorescence of malignant tissue under blue light. This study will evaluate whether similar visualization can be achieved in the upper urinary tract to aid in the identification and resection of UTUC. Up to 10 participants will be enrolled. Safety, technical feasibility, and tumor detection outcomes will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or older undergoing diagnostic or therapeutic ureteroscopy for a known or suspected upper tract urothelial tumor
* Able to provide informed consent
* Able to comply with study requirements

Exclusion Criteria:

* Known porphyria or hypersensitivity to porphyrins
* Pregnant or breastfeeding women
* AST or ALT \> 2x upper limit of normal within 30 days prior to surgery
* Participation in another investigational study within 30 days
* Known allergy or contraindication to 5-ALA or its components
Negative Pressure Wound Therapy With Instillation of Saline Solution Versus Collagenase Ointment in Full-thickness Wounds

Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds.

This study evaluates changes in wound bed surface area of clean, healthy viable tissue in subjects with full-thickness wounds using negative pressure wound therapy with instillation of saline solution versus a collagenase ointment.

Eligibility Criteria:
Inclusion Criteria:

The Subject:

1. is anticipated to be hospitalized for the duration of treatment (minimum of 6 days).
2. is ≥ 18 years of age.
3. or their legally authorized representative is able to provide informed consent.
4. has been diagnosed with a wound (eg, chronic, acute, traumatic, or dehisced wounds) and/or ulcer (ie, full- thickness wounds) that meets the following criteria:

   1. total surface area measuring ≥ 16 cm2, including a minimum width of 2 cm (before removal of eschar at the bedside and excluding undermining).
   2. \< 20 cm across (edge-to-edge) at any point perpendicular to the wound edges.
5. has, in the opinion of the investigator, no more than 2/3 of the wound bed surface area considered to be clean, healthy, and viable. If eschar is present at baseline, it must be removed by bedside debridement prior to assessing the percentage of clean, healthy, and viable wound bed.
6. has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) and is willing to take precautionary measures to prevent pregnancy during the duration of the study (up to 9 days).

Exclusion Criteria:

The Subject:

1. has been diagnosed with malignancy in the wound.
2. has untreated osteomyelitis.
3. has an untreated systemic infection.
4. has active cellulitis in the periwound area.
5. has a known allergy or hypersensitivity to study materials: collagenase ointment, dressing(s), and/or dressing components such as acrylic adhesives or polyurethane.
6. has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures.
7. has had radiation directly to the wound area.
8. has been diagnosed with a major vascular deficit limiting arterial inflow to the wound region, as determined by the Investigator's interpretation of the Subject's medical history.
9. has eschar in the wound that cannot be removed by bedside sharp and/or mechanical debridement.
10. is participating in another interventional clinical trial for the duration of the study.
11. has unexplored fistulas in the wound or fistulas in the wound that connect to other body cavities.
12. has a wound with any tunneling present.
13. has inadequate hemostasis at the wound site, as determined by the investigator.
Effects of UE Aerobic Exercise on Exercise Capacity and PA in Patients With Pulmonary Arterial Hypertension.

Group A will be training group and group B will be control group. Deep breathing exercises will be done as baseline treatment in both groups. Both groups will be assessed with Modified Borg scale, 6-PBRT and Fatigue severity scale at the baseline. The control group patients will perform functional active alternating movements for the upper limbs at home involving three sets with 10 repetitions and a rest interval between 1- and 2-minute.

Intervention will be for 3 times a week or 6 weeks. The treatment group patients will perform upper extremity aerobic exercises by using an arm ergometer under the supervision of a physiotherapist. Training intensity will adjust according to 50 80 % of max HR or intensity of dyspnea to 4 points on modified Borg scale (MBS) for at least 15 45 min, 3 times/week over 6 weeks.

Group A will be training group and group B will be control group. Deep breathing exercises will be done as baseline treatment in both groups. Both groups will be assessed with Modified Borg scale, 6-PBRT and Fatigue severity scale at the baseline. The control group patients will perform functional active alternating movements for the upper limbs at home involving three sets with 10 repetitions and a rest interval between 1- and 2-minute.

Intervention will be for 3 times a week or 6 weeks. The treatment group patients will perform upper extremity aerobic exercises by using an arm ergometer under the supervision of a physiotherapist. Training intensity will adjust according to 50 80 % of max HR or intensity of dyspnea to 4 points on modified Borg scale (MBS) for at least 15 45 min, 3 times/week over 6 weeks. This study will measure and record HR by using the heart rate monitor, oxygen saturation (SpO2) by using pulse oximetry and blood pressure, breathing frequency (BF), dyspnea, fatigue, and arm fatigue by using MBS before, during, and after training.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with pulmonary arterial hypertension.
* Both the sex was considered.
* Age range from 35 to 60 years.
* Patients who were stable.
* Patient under optimal medical therapy for at least three months before participating in this study
* Willing to participate in study (13).

Exclusion Criteria:

* Patient with cognitive disorders.
* Patient with orthopedic or neurological diseases. acute infection or pneumonia
* Patient with class IV heart failure.
* Patient with acute infection or pneumonia.
Predictors of Intrauterine Growth Restriction

The main objectives of modern antenatal care programs are to identify high risk pregnancies then to predict any possibility of adverse pregnancy outcome as early as possible.

The earliest attempts to achieve this goal were possible with the introduction of ultrasound in obstetrical practice in the 1950s. A breakthrough that enabled obstetricians to directly visualize the fetus, placenta and amniotic fluid. At first 2-dimensional (2D) imaging was employed whereby fetal biometry and placental location were detected. Later on, Doppler measurements \& 3-dimensional (3D) representation became feasible further revolutionizing this area


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant female.
2. Pregnant ± 22 to 26 weeks gestation
3. Singleton pregnancy.
4. Consenting to participate

Exclusion Criteria:

1. Intrauterine fetal death
2. Diagnosed to have Any congenital anomalies
3. Symmetrical IUGR
4. Established fetal compromise that necessitates delivery
Normal and Abnormal ERP During ToM and Emotional Conflicts in Schizophrenia

Case-control comparison of clinical population, interventional and single-center research.

The main objective of this study is to define and characterize electrophysiological markers of the existing social cognition disorders in schizophrenia. Two groups of subjects are recorded : schizophrenic patients and healthy controls. Visual reinforcement effect during theory of mind judgment is tested.

Eligibility Criteria:
Inclusion Criteria:

Written informed consent French mother tongue Schizophrenia diagnosis according to DSM-IV-R for the patient group

Exclusion Criteria:

Coma history, epilepsy, head trauma with loss knowledge greater 10 min ECT older than 1 month DSM-4 R criteria of toxic addiction in the last 6 months Deafness or blindness Scalp pathology Intracranial implanted device
Exploratory Study of KPI-121 Effect on Intra- or Subretinal Fluid Due to Retinal Vein Occlusion/Diabetic Macular Edema

The primary objectives of the study are to evaluate the safety and effect of KPI-121 0.25% ophthalmic suspension and KPI-121 1.0% ophthalmic suspension on intraretinal or subretinal fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema.

This is a multicenter, randomized, single-masked study evaluating the safety and effect of topical ocular administration of either KPI-121 0.25% ophthalmic suspension or KPI-121 1.0% ophthalmic suspension in subjects with intraretinal or subretinal fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema.

Eligibility Criteria:
Inclusion Criteria:

* Have documented presence of intraretinal or subretinal fluid secondary to Retinal Vein Occlusion or Diabetic Macular Edema at Screening

Exclusion Criteria:

* Treatment with topical, intravitreal injection, posterior sub-Tenon's, or periocular corticosteroids within 120 days prior to Visit 1 and for the duration of the study
* History of uncontrolled glaucoma, IOP over 21 mmHg at Visit 1, or are being treated for glaucoma in the study eye
* Any significant ocular disease that could compromise vision in the study eye (including ongoing ocular infection, wet age-related macular degeneration, myopic degeneration with active subfoveal choroidal neovascularization)
* Known hypersensitivity or contraindication to the investigational product(s) or their components
* Diagnosis of severe/serious ocular condition that in the judgment of the Investigator could confound study assessments or limit compliance; or severe/serious systemic disease or uncontrolled medical condition that in the judgment of the Investigator could confound study assessments or limit compliance
* Exposed to an investigational drug within 30 days prior to Visit 1 and for the duration of the study
* In the opinion of the Investigator or study coordinator, an unwillingness or inability to comply with the study protocol or inability to successfully instill eye drops
The Correlation Between Sevoflurane and qNOX

This study purpose to observation the sevoflurane analgesia effect, and using nociception real-time monitoring NOX to test the correlation between the sevoflurane and NOX index.

This study purpose to observation the sevoflurane analgesia effect, and using nociception real-time monitoring NOX to test the analgesia effect of the sevoflurane.

And test the correlation between the sevoflurane and NOX index.

Eligibility Criteria:
Inclusion Criteria:

1. Elective thoracoscope surgery patients
2. Age ranging from 25 to 85 years
3. American Society of Anesthesiologists (ASA) Physical Status score of 2 to 4
4. a body mass index (BMI) ranging from 18.5 to 40 kg/m2.

Exclusion Criteria:

1. Clinical diagnosis of Alzheimer's Disease
2. implanted pacemaker
3. Clinical diagnosis of psychiatric diseases
4. Clinical diagnosis of epilepsy
5. Clinical diagnosis of autonomic nervous system disorders which might affect the EEG
A Study Comparing Outcomes of Kidney Transplants in Patients on Steroids Versus Those Who Discontinue Steroids

The purpose of this study is to compare the risks and benefits of steroid elimination versus steroid therapy in renal transplant patients particularly looking at the effects on bone mass, lipids, hypertension, and new onset diabetes.

The use of steroids after renal transplantation has been invaluable, resulting in higher rates of long term survival of the transplanted kidney. However, post-operative steroids are also associated with frequent post-operative and long term complications. There have been steroid elimination studies analyzing acute rejection rates, graft and patient survival. These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids.

With this study we will be using a rapid steroid elimination protocol for 40 patients and compare 20 patients who remain on steroids. We hope to show a decreased rate of complications such as osteopenia/osteoporosis, new onset diabetes, and a decrease in cardiovascular risk factors such as hyperlipidemia and hypertension.

Solumedrol will be given to all patients at the time of transplant followed by a prednisone taper. Those remaining on steroids will be discharged on prednisone 5 mg daily. Those in whom steroids are eliminated will be off prednisone by discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a single renal transplant from deceased or living donor
* Adults 18 years and older
* First or second renal transplant
* Capable of understanding the purposes of the study, has given written informed consent, and agrees to comply with the study requirements
* Women of child bearing age should have a negative serum pregnancy test

Exclusion Criteria:

* Greater than 2 renal transplants
* Age \< 18 years
* Patients receiving immunosuppressive therapy within the preceding 28 days for first transplant and 3 months for the second transplant
* Cold ischemia time \> 30 hours
* History of malignancy in the last 5 years except successfully treated localized non-melanoma skin cancer
* HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) positive serology
* Loss of previous transplant in \< 1 year
* History of non-compliance
* Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may impair communication with the investigator or compliance with study procedures
* Multiple organ transplant
* History of chronic steroid use except for inhaled steroids for asthma
* Pregnant or lactating females
* Women of childbearing potential not willing to use a reliable form of contraception.
* Patients with severe medical condition(s) that, in the view of the investigator, prohibits participation in the study
* Known sensitivity to study drugs or class of study drugs
* Use of any investigational agent in the last 30 days
Taiwan Diabesity Study:Comparison With Mild Obese T2DM Patients Who Under Metabolic Surgery

T2DM has become a major health burden for our society. More and more data support the relative effectiveness of gastrointestinal metabolic surgery, known as bariatric surgery, in the remission of T2DM of BMI less35. The metabolic surgery guidelines of IDF recommend BMI over 27.5 in Asia.

The evidence reviewed above strongly points to the need for a large randomized, controlled trial to evaluate the risks and benefits of obesity surgery in the treatment of type 2 diabetes Mellitus. This study is expected to provide very significant findings about the natural course of diabetes in obese diabetic patients.

This study will recruit 200 obese T2DM patients at MSGH, for a total of 1000 in Taiwan. The inclusion criteria are those with T2DM more than 6 months, under medical management in diabetes center, BMI over 25, age between 20 and 67 years. The goals of this study are to evaluate the nature course of the diabetes for 10 years. The primary outcomes for the treatment will be assessed every year after intervention and will be composite of CVD risk factor; specifically, the proportion of patients with HbA1c \< 7%, LDL cholesterol \< 100 mg/dl and systolic blood pressure \< 140 mmHg.

Eligibility Criteria:
Inclusion Criteria:

* Diabetic Mellitus Type 2 medically controlled at Diabetes Center for at least six months
* BMI over 25
* age between 20 and 67

Exclusion Criteria:

* Diagnosed with cancer within past five years
* HIV positive
* Active TB patients
* CV events in past six months
* serum cretinine over 2.0 mg/dl
* C-peptide bellow 1.0 ng/ml in past three months
* Diabetic retinopathy; vision bellow 0.1
* Cushing's syndrome
* History of organ transplant
* History of bariatric surgery
* History of alcohol or drug dependency in past five years
* Psychological problems likely to interfere with adherence to protocol
Pharmaceutical Care in Type 2 Diabetes

The purpose of this study is to examine the effect of a pharmaceutical care program on the level of glycated hemoglobin for hyperglycemic users of brazilian public health care system in drug treatment for type 2 diabetes.

The chronic diseases, including diabetes mellitus (DM) are a major public health problems of today. There is evidence that glycated hemoglobin (A1C) levels above 7% are associated with a progressively greater risk of chronic complications related to DM. However, approximately 60% of diabetics do not achieve glycemic control. In Brazil, pharmacists are not involved in direct care of patients with DM. The investigators conducted a randomized controlled trial, for six months, in Ouro Preto, Minas terais to determine the effect of pharmaceutical intervention on glycemic control in patients with diabetes and hyperglycemic (A1C \> 7%). One hundred and twenty-nine subjects were randomized to receive usual care only or usual care and pharmaceutical intervention. The population of those who had access in the brazilian public health care system, as consultations with doctors, nurses and nutritionists, laboratory tests and access to essential medicines were considered as conventional health care.

Eligibility Criteria:
Inclusion Criteria:

* MINIMAL AGE 18 YEARS OLD
* USE OF DIABETES ORAL MEDICATION
* MINIMAL GLYCOHEMOGLOBIN 7%

Exclusion Criteria:

* PREGNANT AND NURSING WOMEN
* PEOPLE UNABLE TO ATTEND THE STUDY SITE
* PARTICIPANTS OF OTHER PROGRAMS OF PHARMACEUTICAL CARE
Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients

The primary objective is to assess the effect of rimonabant compared to placebo on weight loss over a period of 6 months when prescribed with a mild hypocaloric diet in obese patients with binge eating disorder.

The secondary objectives are:

* to assess the effect of rimonabant on the number of binge episodes per week, to assess the effect of rimonabant on eating behavior using the Binge Eating Scale (BES) and Three Factor Eating Questionnaire (TFEQ),
* to evaluate the safety and tolerability of rimonabant over a period of 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≥30 to ≤45 kg/m²
* Diagnosis of eating disorder using The Questionnaire on Eating and Weight Patterns (QEWP-R) for diagnosing Eating Behaviors

Exclusion Criteria:

* History of surgical procedures for weight loss
* Treatment with anti-obesity drugs within 3 months prior to screening visit
* Presence or history of Diagnostic and Statistical Manual of Mental Disorders (4th edition)(DSM IV) bulimia or anorexia nervosa

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.