cyrilzakka/clinical-trials huggingface dataset:
Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia

Individuals with schizophrenia are three times as likely to smoke cigarettes as individuals without schizophrenia. While a great deal of research has been focused on smoking cessation programs for healthy individuals, little attention has been directed towards developing an effective smoking cessation treatment for schizophrenics. This project will evaluate the effects of 0, 21 and 42 mg transdermal nicotine on smoking, urge to smoke, and nicotine withdrawal symptoms after 5 hrs abstinence in smokers with schizophrenia and heavy-smoking non-psychiatric control smokers.

Nicotine is the most commonly abused drug among individuals with schizophrenia; at least 60 percent of schizophrenics smoke cigarettes. Nicotine withdrawal may cause a temporary worsening of schizophrenia symptoms, making it especially difficult for these individuals to quit smoking. Little research has been done on the most effective way to control nicotine use in schizophrenic individuals. Transdermal nicotine and bupropion reduce smoking in non-psychiatric smokers, but little is known about the effects of these medications in smokers with schizophrenia. This project examines the effects of 0, 21 and 42 mg transdermal nicotine on smoking behavior and related subjective effects (urge to smoke and nicotine withdrawal symptoms) in smokers with schizophrenia and non-psychiatric heavy smoking controls. Participants come to the laboratory at 9 am, at which time placebo or nicotine patches are applied. After 5 hrs of smoking abstinence, participants undergo a smoking cue reactivity assessment in which craving and withdrawal symptoms are measured after viewing and handling neutral cues and smoking cues. This is followed by 90 min period in which participants can smoke freely, and smoking topography variables are measured.

Eligibility Criteria:
Inclusion Criteria:

* Smokes between 20 and 50 cigarettes per day
* Diagnosis of schizophrenia or schizoaffective disorder

Exclusion Criteria:

* If enrolled in the control group, must not be diagnosed with a psychiatric disorder
* Currently dependent on alcohol or any drug (other than nicotine)
* Currently trying to quit smoking
* Currently taking bupropion, desipramine, clonidine, buspirone, or doxepin
* History of liver disease
* History of heart attacks or chest pain
* Allergic to adhesives
* Pregnant or breastfeeding
Effects of Different Physical Therapy Programs on Pulmonary Rehabilitation in Patients With Lung Cancer

This study applies external diaphragm pacemaker and positive expiratory pressure therapy to patients who received thoracic surgeries, in order to explore the effects of different physical therapy programs on pulmonary rehabilitation in patients with lung cancer. As well as we hope that these physical training programs can effectively improve the lung function of patients, reduce postoperative pulmonary complications, hospitalization days, hospitalization expenses, etc.

This study applies external diaphragm pacemaker and positive expiratory pressure therapy to patients who received thoracic surgeries, ninety patients may be enrolled in this study.

Some metrics are used to evaluate the pulmonary rehabilitation status in postoperative patients which include pulmonary function test, 6-Min Walking Test，Borg index, complications incidence, chest tube draining time, and diaphragm muscle mobility.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are diagnosed with non-small cell lung cancer with clear pathological cytology by fiberoptic bronchoscopy and CT, and plan to undergo lobectomy or segmentectomy under general anesthesia for tracheal intubation;
2. Age 18-80 years old;
3. Those who have stable vital signs and can participate in this research;
4. Pulmonary function test FEV1/FVC\>0.8.
5. Volunteer to participate in this research and sign an informed consent form.

Exclusion Criteria:

1. Pneumonectomy patients;
2. Wedge resection patients
3. Patients with distant metastasis of cancer;
4. Patients with other malignant tumors;
5. Severe complications occurred during the operation, and respiratory function training and testing are not allowed before and after Evaluator;
6. Patients with severe physical or mental illness who cannot cooperate with the test;
7. Patients with pacemakers, active tuberculosis, and pneumothorax.
Predictive Factors for Resection and Survival in Type A Borderline Resectable Pancreatic Ductal Adenocarcinoma Patients After Neoadjuvant Therapy

Radical surgical resection is the only curative treatment option for pancreatic cancer, but borderline resectable tumors have a high probability of incomplete exeresis. Although neoadjuvant therapy can improve the chances of complete exeresis, not all patients respond as expected.

Pancreatic cancer is an important cause of cancer-related death worldwide. Radical surgical resection still is the only curative treatment option today, but not all tumors are considered resectable. Among resectable tumors, some are deemed borderline and have a high probability of incomplete exeresis. Neoadjuvant therapy (NAT) can be a game-changer for borderline cases, and there is a lack of evidence on the predictive factors associated with resectability after neoadjuvant treatment.

This study aims to assess the prognostic factors for resectability and survival after NAT in type A borderline resectable pancreatic ductal adenocarcinoma patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old.
* Both sexes.
* Diagnosed with a type A BR-PDAC between January 2010 and December 2019.
* Minimum follow-up period of 12 months.

Exclusion Criteria:

* Patients diagnosed with a type B or type C BR-PDAC.
* Patients diagnosed with a type A BR-PDAC who had disease progression prior to receiving NAT.
ARIXTRA® Adherence in SVT Patients.

Fondaparinux is an anticoagulant used in the prevention and treatment of thromboembolic disease. It has recently been approved in the European Union (EU) for the treatment of patients with isolated superficial vein thrombosis (SVT), i.e. without concomitant deep vein thrombosis (DVT), of the lower limbs. As part of EU approval, GlaxoSmithKline (GSK) committed to evaluate physicians' adherence to fondaparinux prescribing information regarding proper diagnosis and dosing for the treatment of SVT.

The primary objective is to evaluate physicians' adherence to fondaparinux prescribing information for the treatment of patients with SVT without concomitant DVT.

The study is designed as a non-interventional, retrospective chart review of patients prescribed fondaparinux to treat their SVT. The study will be conducted in several EU countries.

ARIXTRA® is a registered trademark of the GlaxoSmithKline group of companies.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SVT
* Prescribed fondaparinux for the treatment of SVT
* Age 18 years or older

Exclusion Criteria:

* Patients should not have been involved in any clinical trial that could influence SVT treatment during the observational period.
Radiation Therapy in Treating Women Who Have Undergone Breast Conservation Surgery and Systemic Therapy for Early Breast Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known which radiation therapy schedule is more effective in treating breast cancer.

PURPOSE: This randomized phase III trial is studying three different radiation therapy schedules to compare how well they work in treating women who have undergone breast conservation surgery and systemic therapy for early breast cancer.

OBJECTIVES:

* To test dose-escalated intensity-modulated radiotherapy after breast conservation surgery in women with early breast cancer who are at higher than average risk for local recurrence.

OUTLINE: This is a multicenter study. Patients are stratified according to center. Patients are randomized to 1 of 3 treatment arms.

* Arm I (control): Patients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy).
* Arm II: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy).
* Arm III: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 53 Gy).

Quality-of-life questionnaires are administered at baseline, 6 months, and at 1, 3, and 5 years. Photograph assessments of the breasts are taken at baseline and at 3 and 5 years. Blood samples are collected at baseline and periodically thereafter. Tissue samples are also collected from primary tumor, including new primary tumor in either breast, and recurrent tumor.

After completion of study treatment, patients are followed annually for 10 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed invasive breast cancer

  * Resectable, unilateral disease
  * T1-3, N0-1, M0 disease
* Has undergone prior breast conservation surgery with complete microscopic resection AND received appropriate systemic therapy for early breast cancer
* Requires a tumor bed boost plus whole breast radiotherapy as indicated by ≥ 1 of the following:

  * Age 18-49 years
  * Tumor size \> 2.0 cm after primary surgery (maximum microscopic diameter of invasive component)
  * Tumor of any size treated by primary medical therapy
  * Grade III disease
  * Minimum microscopic margin of noncancerous tissue \< 5 mm (excluding deep margin if at deep fascia)
  * Lymphovascular invasion
  * Axillary node positive
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* No prior malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior mastectomy
* No concurrent chemotherapy except primary or sequential chemotherapy
IVF in Pediatric Concussion

Children with concussion may improve with intravenous fluids.


Eligibility Criteria:
Inclusion Criteria:

* History of acute concussion

Exclusion Criteria:

* Other significant medical illness
SUPER-DIALYSIS-Study: Supera Stent Interventions in Juxta-anastomotic (re)Stenosis

The purpose of this exploratory study is to evaluate safety and effectiveness of treatment of juxta-anastomotic (re)stenosis with SUPERA stent by improving hemodynamic situation through obtuse shaping of the anastomosis.

Up to 50 patients undergoing percutaneous intervention due to juxta-anastomotic (re-)stenosis of the AV fistulas will be enrolled in this single-arm, prospective, multi-center CE marked study (IIT). Hemodialysis patients with failing radial-cephalic arteriovenous fistula (AVF) will receive treatment with the SUPERA stent and will be followed-up at 1, 3, 6 and 12 months after the procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be ≥ 18 years of age, able to perform follow-up visits, have a life expectancy \> 12 months.
2. Hemodialysis patients undergoing endovascular angioplasty due to a clinically symptomatic stenosis (de novo or restenosis) of the juxta-anastomotic radiocephalic AVF with significant stenosis (lumen diameter \< 2.7mm)
3. Patients with at least one previous endovascular intervention to restore AVF function
4. The target lesion consists of one or more lesions with a target lesion length of less than or equal to 80 mm in the juxta-anastomotic segment of the radiocephalic AVF
5. The target blood vessel diameter of the target lesion is between 4.0 and 7.5 mm (in angiographic or ultrasound evaluation)
6. If there are other non-target lesions, then non-target lesions must be successfully cured with a balloon before treating the target lesion

Exclusion Criteria:

1. Patients with AVF stenosis observed and estimated as nonsignificant (lumen diameter \> 2.7mm) or a vessel \<4.0 and \> 7.5 mm in diameter by visual estimation
2. Patients with a known hypersensitivity or contraindication to anticoagulant/anti-platelet therapies, or sensitivity to contrast media that cannot be adequately pre-medicated.
3. Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the study device.
4. Patients that are currently participating in another clinical trial involving any investigational drug or device that may potentially confound the results of the study, or that would limit the patient's compliance with the follow-up requirements of the study.
5. Prior enrolment in this trial
6. Women who are pregnant or lactating
7. Patients, who underwent a major surgery (such as thoracotomy, craniotomy, etc.) within 30 days prior to the study.
8. Patients, who have scheduled a major surgery (such as thoracotomy, craniotomy, etc.). within 30 days after enrolment -
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 to Slow Progression of Progressive Supranuclear Palsy (PSP)

PROSPER trial is a trial to assess the efficacy of FNP-223 in slowing disease progression in participants with PSP as measured by the PSP Rating Scale (PSPRS) over 52 weeks and to assess the safety and tolerability of FNP-223 for 52 weeks in participants with PSP.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged 50 to 80 years, inclusive, at the time of informed consent.
* Diagnosis of possible or probable PSP of the Richardson's Syndrome (PSP-RS) phenotypes according to the Movement Disorders Society's Progressive Supranuclear Palsy (MDS PSP) clinical features criteria. At least 1 (either 1 or both) of the following 2 items must be met:

  1. Vertical supranuclear gaze palsy.
  2. Slowing of vertical saccades AND postural instability with falls within the first 3 years of PSP symptoms.
* Presence of PSP symptoms within ≤3 years prior to screening.
* MoCA score ≥23
* Full 28-item PSPRS score ≤40.
* Able to ambulate independently or with minimal assistance defined as the ability to take at least 10 steps (stabilization of 1 arm \[ie, use of cane\]).
* Body weight range ≥43 kg/95 lbs to ≤120 kg/265 lbs.
* Reside outside a skilled nursing facility or dementia care facility, except for participants residing in an assisted living facility.
* Has a caregiver or study partner who will accompany them to the study visits. The caregiver or study partner must be a person who has frequent contact (at least 7 hours per week at 1 time or in different days) with the participant and is able to provide information about the participant's medication and overall condition. Prior to the conduct of any study procedures, the caregiver or study partner must be willing to sign the independent ethics committee (IEC)/institutional review board (IRB) approved informed consent.

Exclusion Criteria:

Non-PSP- RS Movement Disorders or other central nervous system (CNS) Diseases

* Score of 3 on any functional domain in the PSP-CDS.
* Participants with known PSP genetic mutation (based on familiar or clinical history).
* Evidence of other neurological disorder that could explain signs of PSP (eg, Parkinson's disease, Alzheimer disease, etc.).
* Brain magnetic resonance imaging (MRI) within 1 year of screening consistent with:
* Primary degenerative diseases other than PSP.

Procedures

* For the optional substudy only: Contraindication or refusal to undergo 2 lumbar punctures for obtaining CSF.
* Contraindication or inability to tolerate MRI for screening MRI and volumetric brain MRI assessments throughout the substudy.
The Effect of Ulnar Nerve Entrapment Localization on Ipsilateral Upper Extremity Functions. The Effect of Ulnar Nerve Entrapment Localization on Ipsilateral Upper Extremity Functions. The Effect of Ulnar Nerve Entrapment Localization on Ipsilateral Upper Extremity Functions.

Regardless of the cause of ulnar nerve entrapment neuropathy, investigators are planning to explore the relationship between the ipsilateral upper extremity dysfunction that may develop due to ulnar neuropathy and the level of entrapment in electromyelography.


Eligibility Criteria:
Inclusion Criteria:

* having ulnar nerve entrapment neuropathy with clinical examination and EMG (electroneuromyography)
* to be between the ages of 18-65
* be give informed consent

Exclusion Criteria:

* inflammatory arthritis
* hemiplegia
* contractures of shoulder-arm-hand joints
68Ga-RM2 Compared to 68Ga-PSMA-617 PET/CT for Intermediate Risk Prostate Cancer Imaging

Patients with primary intermediate risk prostate cancer for whom radical prostatectomy is indicated, will be invited to participate to the present study.

Positron Emission Tomography coupled with scanner (PET-CT) using a radiotracer : 68Ga-RM2 and Positron Emission Tomography coupled with scanner (PET-CT) using another radiotracer : 68Ga-PSMA-617, will be scheduled.

European Association of Urology (EAU) Guidelines for initial staging of intermediate risk prostate cancer (Gleason score 3+4 and 4+3) include tomodensitometry (CT scan), magnetic resonance imaging (MRI) and bone scintigraphy. However, this group of tumor is highly heterogeneous. A distinction exist between tumors with Gleason score 3+4 (lower risk) and 4+3 which may be closer to high risk prostate cancer.

Consequently, management of these two sub-groups of tumors differs. The key point for optimal management of these tumors is to get specific and non-invasive molecular tools for better classification and stratification. This is of critical importance for personalized treatment decision-making.

Novel innovative radiotracers are today available for prostate cancer imaging notably small molecules, radiolabeled with 68Ga, targeting the prostate specific membrane antigen (PSMA) or antagonists, radiolabeled with 68Ga, targeting the Gastrin-Releasing Peptide receptor (GRP-R, a bombesin receptor subtype).

There are on growing evidences that Positron Emission Tomography coupled to Computed Tomography (PET-CT) with radiolabeled prostate specific membrane antigen analogues (PSMA) could be more sensitive and more specific for the detection of lymph node metastasis in high-risk cancers, as shown with PSMA-617 in recent studies.

Eligibility Criteria:
Inclusion criteria:

15 patients divided in :

* 7 patients with favourable intermediate risk prostate cancer (cT2b or Gleason score 7 (3+4) or PSA value 10-20 ng/mL, Briganti 5-20%,)
* 8 patients with unfavourable intermediate risk prostate cancer (cT2b or Gleason score 7 (4+3) or PSA value 10-20 ng/mL, Briganti 5-20%,)
* who are candidate for radical prostatectomy after discussion in multidisciplinary committee
* covered by the national health insurance system
* with freely written informed consent obtained

Exclusion criteria:

* Any kind of previous treatment for prostate cancer (hormonal treatment, EBRT, brachytherapy, cryotherapy, etc...);
* Patient with prostate cancer not candidate for radical prostatectomy and/or unable to benefit from surgery
* Freedom privated patient
* Patient under legal protection or unable to express its own consent
* Known contraindication to radiopharmaceuticals and / or excipients ......
SkinPen Efficacy on Acne Scars on the Face and/or Back

This single-center, clinical trial will take place over a 90 day course followed by 1-month and 6-month post treatment visits to assess the efficacy and tolerability of the SkinPen device when used on both men and women on the face and/or back.

At least 20 subjects of varying Fitzpatrick skin types will be admitted to the trial for treatment on their moderate to severe acne scars on the face and/or back. Implementation of needle depths ranging from 0.25 mm to 2.0 mm will depend on severity of scars and their location. Each subject will undergo 3 treatments in 30 day increments and will take pre-treatment images as well as 1-month and 6-months post treatment images. Assessment will be based on the Goodman and Baron's grading system, the Clinician's Global Aesthetic Improvement Scale, as well as a self-assessment.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 to 60 years of age.
* Subjects in good health.
* Approximately 5 to 10 atrophic acne scars of mixed types (boxcar and/or rolling scars with some icepick scars allowed) on face and/or back that are moderate to severe.
* Desire correction of his/her acne scarring.
* Subjects of child bearing potential must take a urine pregnancy test and must test negative.
* Subjects willing to sign a photography release.
* Willingness to cooperate and participate by following study requirements.

Exclusion Criteria:

* Allergies to facial or general skin care products
* Presence of an active systemic or local skin disease.
* Severe solar elastosis.
* Sensitivity to topical lidocaine.
* Recent history of significant trauma to the face (\< 6 months).
* Significant scarring other than acne scars in treated area(s).
* Severe of cystic active and clinically significant acne on the area(s) to be treated.
* History of systemic granulomatous diseases.
* History of hypertrophic or keloid scars.
* Current cancerous or pre-cancerous lesions in area(s) to be treated.
* Had microdermabrasion or glycolic acid treatment to treatment area(s) within 1 month prior to study participation.
* History of chronic drug or alcohol abuse.
* Current smokers or have smoked in the last 5 years.
* History of cosmetic treatments: Skin tightening within last year, injectable filler of any type within the last year, neurotoxins within the last 3 months, ablative resurfacing laser treatments, non-ablative, rejuvanative laser treatments in last 6 months, chemical peel, dermabrasion, non-ablative laser or fractional laser resurfacing of face and neck within the last 4 weeks.
* History of certain prescription medications (accutane or other retinoids, topical retinoids, prescription strength skin lightening devices, anti-wrinkle, skin lightening devices, antiplatelet agents/Anticoagulants, and/or psychiatric drugs).
* Nursing, pregnant, or planning to become pregnant during study.
* Current or pre-existing dermatologic diseases on the face or body (psoriasis, rosacea, eczema, etc.)
* History of immunosupression/immune deficiency disorders.
* Current or history of uncontrolled disease such as asthma, diabetes, hyperthyroidism, etc.