cyrilzakka/clinical-trials huggingface dataset:
The Umeå High-Intensity Training Study

This randomized controlled trial will evaluate the effect of high-intensity training (HIT) in older sedentary people. Seventy older people, aged 65 and over, will be randomized to HIT or moderate-intensity continuous training (MICT). HIT sessions will consist of 10 repeated 6-seconds regulated high intensity cycling sprints against an individualized load. MICT (control group) sessions will consist of aerobic training regulated against an individualized load set to reach a moderate submaximal exercise intensity. Both groups will be performed twice weekly for 12 weeks. The study will evaluate the effects on 1) Cardiovascular function, 2) Brain health, 3) Muscular function, 4) Psychological health, 5) Physical activity, 6) Metabolic health, and 7) Examine the feasibility (attendance, achieved intensity, adverse events) as well as the experiences of HIT. Most outcomes will be assessed at baseline, 3 months (directly after intervention period), and 9 months by blinded assessors.

Information about modifications of the study protocol (September 2020): Experiences of exercising and its effects were at the 9-month follow-up collected through individual interviews instead of focus group interviews (secondary outcome measures no. 31). Due to Covid-19, at the 9-month follow-up all outcome measurements besides the questionnaire (secondary outcome measures no 9, 10, 11, 12, and 14) and interviews (secondary outcome measure no 31) were terminated for 37 of the participants.

Eligibility Criteria:
Inclusion Criteria:

* Not regularly physically active at moderate or high intensity over the last year.
* Independent in activities of daily living (ADL) and able to transfer from home to exercise facility.

Exclusion Criteria:

* Chronic and progressive neurological diseases.
* Movement related conditions and functions (e.g. pain) or heart and lung conditions and diseases that prohibit exercise or tests, based on screening by a physician.
* Cognitive impairment (Mini-Mental State Examination score below 27)
Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)"

To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound management.


Eligibility Criteria:
Inclusion Criteria:

1. Acute wound: traumatic wound (dermabrasion, skin tears, other), benign burn requiring the use of dressings
2. Acute wound size between 3 cm² and 240 cm2 (wound could be covered by 2 investigational products maximum)
3. Wound whose duration is ≤ 3 days
4. Both gender with an age ≥ 18 years
5. Subject able to understand and voluntarily sign the informed consent
6. Subject able to follow the protocol
7. Subject insured to the French social security system

Exclusion Criteria:

1. Surgical wound
2. Infected, moderately to strongly exudative and haemorrhagic wound
3. Diagnosed underlying disease (e.g. diabetic neuropathy, stroke, ...) which, as judged by the investigator, could interfere with the pain assessment
4. Known allergy/hypersensitivity to any of the components of the investigational products
5. Participation in other clinical investigation within one month prior to start of investigation
6. Pregnant or breast-feeding women
7. Person protected by a legal regime (tutorship or guardianship)
Messages and Plans to Increase Gym Utilization

This primary object of this study is to test to the hypothesis that the both the nudge and boost messages will increase short term gym utilization relative to the control condition but that only the boost message will increase long-term gym utilization.

Non-technical summary: College students will receive one of three messages about exercise. Their card swipe data as a measure of gym utilization will be tracked as an assessment of the effect of those messages.

Our study uses a survey methodology. Within the survey, participants are randomly assigned to experimental conditions. After completion of the survey, participants' real-world behavior is assessed via gym card swipe data.

Within the survey, an experimental quantitative three group design will be used to answer our research question. Thus, our independent variable has three levels: the control message, the nudge message, and the boost message. Our dependent variable will be collected gym card swipes over the semester.

The three experimental message conditions will be delivered within the questionnaire that participants complete. The control group will read only summary information about the David Pottruck Health and Fitness Center. Participants in the nudge condition will read a similar summary but will also be given a prompt to form an implementation intention. Those in the Boost condition will also have summary information about the Pottruck gym but will also be given information about why an implantation intention is an effective way to attain long term goals. They will also be given a prompt to form an implementation intention.

Eligibility Criteria:
Inclusion Criteria:

* Must be undergraduates at the University of Pennsylvania

Exclusion Criteria:

* N/A
A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment

The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).

The study is a randomized (study drug assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled Phase IIb trial with TMC435 in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who have failed standard treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV). The study will compare the efficacy, tolerability and safety of different regimens with TMC435 combined with standard treatment (Peg-INF-alfa-2a and RBV) versus standard treatment alone. The trial will consist of a screening period of maximum 6 weeks, a 48-week treatment period, and a 24-week follow-up period. Participants will be eligible to enroll in the trial if they failed to respond to a prior course of standard treatment or relapsed following standard treatment. Participants will be randomly assigned to receive TMC435 with standard treatment for 12 weeks followed by standard treatment (plus placebo) for 36 weeks, TMC435 (100 mg or 150 mg once a day) with standard treatment for 24 weeks followed by standard treatment (plus placebo) for 24 weeks, TMC435 (100 mg or 150 mg once a day) with standard treatment for 48 weeks, or a placebo with standard treatment for 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Must have chronic hepatitis C infection as evidenced by liver biopsy, anti-hepatitis C virus (HCV) and HCV RNA positive
* Must have chronic hepatitis C infection (genotype 1) with HCV RNA level greater than10000 IU/mL
* Patient must have failed at least 1 prior course of peg interferon (Peg-IFN-alfa-2a)/ribavirin (RBV) therapy (standard treatment)
* Must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication

Exclusion Criteria:

* Has an evidence of decompensated liver disease
* Co-infection with any other Hepatitis C virus genotype or co-infection with the human immunodeficiency virus (HIV)
* Has a medical condition which is a contraindication to Peg-INF or RBV therapy
* Have had history of, or any current medical condition which could impact the safety of the patient in the study
A Trial of Parent-coached Exposure Therapy for Children With Anxiety Disorders and OCD

The purpose of this study is to examine the effectiveness of parent coached exposure therapy (PCET) and standard cognitive behavioral therapy (CBT) in treating childhood anxiety disorders and obsessive compulsive disorder (OCD).

The purpose of this study is to examine the effectiveness of parent coached exposure therapy (PCET) through baseline comparisons, to compare effectiveness of individual PCET and individual standard cognitive behavioral therapy (CBT), to compare efficiency of individual PCET and individual standard CBT, to compare effectiveness of group intensive PCET, individual PCET, and individual standard CBT, and acceptability.

Eligibility Criteria:
Inclusion Criteria:

* Have a DSM-5 anxiety disorder diagnosis, including generalized anxiety disorder, obsessive compulsive disorder, panic disorder, agoraphobia, separation anxiety disorder, social and specific phobias, as assessed on the relevant modules of the (MINI-Kids; (Sheehan et al., 2010) by study staff in the PADC.
* Be appropriate for the PADC standard outpatient therapy program, and be interested in starting outpatient therapy,
* Have the anxiety disorder as their primary diagnosis,
* If taking a selective serotonin reuptake inhibitor, SNRI, tricyclic, or antipsychotic medication, had no medication changes made at least 8 weeks prior to initiating participation in the study and agree to no changes during the 12 weeks of the study.

Exclusion Criteria:

* History of and/or current psychosis, autism, bipolar disorder, or current suicidality, or eating disorder as assessed during the initial clinical interview and all available clinical information.
* Current positive diagnosis in the child's caregiver of mental retardation, psychosis, or other psychiatric disorders or conditions that would limit his/her ability to understand CBT and follow-through with treatment directives (based on clinical interview).
* Secondary diagnosis of oppositional defiant disorder or major depression of sufficient severity to prevent anxiety treatment.
* Severity of symptoms that warrant higher level of care (i.e. intensive, residential, IOP, inpatient)
* Family is unable to attend weekly sessions (i.e. geographical or scheduling barriers)
* History of good quality exposure or CBT.
Comparison of Segmentectomy Versus Lobectomy for Non-small Cell Lung Cancer ≤ 2 cm in the Middle Third of the Lung Field

This study aims to investigate whether segmentectomy had non-inferiority long-term oncological effects (disease-free survival and overall survival) compared with lobectomy in the treatment of patients with early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field.

Nowadays, the role of segment resection in the treatment of non-small cell lung cancer ≤ 2 cm in the outer third of the lung field has been evaluated in multiple studies. Recently, professor Hisao Asamura released the long-term results of the JCOG0802 project in AATS 2021. Segmentectomy had a higher 5-year overall survival (94.3% vs. 91.1%) than lobectomy (P \< 0.001) for non-small cell lung cancer ≤ 2 cm (CTR \> 0.5) in the outer third of the lung field. However, a substantial portion of lung nodules was not located in the outer third, but the middle third of the lung field. Whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of lung field remains unclear. This randomized controlled trial study aims to investigate whether segmentectomy has non-inferiority long-term oncological effects compared to lobectomy for early-stage non-small cell lung cancer ≤ 2 cm in the middle third of the lung field.

Eligibility Criteria:
Inclusion Criteria:

1. Patient aged 18-75 years old;
2. 6 mm ≤ tumor size ≤ 20 mm;
3. 0.25 \< CTR \< 1;
4. Center of tumor located in the middle third of the lung field;
5. ECOG score of 0,1 or 2;
6. Lung function (FEV1 ≥ 1 L and ≥ 70%);
7. Both lung segmentectomy and lobectomy could achieve R0 resection;
8. No serious cardiopulmonary complications, and could withstand both lung segmentectomy and lobectomy;
9. No hilus pulmonis and mediastinal lymph node metastasis and no distant metastasis;
10. Single tumor nodule or the concomitant nodule \< microinvasive tumor;
11. Written informed consent.

Exclusion Criteria:

1. The tumor nodule is located in right middle lobe;
2. A history of other malignancies in the last 5 years (exclusion of early-staged thyroid cancer);
3. Have received preoperative anti-tumor therapy, including prior chemotherapy, radiation therapy, target therapy and so on;
4. A serious mental illness;
5. Pregnant and lactating women;
6. Congestive heart failure, myocardial infarction, severe stenosis of coronary artery within recent 6 months;
7. With the history of cerebral infarction or cerebral hemorrhage within 6 months;
8. With the history of sustained systemic corticosteroid therapy within 1 month;
9. The predicted surgical margin is less than 2 cm or the maximum diameter of the tumor at the 3D-CTBA
10. Other unsuitable situations;
Study to Evaluate Efficacy and Safety of NDS-446 in Men With Lower Urinary Tract Symptoms (LUTS)

Prospective, Randomized, Double-Blind, Placebo Controlled clinical trial to study the efficacy and the safety of NDS-446 (500 mg/cap) in Men 45 years of age or older with moderate to severe lower urinary tract symptoms (LUTS)


Eligibility Criteria:
Inclusion Criteria:

1. Men ≥45 years of age.
2. LUTS, based on IPSS total score ≥8 and \<25
3. Peak urinary flow rate (Qmax) ≥4 and ≤15 mL/sec at screening
4. Post Void Residual (PVR) urine volume ≤ 200 mL at screening
5. PSA level at screening \< 10 ng/mL. Subjects with a PSA \> 4ng/mL and \< 10 ng/mL are eligible only if prostate cancer has been ruled out
6. Subjects who understand and speak English
7. Able and willing to give informed consent and comply with all study protocol procedures (diaries and other study tools).

Exclusion Criteria:

1. Not suitable for medical intervention (e.g., requiring TURP, etc.)
2. History of interstitial cystitis, bladder stones, urethral stricture, current prostatitis, acute urinary retention requiring catheterization in the last 3 months, or any other condition suspected to be the cause of LUTS other than BPH
3. Screening serum Creatinine (Cr) or liver function tests \[ALT (SGPT), AST (SGOT)\] \> 3 times the upper limit of normal (ULN) confirmed on a second measurement.
4. Cancer of the prostate or bladder by history or current diagnosis.
5. Prostate nodule(s) on screening digital rectal exam (DRE).
6. Prior surgical procedure of the urinary tract such as TURP, laser prostatectomy, photovaporization of the prostate
7. No minimally invasive surgery to the prostate such as TUMT or TUNA within the last 6 months.
8. Active urinary tract infection.
9. Unstable or uncontrolled medical or psychiatric condition.
10. Abnormal screening labs \> 2 times the upper limit of normal (ULN) \[for all parameters other than those listed for exclusion criteria#3\]
11. Myocardial infarction or CVA within the past 90 days.
12. Requiring ongoing administration of antibiotics, antifungals, antiviral, chemotherapy, steroidal or immunosuppressive treatments.
13. Requiring chronic administration of aspirin at a dose \>81 mg/day.
14. Known hypersensitivity to study drug ingredient(s) or allergy to berries.
15. Use of the following medications: alpha blockers (28 days of screening), herbal or nutritional BPH supplements (28 days of screening), OAB medications (28 days of screening), 5 alpha reductase inhibitors (175 days of screening), PDE5 inhibitors (permitted as needed for erectile dysfunction only, but not to exceed 1 dose per week and not to be dosed within 5 days of a visit)
16. Use of an investigational agent (drug, biologic, device, etc.) within 30 days of screening
17. Any reason or condition that in the judgment of the Clinical Investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.
Effects of Intra-articular Versus Subacromial Steroid Injections on Clinical Outcomes in Adhesive Capsulitis

The primary objective is to compare the clinical outcomes of patients with a clinical diagnosis of Adhesive Capsulitis who receive intra-articular versus subacromial steroid injections.

The secondary objective is to verify that steroid injections in combination with physical therapy lead to more favorable outcomes than local anesthetic injections in combination with physical therapy.

Current treatment for Adhesive Capsulitis involves physical therapy. Steroid injections have not been shown to be as effective alone without the physical therapy. However, there are multiple studies that document the benefit of adding a steroid injection to the physical therapy. After a review of the literature, there are studies that compare different dosages of intra-articular steroid injections,value and site of the injections, and accuracy of clinical injections. There are currently no studies that compare the results after intra-articular versus subacromial injections in combination with physical therapy. This study would help us determine if location of the injection is a major factor in regaining motion. If it is significantly important to be intra-articular with the steroid, than it may be important to send patients for fluoroscopic guided injections routinely rather than risk the chance of not being within the joint.

Eligibility Criteria:
Inclusion Criteria:

* Meet clinical diagnosis of primary Adhesive Capsulitis
* Restriction in abduction to less than 130 degrees
* 50% reduction in external rotation as compared with the contralateral side
* An intact rotator cuff
* Between 18-75 years of age

Exclusion Criteria:

* Previous shoulder capsular surgery
* History of steroid injection(s) into affected shoulder
* Inability to provide informed consent
* Iodinated contrast dye allergy
* Allergy to lidocaine
* Other suspected shoulder pathology (i.e., tumor, rotator cuff rupture. infection, arthritis)
* Known bleeding diathesis
* Cervical spine pathology
* History of trauma to the shoulder
* Pregnancy
Study of the Effects of Adapted Tango and Multidimensional Intervention in pREvention of Dementia in agiNG (STRENGTH)

The STRENGTH project is a randomized controlled trial to assess the effects of a 6 months multimodal intervention consisted of adapted Tango dancing together with music therapy, engagement in social activities, cognitive intervention and psycho-education on functional, biological, cognitive outcomes and psycho-social aspects in 300 subjects with mild cognitive impairment.

Cognitive decline represents a pathological condition for elderly with negative consequences on social functioning and independent living. To reduce the incidence of cognitive deficits in mild cognitive impairment (MCI), treatments that prevent or delay dementia are needed. The main objective of STRENGTH Project, is the assessment of the effects of a comprehensive intervention in 300 subjects with MCI, finalized to improve functional, biochemical, cognitive outcomes and psycho-social aspects. The study uses a multidisciplinary approach, has a 3-year duration, and includes 3 follow-up phases. Participants will be assigned to: a) Experimental group, which will undergo a multimodal intervention for improving cognitive outcomes, functional status and mobility. Treatment will include sessions of Adapted tango, music therapy, engagement in social activities, comprehensive cognitive intervention and psycho-education for 6 months; or b) Control group, which will receive psycho-education and advice on healthy life-style for 6 months. Cognitive and psycho-social outcomes, functional, cardiovascular status, life-style characteristics, biochemical determination, will be evaluated at baseline and longitudinally. Our hypothesis is based on expectation that the proposed could improve cognitive, functional outcomes and quality of life, with a positive impact on prevention of onset of dementia and cognitive decline in MCI subjects.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of mild cognitive impairment
* presence of a caregiver
* capability to sign the informed consent

Exclusion Criteria:

* diagnosis of dementia
* serious medical and/or psychiatric conditions
Is Olfaction the Key to PTSD

Participants arriving to the ED following a potentially traumatic event such as a motor vehicle accident will be recruited into the study. Inclusion criteria: aged 18-65, Hebrew as a first language, no current psychiatric disorder. Exclusion criteria: loss of consciousness, unable to understand study procedure. Participants will answer self report questionnaires in the ED. They will be invited for a follow up interview 2 weeks and six months post trauma. Between 2 weeks and 6 months they will be folllowed up via online questionnaires. At the interviews, they will encounter 20 different olfactory stimuli, answer self-report questionnaires, and a clinical interview assessing Axis 1 disorders and PTSD will be completed. At six month, participants with PTSD will be offered therapy in the embedded RCT. Patients will receive VRET (Virtual reality exposure therapy) with or without olfaction.

The goal of this project is to carry out a systematic longitudinal study with an embedded RCT examining olfactory memories in PTSD, in order to test the following hypotheses. Firstly, olfactory memories occur after all traumatic events; secondly, olfactory memories are predictors of PTSD development and thirdly, adding olfaction to PTSD treatment will enhance treatment outcome. The project comprises of a longitudinal study recruiting participants in the Emergency Room within hours of a traumatic event, assessing them at two weeks post trauma for olfactory memories, and at six months for PTSD. This will allow the first two hypotheses to be examined. Participants with PTSD and olfactory memories will be offered treatment and will be randomized to a Virtual Reality Exposure Therapy with and without added odors. Post treatment assessments will examine the third hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* hebrew native speaker
* understand study requirements

Exclusion Criteria:

* current psychiatric disorder
* suicidality
* vertigo
* epilepsy