cyrilzakka/clinical-trials huggingface dataset:
Use of Demineralised Bone Matrix (DBX) in Osteochondritis Dissecans (OCD)

This is a 1:1 randomised pilot study in 30 patients in 1 site in Helsinki, Finland.

The investigators hypothesize that function, pain, type and quality of cartilage in adult patients with osteochondritis dissecans of the knee will be better in the DBX group compared to the mosaicplasty group.


Eligibility Criteria:
Inclusion Criteria:

* Males or females, age between 18 years and 65 years
* Females of childbearing potential must have a negative serum or urine pregnancy test at the time of inclusion
* Females of childbearing potential must be willing to use effective means of birth control for at least 1 year post surgery. Medically acceptable contraceptives include:

  1. Surgical sterilisation
  2. Approved hormonal contraceptives
  3. Barriers methods combined with a spermicide
  4. An intrauterine device
  5. Abstinence alone is not considered an acceptable method of contraception
* Late stage Osteochondritis Dissecans (ICD-10 code M93.2) of the knee classified as stage III or IV (Anderson MRI classification)
* Mature skeleton
* Written informed consent prior to any study specific procedures (except the procedures necessary to determine eligibility)
* Ability and willingness to comply with all study specific procedures, including attending all follow-up visits up to 12 months postoperative and completing questionnaires in a local language

Exclusion Criteria:

* More than 1 knee affected
* Patients who can be treated with conservative treatment alone, unless there is evidence of at least 6 months failed previous treatment
* Systemic disease including AIDS, HIV, Hepatitis or any other disease that would prevent normal organ and marrow function.
* Patients undergoing systemic cortisone treatment or immunosuppressive therapy (e.g. avascular necrosis)
* Patients undergoing active cancer therapy (chemotherapy, radiation treatment).
* History of alcohol abuse or illegal drug use.
* Participation in any other device or drug trial within 3 months prior to the inclusion in the study
* Presence of at least one contraindication for DBX® Putty
Girls Can...Move! Testing the Feasibility of a Community-based Physical Activity Intervention for Adolescent Girls

The purpose of this research is to learn about how to promote physical activity among adolescent girls by testing the feasibility and initial effectiveness of the Girls Can...Move! intervention. Girls Can...Move! will target each component of physical literacy by providing opportunities for adolescent girls to gain knowledge about their own physical activity level, to explore and practice different types of physical activities, and to learn from active female role models. Female participants (n = 30) from one middle school will be randomly assigned to the Girls Can...Move! intervention group or a control group at a 1:1 ratio. The primary outcome variables, physical activity and physical literacy, will be assessed before and after the 8-week Girls Can...Move! intervention using accelerometers and online surveys.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Enrolled in 6th, 7th, or 8th grade at target school

Exclusion Criteria:

* Engage in 60 minutes of moderate-to-vigorous physical activity on more than 3 days per week
* Doctor has told child/parent that there are certain types of activities that the child should not do
* Preexisting injuries or health conditions that limit physical activity
Safety and Effectiveness of Apixaban Compared to Warfarin in Patients With Non-valvular Atrial Fibrillation (a Type of Irregular Heart Rhythm) at Higher Chance of Bleeding

* The purpose of this study is to compare effectiveness and safety of warfarin and apixaban among non-valvular atrial fibrillation (NVAF) patients at higher chance of bleeding using a Japanese nation-wide administrative claims database.
* Atrial fibrillation (AF) is characterized by a fast, irregular heartbeat which can cause blood to pool in the atria and increase the chance of the formation of blood clots.
* An anticoagulation therapy is a critical treatment to prevent thromboembolism in NVAF patients.
* Apixaban was demonstrated superiority compared to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality in patients with AF in Phase 3 clinical trial.
* Previously we have shown that bleeding risks as well as stroke/SE risks are less in real world clinical practice in Japan compared to warfarin. However there are limited apixaban data for Japanese NVAF patients with high bleeding risk(s).
* This study will evaluate the risk of stroke/systemic embolism as well as the risk of bleeding in the real world settings in Japanese patients with NVAF who has higher chance of bleeding


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with atrial fibrillation (AF) anytime in the baseline period or on the index date, also have definitive diagnosis of AF anytime in the baseline period, on the index date, or post-index period.
* Prescribed apixaban or warfarin on or after the day of AF diagnosis. The first observed prescription will be used to identify the patient's index date and treatment cohort
* No use of the any oral anticoagulants (OACs) during the baseline period (the 180 days before the index date)
* Age of 18 years or older on the index date

Exclusion Criteria:

* Having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the baseline and post-index period
* Having a procedure of prosthetic heart valve during the baseline period
* Having a cardiac surgery procedure record during the baseline period
* Having a diagnosis of venous thromboembolism during the baseline period
* Having a hemodialysis during the baseline period
* Female patients with pregnancy during the baseline and follow-up period
* Patients prescribed apixaban other than approved daily dose (\<5 mg or \>10 mg)
* Patients prescribed OACs during baseline period
IL-39 & IL-35 Gingival Crevicular Fluid Levels in Diabetic Patients With Generalized Periodontitis

The sudy was aiming to assess and compare GCF levels of IL-39 \& IL-35 in gingival crevicular fluid and to correlate the relationship between different patient groups before and after non-surgical therapy.

Methodology:

Group I (Periodontitis Group): 19 patients suffering from generalized periodontitis with T2DM age range, 35-50 years.

Group II (Periodontitis Group): 19 patients suffering from generalized periodontitis \& systemically healthy, age range: 35-50 years.

Group III (Control group): 19 Periodontally and systemically healthy volunteers who served as control subjects age range: 30-45 years.

Periodontitis participants will be collected from the outpatient clinic of oral medicine and periodontology departments in Fayoum, Beni-Swief and Ahram-Candian universities. The periodontitis included subjects will be diagnosed according to the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Tonetti, MS, Greenwell, H, Kornman, KS. Staging and grading of periodontitis: framework and proposal of a new classification and case definition. J Periodontol.; 89( Suppl 1): S159- S172, 2018.)

Diabetic patients will be enrolled in this study according to the criteria of American Diabetes Association. (American Diabetes Association. (2) Classification and diagnosis of diabetes. Diabetes Care 38: S8-S16, 2015.)

The control group will be selected from healthy subjects who attended the restorative dental clinic and has apparently clinically healthy gingiva.

Micropipettes will be used for collection of GCF samples for control group and periodontitis patients before \& after periodontal treatment.

A complete mouth non-surgical periodontal therapy will be carried out for both periodontitis groups

The levels of IL-35 in the GCF samples were assessed using an ELISA kit following the guidelines by the manufacturer.

Eligibility Criteria:
Inclusion Criteria Stage III Grade C Generalized periodontitis with diabetes Stage III grade B Generalized periodontitis in systemic healthy subjects

Exclusion Criteria:

1. Patients treated with any type of medications and/ or antibiotics during the past 3 months,
2. Pregnancy
3. Lactation
4. Receiving professional periodontal treatment during the past 6 months
5. Current or former smokers
The SOLVE-IT National Randomized Trial

This study will evaluate the effectiveness of an interactive virtual environment computer game in reducing risky sexual behaviors among men who have sex with men.

HIV and sexually transmitted diseases (STDs) are a major public health concern worldwide. Although prevalent across all groups of people, HIV/STDs have had a remarkable effect on men who have sex with men (MSM), who accounted for 71% of all HIV infections among American males in 2005. After years of decline, the number of HIV diagnoses appears to have increased for MSM, especially within the black MSM population. Thus, new approaches geared for HIV prevention and education and built on past HIV prevention methods are needed. New technologies, such as interactive computer games, delivered in a modern and appealing manner may gain or recapture the attention of MSM who have disregarded more traditional HIV prevention and educational services. Socially Optimized Learning in a Virtual Environment (SOLVE)-IT is an interactive virtual environment computer game, designed specifically for MSMs, that simulates the emotional, interpersonal, and contextual narrative of an actual sexual encounter and provides challenging decision-making opportunities. By promoting development of self-regulatory and behavioral skills, SOLVE-IT may be an effective approach to reduce sexual risk behaviors. This study will evaluate the effectiveness of SOLVE-IT in reducing risky sexual behaviors among MSM.

Participation in this study will last 6 months from the beginning of treatment. All participants will first undergo baseline assessments that will include questionnaires about sexual behavior, drug use, health history, feelings, and beliefs. Participants will then be assigned randomly to receive SOLVE-IT immediately or after a 6-month waitlist period. SOLVE-IT will include two 1-hour sessions conducted on a computer over the Internet, occurring at baseline and 6 months later. During sessions, participants will play an interactive computer game that presents dating or sexual scenarios and allows participants to choose how the scenarios unfold. Participants will repeat baseline questionnaires at Months 3 and 6 of follow-up. Participants in the waitlist group will be offered to receive SOLVE-IT after completion of the Month 6 follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Self-identifies as Latino, black, or Caucasian
* Men who have sex with men
* Not HIV infected
* Engaged in unprotected anal sex at least twice in the 90 days before study entry with a nonprimary male partner
* Has broadband access during course of study
* Lives in United States
* Biological male

Exclusion Criteria:

* History of nonprescription drug injection use
* Has participated in SOLVE-IT at any phase
Are There Different Objective Fixation Disparity Values for Two Different Test Paradigms

In optometry, binocular coordination is measured subjectively. The result is subjective fixation disparity. In research different experiments have proven, that subjective and objective fixation disparity are different. A binocular eyetracker has to be calibrated. There are two well known calibration methods: associated and dissociated calibration. Objective fixation disparity is measured in arcMin. Therefore, the precision of the eyetracker plays a crucial role. Now, the investigators try to compare dissociated calibration with polarized filters and associated calibration under different test paradigms.


Eligibility Criteria:
Inclusion Criteria:

* VA without glasses/contact lenses 0.63
* Accurate accommodation on 57cm

Exclusion Criteria:

* Tiredness at day of investigation
* Presbyopia
* Alcohol or drug abuse
* No eye related pathology
* No strabism
* No known epilepsy-attack in family
Ultrasonography as a Single Tool for Guided Percutaneous Transhepatic Biliary Drainage in Obstructive Jaundice

Obstructive jaundice may be of malignant and benign etiologies. Carcinoma of the gall bladder, cholangiocarcinoma, pancreatic adenocarcinoma, metastasis, and lymph nodal compression of common bile duct (CBD) constitute the majority of malignant causes.

Most of the patients with malignant obstructive jaundice are already advanced and inoperable by the time they are diagnosed, hence carry bad prognosis with palliation being the only option left. Obstruction needs to be drained even in such cases for reducing pain, cholangitis, anorexia and pruritus as well as to reduce the serum bilirubin levels in certain cases to initiate chemo or intrabiliary brachytherapy.

Over the years, palliation has evolved with the introduction of newer methods and improvisation of existing techniques. Recent palliative measures prolong longevity and improve the quality of life, hence increasing the acceptance to such procedures; Methods of biliary drainage include: a. Surgical bypass b. Minimally invasive procedures; Endoscopic retrograde (ERCP) (cholangiopancreatography (ERCP), and Percutaneous transhepatic biliary drainage (PTBD).

ERCP as well as PTBD are well-established and effective means for biliary drainage as palliative treatment in unresectable cases.

With the current modern technique in experienced hands, Percutaneous Transhepatic Biliary Drainage (PTBD) equals endoscopic retrograde cholangio pancreatography (ERCP) regarding technical success and complications. In addition, there is a reduction in immediate procedure-related mortality with proven survival benefit. Moreover, it is the only immediate lifesaving procedure in cholangitis and sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Any adult Patients with malignant obstructive jaundice will included in this study

Exclusion Criteria:

* Patients with bleeding diathesis.
* Patients with associating comorbidities.
* Patients with insufficient intrahepatic biliary dilatation \< 0.5 cm or with extensive tumor infiltrates.
FPT155 in Patients With Advanced Solid Tumors

This study is a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and activity of FPT155 as monotherapy in patients with advanced solid tumors.

This Phase 1 study is comprised of dose escalation and cohort expansions for FPT155 monotherapy and for FPT155 in combination with pembrolizumab. Monotherapy dose escalation is designed with initial accelerated titration followed by a standard 3+3 dose escalation; combination dose escalation uses a standard 3+3 design. Patients will remain on study treatment until progression of disease, unacceptable toxicity, or other specified reason for discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed solid tumors (except primary central nervous system tumors). For patients enrolled for treatment with FPT155+pembrolizumab: histologically confirmed non-small cell lung cancer not eligible for curative therapy.
* Disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments
* All patients must have at least one measurable lesion at baseline according to RECIST v1.1
* Availability of archival tumor tissue and consent to provide archival tumor for retrospective biomarker analysis, or consent to undergo a fresh tumor biopsy during screening
* For patients participating in cohort expansions: consent to undergo a mandatory fresh tumor biopsy during screening and on treatment
* ECOG performance status of 0 or 1
* Prior radiotherapy must be completed at least 2 weeks before first dose of study treatment administration. No radiopharmaceuticals (eg, strontium, samarium) within 8 weeks before first dose of study treatment administration.
* Prior surgery that requires general anesthesia must be completed at least 14 days before first dose of study treatment
* Adequate bone marrow, liver and kidney function

Exclusion Criteria:

* Uncontrolled or significant cardiac disease
* Any uncontrolled medical condition or psychiatric disorder including infection, autoimmune disease, bleeding disorder or symptomatic involvement of the central nervous system
* Treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 28 days or ≤ 5 half-lives (whichever is shorter)
* Patients who discontinue prior immune-modulating therapies (including regimens containing an immune agonist or a PD-L1/PD-1 antagonist) due to toxicity or have received treatment within 5 half lives or 90 days
* Pregnancy or breastfeeding
* For patients participating in cohort expansion: Prior treatment with a CTLA-4 antagonist, including ipilimumab and tremelimumab
Dance for the Improvement of Balance and Gait After Stroke

Stroke can drastically impact the ability to walk and keep your balance. In addition people with chronic stroke feel social isolated, become less satisfied with their walking and lose confidence in their ability to move without falling.

Ned new treatments are needed for walking and balance. Dancing is a fun, social activity that has similar benefits to traditional exercise. Another benefit of dancing is the use of music, which improves mood, increases motivation and can even improve motor performance. Finally, moving in synchrony with other people during dancing can make people feel connected. We believe that dance classes can benefit people with stroke, but few studies have been done.

The objective of our project is to conduct a randomized controlled trial to test whether dance can improve balance and walking for people with chronic stroke. The investigators are also interested in whether dancing improves people's confidence in their ability to do activities without losing their balance (i.e. balance confidence), decreases their feelings of isolation and increases their quality of life.

This study is a randomized controlled trial to investigate the effects of an adapted dance program for people with chronic stroke. Participants with stroke living in the community will be randomly assigned to either the dance group or the control group. Participants will attend classes 2 times a week for 12 weeks. The primary outcomes are change in balance balance (measured with the Mini BESTest) and change in gait speed. Participants will be assessed before and after the 12 week program.

Eligibility Criteria:
Inclusion Criteria:

1. \> 6 months post stroke
2. Ability to transfer sit to stand and stand to sit with minimal use of arm rests
3. Ability to stand without physical support from an aid or another person for 30 seconds
4. Ability to walk 10m without physical assistance from a walking device, but with standby assistance from another person if needed
5. Ability to follow 2-3 step instructions with minimal prompting from another person
6. Have received clearance from their physician to participate in exercise.

Exclusion Criteria:

1. Severe hearing loss
2. Pre-existing conditions that significantly impact gait and balance (e.g. osteoarthritis)
3. Other neurological conditions that impact gait and balance (e.g. PD).
4. Have participated in a dance class within the past 12 months
Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) in Patients With Multiple Myeloma

Background: In some studies, thalidomide in combination with chemotherapy has been shown to be effective in patients with relapsed or refractory multiple myeloma (MM). In this study, the researchers have chosen a regimen which can be administered on an outpatient basis.

Induction therapy: To evaluate the efficacy and toxicity of thalidomide, cyclophosphamide, oral idarubicin and dexamethasone (T-CID) in patients with relapsed or refractory multiple myeloma.

Maintenance therapy: Randomized trial to compare efficacy and toxicity of thalidomide and thalidomide plus oral idarubicin as maintenance therapy in patients with at least stable disease after T-CID.

Background: In some studies, thalidomide in combination with chemotherapy has been shown to be effective in patients with relapsed or refractory multiple myeloma (MM). In this study, the researchers have chosen a regimen which can be administered on an outpatient basis.

After 3-8 cycles of T-CID patients with at least stable disease will be randomized to receive thalidomide or thalidomide plus oral idarubicin as maintenance therapy for at least one year or until progression.

Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple myeloma according to British Columbia Cancer Agency Criteria
* Stage IIA/B or IIIA/B according to Durie/Salmon
* Symptomatic or progressive disease
* Status of disease:

  * refractory disease after standard induction therapy
  * OR relapse after standard induction therapy
  * OR relapse after high-dose chemotherapy/stem cell transplantation
  * OR patients with plasma cell leukemia
* Patients with measurable paraprotein in urine or serum or quantifiable bone marrow infiltration
* Written informed consent

Exclusion Criteria:

* Age \< 18 years
* Life expectancy of less than 3 months
* Intolerance to the study drugs
* No change or progressive disease after prior therapy with idarubicin or cyclophosphamide
* Cardiac insufficiency New York Heart Association (NYHA) grade 3 or 4
* Acute infection
* Actually decompensated diabetes mellitus
* Total bilirubin \> 3.0 mg/dl
* Pregnant or breast-feeding women
* Polyneuropathy grade 2 or higher
* Ulcus ventriculi or duodeni
* Narrow or open angle glaucoma
* Not-compensated psychiatric diseases
* Prior erythroblastopenia
* Prior therapy with investigational drugs within the last 4 weeks
An Extension Study of Methylnaltrexone Bromide (MNTX) in Participants With Advanced Pancreatic Cancer

This open-label extension study will evaluate the long-term safety and efficacy of oral MNTX in participants with advanced pancreatic cancer (adenocarcinoma) who were previously enrolled in Study SAL-REL-2042 (NCT04083651).


Eligibility Criteria:
Inclusion Criteria:

* Adult participants greater than or equal to (≥)18 years of age on the date the Informed Consent Form (ICF) is signed, with the capacity to provide voluntary informed consent.
* Enrolled in double-blind Study SAL-REL-2042 (NCT04083651) and completed an end of study (EOS) visit (Day 168) or completed Day 56 of the Study SAL-REL-2042 (NCT04083651).
* Must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)-approved ICF and provide authorization, as appropriate, for local privacy regulations.
* Willing and able to comply with scheduled visits, the treatment plan, and laboratory tests.
* Signed an informed consent/Health Insurance Portability and Accountability Act (HIPAA) form.

Exclusion Criteria:

* Concurrent therapy with any other investigational agent during the study.
* Current use of a peripherally acting mu-opioid-receptor antagonist.
* Current evidence of untreated brain metastasis(es).
* Diarrhea greater than Grade 1, based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
* Bowel obstruction.
* Advanced liver disease.
* Renal disease.
* Any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Principal Investigator, would make the participant inappropriate for the study.