cyrilzakka/clinical-trials huggingface dataset:
BV in the Treatment of Relapsed/refractory Hodgkin Lymphoma

The goal of this clinical trial is to explore the real-world Chinese relapsed/refractory patients to evaluate the efficacy and safety of BV monotherapy or combination therapy in CHL patients. The main questions it aims to answer are:

To evaluate the efficacy and toxicity of BV-containing regimen in relapsed/refractory CHL patients in China, and to provide reference for the rational and safe use of BV in clinical practice.

Part I: Retrospective study The clinical data of 50 cases of relapsed/refractory CHL treated with BV in multiple centers in the past 3 years were collected. Statistical methods were used to compare the efficacy and safety between groups and subgroups.

Part II: Prospective study The study was conducted in about 20 centers in China. The preliminary plan was to select a large grade A tertiary hospital with lymphoma specialty center as a sub-center, and an investigator meeting was held to further discuss the choice of drug administration and combination therapy for patients. It was initially planned that BV monotherapy would be divided into two groups: a 2-week (2W) dosing group and a 3-week (3W) dosing group. The specific dosing method was determined by the investigator, but the duration of dosing could not exceed 1 year. For the combined treatment group, it is recommended to use drugs with low neurotoxicity, such as bendamustine and gemcitabine, and dacarbazine and etoposide can also be selected. Anti-pd-1 monoclonal antibody is recommended to be administered once every 3 weeks, and sintilimab or somatorellimab can be selected. Patients who had failed previous treatment with anti-PD-1 anti-PD-1 monoclonal antibody could also be enrolled, at the discretion of the investigator. PET-CT is recommended for efficacy evaluation, and enhanced CT can also be used for patients with poor economic conditions.

Eligibility Criteria:
Inclusion Criteria:

* Histologically, classical hodgkin lymphoma（cHL） was diagnosed and relapsed or refractory.
* Patients were treated with BV-containing regimen at least once
* Presence of tumor (measurable or nonmeasurable).
* Signature of the form consent for participation in the study.

Exclusion Criteria:

* \<18 years
Oral Misoprostol Solution in Labor Induction

This study compares safety and efficacy between repetitive hourly dose of oral misoprostol and two hourly dose oral regimens for cervical ripening and labor induction.

Misoprostol is an effective agent for the induction of labor.existing guidelines recommend oral misoprostol solution every two hours.However,more research is required to optimize the use of oral misoprostol solution for labor induction.The current study is to compare efficacy and safety of repetitive hourly dose of oral misoprostol solution with two hourly dose of oral misoprostol solution for cervical ripening and labor induction.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparas
* Term pregnancy(equal or more than 37 wks)
* Bishop score \<6
* Cephalic presentation
* reassuring fetal heart rate pattern
* Not in labor ( no uterine contractions)
* Clinically adequate pelvis
* Singleton live pregnancy

Exclusion Criteria:

* Allergic to misoprostol or prostaglandin analogues
* Previous uterine scar( cesarean section,hysterotomy,myomectomy)
* Multiple fetal gestations
* Fetal demise
* Preterm labor
* Malpresentations
* Non reactive cardiotocography at admission
* Cephalo pelvic disproportion
* Fetal macrosomia
Coronary Heart Disease as Measured by Coronary Calcium Score Among Individuals With Chronic Traumatic Spinal Cord Injury

This study includes male subjects age 45 to 70, who have sustained a traumatic Spinal Cord Injury (SCI) at least 10 years prior. Subjects will be interviewed for demographic data, including heart disease risk factors. A blood test for cholesterol levels will be drawn. A CT scan of arteries of the heart will be performed to determine the presence of coronary calcium, a marker of subclinical Coronary Heart Disease. Scoring of Coronary Calcium or Coronary Calcium Score (CCS) is automated by the CT scanner. Each subject's Framingham Risk Score will be calculated; This is an individuals 10 year risk of having a Coronary Heart Disease event (significant symptoms). In addition, it will be determined if subjects are being treated for diagnosed dyslipidemia (high cholesterol) according to the National Cholesterol Educational Program (NCEP) guidelines.

The proposed pilot study aims to better understand the problem of Coronary Heart Disease in individuals with Spinal Cord Injury, specifically CCS in SCI, when compared to the general population.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Spinal Cord Injury due to externally inflicted trauma
* \> or = 10 years post injury
* American Spinal Injury Association (ASIA) Scale A,B, or C
* 45 to 70 years of age
* Communication and comprehension sufficient for compliance with all testing procedures
* Voluntary informed consent

Exclusion Criteria:

* Spinal Cord Injury of non-traumatic etiology
* Injury \< 10 years prior to enrollment
* Known Coronary Heart Disease
WOODCAST Hand Resting Splint - Study of User Experience

The aim of the study is to collect comments form users of new type of hand resting splint.

An ecologically friendly and biodegradable wood-plastic composite cast (WOODCAST) is used as a hand resting splint in this study.

Eligibility Criteria:
Inclusion Criteria:

* patient treatment involves hand resting splint; age of patient 18 - 90 years; skills with language Finnish language (written and spoken)

Exclusion Criteria:

* decreased co-operation of the patient; patient with multiple illnesses; malignancy; an illness affecting the general health.
Biomarker Discovery in Parkinson's Disease

There are approximately one million Americans who live with Parkinson's disease with 50,000 new cases per year and this rate is expected to rise with an aging population. The underlying pathophysiology and disease understanding of PD still remains elusive due to a combination of disease complexity and lack of predictive capability of existing models.

The Berg Interrogative Biology™ discovery platform has demonstrated a unique capability in producing drug targets and biomarkers that truly represent a disease phenotype. It has been able to catalyze molecules now in late stage clinical trials in cancer and many pre-clinical candidate therapeutics and biomarkers in endocrinology and central nervous system (CNS) diseases. The platform is able to decipher normal versus disease signatures by integration of data sets from the genome, metabolome, proteome, and lipidome in an agnostic manner that is subjected to Bayesian Artificial Intelligence informatics. The resulting nodes are then put back into wet-lab validation before proceeding to proof-of-principle pre-clinical testing.

By utilizing clinical data and specimens obtained by the medical specialists at The Parkinson's Institute, along with Berg's Interrogative Biology™, this study aims to discover a disease biomarker enabling the creation of a diagnostic test for Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

For PD cases:

Inclusion Criteria:

* Men and women with the clinical diagnosis of idiopathic PD
* Willing and able to give informed consent
* Willing and able to comply with scheduled visits, required study procedures and laboratory tests

Exclusion Criteria:

PD Subjects with any of the following may not be enrolled:

1. Presence of atypical or secondary parkinsonism
2. Inability to provide a blood and/or urine sample
3. History of renal failure and/or on dialysis
4. Currently taking a medication in the following categories: dopamine blockers, neuroleptics, and/or dopamine blocking agents.
5. Any medical, psychiatric or other condition which, in the opinion of the investigator, would preclude participation

Healthy Controls:

All of the following criteria must be met for a Healthy Control to be enrolled in the study:

1. Healthy controls with no diagnosis of PD and any of the exclusion criteria
2. Willing and able to give informed consent
3. Willing and able to comply with scheduled visits, required study procedures and laboratory tests

Healthy Controls with any of the following may not be enrolled:

1. No clinically significant or unstable medical or psychiatric condition that would interfere with the conduct of the study
2. Diagnosis of PD or presence of signs of a neurodegenerative disorder, e.g. essential tremor
3. First degree relative with PD/parkinsonism
4. Inability to provide a blood and/or urine sample
5. History of renal failure and/or on dialysis
6. Any medical, psychiatric or other condition which, in the opinion of the investigator, would preclude participation
Emdogain and Straumann Bone Ceramic in Infrabony Defects

Randomised, controlled, clinical study to compare the effect of the combination of bone ceramic and enamel matrix proteins (test) versus autogenous bone graft alone (control) in the treatment of deep-wide intrabony defects

30 subjects (15 test and 15 control) diagnosed with moderate to severe periodontitis (Armitage, 1999) will be enrolled in the study and randomized to either the test or the control group.

The surgical procedure shall be performed within 15 days from the baseline visit of the subjects and will be the same for both groups. In both groups, the flap is replaced subsequently.

In total 5 visits per patient are scheduled in this study. The total study duration for each patient should be 12 +/- 2 weeks.

The study devices Emdogain® and Straumann Bone Ceramic are CE-marked, and approved by the FDA.

One center in France will participate.

Eligibility Criteria:
Inclusion Criteria:

* Males and females must be at least 18 years and not more than 75 years of age
* The patient will have to be able to understand and sign the informed consent prior to starting the study.
* The patient also will have to have the ability and the willingness to comply with all study requirements.
* The patients will be in good general health without any systemic diseases.
* The teeth included in the study will be mandibular molars, maxillary and mandibular premolars, and canines.
* The patients will have to have at least one defect with pocket depth ≥ 5 mm.
* Intra-bony defects will have to have 1 or 2-wall morphology (at least 2/3 of the defect).
* Depth of the intrabony component of at least 3 mm
* The selected sites will have to have vertical intra-bony component ≥ 3 mm and an angle ≥ 30 degrees as assessed from standardized intra-oral radiographs.
* Oral hygiene parameters: Plaque Index (PI) ≤ 20 % and bleeding on probing (BoP) ≤ 20%

Exclusion Criteria:

* Heavy smokers: more than 20 cigarettes per day
* Mucosal diseases such as erosive lichen planus
* History of local radiation therapy
* Presence of oral lesions (such as ulceration, malignancy)
* Teeth with untreated endodontic or cardiologic problems
* Physical handicap that will interfere with patient's ability to exercise good oral hygiene on a regular basis.
* Patients presenting antibiotic treatment within the 3 months preceding the surgical procedure.
* Patients using anti-inflammatory drugs on a regular basis.
* Intra-bony defects with a 3-wall morphology.
* Intra-bony defects with furcation involvement.
* Incisors and maxillary molars, will be excluded.
* Alcoholism or chronically drug abuse causing systemic compromize
* Medical conditions requiring prolonged use of steroids
* Current pregnancy at the time of recruitment and/or breastfeeding women.
* Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
Lorcaserin in the Treatment of Cocaine Use Disorder

The objective of this study is to evaluate the efficacy and safety of lorcaserin in the treatment of cocaine use disorder.

This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of lorcaserin (10mg, b.i.d) to matched placebo in the treatment of cocaine use disorder. Up to 3 weeks will be allowed for the Screening Period and a 13-week treatment phase, with a 3-week follow-up period, with scheduled visits during Study weeks 14 and 16.

Eligibility Criteria:
Inclusion Criteria:

* Has a DSM-5 diagnosis of current cocaine use disorder as verified by the Structured Clinical Interview for DSM-5
* Is seeking treatment for cocaine use disorder
* Is able to understand and provide written informed consent
* Has used cocaine on at least 1 day in the last 30 days prior to screening
* Has completed all psychological assessments and procedures during the screening period
* If female, not pregnant, lactating, unable to conceive OR must agree to use an acceptable method of birth control
* Has a total body weight greater than 110 pounds and body mass index greater than 20

Exclusion Criteria:

* Contact site for more information
Efficiency of Art-therapy in Psychotic Disorders

The main purpose of the protocol is to test the efficiency of art-therapy versus metacognitive rehabilitation on the visual perception disorders observed in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* schizophrenia according to DSM IV

Exclusion Criteria:

* addiction problem
* invalidating visual sensory problems
* neurological history
Safety and Tolerability of the First IV Dosing of SLV338 in Healthy Volunteers

This study will investigate the safety and tolerability of the first IV dosing of SLV338 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* not healthy
Post-Approval Study for the MOSAIC® Bioprostheses

A Single Center Non-Interventional Post-Market Release, Long Term Follow Up study of patients who underwent Isolated Aortic Valve Replacement or Isolated Mitral Valve Replacement with a Medtronic Mosaic Bioprosthesis. The purpose of this study is to evaluate the long term safety, efficacy and clinical performance of the Mosaic Bioprostheses.

Objectives:

The primary objectives of this study are to evaluate the long-term safety, efficacy and clinical performance.

Study Design:

This is a prospective, single center, non-interventional, non-randomized, post-market release clinical study

Sample Size and Study Duration:

A total of 255 patients had aortic valve replacement and 47 patients had mitral valve replacement in the Albertinen-Krankenhaus (Hamburg, Germany) during the previous Mosaic Pre-Market approval (PMA) study.

All surviving patients from the Mosaic Pre-Market Approval study at this center, will be invited to participate. Approximately 225 patients will be invited.

This study is intended to serve as an ongoing source of information on long-term durability and safety of the CE-marked Medtronic Mosaic bioprosthesis. As such the study is to continue indefinitely until the last follow-up visit (until patient study exit due to patient death, withdrawal of patient consent,...) of the last study patient.

PATIENT SELECTION:

Inclusion criteria:

* All patients who were enrolled and implanted with the Mosaic bioprosthesis in the Albertinen-Krankenhaus (Hamburg, Germany) during the previous Mosaic PMA study, will be invited to participate in this long- term follow-up study.
* Patients who are able to provide informed consent

Exclusion criteria:

* Patients who are not from the Albertinen-Krankenhaus (Hamburg, Germany) and who did not participate in the Mosaic PMA study are ineligible for this study.
* Patients refusing or not able to provide informed consent.
* Patients not willing and unable to comply with the Clinical Investigation Plan (CIP)-requirements.

Data Requirements and analysis:

For each patient enrolled in the study, information will be collected annually. Data will be collected on the patient status and device hemodynamic performance by echocardiography. Patient identity is anonymized.

Appropriate statistical analysis will be performed for the collected clinical data.

Eligibility Criteria:
Inclusion Criteria:

* All patients who were enrolled and implanted with a Mosaic bioprosthesis in the Albertinen-Krankenhaus (Hamburg, Germany) during the previous Mosaic PMA study, will be invited to participate in this long-term follow- up study.
* Patients who are able to provide informed consent

Exclusion Criteria:

* Patients who are not from the Albertinen-Krankenhaus (Hamburg, Germany) and who did not participate in the Mosaic PMA study are ineligible for this study.
* Patients refusing or not able to provide informed consent.
* Patients not willing and unable to comply with the CIP-requirements
Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)

This study will examine if there is a benefit of an online intervention for persons with bipolar diagnoses, and what components appear to be most useful.

This study will examine whether exposure to the three different components of the MoodSwings 2.0 intervention results in decreased depressive symptoms as measured by the Montgomery Asberg Depression Rating Scale (MADRS), and decreased manic symptoms as measured by the Young Mania Rating Scale (YMRS). The three components of the MoodSwings 2.0 intervention are:

* Moderated peer discussion board
* Psychoeducation learning modules
* Interactive psychosocial tools

This study will also examine whether there is an association between graduated levels of involvement and resulting improvement. These graduated levels are:

* Moderated peer discussion board only (Level 1)
* Moderated peer discussion board and psychoeducation learning modules (Level 2)
* Moderated peer discussion board, psychoeducation learning modules and interactive psychosocial tools (Level 3).

We expect that those participants assigned to the control condition (Level 1), will have fewer positive outcomes than those in Level 2 or Level 3 conditions.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of bipolar I disorder, bipolar II disorder, or bipolar disorder not otherwise specified (NOS) verified with the Structured Clinical Interview for the Diagnostic Manual for Mental Disorders (SCID) mood disorders module.
* Age 21 to 65
* Access to a computer with internet access. Access to a printer is preferable, but not required.
* Able to speak and read English proficiently.
* Some degree of medical supervision of bipolar disorder (sees a health professional at least twice a year to discuss symptoms and treatment needs).
* Local access to emergency care.

Exclusion Criteria:

* Current psychosis, as assessed in screening phone interview with the SCID psychotic screening module.
* Acutely suicidal (defined as having a Hamilton Rating Scale for Depression \[HAM-D\] item 3 scores of ≥ 3)
* Current mania, assessed using the SCID mood disorder module.
The MDA Test to Differentiate of Benign and Malignant Pulmonary Nodules

* The purpose of the study is the identification of the efficacy of MDA Test to Differentiate of Benign and Malignant Pulmonary Nodules.
* In this study, the investigators are going to validate the efficacy of the MDA test for diagnosing early lung cancer by comparing results of the pre-surgery MDA test with the post-surgery pathology.

* Current state-of-the-art lung cancer early screening utilizes low-dose CT scan to identify lung nodules smaller than 3 cm in diameter. However, it's still a clinical challenge to differentiate between malignant and benign nodules.
* This study is being conducted to evaluate the efficacy of the MDA TEST to detect Targeted chromosomal aberrations in circulating abnormal cells by FISH analysis that might be an early indicator of lung cancer. Approximately 200 Pre-surgery adult patients with single pulmonary nodule found by CT scan, will be enrolled in the study. The sample type of MDA test is Peripheral Blood. This study will compare the results of the pre-surgery MDA Test with the post-surgery pathology to determine if the test can detect lung cancer or the lack of lung cancer .
* The results of the test will not be provided to the subject, the investigator and will not be used to diagnose or treat the subject.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or above
* single pulmonary nodule found by CT scan.
* the diameter of the pulmonary nodule is between 5mm to 30mm.
* plan to accept pneumonectomy due to the pulmonary nodule.
* agree to sign informed consent

Exclusion Criteria:

* fail to understand or agree to sign informed consent.
* pregnant or lactating women.
* the diameter of the pulmonary nodule is more than 30mm.
* there are 2 or more pulmonary nodules in one single patient.
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model

To evaluate the efficacy of prednisolone acetate 1% ophthalmic suspension as compared to prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2% ophthalmic suspension, and placebo (Tears Naturale® II) in the prevention of the signs and symptoms of allergic conjunctivitis. Comparisons will be made following 1 week of twice daily (BID) dosing and 1 week of four times daily (QID) dosing.

Structure:

Prospective, single center, randomized, double-masked, parallel treatment comparison study. Subjects will be randomized to one of the following treatment arms to be dosed bilaterally twice daily (BID) for the first dosing period and four times daily (QID) for the second dosing period:

1. Prednisolone Acetate 1% ophthalmic suspension
2. Prednisolone Acetate 0.12% ophthalmic suspension
3. Loteprednol Etabonate 0.2% ophthalmic suspension
4. Tears Naturale® II

Duration:

Approximately four (4) weeks

Controls:

Artificial Tears (Tears Naturale® II)

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age \& either sex, any race
* Willing and able to follow all instructions
* Positive history of ocular allergies
* Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge

Exclusion Criteria:

* Have planned surgery during trial period
* Female currently pregnant, planning a pregnancy or lactating
* Use of disallowed medications
* Have ocular infections, or ocular conditions that could affect study parameters
* Have moderate to severe dry eye
* Have used an investigational drug or device within 30 days of start of study
* Female that is currently pregnant, planning a pregnancy or lactating