cyrilzakka/clinical-trials huggingface dataset:
Cusatuzumab in Combination With Background Therapy for the Treatment of Participants With Acute Myeloid Leukemia

The purpose of the study is to characterize safety and tolerability of cusatuzumab in combination with various therapies used to treat acute myeloid leukemia (AML).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute myeloid leukemia (AML) according to World Health Organization 2016 criteria . Participants with acute promyelocytic leukemia (APL) are not eligible
* Must be ineligible for intensive chemotherapy
* De novo or secondary AML
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Previously untreated AML except: emergency leukapheresis, hydroxyurea, and/or 1 dose 1-2 gram per meter square (g/m\^2) cytarabine during the Screening Phase to control hyperleukocytosis. These treatments must be discontinued greater than or equal to (\>=) 24 hours prior to start of study drug. Empiric all trans retinoic acid (ATRA) treatment for presumed acute promyelocytic leukemia (APL) is permitted but APL must be ruled out and ATRA must be discontinued \>=24 hours prior to the start of study drug
* Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies

Exclusion Criteria:

* Leukemic involvement of the central nervous system
* Eligible for an allogeneic hematopoietic stem cell transplantation at study entry
* Received a live, attenuated vaccine within 4 weeks prior to initiation of study drug
* A history of human immunodeficiency virus (HIV) antibody positive or tests positive for HIV if tested at screening
* Known allergies, hypersensitivity, or intolerance to cusatuzumab, venetoclax, azacitidine, or their excipients (example: mannitol, an excipient of azacitidine)
Validation of the French Version of the Primary Lateral Sclerosis Functioning Rating Scale (PLSFRS)

This is a national, multicentric, prospective, descriptive study evaluating the psychometric properties of the French version PLSFRS scale

This is a prospective study conducted in 8 French ALS centers which will enroll 80 patients with PLS. All these patients will undergo an evaluation of their functional status from the ALSFRS-r and PLSFRS scales. All patients will be evaluated at 3 time points (T0,M6 at the outpatient clinic) and at M3 remotely. The aim of the study will be to validate a trans-cultural and psychometric version of the PLSFRS available for the French PLS population.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary lateral sclerosis (PLS)
* Age over 18 years
* Informed consent signed
* Patients cared in a French ALS centre

Exclusion Criteria:

* patients with no oral and written command of the French language
* Patients unable to answer a questionnaire
* Opposition to data processing
ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)

The purpose of this study is to gain additional safety information as well as to determine after the study drug has been given to patients who have undergone total hip replacement surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood clots in legs) or pulmonary embolism (blood clots in lungs).


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side).
* Patients who have given written informed consent to participate in this study.

Exclusion Criteria:

* Patients with a contraindication to contrast venography
* Patients with an increased risk of bleeding.
* Patients with a predefined risk for prethrombotic episodes or a history of thrombophilia.
* Other inclusion or exclusion criteria to be determined by the physician and study sponsor.
A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris

This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 12-40 years old
* Diagnosis of Grade II-III acne vulgaris with Pillsbury grading system
* Provide written informed consent if the subject is aged 18 or older. Ages 12-17 should provide written assent and written informed consent from patient's parent or legal guardian.

Exclusion Criteria:

* Known hypersensitivity to adapalene, clindamycin hydrochloride, clindamycin phosphate, lincomycin or any ingredient of the study drug, or of allergic constitution
* Secondary Acne, such as occupational acne and steroid acne
* Has a dermatological condition of the face that could interfere with the clinical evaluations, such as sunburn, psoriasis, seborrheic dermatitis or eczema
* History of Crohn's disease, ulcerative colitis or antibiotic-associated colitis
* History of serious heart disease or hypertension
* Serious liver or kidney disease, AST or ALT more than twice the upper limit of normal, or Cr above normal
* Serious endocrine, hematologic or psychiatric disease
* Known immunocompromised conditions, or require long-term steroids or immunosuppressants
* Females who are pregnant, lactating, or not willing to use effective contraception
* Drug or alcohol abuse
* Used any topical acne treatment within 2 weeks
* Used any systemic retinoid, antibiotic or other acne treatment
* Used any investigational drugs or device within 3 months, or concurrently enrolled in another clinical trial
* Patient who the investigator deemed to be unsuitable for any reason
Sickle Cell Uric Acid (SCUA) - Cohort Repository

The purpose of this research is to study the causes of Sickle Cell kidney disease, as well as to collect and store samples and information about people with Sickle Cell Disease.

Sickle Cell Disease causes kidney injury over time, but it is not clear why some individuals have very significant chronic kidney disease and why some do not. The purpose of this research is to study whether having high levels of 'uric acid,' which is a naturally occurring molecule in the body that may increase kidney injury and systemic inflammation, accelerates the progression of chronic kidney disease over time. Researchers will measure the number of participants that have high uric acid levels at the beginning of the study, as well as the number of participants that develop new high levels throughout the study. The study will also try to determine what causes the high uric acid levels in some patients but not others. The results of this study could help understand kidney injury and uric acid in sickle cell disease better.

Eligibility Criteria:
Inclusion Criteria:

* Age 5-29 years
* Sickle cell disease as diagnosed by hemoglobin electrophoresis, or by newborn screen per standard of care
* Currently receiving comprehensive sickle cell care at the Children's Hospital of Richmond at VCU or in the adult Internal Medicine sickle cell care clinic at VCU.

Exclusion Criteria:

* Those who have received organ, stem cell, or bone marrow transplantation. - Those who require chronic dialysis
Clinical Trail of Tang-min-Ling Pills in Type 2 Diabetes Mellitus

This is a randomized, doubled blind, dose-paralleled control, multi-centre clinical trail,to evaluate the efficacy of Tang-min-ling pills in the treatment of type 2 diabetes mellitus.

Type 2 diabetes mellitus combined liver-stomach heat retension syndrome were recruited, which were divided into 3 groups .The patients were randomly taken with high-dosage (12g Tang-min-ling pills every time), low-dosage (6g Tang-min-ling pills every time), placebo by 3 times every day for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* initial treatment type 2 diabetic patient
* liver-stomach heat retention syndrome
* BMI ≥24kg/m2
* aged 30-65 years
* after screening stage(lifestyle intervention),Hba1C≥7.0%,FPG7.0-13.3mmol/L or PG2h\>11.1mmol/L;
* voluntary signs the informed consent

Exclusion Criteria:

* have used anti-diabetes drug before more than 1 month
* used drug to control the blood sugar with 3 weeks
* diabetic ketosis,keto-acidosis,serious infection or trauma,major surgery within 1 month
* liver or kidney insufficiency,lung insufficiency,heart failure,acute myocardial infarction or other serious primary disease
* SBP/DBP \>160mmHg/100 mmHg
* serious chronic diabetic complication
* chronic stomach-intestine disease,bad condition of the whole body
* pregnancy,preparing to pregnant,or breast-feed stage women
* allergic to TCM component
* mental disease
* allergic habitus
* attending to other clinical test
* attended this test before
* bibulosity and/or mental active drug,drug abuse or depend
* usually change the working environment,unstable live environment,etc.which will complied the inclusion
* unstable dose or type of anti-hypertension drug
* taking the drug or health food which will change the body weight
Cognitive Training in Parkinson's Disease

The study evaluates a computerized cognitive therapy in patients with Parkinson's disease who have a mild cognitive impairment or mild dementia. The control group is "trained" using Nintendo Wii. The main outcome parameter is a neuropsychological evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease and mild cognitive impairment (MCI) or mild dementia

Exclusion Criteria:

* Moderate or severe dementia, other pathologies of the brain, physical conditions that prevent the participation, unsufficient knowledge of german, pregnancy
Evaluation of 4th Generation Bipolar Radiofrequency Endometrial Ablation Device

All women presenting to the gynaecology outpatient clinic with heavy menstrual bleeding (HMB) in the absence of recognizable pelvic pathology, as determined by one or all of a normal pelvic ultrasound, hysteroscopy and / or endometrial biopsy, refractory to medical therapy that persists despite treatment with recommended pharmacological agents(1,2), who have no desire to preserve their fertility and are willing to have an endometrial ablation will be invited to participate. Eligible women with HMB will undergo radiofrequency G4 endometrial ablation in either an inpatient or outpatient setting according to their preference.

Outcomes will be assessed by administering postal questionnaires to measure menstrual bleeding symptoms including rates of amenorrhoea, dysmenorrhoea and life quality at baseline and at 6, and 12 months after ablative treatment. After the main study, there will be an additional evaluation of the long-term effects of outpatient ablative treatments of the endometrium by postal survey at 5 years.


Eligibility Criteria:
Inclusion Criteria:

1. Women with no desire to preserve their fertility who have heavy menstrual bleeding without organic pathology (DUB) of more than six months duration
2. Associated functional disability (negative impact on life quality).
3. Lack of response to medical treatment.
4. Prepared to undergo surgical treatment without general anaesthesia

Exclusion Criteria:

1. Women under 25 years
2. Suspected genital tract infection
3. Uterine pathology including endometrial pathology on endometrial biopsy (e.g. endometrial hyperplasia or carcinoma) and structural lesions (e.g. uterine malformations, adhesions, polyps, submucous fibroids or extracavity fibroids \> 3cm in diameter) as identified on pelvic ultrasound and/or outpatient hysteroscopy.
4. Uterine cavity length \>11cm
5. Adnexal pathology
6. Previous open myomectomy or endometrial ablation / resection and classical caesarian section
7. Patients considered vulnerable (e.g. current mental illness, emotionally labile, learning difficulties, immaturity)
Splanchnic Nerve Anesthesia in Heart Failure

Patients admitted for acute heart failure and undergoing right heart catheterization will be enrolled in this study. Subjects will undergo catheterization of the heart to obtain central cardiac pressure and other cardiac hemodynamic parameters. Subsequently, the subject will undergo a regional nerve block of the splanchnic nerves. Patients will remain in the catheterization lab for the duration of anesthetic block and will be continuously hemodynamically monitored.

This study will be a prospective, uncontrolled clinical trial. The study will not be controlled as invasive monitoring of hemodynamics will be performed, allowing clear demonstration of a cause-effect relationship. The goal of the study is to provide proof of concept.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of heart failure (HF)
* Prior admissions for decompensated HF
* Symptomatic with dyspnea with clinical, radiographic or echocardiographic signs of fluid overload
* On a stable HF drug regimen prior to admission
* Anticipated hospital stay of at least 2 nights following catheterization procedure

Exclusion Criteria:

* Ongoing treatment with oral anticoagulation other than aspirin
* Immunosuppressive medications for solid organ transplant
* Acute MI (STEMI or NSTEMI) within 7 days
* Evidence of cardiogenic shock within 48 hours
* Systolic blood pressure \< 90 mmHg or \>180 mmHg
* Restrictive or constrictive cardiomyopathy
* Chronic kidney disease stage 3 or higher due to primary renal pathology
* Pregnancy
Eccentric Exercise in Patients With Non-Specific Neck Pain

Neck pain is one of the most frequently investigated and common musculoskeletal disorders that cause disability in the community.If neck pain is due to multifactorial etiology, it is defined as non-specific neck pain.Eccentric exercises are used to increase muscle strength and muscle mass.

Non-specific neck pain affects negatively and often leads to severe disability. Various rehabilitation techniques are available to reduce pain and disability and increase functional level.

This study aimed to compare the pain and functional status of eccentric exercise training and home program exercise groups of people with non-specific neck pain.

It is known that exercise treatments are useful in strengthening neck muscles and controlling postural disorders in patients with neck pain, which is currently accepted. Eccentric exercises are used to increase muscle strength and muscle mass.

Home exercise and eccentric exercise training groups were included in a total of 24 sessions (8 weeks\*3 days); home exercise program was applied to the individuals in the control group. Visual Analog Scale, Mc Gill Melzack Pain Assessment, Neck Disability Index, hand grip strength, and skin resistance assessments.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with Non-Specific neck pain by a physician
* Having a complaint of non-specific neck pain for at least 3 months
* Neck pain severity \>40mm according to VAS
* Voluntary participation of the individual in the study

Exclusion Criteria:

* Radiculopathy and structural defect in the cervical region,
* Surgical history on the cervical region,
* Inflammatory disease,
* Severe psychological illness,
* Presence of infection in bone and soft tissue in the cervical spine,
* Malignancy,
* Advanced osteoporosis,
* Having upper extremity pathologies,
* Having a neurological disease that will prevent treatment
* Having previously undergone cervical region and spine surgery
* To be included in the physiotherapy program from the neck and back region in the last 6 months,
* In case of administration of drugs such as NSAIDs, opioids in the last 24 hours
Use of Medicinal Plants and Other Alternative and Complementary Medicines by Patients With Cancer in Reunion Island

Exploratory, observational and cross-sectional study with the aim of describing the use of plants for medicinal purposes (and other Complementary and Alternative Medicine) and identifying the determinants of this use. The methodology envisaged is mixed with an exploratory design combining qualitative (interviews) and quantitative techniques (questionnaires).

To knowledge of investigators, no study has been carried out in Reunion Island on the use of plants and other alternative and complementary medicines among cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Living in Reunion Island
* Suffering from cancer (solid tumors, hematological malignancies)
* Able to answer a questionnaire
* Patient who does not oppose to the research

Exclusion Criteria:

* Person of legal age under guardianship or under legal protection
* Persons who do not understand French or Reunionese Creole
Research Study of Treatment for Winter Depression With Different Colors of Light

The specific aim of this study is to test the hypothesis that light stimuli concentrated around 467 nm will evoke a significantly stronger therapeutic response in SAD patients compared to light stimuli concentrated around 657 nm at an equal photon density.

The secondary objective of this study is to determine the efficacy of different colors and levels of light in order to optimize therapeutic benefit, while also minimizing side effects and maintaining safety of light exposure.

Studies report as many as 1 out of every 5 Americans is affected by mild to severe Seasonal Affective Disorder (SAD, winter depression). Although the exact cause of this condition is unknown, bright light has proven to be an effective therapeutic treatment for many people with SAD. The light sources that have been traditionally used for treatment of SAD produce white light with great variability in the balance of wavelengths that are emitted across the visible spectrum. Although several studies have attempted to test the effectiveness of different wavelengths for treatment of SAD, the devices used in those studies employed broad bandwidths of light. With the technological advancements in light emitting diodes (LEDs) the production of new light therapy equipment with much narrower bandwidths of light is possible. Side effects of exposure to traditional white light therapy for SAD have included hypomanic activation, irritability, headache, eyestrain and nausea. We hypothesize that when the wavelength of light therapy is optimized, it should be feasible to elicit strong therapeutic benefits with lower light intensities and fewer side effects. Previous studies, approved by the Jefferson IRB and successfully completed by our laboratory have shown that some colors of light are more effective in treating SAD than other colors.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Seasonal Affective Disorder
* Over 18 years old
* Stable sleeping pattern with a bedtime no later than 1 a.m.

Exclusion Criteria:

* Pregnant women
* Concurrent psychiatric illness that would preclude compliance with the protocol
* active suicidal or homicidal ideation or plan
* variable psychiatric illness (i.e. rapid cycling disorder or severe premenstrual syndrome)
* individuals with substance abuse or dependence who have not been in remission for at least one year
* individuals taking photosensitizing medications
* individuals with macular degeneration or other ocular conditions which might be adversely affected by light
* less then six weeks after onset of psychotherapeutic treatment
Natural History Study for DNA Repair Disorders

This will be a single-center, single-arm, non-interventional natural history study to evaluate the longitudinal clinical course, functional outcome measures, and candidate biomarkers for individuals with DNA repair disorders, including Cockayne syndrome (CS), xeroderma pigmentosum (XP), and trichothiodystrophy (TTD).

This will be a single-center, single-arm, non-interventional natural history study to evaluate the longitudinal clinical course, functional outcome measures, and candidate biomarkers for individuals with DNA repair disorders, including Cockayne syndrome (CS), xeroderma pigmentosum (XP), and trichothiodystrophy (TTD). Our hypothesis is that a reliable and reproducible baseline natural history course can be established for DNA repair disorders using the Early Childhood Assessment of Balance (ECAB) as a primary endpoint and other measures as secondary and exploratory endpoints that may be used in future therapeutic clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Cockayne syndrome (CS), xeroderma pigmentosum (XP), or trichothiodystrophy (TTD), based on genetic testing and/or key clinical characteristics l characteristics
* Has one or more of the following neurodevelopmental or neurological complications
* Gross motor delay (non-ambulatory or started walking after age 18 months)
* Language delay (non-verbal or started talking after 18 months)
* Altered muscle tone (hypertonia, dystonia, hypotonia)
* Gait difficulties, including stiff gait, short stride, frequent falls, use of orthotics, use of walker
* Tremors
* Microcephaly
* Is a family member of an individual with the above condition
* No restrictions regarding current ambulatory status
* Minimum age for enrollment eligibility will be 6 months due to fragility of neonates with severe forms of DNA repair disorders and limitations of motor assessment scales in infants younger than 6 months. There will be no maximum age for enrollment eligibility.
* No restrictions regarding gender, race, or ethnicity.
* Voluntary written consent from the participant if adult capable of consenting or parent/guardian if minor or not capable of consenting
* Written consent of Legally Authorized Representative if enrolling adult lacks capacity to consent

Exclusion Criteria:

* Any prior history of systemic gene or cell-based therapy
* Current participation in an interventional clinical trial
Evaluation of a Claims-based Algorithm for the Identification of Transthyretin-mediated Amyloidosis (ATTR) Amyloidosis in Medical Records

The primary objective of this study is to evaluate the diagnostic performance of an algorithm in identifying patients with ATTR amyloidosis.

A screening strategy to identify ATTR in the large background population of patients with one or more common ATTR manifestations, would be of significant clinical value.

In addition, novel ATTR therapies have been recently made available or are currently in development in late-stage clinical trials. As early diagnosis and treatment is expected to achieve better outcomes, this makes the development and validation of an easily implemented, rapid and electronically-enabled diagnostic algorithm especially important.

A medical and pharmacy claims-based algorithm was developed to potentially identify patients at risk of having ATTR. The goal of this study is to evaluate the ability of the algorithm to identify patients with ATTR by performing diagnostic clinical work up in patients that the algorithm identifies in a large dataset of patients at Yale.

The primary objective of this study is to evaluate the diagnostic performance of the algorithm in identifying patients with ATTR amyloidosis.

The secondary objective of this study is to estimate the clinical benefit of the algorithm, as measured by the added diagnostic value, i.e. the proportion or rate of patients who were previously undiagnosed. The total obtained prevalence will be assessed and informally compared to the referral-based prevalence of ATTR amyloidosis patients at Yale.

Eligibility Criteria:
Inclusion Criteria:

* Identified by the ATTR diagnostic algorithm and matched by Yale's list of potential subjects defined as:

  1. subjects within the claims dataset that are predicted to be at risk of having ATTR who are also being managed within YNHHS
  2. patients who need to be contacted and offered additional clinical evaluation to determine whether they have a diagnosis of ATTR (non-hereditary or Hereditary ATTR amyloidosis).

     Exclusion Criteria:
* Patients who have opted out of research in the Epic system will be excluded entirely from the study
* Patients who are pregnant or who may become pregnant