cyrilzakka/clinical-trials huggingface dataset:
Black Cohosh as Alternative Therapy for Treating Menopause-Related Anxiety

This study will determine the effectiveness of the herb black cohosh for treating menopause-related anxiety symptoms in women.

Study hypotheses: 1) Black cohosh will have a superior anti-anxiety effect compared to placebo. 2) Black cohosh will have a comparable safety profile to that of placebo.

During menopause, up to 90% of women will experience symptoms of anxiety, such as nervousness, irritability, fatigue, muscle aches, depression, and low libido. Concern over the safety and effectiveness of hormone replacement therapy for relieving these symptoms has caused many women to seek alternative medical treatments. Data suggest that black cohosh has a direct effect on the neurotransmitters and receptors involved in anxiety. This study will determine whether black cohosh can effectively treat anxiety symptoms in menopausal women.

This study will last 12 weeks. Participants will be randomly assigned to receive either black cohosh or placebo daily for the duration of the study. Self-report scales will be used to assess participants' anxiety symptoms and quality of life at the beginning and end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Currently experiencing menopause or postmenopausal
* Have symptoms of menopause-related anxiety

Exclusion Criteria:

* Any form of generalized anxiety disorder (GAD) unrelated to menopause
* Onset of GAD at least 3 years prior to menopause or at least 5 years after menstruation has stopped
* Alcohol or drug dependence within 3 months prior to study entry
* Allergy to black cohosh
* History of hormone replacement therapy
* Current use of vaginal estrogen cream or phytoestrogens
* Current use of tranquilizers, antidepressants, or antianxiety therapies
* Abnormal uterine bleeding
* History of estrogen-dependent cancer
* History of endometrial hyperplasia (abnormal increase in cells) or endometrial cancer
* Rapidly growing uterine fibroids
* Abnormal finding upon gynecological examination that would interfere with the study
* Abnormal breast examination or mammogram
* Any unstable medical condition
The Effects of Fractional CO2 Laser on Poikiloderma of Civatte

This study will assess the safety and efficacy of fractional CO2 laser treatment for Poikiloderma of Civatte (POC).POC is a chronic vascular and pigmentary disorder typically involving the lateral and inferior neck region, as well as the chest area. Clinically, poikiloderma appears as a combination of telangiectasia, irregular pigmentation, and atrophic changes.Little data exist regarding the use of fractional CO2 laser for management of POC. This study hopes to fulfill this purpose. The primary outcome will be a blinded assessment by dermatologists in the improvement in POC using the Physician's Global Aesthetic Improvement Scale following therapy. The secondary outcomes include subject satisfaction post-treatment and assessment of all procedure-related adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, English and non-English speakers, and subjects more than 18 years old
* Clinical diagnosis of poikiloderma of Civatte affecting the neck and chest
* Agree to not undergo any other procedures on the neck and chest area during the study
* Agree to refrain from tanning for 6 months post-procedure
* Willing and able to read, understand, and sign the consent form
* Willing and able to adhere to the treatment and follow-up schedule as well as post-treatment care

Exclusion Criteria:

* Patients under 18 years old
* Active skin infection, dermatitis, or a rash on the treatment area
* Pregnant or lactating patients
* Patients on immunosuppressive medications
* Any laser procedures or chemical peel procedures on the neck or chest area within the past 6 months
* Patients with multiple comorbidities such as diabetes mellitus, cardiovascular diseases, neurologic disorders, internal malignancies
* Personal history or family history of forming keloids or hypertrophic scars, or abnormal wound healing
* Patients with known bleeding disorders or taking more than one anticoagulation medications
* Undergoing any surgery in the treatment area within the past 12 months
* History of radiation to the head, neck, and chest area
* Systemic use of isotretinoin within 6 months
* Any use of gold therapy
* Current smoker or history of smoking within 12 months of study
* Any physical or mental condition in which the investigators deem unsafe for the subject to participate in the study.
* History of recurrent herpes simplex on the neck or chest.
Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice

One of the most common diseases in the neonatal period is indirect hyperbilirubinemia (IHB). After phototherapy was discovered accidentally in 1958, it has been used as the most effective treatment method for IHD for more than 60 years. Sources that provide phototherapy are developing rapidly technologically. However, there is no clearly defined usage table in the literature for applying phototherapy with faster effects and fewer side effects. In recent years, the use of intermittent phototherapy has been recommended with similar effectiveness. Phototherapy has significant side effects such as dehydration, diarrhea, chromosome breaks, retinal damage, skin rashes, hypocalcemia, thrombocytopenia. As phototherapy exposure decreases, its side effects decrease.In our study; We plan to find the most ideal method in the treatment of IHB by comparing intermittent PT with continuous phototherapy in terms of effectiveness. We aim to achieve the best bilirubin reduction and minimal side effects with less exposure to phototherapy.

n the intermittent phototherapy group, phototherapy will be applied for 1 hour and phototherapy will be turned off for 2 hours, allowing time for the skin to be cleaned. The 3-hour cycle is completed twice and the 6-hour session is completed, and at the end, the total bilirubin will be measured and the hourly bilirubin decrease rate will be calculated.

In the continuous phototherapy group, total bilirubin will be measured at the end of 6 hours of uninterrupted phototherapy and the hourly bilirubin decrease rate will be calculated.

It was planned to compare the effectiveness of the two groups in terms of the bilirubin level reduced as a result of 6-hour sessions, hourly reduction rate, rebound bilirubin level, total phototherapy time received, hospitalization time, and additional treatments required.

It was planned to compare both groups in terms of the frequency of side effects such as the number of defecations, body temperature changes, and skin rash during the phototherapy session.

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria was being a late preterm or term neonate who had IHB in the first 15 days of life-

Exclusion Criteria:

* Those who had sTB values at the blood exchange limit according to the nomogram, any associated congenital anomalies including chromosomal anomalies or were less than 34th gestational week were excluded.
Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetes
* 18 years or older
* Non-clinically significant diabetic macular edema
* Mild to moderate diabetic retinopathy in the study eye, vitreous hemorrhage in the study eye
* Relatively good vision (20/30 or better)

Exclusion Criteria:

* Surgery or laser treatment in the study eye
* Glaucoma in the study eye
* Glycosylated hemoglobin (HbA1c) greater than 11%, or systolic blood pressure greater than 170 millimeters of mercury (mmHg)
* Liver disease, dialysis or renal transplant
Early Detection of Silent Myocardial Ischemia

Early-Synergy investigates a diagnostic imaging approach in asymptomatic individuals from the general population for early detection of silent myocardial ischemia and cardiac dysfunction. The diagnostic imaging approach consists of cardiac computed tomography for coronary artery calcium scoring (CT-CAC) and cardiac magnetic resonance (CMR) stress perfusion imaging. Early-Synergy investigates the effect of early detection of silent myocardial ischemia and cardiac dysfunction by CMR in asymptomatic individuals with increased CAC. In addition, the diagnostic yield of CMR for early detection of silent myocardial ischemia and cardiac dysfunction is investigated. Asymptomatic individuals at increased risk (CAC ≥ 300) are therefore randomized 1:1 to either CMR stress perfusion imaging or a control group.

Early-Synergy is a prospective multi-center study performed in the Netherlands. Potential candidates for participation in Early-Synergy have had CT-CAC scanning as part of participation in two ongoing population-based studies (ROBINSCA and ImaLife) and had CAC ≥300.

Participants are randomized in a 1:1 fashion to (1.) CMR stress perfusion imaging with feedback of clinically actionable findings or (2.) control group.

In the CMR group, feedback on CMR stress perfusion imaging is provided to the participant and general practitioner only in case of CMR findings that require further management based on current clinical guidelines. Participants in the control group will not receive stress CMR perfusion imaging but will be followed in time to evaluate the clinical presentation of the natural course of coronary atherosclerosis.

Follow-up will be performed up to 5 years in both groups by sending questionnaires and collecting medical information from health care providers and registries. Additionally, blood is drawn from participants in the CMR group during the hospital visit for CMR scanning and is stored to allow evaluation of cardiac blood markers as predictors of CMR findings.

Eligibility Criteria:
Inclusion Criteria:

* Participation in ROBINSCA or ImaLife study
* CT-CAC ≥300

Exclusion Criteria:

* History of ischemic heart disease or other cardiac disease (myocardial infarction, sudden cardiac arrest, heart failure, cardiomyopathy, congenital cardiac disease, percutaneous coronary intervention, coronary artery bypass grafting surgery, valvular surgery, other major cardiac surgery (e.g. cardiac transplantation) and/or previous invasive coronary angiography or catheter ablation)
* Contra-indication for stress CMR perfusion imaging (claustrophobia, CMR incompatible device (e.g., Implantable Cardioverter Defibrillator/pacemaker), contrast agent or vasodilator intolerance, contra-indications for adenosine or regadenoson (e.g. 2nd/3rd degree atrioventricular block, severe hypotension) and/or weight \> 125 kg)
* Severe comorbidity and/or a life expectancy of less than 1 year
* Unable to provide written informed consent
* Pregnancy
Effect of Personalized Accelerated Pacing in Symptomatic Patients With Non-Obstructive Hypertrophic Cardiomyopathy

This will be a two-arm investigator-initiated randomized controlled study of patients with nHCM and LV ejection fraction ≥50% and NYHA II-III symptoms, normal intrinsic conduction system and pre-existing suitable dual-chamber implantable cardioverter defibrillators (ICD) systems. Patients will be randomly assigned to either personalized accelerated pacing (using the myPACE+ algorithm with mono-fractional exponent) or usual care groups. At baseline and after 3 months of pacing all patients will undergo a CPET, echocardiogram, blood work for NT-proBNP levels and complete the KCCQ-OSS and HCMSQ, questionnaires.

The investigator team hypothesizes that personalized accelerated pacing will be safe and improve symptoms and heart-failure related quality of life, physical activity, pVO2, biomarkers (i.e. NT-proBNP), diastolic parameters and cardiac structure.

This will be a two-arm investigator-initiated randomized controlled study of patients with nHCM and LV ejection fraction≥50% and NYHA II-III symptoms, normal intrinsic conduction system and pre-existing suitable dual-chamber implantable cardioverter defibrillators (ICD) systems. Patients will be randomly assigned to either personalized accelerated pacing (using the myPACE+ algorithm with mono-fractional exponent) or usual care groups. At baseline and after 3 months of pacing all patients will undergo a CPET, echocardiogram, blood work for NT-proBNP levels and complete the KCCQ-OSS and HCMSQ, questionnaires.

The investigator team hypothesizes that personalized accelerated pacing will be safe and improve symptoms and heart-failure related quality of life, physical activity, pVO2, biomarkers (i.e. NT-proBNP), diastolic parameters and cardiac structure. An interim data safety analysis will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Non obstructive HCM: Left Ventricular Outflow Tract (LVOT) gradient \<30mmHg at rest and with provocation
* Left ventricular ejection fraction (LVEF) ≥50%
* New York Heart Association (NYHA II-III) symptoms
* Normal intrinsic conduction system
* Suitable dual-chamber implantable cardioverter defibrillators (ICD) system

Exclusion Criteria:

* Pregnancy
* LVEF \<50%
* LVOT gradient \> 30mmHg at rest or with provocation
* Prolonged PR \> 250ms
* Baseline RV-pacing burden of \> 1% more than moderate valvular stenosis or regurgitation
* Aortic valve replacement in the past one year
* Significant primary pulmonary disease on home oxygen
* Uncontrolled hypertension as defined by BP \>160/100 mmHg on two measurements ≥15 minutes apart
An Extension Study of JR-171-101 Study in Patients With MPS I

Phase I/II, open label, multicenter, multinational (Japan, Brazil and the US) extension study of JR-171-101 for the treatment of MPS I

Patients who have completed the Part2 of JR-171-101 study and fulfill all eligibility criteria can be enrolled in this JR-171-102 study. In the JR-171-102 study, subjects will receive either 2.0 or 4.0 mg/kg/week of JR-171 intravenously at the same doses received at Week 12 of the JR-171-101 study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed the Part 2 of JR-171-101 study
* A patient from whom written informed consent can be obtained. If the patient is aged under 18 years (20 years in case of Japan) at the time of assent or willingness to participate in the study cannot be confirmed due to MPS I-related intellectual disability, informed permission from the patient's legally acceptable representative (e.g., his/her parents or guardians) need to be obtained instead of his/her consent. Even in this case, written informed consent should be obtained from the patient, wherever possible
* Female patient or male patient whose co-partners is of child-bearing potential agree to use a medically accepted, highly effective method of contraception, such as spermatocidal gel plus condom, an intrauterine device or oral contraceptives until one month after the final administration.

Exclusion Criteria:

* A patient who is unable to perform the study procedures, except for 6-minute walk test, neurocognitive testing, BVMT-R, HVLT-R, and T.O.V.A.
* Judged by the principal investigator or subinvestigator as being unable to undergo lumbar puncture, including those who have difficulties in taking a position for lumbar puncture due to joint contracture or those who are likely to experience difficulty breathing during the lumbar puncture process
* Judged by the principal investigator or subinvestigator to be ineligible to participate in the study due to a history of a serious drug allergy or hypersensitivity to any drugs
* Otherwise judged by the principal investigator or subinvestigator to be ineligible to participate in the study in consideration of patient's safety
Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)

The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine licensed in Europe.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to \<61 years of age
2. mentally competent to understand the nature, the scope and the consequences of the study
3. able and willing to give written informed consent prior to study entry
4. in good health as determined by:

   1. medical history,
   2. physical examination,
   3. clinical judgment of the Investigator.

Exclusion Criteria:

1. unwilling or unable to give written informed consent to participate in the study
2. participation in another clinical trial of an investigational agent within 90 days prior to Visit 1 and throughout the entire study
3. currently experiencing an acute infectious disease
4. any serious disease, such as, for example:

   1. cancer,
   2. autoimmune disease (including rheumatoid arthritis),
   3. advanced arteriosclerotic disease or complicated diabetes mellitus,
   4. chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
   5. acute or progressive hepatic disease,
   6. acute or progressive renal disease,
   7. congestive heart failure
5. surgery planned during the study period
6. bleeding diathesis
7. history of hypersensitivity to any component of the study medication or chemically related substances
8. history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine component
9. known or suspected impairment/alteration of immune function, for example resulting from:

   1. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),
   2. receipt of immunostimulants,
   3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study,
   4. high risk for developing an immunocompromising disease
10. history of drug or alcohol abuse
11. laboratory-confirmed influenza disease within 6 months prior to Visit 1
12. receipt of influenza vaccine within 6 months prior to Visit 1
13. receipt of another vaccine within 60 days prior to Visit 1, or planned vaccination within 3 weeks following study vaccination
14. any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever (i.e., axillary temperature ≥ 38 degree C) within 5 days prior to Visit 1
15. if female, pregnant or breastfeeding
16. if female, refusal to use a reliable contraceptive method during the three weeks following vaccination
17. planned relocation abroad during the study period
18. any condition that, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
Cemented K-wire Fixation vs Plating for Finger Fractures

To introduce a novel external-fixation technique using the combination of K-wires and cement. For comparison, we also included another group of patients who were treated using a mini plate and screw system. Bone healing, range of motion of the fingers, costs of treatments, and patient satisfaction were assessed.

Shaft fractures of the proximal phalanx are common injuries that may significantly affect hand function. Good fracture stability to allow early mobilization of joints and thus early return of function. The objective of this report is to introduce a novel external-fixation technique using the combination of K-wires and cement. For comparison, we also included another group of patients who were treated using a mini plate and screw system. A total of 104 patients (131 fingers) were randomly allocated into group A (56 patients) and B (51 patients). Patients in group A were treated with cemented K-wire fixation; and patients in group B were treated with conventional mini-plate. Bone healing, range of motion of the fingers, costs of treatments, and patient satisfaction were assessed.

Eligibility Criteria:
Inclusion Criteria:

* patient aged between 18 and 65 years;
* acute fractures within 15 days;
* closed fracture or open injury with small wound less than 1.5 cm;
* involvement of proximal phalanges of index to little fingers; shaft fractures;
* at least 5 mm in length of the most distal and proximal fragments so that the K-wires or screws can be engaged;
* oblique, spiral, and comminuted fractures;
* normal opposite hand for comparison.

Exclusion Criteria:

* patients younger than 18 years are excluded because of skeletal immaturity;
* patients older than 65 years are excluded because of possible osteoporosis;
* severe open injury or crush injuries; tendon or neurovascular injuries; - involvement of articular surface;
* old fractures exceeding 15 days because close reduction was most likely difficult;
* a combined tendon, nerve, or artery injuries or diseases; diabetes, gout, ganglion;
* osseous tumors, and other disease affecting bony structures and joint motion;
* patients who declined to participate.
Instrumental Activities of Daily Living Approach in Home Environment for Patients With Stroke

The purpose of this study was to conduct a randomized clinical trial. Implement instrumental daily activities of daily living (A-IADL) in home rehabilitation. To explore the effect of A-IADL on stroke patients' movement, cognition, social participation, daily life function and quality of life.

Subjects were randomized to intervention group and control group. The experiment was designed as randomized cross-over control trial. The primary outcome included 11 measures, Fugl-Meyer Assessment, Balance computerized adaptive testing, Mini Mental State Examination, Participation Measure-3 Domains ,4 Dimensions, Canadian Occupational Performance Measure, Barthel Index-based Supplementary Scales, Frenchay Activities Index, Lawnton Instrumental Activities of Daily Living, stroke impact scale, Stroke Self-Efficacy Questionnaire, and Kingston Caregiver Stress Scale.

Eligibility Criteria:
Inclusion Criteria:

* age \> 20 years
* Diagnosis of stroke
* The modified Rankin Scale : 2\~4
* Keep sitting for half an hour by himself/herself
* Follow instructions
* Willing to sign the subject's consent

Exclusion Criteria:

* Diagnosis of dementia
* History of orthopedic diseases or peripheral nerve injury
The Effect of Melatonin on Cognitive Function in Patients Diagnosed With Mild Cognitive Impairment

Recent studies have described the role of melatonin as a sleep regulator and as an anti- oxidative neuroprotective agent in improving sleep quality and delaying cognitive decline in Alzheimer's disease (AD).

In accordance with this data, our hypothesis is that melatonin will delay the cognitive decline in Mild Cognitive Impairment (MCI) patients and reduce the conversion rate from MCI to AD.


Eligibility Criteria:
Inclusion Criteria:

1. MCI assessment according to the Peterson et al. (2001) criteria.
2. Age 55-90 years, inclusive.
3. Study informant available.
4. Mini Mental Status Examination ; MMSE 24-30.
5. Adequate vision and hearing for neuropsychological testing.
6. Normal vitamin B12 level and thyroid function.

Exclusion Criteria:

1. Significant cerebral vascular disease (Modified Hachinski scale \> 4).
2. Depression (Hamilton Depression Rating Scale \> 12).
3. Central nervous system infarct, infection or focal lesions of clinical significance on CT or MRI scans.
4. Medical diseases or psychiatric disorders that could interfere with study participation.
5. Pregnant, lactating or childbearing potential.
6. Taking vitamin supplements or other supplements.
7. Restrictions on concomitant medication usage, including those with significant cholinergic or anti-cholinergic effects or potential adverse effects on cognition.