cyrilzakka/clinical-trials huggingface dataset:
Motor Excitability Study of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Chronic Stroke

High definition tDCS will be conducted to both stroke and healthy subjects on primary motor cortex area to explore the motor excitability changes before and after stimulation. In next stage, a randomized control trial with 20-session training will be conducted to evaluate the effectiveness of transient modulation of cortical excitability through multisite HD-tDCS with EMG driven robot hand training, a sham stimulation with EMG-driven robot hand training will be applied as control group.


Eligibility Criteria:
Inclusion Criteria:

1. Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment;
2. Have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meter Assessment (FMA), and Action Research Arm Test (ARAT));
3. Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection

Exclusion Criteria:

1. Severe hand spasticity, open hand wound or hand deformity;
2. Visual field deficits;
3. Aphasia, neglect, and apraxia;
4. History of alcohol, drug abuse or epilepsy;
5. Bilateral infracts;
6. Uncontrolled medical problems;
7. Serious cognitive deficits \[Mini-Mental State Examination (MMSE) \< 21\];
8. Major depression
9. Metal implants inside body
10. MRI, TMS and tDCS contraindications
To Investigate the Influence of Surgery and Anesthesia on Elderly Population by Using the Comprehensive Geriatric Assessment

Aging is a universal and progressive physiological phenomenon clinically characterized by degenerative changes in both the structure and the functional capacity of organs and tissues. A comprehensive geriatric assessment (CGA) has now become a standard assessment for caring for the elderly. CGA is a multidisciplinary team with the goal of improving the overall well-being of the elderly. It encompasses screening, diagnosis and treatment of the elderly. In this study, we use the comprehensive geriatric assessment to study the effects of surgery and anesthesia on elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Participants receiving general anesthesia for longer than 1 hour.

Exclusion Criteria:

* Participants receiving local anesthesia.
* Participants receiving regional anesthesia.
* Participants receiving general anesthesia for less than 1 hour.
* Participants with psychiatric disorder.
Combination of Recombinant Human IL-21 (rIL-21) and Sunitinib in Stage IV Renal Cell Carcinoma Patients

This phase 1/2a trial is conducted in Europe. The first part of the trial is a dose escalation safety trial determining the maximum tolerated dose of rIL-21 when administered in combination with sunitinib.

The second part, scheduled to start in September 2008, is a randomised 2-arm trial comparing the anti-tumour effect of rIL-21 plus sunitinib with sunitinib alone.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified and surgically incurable stage IV Renal Cell Carcinoma
* ECOG performance status of 0 or 1 (i.e. good performance status)
* Life expectancy of at least 3 months

Exclusion Criteria:

* Prior systemic therapy for metastatic disease
* Radiotherapy within the last 4 weeks prior to start of treatment
* Receipt of any investigational drug within 3 months of starting treatment
* History of any other active malignancy within five years prior to enrolment
Open Trial of a Program to Support Parents of Children With Attention-deficit/Hyperactivity Disorder (ADHD)

Behavioral parent training is an evidence-based treatment for ADHD. The intervention can be implemented individually, or in groups. Currently, group-based parent training programs require considerable coordination, including ascertainment of a large physical space, the coordination of all families traveling to the same location at the same time, and the require for the provision of childcare. Innovations in online connectivity and ease of implementation of online support applications (e.g., Zoom) may reduce these barriers. However, it is necessary to investigate the feasibility and promise of the online approach to ensure it supports parents effectively.

This study will utilize a pre-post, open trial design as the primary aim is to investigate feasibility. Approximately sixty parents will complete prepost ratings of parenting behaviors and measures of child functioning. They will also complete post treatment measures of satisfaction and open-ended questions about feasibility and suggestions for future iterations of the approach. Process measures will include data collection related to attendance and engagement in the activities. Risks include breach of confidentiality and a lack of effectiveness of the intervention for the child's presenting problems. Benefits include the parent receiving an effective intervention.

Eligibility Criteria:
Inclusion Criteria:

* ADHD diagnosis
* Intelligence Quotient (IQ) greater than or equal to 70
* At least 1 parent/guardian who can attend zoom sessions
* Access to reliable internet connection for zoom meetings

Exclusion Criteria:

* Evidence of psychosis, suicidal behaviors, or autism level 2/3
Characteristics of Culprit Lesion and Changes in Plaque Composition. A Dual Energy Cardiac CT Study

Identifying patients who are at risk for a future myocardial infarction, is still one of the biggest challenges in cardiology.

In this study the investigators will investigate culprit lesion in patients with NSTEMI and the ability of cardiac CT with dual energy computed tomography (DECT) scanning to describe and identify plaques that may be vulnerable. The investigators will also describe changes in characteristic in both stable and unstable plaques during 1 year follow up of NSTEMI and a matching group of stable angina pectoris (SAP) patients.

Patients with verified NSTEMI undergo contrast-enhanced coronary DECT before conventional coronary angiography (CAG), and DECT characteristics of the culprit lesion will be determined. All Non-culprit lesions will be observed during 2 month and 1 year follow up characteristics and changes in plaque composition, volume and core content will be assessed.

Patients with SAP undergo a baseline DECT similar to NSTEMI group. Because the expected change in coronary plaques in SAP group is minimal, there is no need for follow up at 2 month.

Eligibility Criteria:
Inclusion Criteria:

* Patients with NSTEMI and scheduled to CAG or patients with SAP

Exclusion Criteria:

* Not suitable to undergo CT with contrast agent:
* Known allergy-like reactions to contrast or Claustrophobia
* Atrial fibrillation or significant arrhythmia judged to potentially limit quality of CT
* Known renal failure/insufficiency or s-creatinin\> 140 µmol/L.
* Severe/symptomatic thyrotoxicosis
* pacemaker
Prevalence of Premenstrual Syndrome in Women of Reproductive Age

The menstrual cycle is a recurring process in the lives of women from puberty until menopause. This cycle can cause various discomforts, including premenstrual syndrome.

Described differently, premenstrual syndrome is a collection of physical and psychological symptoms that occur during the luteal phase of the menstrual cycle and subside upon the arrival of menstruation. This definition is conditioned by the existence of a free interval of at least one week between the end of the period and the appearance of these symptoms, as well as a global impairment of functioning and quality of life for women.

The impact on the personal, social, and professional lives of affected women, as well as the pain and discomfort it causes, may be perceived as insignificant or normal by women. Therefore, few women report the existence of these disorders to healthcare professionals. As the subject is not approached, these women are not taken care of even though therapeutic solutions could be proposed.

This pathology affects a large number of women, but its prevalence differs greatly depending on the studies conducted on the subject, suggesting a lack of knowledge of this syndrome.

The main aim is to describe the prevalence of premenstrual syndrome among women of reproductive age.

Eligibility Criteria:
Inclusion Criteria:

* women in childbearing age, i.e., menstrual or secondary amenorrhoea, non-menopausal
* Over 18 years of age
* Agreeing to participate in the study

Exclusion Criteria:

* Menopause
* Having had a hysterectomy
* With primary amenorrhea
* Protected by law
* Refusing to participate in the study
Pharmacokinetic Study of Vildagliptin in Patients With Renal Impairment

This study will evaluate the pharmacokinetics of vildagliptin and its metabolites in patients with mild, moderate or severe renal impairment and healthy volunteers.


Eligibility Criteria:
Inclusion Criteria (general):

* Men and women (age 18 to 85 years)
* Participants must be nonfertile or using a medically approved birth control method. Additional information regarding this requirement available at screening
* Body mass index (BMI) ≤42 kg/m2 (inclusive)

Inclusion Criteria (for renal insufficient patients):

* Patients with mild, moderate, or severe kidney impairment. Please consult with participating physicians regarding the definitions of these levels of severity.
* Patients with diabetes must be treated with standard anti-diabetic therapy (diet and exercise, stable dose of sulfonylurea, insulin, or metiglinides) and agree to continue for the study duration

Inclusion Criteria (for healthy subjects):

* No current significant medical conditions as determined by history and physical.
* Serum creatinine with a calculated creatinine clearance (CrCl) of \>80 ml/min.
* Matched to renal impaired patients in the study by age (±5 years), sex and weight (±10% BMI)
* Vital signs guided by the following ranges:

oral body temperature between 35.0-37.2 °C systolic blood pressure, 100-140 mm Hg diastolic blood pressure, 60-110 mm Hg pulse rate, 45-90 bpm

Exclusion criteria:

* Pregnant or lactating female.
* A history of type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, acute metabolic diabetic complications (eg, ketoacidosis or hyperosmolar state (coma))
* Subjects that have been enrolled in previous vildagliptin studies or other DPP
* 4 inhibitor studies within six months
* History of renal transplant or immunosuppressant therapy
* Acute infections which may affect blood glucose control or other medical condition that may interfere with the interpretation of efficacy and safety data during the study
* Any pre-existing or history of diabetic ulcer
* Any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery or percutaneous coronary intervention, unstable angina or stroke
* Any of the following electrocardiogram (ECG) abnormalities: Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation, second degree atrioventricular (AV) block (Mobitz 1 and 2), third degree AV block, prolonged QTc (\>500 ms)
* Malignancy including leukemia and lymphoma within the last 5 years.
* Liver disease such as cirrhosis or positive hepatitis B and C.
* Any alcohol related hepatic disease.
* Patients undergoing any method of dialysis
* Use of some concomitant medications
* Significant laboratory abnormalities as specified in the protocol
* History of active substance abuse (including alcohol) within the past 2 years.
* Smokers (i.e., 10 or more cigarettes per day)
* History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures

Other protocol-defined inclusion/exclusion criteria may apply
Phase 3 Study of Dienogest for the Treatment of Endometriosis in Chinese Patients

This study is aimed to evaluate efficacy and safety of dienogest 2 mg oral tablets in the treatment of endometriosis.

There will be 2 study phases: a double-blind, randomized, placebo-controlled, parallel-group phase over 24 weeks, and an open-label extension phase with 2 mg DNG daily p.o. over 28 weeks for all subjects who completed the double-blind phase, irrespective of their treatment assignment in the first study phase.


Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 45 years of age, inclusive
* Women with endometriosis confirmed by laparoscopy or laparotomy within ten years but no later than 2 weeks before the Screening Visit
* A score of at least 30 on a 100 mm visual analog scale (VAS) for endometriosis-associated pelvic pain at Screening Visit and Baseline Visit
* Good general health (except for findings related to endometriosis, with or without infertility), as evidenced by medical history and complete physical and gynecological examination
* Willingness to use a barrier method of contraception is required

Exclusion Criteria:

* Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
* Wish for pregnancy within intended treatment period
* Before menarche or after menopause
* Amenorrhea (more than three consecutive months in the six months before screening)
* Undiagnosed abnormal genital bleeding
* Previous/use of hormonal agents
* Any disease or condition that may worsen under hormonal treatment
* Signs and/or symptoms of therapy-resistant endometriosis despite more than one prior attempt at drug treatment or surgical therapy
* Need for primary surgical treatment of endometriosis
* Regular use of pain medication due to other underlying diseases
* Contra-indication for the supportive analgesic medication (ibuprofen)
VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma

This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of VR-CAP (Bortezomib and Rituximab-Cyclophosphamide, Epirubicin and Prednisone) in the first-line treatment for patients with marginal zone lymphoma.

Marginal zone lymphoma (MZL) is a relatively common group of non-Hodgkin's lymphoma (NHL). The incidence rate is only inferior to diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL). Currently, NCCN guidelines recommend same treatment plan of FL like R-CHOP as the primary treatment for MZL. However, due to the great difference in cell origin and biological characteristics between FL and MZL, some patients can not achieve complete remission or relapse quickly after standard first-line treatment. A number of phase II clinical studies have evaluated the good efficacy of rituximab combined with chemotherapy in the treatment of MZL. Previous studies have shown that NF-κB signaling pathway is in abnormal activation state in MZL. Bortezomib, a proteasome inhibitor targeting NF-κB pathway, has a promising therapeutic prospect in relapsed and refractory MZL. The goal of our trial is to assess the efficacy and safety of VR-CAP (Bortezomib and Rituximab-Cyclophosphamide, Epirubicin and Prednisone) in the first-line treatment for patients with marginal zone lymphoma.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 70 years old (including 18 and 70)
2. Diagnosed as marginal zone lymphoma
3. No receiving chemotherapy before enrollment
4. Indications for treatment: 1) symptoms related to tumor; 2) end-organ function damage; 3) large mass; 4) continuous or rapid progress of disease; 5) patient's willingness
5. Having at least one measurable lesions
6. World health organization-Eastern Cooperative Oncology Group Performance tatus (ECOG) 0-1
7. Life expectancy no less than 3 months
8. enough main organ function
9. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study
10. Agreeing to sign the written informed consents

Exclusion Criteria:

1. Diagnosed as central nervous system lymphoma
2. World health organization-Eastern Cooperative Oncology Group Performance tatus (ECOG) ≥2
3. Other malignant tumor history or active malignant tumor need be treated
4. Serious surgery and trauma less than two weeks
5. Systemic therapy for serious acute/chronic infection
6. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months
7. Active tuberculosis. Patients suspected of active TB need to be examined for chest X-ray, sputum and clinical symptoms and signs
8. HIV-positive, AIDS patients and untreated active hepatitis（HBV/HBV and HCV）
9. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months
10. Patients with a history of mental illness
11. Researchers determine unsuited to participate in this trial
Effects of an Aquatic Therapy Program Versus a Land Program in Patients Who Suffered a Stroke

The objective of this study is to investigate the relative effectiveness of CCT on water versus on land in stroke patients. Additionally, the study will to determine if there are differences in the results obtained, between two CCT programs in the following parameters: gait, balance and dexterity

This study is a randomized controlled trial of the effectiveness of a structured CCT program in water versus a structured CCT program on land in the rehabilitation of stroke survivors.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of stroke (ischemic or hemorrhagic) onset ≤ 3 years; with hemiparesis secondary;
* age ≥18 to ≤ 90;
* provide a written informed consent;
* able to walk for at least 10 m without assistance

Exclusion Criteria:

* patients with uncontrolled or risky conditions (acute myocardial infarction, arrhythmia, heart failure, uncontrolled hypertension or unstable cardiovascular state);
* with infectious diseases, ulcers or urinary and / or faecal incontinence;
* additional neurological and / or orthopedic deficits that alter ambulation;
* unable to follow treatment (cognitive, visual ...).
The Effect of Breastfeeding Support System

This study aimed to examine the impact of a breastfeeding support system on breast milk production and mother-infant bonding in preterm infants. The sample included 70 preterm infants and their mothers, divided into two groups: 35 in the control group and 35 in the experimental group, all of whom met the study criteria.


Eligibility Criteria:
Inclusion Criteria:

For the infant:

Gestational age between 30 and 34 weeks Birth weight of 1000 g or more

For the mother:

Age over 18, literate, and able to speak Turkish Willingness to breastfeed and no chronic illness preventing breastfeeding

Exclusion Criteria:

Infants without identification Infants with unstable vital signs Mothers with conditions that prevent breastfeeding
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia

The goal of this investigator-initiated, randomized, blinded, 3-armed placebo-controlled, pragmatic, clinical superiority trial is to examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia in patients with psychiatric disorders. The aims of the study are:

* To examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia
* To examine how melatonin or low-dose quetiapine affects global symptom severity, sleep quality, psychosocial functioning and subjective well-being.

Participants will receive six weeks of treatment with either melatonin, quetiapine or placebo followed by a brief taper off.


Eligibility Criteria:
Inclusion Criteria:

* 16 to 64 years of age
* ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-95)
* For the diagnoses F84 and F90 a previous period of treatment with melatonin is required
* For the 16-17 years old: Non-pharmacological treatment options including sleep hygiene education, weighted blanket or other gravity products have been tested with insufficient effect
* Self-reported sleep difficulties at least three times per week in the preceding 3 months
* Insomnia Severity Index score ≥11
* Women of childbearing potential: negative pregnancy test at baseline and use of highly effective contraception measures
* Informed consent

Exclusion Criteria:

* Current treatment with melatonin or quetiapine
* Severe somatic comorbidity
* BMI ≥ 35 kg/m2
* Breastfeeding
* Alcohol and/or substance dependency within the last 3 months
* Inadequate Danish language skills
* Not able to make an informed consent
* Increased cardiac risk as assessed by presence of cardiac risk factors, cardiac symptoms, or prolonged QT-interval at baseline ECG
Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

This is a Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea.


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female who is at least 18 years of age or older.
2. A clinical diagnosis of facial rosacea.
3. A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).
4. A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).

Key Exclusion Criteria:

1. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
2. Presence of three (3) or more facial inflammatory lesions of rosacea.
3. Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists.
4. Less than 3 months stable dose treatment with tricyclic antidepressants, cardiac glycosides, beta blockers or other antihypertensive agents.
5. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
Discovery of Biomarkers for Intrinsic Radiation Sensitivity in Cancer Patients

Patients with cancers that are sensitive to radiotherapy treatment and/or patients who have experienced severe acute/ late side effects to radiotherapy will be recruited to the study. Blood and/or matched tumour-normal tissue pairs will be collected. Blood and/or tissue samples will be processed and studied for genetic and biochemical markers that have potential to be used for predicting sensitivity to radiation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe side effects from radiotherapy
* Patients with a type of cancer that is associated with sensitivity to radiotherapy

Exclusion Criteria:

* Age of patient must be between 21 (inclusive) and 99 (exclusive)