cyrilzakka/clinical-trials huggingface dataset:
Symptom Evaluation Following Repetitive Transcranial Magnetic Stimulation

A prospective study to evaluate symptoms following repetitive transcranial Magnetic stimulation.

Open-label, multicenter, prospective pilot study conducted in an adult population receiving rTMS treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Adults, 22 to 70 years of age
2. Voluntarily provides written informed consent and agree to comply with study procedures, including attending all study visits and completing all study assessments.
3. Score \> or = 8 on ISI scale
4. If subject is on any psychiatric or sleep medication, dose must be stable for two weeks prior to enrollment and remain stable throughout the trial.
5. If female, not breastfeeding, no known or suspected pregnancy, a status of nonchildbearing potential or use of an acceptable form of birth control.
6. Subject on stable dose regime for other concurrent medications like hormonal therapy for menopause transition etc.

Exclusion Criteria:

1. Subject meets any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.
2. History of head trauma associated with loss of consciousness or diagnosed as concussion.
3. History of fainting, syncope, hearing problems or ringing in the ears (tinnitus)
4. Has any metallic implant(s) in or near the head (e.g., pacemaker, defibrillator, neurostimulator, etc.) including any splinters, fragments, clips, etc.
5. Has an implanted stimulator device (including device leads) in or near the head. (e.g. deep brain stimulator, cochlear implant, vagus nerve stimulator.)
6. Has medication infusion device.
7. Subjects with any prior TMS or MRI complications, or any other issues/circumstance which, in the opinion of the investigator, might interfere with safety, study participation, or which might confound data interpretation.
8. PHQ-9 total score \> or = 10 or QIDS total score \> or = 11.
9. Drug abuse or dependence of the illicit substance. (Abuse or Dependence, as defined by DSM-V-TR)
10. Current diagnosis or known history of neurologic disease (e.g., epilepsy, convulsion, seizure)
11. Other known disorder (e.g., narcolepsy, a breathing-related sleep disorder like Obstructive Sleep Apnea, a circadian rhythm sleep-wake disorder, a parasomnia) as defined by DSM-V-TR.
12. Has a clinically significant abnormality on the screening examination.
13. Participation in any clinical trial with an investigational drug or device within the past month or concurrent with study participation.
Antineoplaston Therapy in Treating Patients With Primary Liver Cancer

Current therapies for Primary Liver Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Primary Liver Cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with advanced Head and Neck Cancer.

Primary Liver Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with advanced Primary Liver Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in patients with advanced Primary Liver Cancer.
* To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed primary liver cancer that is unlikely to respond to existing therapy and for which no curative therapy exists
* Measurable disease by CT scan or MRI
* Tumor must be at least 2 cm

PATIENT CHARACTERISTICS:

Age:

* 14 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 2 months

Hematopoietic:

* WBC at least 2,000/mm3
* Platelet count at least 50,000/mm3

Hepatic:

* Bilirubin less than 3 mg/dL
* SGOT/SGPT no greater than 10 times upper limit of normal
* No hepatic failure

Renal:

* Creatinine no greater than 2.5 mg/dL
* No history of renal conditions that contraindicate high doses of sodium

Cardiovascular:

* No uncontrolled hypertension
* No known chronic heart failure
* No history of congestive heart failure
* No history of other cardiovascular conditions that contraindicate high doses of sodium

Pulmonary:

* No serious lung disease (e.g., chronic obstructive pulmonary disease)

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception for 4 weeks before study, during study, and for 4 weeks after study
* No serious medical or psychiatric disease
* No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior immunotherapy and recovered
* No concurrent immunomodulating agents

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
* No concurrent antineoplastic agents

Endocrine therapy:

* Concurrent steroids allowed

Radiotherapy:

* At least 8 weeks since prior radiotherapy and recovered

Surgery:

* Recovered from prior surgery

Other:

* No prior antineoplaston therapy
* Prior cytodifferentiating agents allowed
Yoga and MBSR for TTH

Primary study objectives

1. evaluate the short-term effect of yoga intervention in addition to routine care on headache frequency in patients with frequent or chronic tension-type headache compared to routine care alone (waiting group).
2. to evaluate the short-term effect of yoga intervention in addition to routine care on headache frequency in patients with frequent episodic or chronic tension-type headache compared with stress management through mindfulness-based stress reduction (MBSR) in addition to routine care.

Secondary study objectives

Evaluation of the medium-term effect of the intervention on headache frequency as well as the short- and medium-term effect on the secondary target parameters in comparison to the waiting group and MBSR. Further evaluation of the safety and acceptability of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* episodic or chronic tension-type headache according to ICHD-3 definition

Exclusion Criteria:

* medication induced headache according to ICHD-3 definition
* Cluster-headache according to ICHD-3 definition
* serious chronic systemic or acute physical or mental illness
* Dementia
* Pregnancy
* actual in a yoga or MBSR class
Variations in the DIO2 and MCT10 Genes and Effect of Triiodothyronine Treatment

Hypothesis: Variations in the deiodinase 2 gene and monocarboxylate transporter 10 gene is associated with improvement in quality of life after initiation of combination therapy with L-Thyroxine and Liothyronine in patients with persistent hypothyroid symptoms despite conventional L-thyroxine mono-therapy.

Purpose: To re-test this hypothesis in patients with continued perceived effect of Liothyronine treatment at least one year after initiation in a patient population more representing of daily clinical practice. The study will help determine whether testing of specific gene variations might predict longtime effect of combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the department of endocrinology with the diagnose hypothyroidism because of persistent hypothyroid symptoms despite treatment with L-thyroxine mono-therapy and normal and stable TSH (for at least 6 months).
* Started in combination therapy with L-thyroxine and Liothyronine in an approximately 17/1 ratio
* Exclusion of an alternative explanation for persistent hypothyroid symptoms

Exclusion Criteria:

* Initiation of L-thyroxine treatment in patients with s-TSH below upper normal limit (with assay in current use, that is TSH \< 4 mU/L)
* Ongoing pregnancy
* Age below 18 years or above 80 years.
* Patients who do not read and understand information material given
* Patients who are not competent to give informed consent
ImproveR International (BI-001-IM)

The objectives of this registry are to assess the use of the thrombin-specific anticoagulant bivalirudin during percutaneous coronary intervention (PCI) in a real life setting. In particular, data will be collected to analyze experiences of bivalirudin use in respect to the following objectives;

* examine the aspects of safety and effectiveness of bivalirudin
* gain experience regarding the characteristics of patients in bivalirudin treatment
* evaluate the handling of bivalirudin and its practicality


Eligibility Criteria:
Inclusion Criteria:

\> 18 years, undergoing planned or urgent PCI with the intention to use bivalirudin as anticoagulant, written informed concent to entry of data information registry.

Exclusion Criteria:

None
A Pilot Study of the Immediate Effects of DLPFC tDCS on Attention Bias in Depression

Depression and other psychiatric conditions are marked by exaggerated, preferential processing (or attention bias) of negative information relative to neutral or positive information. This depression-related attention bias can be measured using the Dot Probe task and Visual Search, that allow assessment of the degree to which one shows bias toward negative information in the presence of neutral or positive information. A clinically effective treatment for depression is noninvasive brain stimulation with transcranial direct current stimulation (tDCS), targeting the dorsolateral prefrontal cortex (DLPFC), delivered in repeated sessions across a period of time. The study will test the effect of a single session of DLPFC tDCS on attention bias in patients with mild to moderate depression.

This prospective pilot study will recruit 25 female participants, ages 18-45 (inclusive), with mild to moderate depression (based on BDI-II score range 14-19 for mild and 20-28 for moderate) to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression. Subjects may or may not be receiving treatment for mild-moderate depression.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-45
* Female
* Mild to moderate depression (determined by BDI-II scores of 14-19 and 20-28, respectively)
* If taking antidepressants, medication must be stable ≥ 30 days prior to screening

Exclusion Criteria:

* Wide-Range Achievement Test-Fourth Edition (WRAT-4) Reading Subtest standard score \<85 (to ensure understanding of test procedures)
* Insufficient visual and motor ability to operate the intervention and assessments as judged by treating neurologist or study staff
* Primary psychiatric disorder other than depression (based on MINI)
* Primary neurologic condition that would prevent ability to participate (as determined by study clinician).
* History of head trauma in the last year
* Medical device implants in the head or neck
* History or current uncontrolled seizure disorder
* Current substance abuse disorder
* . Pregnant or lactating women
* Skin disorder/sensitive skin near stimulation locations
Fast Advanced Closed-Loop Therapy

A double-blind, multinational, multicenter, randomised, 2-period crossover study to assess the efficacy and safety of advanced closed-loop insulin delivery with Minimed 670G 4.0 system comparing Faster Insulin Aspart to Standard Insulin Aspart therapy over 4 weeks in active children and adolescents with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Age between 10 and 18 years of age
* Type 1 diabetes for at least 6 months
* Insulin pump user for at least 3 months
* Total daily dose of insulin \>8 units/day
* Treated with rapid acting insulin analogue
* Subject/carer is willing to perform at least 2 finger-prick blood glucose measurements per day
* Screening HbA1c ≤ 11 % (97 mmol/mol) based on analysis from local laboratory
* Willing to wear glucose sensor
* Willing to wear closed loop system 24/7
* The subject is willing to follow study specific instructions
* The subject/carer is willing to upload pump and CGM data at regular intervals

Exclusion Criteria:

* Physical or psychological disease likely to interfere with normal conduct of the study
* Untreated coeliac disease or thyroid disease
* Current treatment with drugs known to interfere with glucose metabolism
* Participation in another interventional clinical investigation
* Treated with ultra-rapid acting insulin analogue
* Known or suspected allergy to insulin
* Carer's lack of reliable telephone facility for contact
* Subject's severe visual impairment
* Subject's severe hearing impairment
* Medically documented allergy towards the adhesive (glue) of plasters or subject is unable to tolerate tape adhesive in the area of sensor placement
* Serious skin diseases located at places of the body corresponding with sensor insertion sites
* Sickle cell disease, haemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
Prospective Registry of Elderly ESUS With PFO

Patent foramen ovale (PFO) is associated with an increased risk of stroke. PFO-closure was effective in preventing stroke in young stroke patients less than age 60 presented as an embolic stroke of undetermined source (ESUS). However, the benefit of PFO-closure in elderly ESUS patients is not clear. The investigators designed this prospective register-based observational study to verify the efficacy of PFO-closure in elderly ESUS patients with high-risk PFO, older than 60 years

The COACH-ELDERLY ESUS study is a multicenter, prospective, registry-based, observational study in elderly ESUS patients with high-risk PFO treated with PFO-closure + standard antiplatelet treatment or standard antiplatelet treatment only in 20 centers in Korea.

Patients will receive an insertable loop recorder (ILR) to monitor paroxysmal atrial fibrillation. In cases, which are unavailable for ILR, recurrent EKG or Holter monitoring will be done based on the clinician's decision. Based on the attending physicians' decision with a multi-disciplinary approach, patients will receive PFO-closure with standard antiplatelet treatment or standard antiplatelet treatment only.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 60 years-old
2. Patients diagnosed as ESUS within 180 days from onset
3. PFO found from TTE or TEE, which attributed to the ischemic stroke
4. Patients or their legal representative agreed to participate

Exclusion Criteria:

1. Patients with transient ischemic attack
2. Patients with ischemic stroke at the vascular territory with significant stenosis
3. Patients with high risk cardioembolic stroke detected from EKG, Holter monitoring or echocardiography
4. Patients with other causes which may cause stroke (i.e. vasculitis, dissection, vasospasm, drug related or Moyamoya disease)
5. Patients with active cancer
6. Patients who need long term anticoagulation
7. Patients who have side effect on antiplatelet treatment
8. Patients with active internal bleeding
9. Patients who refuse to participate
Effect of Local Anesthesia in Patients With Marginal Periodontitis Undergoing Scaling and Root Planning

A randomised cross-over study comparing two methods of local anaesthesia for patients diagnosed with periodontitis undergoing scaling and root planning. 40 patients will be included in the study, which aims to demonstrate that the effect of a bupivacaine lozenge is non-inferior to lidocaine-adrenalin injections.

40 periodontitis patients undergoing scaling and root planning (SRP) will be randomised to receive local anaesthesia by either a bupivacaine lozenge or lidocaine-adrenalin injection at their first visit. At the following visit, the patients will receive the opposite treatment.

At each visit the patient will evaluate pain before, during and after SRP by:

* Visual Analog Scale (VAS) 0-10 where 0 = no pain, 10 = extreme pain.
* McGills Pain Questionnaire (MPQ), which gives a qualitative pain profile.

At each visit the patient will evaluate discomfort before, during and after the SRP by:

- Visual Analog Scale (VAS) 0-10 where 0 = no discomfort, 10 = extreme discomfort.

Additionally the patient assesses the comfort of administration of the two local anaesthesia as well as the taste of the bupivacaine lozenge. The investigator also evaluates the scaling procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as having, respectively periodontitis marginalis adulta progressiva lenta and periodontitis marginalis adulta progressiva rapid in the hygiene phase, where depurations are repeated within a short timeframe
* Age between 18 and 80 years
* Ability to speak, read and understand danish
* Ability to give oral and written consent

Exclusion Criteria:

* Known allergy to bupivacaine or other local anaesthetics of the amide type
* Other gingival infections (eg lichen planus)
* Pregnancy -if in doubt a pregnancy test will be made
* Breastfeeding
Effects of Legumes Consumption on Weight Reduction

This is a 12-week, randomized nutritional intervention study to determine the effect of legumes consumption on body weight in obese subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female volunteers between the ages of 20 to 70 years
2. Body mass index (BMI) of 25 kg/m2 or higher (based on Asia-Pacific guideline)
3. Volunteers who have agreed to participate in the study and provided a written content by him/herself

Exclusion Criteria:

1. Those with type 2 diabetes, cardiovascular disease, psychiatric problems, thyroid disorders, liver or kidney disease
2. Those under the use of any medications (antihypertensive, lipid-lowering, antiplatelet, antidiabetic, etc.).
Uterus Transplantation From a Multi-organ Donor

Uterus transplantation: screening, in vitro fertilization \[IVF\] treatment to be able to freeze embryos, uterus transplantation, pregnancy and afterwards removal of the uterus.


Eligibility Criteria:
Inclusion Criteria:

* Female with Maier-Rokitansky-Kuster-Hauser syndrome
* Mucosal neovagina of at least 7 cm
* In a stable relationship for at least 1 year
* Child wish
* Good renal function (and presence of both kidneys)
* Psychologically stable and compliant
* At least 8 frozen embryos after IVF/intracytoplasmic sperm injection \[ICSI\]
* Living in Belgium and a good health insurance
* Willing and able to provide informed consent

Exclusion Criteria:

* Major pelvic surgery
* Major chronic illnesses
* Other risk factors or malignancies
* BMI \> 30
Post-exercise Appetite Responses in Type 1 Diabetes

The investigators hypothesise that manipulating the glycaemic index of the meal after exercise will influence the acute appetite responses of Type 1 diabetes individuals


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-50 years old (male or female).
* Free from any diabetes related complications (apart from mild background diabetic retinopathy).
* HbA1c \<8.5%.
* Not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study.
* Demonstrate normal cardiac function in response to exercise.

Exclusion Criteria:

* Aged younger than 18, or older than 50 years.
* Suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy).
* HbA1c \>8.5%.
* Currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or detemir, and lispro or aspart for at least 6 months before the start of the study.
* Failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.
Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease

Objective: To investigate the potential role of endothelial dysfunction as a pathogenic mechanism of cardiovascular events in COPD. Hypothesis: endothelial function is abnormal in patients with COPD, particularly during exacerbations of the disease. Design: prospective and controlled study performed in an university hospital. Population: we compare 4 groups of subjects, 44 patients with stable COPD, 35 patients with acute exacerbation of COPD, 10 smokers or former smokers with normal lung function and 10 never smokers matched by physical activity and BMI. Study variables: a) clinical variables: clinical information, physical examination, pulmonary function tests, ECG and sputum culture; b) Biological variables: number of Circulating Endothelial Progenitor Cells, vascular growth factors (vascular endothelial growht factor and erythropoietin), systemic inflammation (C-reactive protein, white blood cells), peripheral venous blood test (including hemogram, biochemical analysis with glycemia, cholesterol, LDLcol, HDLcol); and c) systemic vascular reactivity assessment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to very severe COPD admitted in the hospital because of an exacerbation, and,
* Patients with moderate to very severe COPD in stable condition.

Exclusion Criteria:

* Patients with an exacerbation of COPD who needed invasive or non invasive mechanical ventilation
* Patients with other chronic inflammatory diseases.
* Patients with other acute or active chronic systemic disease such as heart failure, renal insufficiency, etc.
A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic Agent.

To Investigate the safety and immunologic activity of AGS-004, an autologous HIV Immunotherapeutic, in HIV-infected adults currently on stable antiretroviral therapy (ART) with durable viral suppression.

Although an HIV infection can induce weak immune responses, current HIV immunotherapy using consensus antigens has not shown consistent clinical activity. The absence of clinical activity is associated with an inability to raise cytotoxic T lymphocytes (CTL) against HIV antigens and a failure to induce T cell memory. While strong immune responses may be generated to a consensus antigen, those responses do not offer antiviral protection against a patient's individual viral burden. The infecting virus' antigen variability likely prevents the establishment of effective CD4+ T cell memory and a strong CD8+ T cell effector arm.

We are investigating the induction of CTL responses in HIV-infected subjects by a novel HIV immunotherapeutic agent (AGS-004) in an effort to overcome the lack of polyvalent specificity of the immune response for autologous HIV antigens which has been one of the primary reasons for the failure of HIV immunotherapy to date.

This pilot study will investigate the safety and immunologic activity of AGS-004 an autologous HIV immunotherapeutic agent.

Eligibility Criteria:
Inclusion Criteria:

* Men or women age 18 years and over,
* Documented HIV-1 infection,
* Durable viral suppression (≤ 200 copies HIV-1 RNA / mL) on first ART regimen for at least 12 weeks prior to entry,
* Availability of ≥ 2.5mL of continually-frozen plasma before starting ART (≥30,000 copies/mL),
* CD4+ T cell count ≥200 cells/mm3 at time of pre-ART sample,
* CD4+ T cell count of ≥350 cells/mm3 obtained within 4 weeks of study entry,

Exclusion Criteria:

* No co-infection with HBV or HCV,
* No history of lymph node irradiation or dissection,
* No prior use of any HIV vaccine,
* No use of hydroxyurea,
* No use of systemic corticosteroids or other non-permitted medications,