cyrilzakka/clinical-trials huggingface dataset:
Effects of Botulinum Toxin in Cervical Dystonia

Botulinum toxin injection in the contracting muscles has proven to be a safe and effective method of relieving pain and lessening dystonic posturing. The current hypothesis is that botulinum toxin works on altering sensory input in the central nervous system in addition to its effects on the neuromuscular junction.

Magnetoencephalography (MEG)of brain has been used in dystonia such as writer's cramp and musician's hand dystonia. However, no study has investigated the correlation of central signal changes via magnetoencephalography before and after treatment with botulinum in torticollis patients. Prior studies using somatosensory potentials indicated the possibility of differential activation of precentral cortex in patients with cervical dystonia. Cervical dystonia may result from a disorder of both cortical excitability and intracortical inhibition. The investigators hypothesis is that botulinum injection modulates central inhibition which improves clinical outcome for torticollis.

This study of MEG neuro-imagery will increase the understanding of the central pathway involvement in the efficacy of botulinum toxin treatment for torticollis. Cervical dystonia (spasmodic torticollis) patients will be selected from the Neurology clinic. Subjects will range in age from 18 years old through 90 years old. Subjects are expected to be ambulatory and independent. Patients are generally expected to be in good health. Exclusion criteria include significant intracranial metal (typically fixed dental bridges or braces) generating significant magnetic artifact, medical instability, pregnancy, and certain other factors such as severe head tremors that would produce magnetic artifact. Clinical states of torticollis patients will be assessed by using Tsui scale. Every torticollis patient will have magnetoencephalography on the day of botulinum treatment beforehand and approximately 2-8 weeks after botulinum treatment. We will compare the results of magnetoencephalography between control subject and torticollis patient before botulinum treatment aiming to find any difference between the two populations. We also compare the results of magnetoencephalography in individual torticollis patient before and after botulinum treatment, aiming to detect the changes between these two conditions in the same individual and possibly between the average of data from each condition before and after botulinum treatment.

Eligibility Criteria:
Inclusion Criteria:

* male or female subjects 18 years to 90 years
* females who are child bearing potential, with negative pregnancy testing, who are willing to use reliable form of contraception during the study
* subjects meeting the criteria for torticollis

Exclusion Criteria:

* intracranial metal objects generating significant magnetic artifact
* females who are pregnant, planning pregnancy, unable to use contraception
* mental instability
* any medical condition that may put the subject at increased risk with exposure to botulinum toxin, allergy or sensitivity
* significant head tremor
Fibroids in Women of Reproductive Age and Women Pregnancy

Dydrogesterone Multivitamin Nature treatment of fibroids in women of reproductive age and women pregnancy to lost the size fibroids.

Uterine fibroids are a very common finding in women of reproductive age. But may fibroids grow in the first trimester pregnancy.

Clinically has shown that:

Uterine fibroids are associated with an Heavy or prolonged menstrual periods. Abnormal bleeding between menstrual periods.

Uterine fibroids are associated with an increased rate of spontaneous miscarriage, preterm labor, placenta abruption, malpresentation, labor dystocia, cesarean delivery, and postpartum hemorrhage, pain is the most common complication of fibroids during pregnancy. Can usually be controlled by conservative treatment on Dydrogesterone Multivitamin nature.

Eligibility Criteria:
Inclusion Criteria:

* Procedure to treatment of fibroids in pregnancy and in women desiring future fertility.

Exclusion Criteria:

* Whether or not you are having symptoms from the fibroids
* If you might want to become pregnant in the future
* The size of the fibroids
* The location of the fibroids
* Your age and you might be
The Effect of Rimonabant on Energy Expenditure, Fat Metabolism and Body Composition

This study will determine in obese subjects the direct effects of the weight loss drug rimonabant (ie independent of weight loss) on energy expenditure, fat metabolism and and body fat distribution. We hypothesise that rimonabant will increase energy expenditure. The fuel for the increased energy expenditure will come from fat. As a result of burning more fat there will be a decrease in fat in blood and an improvement in the body's response to insulin.

In obese subjects (BMI 33-38kg/m2) completing 12 months of treatment with the CB1 antagonist rimonabant (SR141716) there was an average weight loss from baseline of approximately 8.5 kg. These studies also showed the weight loss was accompanied by a decrease in plasma triglyceride (TG), an increase in HDL cholesterol and an improvement in insulin sensitivity measured by HOMA-IR. When adjusted for weight loss 50% of the improvements in TG, HDL cholesterol, and insulin sensitivity was not attributable to weight loss. This suggests that rimonabant has direct effects on fat metabolism.

This study will investigate the direct effects of rimonabant (ie independent of weight loss) in a 2 group randomised study. One group will receive rimonabant for 12 weeks and the other group will have a dietary intervention to match the weight loss in the rimonabant group. Measurements of energy expenditure (using indirect calorimetry and Actiheart monitors),fatty acid and triglyceride metabolism (using stable isotope techniques) and body fat distribution (by magnetic resonance imaging) will be made before and after the intervention. To determine the possible mechanisms of the changes in metabolism, gene expression of key regulators of fatty acid metabolism in adipose and muscle tissue and circulating levels of adipokines will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Caucasian postmenopausal women
* BMI 30-38

Exclusion Criteria:

* Not currently weight-stable
* Diagnosed with diabetes
* Cardiovascular disease
* Endocrine disease
* Hepatic and renal disorders
* Neurological/psychological illness/history of depression
* Previous surgical procedures for weight loss
* Medications known to alter body weight or appetite
* β-blockers, fibrates and metformin
* Severe under-reporting of food intake based on a 4 day food diary
Assesment of TDApp1 an eHelath Tool to Make Therapeutic Recommendations for Patients With ADHD

This is a 3-week open label, one group study to determine the agreement between the pharmacological treatment recommended by TDApp1 and the interventions recommended by relevant clinical practice guidelines.

Clinical practice guidelines (CPGP) allow optimizing medical decisions and health care based on the best evidence available. Nevertheless, CPGs have several limitations. First, many GPC are outdated shortly after their publication. Second, CPG recommendations are often not applicable to many patients treated in clinical practice. Most CPGs do not make recommendations for patients with a mild disorder or for complex patients with comorbiditie. Another limitation is that patients involvement in CPGs development is still poor.

We aim to develop and assess TDApp1: an eHealth tool to formulate participatory, individualized and automated therapeutic recommendations for patients with Attention Deficit Hyperactivity Disorder.

A 3-week, one group, open label study will be conducted. Fifty-five patients aged 6-65 with ADHD will use TDApp1. The therapeutic recommendations made by the TDApp1 and by relevant CPG will be compared. Concordance in the recommendations will be studied. Effectiveness, safety, changes in physical activity and satisfaction will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ages 6-65
* A diagnosis of DSM-V ADHD based on clinical assessment

Exclusion Criteria:

* Patients under adequate therapeutic treatment or requiring minor adjustments
* Patients lacking an electronic device (mobile phone, tablet,...) with internet access
Controlled Ovarian Stimulation and Human Uterine Lavage

This is a feasibility study intended to demonstrate the Previvo Uterine Lavage System's ability to recover embryos from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).

The study is a prospective, multi- center, multiple-arm, feasibility study to evaluate the safety and efficacy of the Previvo System in the recovery of embryos.

This study will recruit up to 500 healthy premenopausal volunteers. Subjects will undergo either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI) and have the lavage procedure performed 4-6 days post IUI. It is anticipated that embryos recovered will be cryopreserved for future use or donated for future use.

Subjects will be followed up with for up to 30 days after the lavage procedure. All data will be collected on paper CRFs and analyzed by the Principal Investigator and Study Sponsor.

Eligibility Criteria:
Inclusion Criteria:

1. Premenopausal female 18-40 years of age
2. Physically healthy and reasonably healthy family medical history
3. Having both ovaries with patent fallopian tubes, no known reproductive problems
4. BMI between 18-35 Kg/m2
5. Presence of a normal uterine cavity as assessed by sonohysterogram (SHG), hysterosalpingogram (HSG), or ultrasound
6. Evidence of normal uterine anatomy that would not prevent the introduction of the lavage catheter.

Exclusion Criteria:

1. History of, or presence of hydrosalpinx
2. Addiction to alcohol and/or narcotics
3. Had radiotherapy or chemotherapy
4. Existence of an ovarian cyst at the beginning of cycle with suspicion of malignancy or a large benign cyst
5. Contraindication for oral contraceptive pills or other study medication
6. Clinically significant abnormal basic metabolic panel lab results
7. Positive test or history of any of the following conditions:

   1. Human immunodeficiency virus (HIV)
   2. Hepatitis B infection
   3. Hepatitis C infection
   4. Syphilis (RPR)
   5. Chlamydial pelvic infection
   6. Gonorrheal pelvic infection.
   7. Positive Pregnancy Test
8. Prior IUD for 60 days or less, or one currently in place
9. Allergic to study materials, supplies and medication
10. Any active, uncontrolled, clinically significant medical condition as determined by the treating principal investigator
The STAR™ Tumor Ablation Registry

Registry collecting data on use of The STAR™ Tumor Ablation System.

The STAR Prospective Registry is an observational registry to gather clinical safety and outcome data in patients with painful spinal metastases in the thoracolumbar spine (T1-L5) following targeted radiofrequency ablation (t-RFA) treatment with the STAR™ Tumor Ablation System.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with painful spinal metastatic lesions in thoracolumbar vertebrae (T1-L5) that will be treated with t-RFA using the STAR™ Tumor Ablation System.
* Have signed informed consent

Exclusion Criteria:

* Subjects under 18 years old
* Subjects with heart pacemakers, or other electronic device implants
* Subjects intended for t-RFA in vertebral body levels C1-7
Electronic Device Implantation Through Remote Guidance

Implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) implants are limited by availability and costs of field clinical specialist (FCS) bioengineers. This study explores feasibility of remotely supported implantations through an internet based platform, aiming at enhancing efficiency and overcoming geographical or pandemic related barriers. The first phase of the study included programming and phantom assessments in 20 cases followed by 10 remote guided CRT-D and ICD implantations in additional heart failure patients, compared to 20 procedures with FCS on site. Data analysis revealed no significant differences in acute outcomes or electronic parameters at one year follow-up compared to on-site FCS. Finally, this study demonstrates the safety after testing at one year of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Patients under 85 years
* Patients already implanted with defibrillator and admitted to cardiology division for others invasive procedures
* Patients undergoing defibrillator or cardiac resynchronization therapy defibrillator implantation
* Patients who signed written informed consent

Exclusion Criteria:

* Pacemaker dependent patients
* Patients who underwent generator replacement procedures
Comparison and Evaluation of USSQ, OABSS, and the Drainage/Anti-reflux Effect Between Three Kinds of Ureteral D-J Stents in Patients Who Underwent URL

Indwelling double-J ureteral stent (D-J stent) are routinely placed in patients who received ureteroscopic lithotripsy (URL) in Xinhua Hospital Urology Department. At present, three types of D-J stents, namely Cook/Kang Yi Bo(KYB)/Urovisionare are used, and usually removed in the day ward four weeks after surgery. This study intends to randomly divide patients with urolithiasis based on the preoperative OABSS (overactive bladder symptom score) questionnaire into three groups, namely Cook D-J stent group, KYB anti-reflux D-J stent group, Urovision trigonal D-J stent group, with corresponding D-J stent indwelled for 4 weeks respectively. The patient's USSQ ureteral stent symptom questionnaire）scale and OABSS scale were collected at 1 week, 4 weeks (before the removal of D-J stents), and 5 weeks (1 week after removal of D-J stents) after URL operation, and the D-J stents removed from the patients were collected, and their drainage and anti-reflux effects were measured in vitro.


Eligibility Criteria:
Inclusion Criteria:

1. Abdominal CT scanning indicating ureteral stones or kidney stones that are less than 2 cm in diameter, and patients who are planning to undergo URL surgery.
2. Age between 18 and 80 years old and capable of providing written informed consent;
3. In general, the heart, lung, liver and kidney function are in well condition, able to tolerate surgical treatment, and comply with research requirements.

Exclusion Criteria:

1. Before the onset of urolithiasis, the patient has suffered from obvious overactive bladder syndrome, or chronic lower urinary tract infection, or urinary anatomic deformities, or had previously undergone urinary tract plastic surgery.
2. Other severe complications, infections, etc. that the researchers believe may make the subject unsuitable for this study.
3. The patient is not a local resident and insists on returning to his howetown for D-J stent removal after the URL operation（so that we are unable to retrieve the D-J stent and conduct the in vitro experiment）.
4. The patient refuses to sign the informed consent.
A Trial of CS-747 (Prasugrel) Compared With Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention (PCI)

The purpose of this study is to evaluate the effects of a drug known as CS-747 (also known as prasugrel) on subjects having a procedure called a percutaneous coronary intervention (also referred to as PCI) in which a doctor will attempt to open a blocked vessel (or vessels) in the heart using a catheter (a long thin tube) that has a small balloon on the end. In many cases, patients who have this procedure receive a stent, a small wire spring that helps keep the vessel open.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be candidates for elective or urgent PCI with intended coronary stenting.
* Men or non-pregnant women (that is, postmenopausal women, women who are surgically sterile, or women of childbearing potential who have a negative urine or serum pregnancy test) who are greater than or equal to 18 and less than or equal to 75 years of age.

Exclusion Criteria:

* Patients must not have planned PCI procedure as initial treatment for an acute ST-elevation acute myocardial infarction (STEMI)
* Patients must not be receiving or will receive oral anticoagulation therapy that cannot be safely discontinued for the duration of the study
* Patients must not have cardiogenic shock or severe congestive heart failure
* Patients must not have active internal bleeding or history of bleeding diathesis
* Patients must not have prior history of hemorrhagic cerebrovascular accident (CVA) or nonhemorrhagic CVA within 2 years of enrollment
Observational Cohort Study of Advanced Non-small Cell Lung Cancer (CAPTRA-LUNG)

Investigators propose to establish and maintain a cohort of patients with advanced non-small cell lung cancer, and to assess the treatment pattern, host genetic, and clinical factors which influence the prognosis and survival, as well as the interaction among these factors on disease diagnosis and treatment, short and long-term outcomes.

Study type: Observational (Patient Registry)

Study design: Observational Model: Cohort

Time Perspective: Prospective and retrospective


Eligibility Criteria:
Inclusion Criteria:

* Cohort I: diagnosis of advanced non-small cell lung cancer from 2012-2016;
* Cohort II: documented positive driver gene mutations; and diagnosis of advanced non-small cell lung cancer;
* Cohort III: diagnosis of advanced non-small cell lung cancer and in immune-therapy;
* Cohort IV: diagnosis of advanced non-small cell lung cancer, and with wild-type driver gene or unknown driver gene status;
* Cohort V: treated with anti-VEGF drug in first line, diagnosis of advanced non-squamous and non-small cell lung cancer in 6 months before recruit;
* Age\>18 years;
* Provision of written informed consent.

Exclusion Criteria:

* not applicable
Effects of a Physical Exercise Intervention During Neoadjuvant Chemotherapy in Women With Breast Cancer

To assess in women with triple-negative breast cancer receiving neo-adjuvant chemotherapy the effects of an intense physical exercise program (intervention group) on physical capacity, compared with a control group not meeting the minimum exercise recommendations of the World Health Organization (WHO).

Justification and aims Breast cancer is the fourth most common type of cancer worldwide and the first among women in Spain. It is also the type of cancer with the highest mortality. Several studies have assessed the effects of exercise performed in the neo-adjuvant period, but there is heterogeneity among them.

Principal aim:

To assess in women with triple-negative breast cancer receiving neo-adjuvant chemotherapy the effects of an intense physical exercise program (intervention group) on physical capacity, compared with a control group not meeting the minimum exercise recommendations of the World Health Organization (WHO).

Secondary aims:

To compare the following outcomes in both groups: body composition, and quality of life and depression/anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with breast carcinoma in the 'Hospital Universitario Quirónsalud de Pozuelo' (Madrid, Spain) and following neoadjuvant therapy in the aforementioned center.
* Must have triple negative breast cancer (i.e., negative for estrogen receptors, progesterone receptors, and excess HER2 protein) of size \> or equal to 15 mm

Exclusion Criteria:

* Not meeting all of the above.
Assessment of the Optimal Amount of Proteins at Breakfast for Children

The primary objective of this trial is to identify how much protein is required at breakfast to promote positive whole body protein balance over the following 9h period.

This study will be the first to establish the role of eating protein at breakfast on whole body protein balance in healthy children.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 7-12 years of age
* Healthy and recreationally physically active (obtaining a 3- day average moderate/vigorous physical activity of at least 30 min/day)
* Body mass at ≥10th percentile for 7 year olds and ≤85th percentile for 12 year olds. Values based upon 2000 CDC Growth Charts for the United States
* Having obtained his/her informed assent
* Having obtained his/her consent from parent or legal guardian
* Being able to communicate in local language
* Have a habitual daily protein consumption of between 1.6 g/kg and 2.4 g/kg/bw

Exclusion Criteria:

* Self-report on regular medication impacting the metabolism, such as corticoids, hormone (e.g thyroid, adrenal) treatment, or medication against diabetes or against hypercholesterolemia or hypertriglyceridemia
* Self-reported history of metabolic, hepatic or renal disease
* Self-reported allergy to milk proteins (e.g., whey or casein) or intolerance to any food ingredients to be used in the study products and meals
* Within 1.5 years of estimated age of peak height velocity (PHV)
* Special diet or weight loss program (e.g Atkins diet)
* Consuming breakfast containing more than 21g of protein on each day of the 3-d screening period
* Subject who cannot be expected to comply with the study procedures, including unwillingness to consume study product and meals
* Currently participating or having participated in another nutritional-clinical trial during the last 2 months prior to the beginning of this study
Lorcaserin for Weight Loss Management in Patients on Antipsychotics: A Pilot Study

The purpose of this study is to determine whether lorcaserin is effective for weight reduction in patients with weight gain as a result of antipsychotic medications.


Eligibility Criteria:
INCLUSION CRITERIA:

* Patients currently on atypical antipsychotics
* The patient's BMI is greater than or equal to 30 kg/m2 OR the patient's BMI is greater than or equal to 27 kg/m2 in the presence of at least one weight-related co-morbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, metabolic syndrome, obstructive sleep apnea, or degenerative joint disease such as osteoarthritis.
* Patient agreeable to follow up with provider at the scheduled appointments at week 1, week 2, week 4, week 8, week 12 and week 16 after initiation of medication.

EXCLUSION CRITERIA:

* Pregnancy in women or breastfeeding
* The patient has greater than mild aortic valve regurgitation, or moderate to greater mitral valve regurgitation
* Known hypersensitivity to lorcaserin
* The patient is taking another weight loss medication concurrently
* Dementia
* Age less than 18 or greater than 65
* No recent substance abuse within 3 months
* No suicidal ideation within 3 months
* Unable to give informed consent, unless patient is conserved, then the conservator can provide informed consent