cyrilzakka/clinical-trials huggingface dataset:
Neuroprotection by Cannabinoids in Huntington's Disease

Huntington's disease (HD) is a progressive neurodegenerative disorder, related to an abnormal expansion of CAG triplets in the huntingtin gene, characterized by motor, cognitive and behavioral abnormalities, without known effective symptomatic treatment and without known disease slowing strategy. The most severe neuropathological lesions observed in HD take place in the striatum, one brain area important in motor control and rich in cannabinoid receptors (CBR). CBR are subdivided in two classes: CB1R are located in neurons and play a role in neuronal function; CB2R in brain are located mostly in microglia and modulate neuroinflammation.

CBR disappear early in the course of HD, before there is a massive drop out of cells in the striatum. Cannabinoid transmission is also an early event in brains of animal models of HD. In R6/2 mice, which carry large CAG expansions and develop an early and severe HD phenotype the suppression of the CB1R gene further accelerate the development of a severe clinical syndrome and the characteristic brain inclusions and abnormalities of synaptic density. R6/2 treated mice treated with cannabinoids improve their clinical phenotype, their brain lesions, the synaptic density and the levels of BNDF, a neurotrophic factor which enhances survival and resistance of striatal neurons.

Preliminary studies of cannabinoids in patients with HD have shown that these compounds are safe in these patients. Those studies, however, did not show efficacy because 1) they were underpowered from the statistical point of view, 2) were performed with isolated pure cannabinoids, instead of the more physiological stimulation with a mixture of compounds, and 3) they did use insensitive clinical parameters instead of sensitive end points, such as pathogenically important biomarkers.

The investigators propose a phase II trial with combination of cannabinoids with evaluation of safety, by the profile of adverse events, and efficacy, according to changes of important biomarkers


Eligibility Criteria:
Inclusion Criteria:

1. Patients with HD
2. Older than 18 years.
3. Able to understand the study, to attend the study visits and to provide informed consent.
4. Stable baseline medication for at least 6 weeks prior to randomization.
5. Score in the UHDRS-motor from 5 to 50.
6. Good cognitive status (MMSE\> 25) at the screening visit, with no evidence of major depression, at the discretion of the attending physician, and no evidence of psychosis.
7. Not consumers of products derived from marijuana.

Exclusion Criteria:

1. Pregnant or lactating women.
2. History of drug addition.
3. History of psychosis or with history of suicidal attempt.
4. Patients with diseases of the oral cavity that prevents the safe administration of the drug.
5. Patients in which drug administration is contraindicated according to the SmPC
PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure

The purpose of this study is to determine the value of diagnostic data obtained from Medtronic implantable cardioverter defibrillators (ICDs) with cardiac resynchronization therapy (CRT) to evaluate cardiovascular and heart failure related adverse events and health care utilization.


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet the ICD indications
* Patients with Class III or IV heart failure.
* Patients receiving or who received a Medtronic CRT ICD within the previous 3 months.
* Patient must sign and date informed consent, and be 18 years of age or greater.
* Patient must be available for follow up visits, and be willing and able to comply with study protocol.

Exclusion Criteria:

* Patient with acute myocardial infarction (MI), coronary artery bypass graft surgery (CABG) or percutaneous coronary angioplasty (PTCA)/stent within the last month.
* Patient with a mechanical right heart valve.
* Patient with chronic (permanent) atrial arrhythmias.
* Patient with life expectancy of less than 12 months.
* Patient with status post heart transplant
* Patient undergoing kidney dialysis
* Patients enrolled in a concurrent study that may confound the results of the study.
Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt

The ARTISAN-SNM study is designed to evaluate the safety and effectiveness of the Axonics Sacral Neuromodulation System as an aid in the treatment of the symptoms of urinary urgency incontinence (UUI) in patients who have failed or could not tolerate more conservative treatments.


Eligibility Criteria:
Primary Inclusion Criteria:

1. Diagnosis of UUI demonstrated on a 72-hour voiding diary defined as a minimum of four (4) leaking episodes associated with urgency, at least 50% of all leaking episodes associated with urgency, and at least one leaking episode each 24-hour period.
2. Greater than or equal to 6 months' history of UUI diagnosis
3. For male subjects only: Peak flow rate \> 15 cc/s as verified by uroflowmetry within 6 months prior to enrollment; Residual bladder volume \< 150 cc tested within 6 months prior to enrollment
4. 21 years of age and older
5. Willing and capable of providing informed consent
6. Capable of participating in all testing associated with this clinical investigation

Primary Exclusion Criteria:

1. Stress incontinence or mixed incontinence.
2. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
3. Interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines
4. A female who is breastfeeding
5. A female with a positive urine pregnancy test
Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial

To compare the mean length of hospital stay in laparoscopic trans abdominal preperitoneal repair versus open mesh repair in patients undergoing inguinal hernia repair with mesh.

A total of 334 patients of male gender with Inguinal hernias of any side and ASA score I and II were included in the study. History of Immunosuppression, associated with other abdominal hernias and recurrent hernia were excluded. 167 patients were in Group A or laparoscopic trans abdominal preperitoneal repair group while 167 patients were in Group B or open mesh repair. Data regarding length of hospital stay from both groups was recorded by researcher himself on especially designed proforma.

Eligibility Criteria:
Inclusion Criteria:

* • Age 18-60 years

  * Inguinal hernias of any side as per operational definition
  * ASA score I and II

Exclusion Criteria:

* • H/o Immunosuppression

  * Associated with other abdominal hernias
  * H/o recurrent hernia
Acute Heart Failure Monitoring Via Inferior Vena Cava Ultrasound

Known before diagnosed heart failure and used diuretic therapy patients will be admitted in this study.The objective of this work is whether the Inferior Vena Cava Ultrasound can be used for management of Acute Heart failure therapy. And investigators will calculation correlation of extracted urine amount with Inferior Vena Cava diameter change. Researchers will not interfere to standard recommended treatment protocol, researchers will correlated the urine amount and changed vital signs with therapy with Vena cava inferior diameter.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 years of age) of both sexes)
* Non-trauma patients
* Non- pregnant patients
* All patients will be accepted for this study, that known Heart Failure and must be taken diuretic therapy because of volume overload

Exclusion Criteria:

* Cardiac tamponade
* Aortic dissection
* Patients who had suffered cardiopulmonary arrest or been intubated
MediGuide Registry

The goal of this registry/observational study is to collect data on the clinical utility of MediGuide™ system in cardiac resynchronization therapy (CRT) implantation and electrophysiology (EP) procedures.

The intent of this worldwide registry/observational study is to understand the utility of the MediGuide™ technology in real world clinical practice during CRT implantation and study-specific-EP procedures. The study should provide an understanding of the effect of MediGuide™ technology on:

* The amount of fluoroscopy time and the radiation exposure
* Total procedure time
* Peri-procedural clinical event rate

Additionally, this study will address the following

* Identification of procedural challenges which may aid in developing future MediGuide tools
* Evaluation of newly available MediGuide tools during the study
* Correlation between MediGuide operator experience and the radiation exposure amount and time

Eligibility Criteria:
Inclusion Criteria:

* Anybody coming for CRT or EP procedure utilizing MediGuide system and tools

Exclusion Criteria:

* None
Making Decisions About Participating in a Cancer Clinical Trial for Patients With Stage II, Stage III, or Stage IV Pancreatic Cancer or Stage III or Stage IV Colon Cancer or Rectal Cancer

RATIONALE: Determining how patients makes decisions about participating in a clinical trial may help doctors plan clinical trials in which more patients are willing to participate and are satisfied with their decision to participate.

PURPOSE: This clinical trial is studying how patients with stage II, stage III, or stage IV pancreatic cancer or stage III or stage IV colon cancer or rectal cancer make decisions about participating in a clinical trial.

OBJECTIVES:

* Determine the relationship between disease factors, patient factors, and understanding of the cancer clinical trial, and preferences for decision control in the decision to participate in a cancer clinical trial by patients with stage II-IV pancreatic cancer or stage III-IV colon or rectal cancer.
* Determine the relationship between disease factors, patient factors, understanding of the cancer clinical trial, and preferences for decision control with satisfaction with the decision to participate in a cancer clinical trial.
* Determine how quality of life, trust, and hope impact the decision to participate in a cancer clinical trial and the satisfaction with this decision.

OUTLINE: This is a cross-sectional study.

Patients complete 12 questionnaires to assess their symptom burden (e.g., nausea, pain, fatigue), sociodemographics, hope, quality of life, trust in the healthcare system, trust in health professionals, research decision control, perceived risks, adequacy of research information, clinical trial participation, and decision satisfaction.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following:

  * Stage II-IV pancreatic cancer
  * Stage III-IV colon cancer
  * Stage III-IV rectal cancer
* Offered the opportunity to participate in a phase I-III cancer clinical trial and agreed or declined to participate
* First appointment at the Sidney Kimmel Comprehensive Cancer Center at John Hopkins

PATIENT CHARACTERISTICS:

* Able to read English

PRIOR CONCURRENT THERAPY:

* Not specified
Protection of Ovarian Function With Goserelin Acetate in Premenopausal Early Breast Cancer Patients With Chemotherapy

Primary objective of this study is to determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses via menstrual history, serum FSH and E2 measurements.

The secondary objectives of this study are as follows: To investigate the impact of treatment with chemotherapy with or without goserelin acetate (i.e. impact of the expectation of ovarian function preservation) on participants' quality of life (QOL) by FACT-ES scale, and to compare safety and tolerability of study drugs in two treatment groups by evaluation of adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed invasive breast carcinoma
* Candidates for adjuvant chemotherapy for primary breast cancer
* Premenopausal, verified before chemotherapy is begun as satisfying both cyclic vaginal bleeding and appropriate hormone levels

Exclusion Criteria:

* Previous systemic chemotherapy
* Pregnancy
* Stage IV breast cancer
Robotic-assisted Exercise Training in Heart Failure With Reduced Ejection Fraction

This study will address the challenging task of remobilizing patients with advanced chronic lung or heart failure in a functional New York Heart Association class III-IV by using an externally physically-supported exosuit movement therapy. This soft, wearable robot (Myosuit) assists mobilization according to individual needs by activating neuromuscular feedback systems, promoting physical activity and preventing early physical exhaustion.

The feasibility, tolerance and safety of a Myosuit assisted training was shown in a feasibility trial. In the efficacy trial, patients will be randomized in a 2:1 ratio for an exosuit-supported or non-supported exercise training protocol, training 3 units per week for 8 weeks. Assessment of outcome will be performed by various functional, mobility and endurance tests, questionnaires and clinical parameters. Furthermore, the transfer of regained motor and balance skills to everyday life will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* \>17 years old
* written informed consent
* chronic end-stage systolic heart failure without ventricular assist device, LVEF ≤ 45%
* clinically stable for at least 6 weeks
* ability to mobilize into standing and walking of at least 10 meters with or without rollator
* ability to get up from a chair without rotating the upper body \>45° sagittally

Exclusion Criteria:

* addictions or other illnesses that impact the ability to understand the nature, scope and
* consequences of the trial
* lack of knowledge of German to fully understand study information
* pregnancy, pre-menopausal women
* contraindications of cardiopulmonary exercising
* BMI \> 35 kg/m², waist size \> 135 cm.
* Height \<150 cm, \>195 cm
* Weight\<45 kg, \>110 kg
* Functional Reach Test \<15,24 cm
* Flexion contracture in the knee/hip joint \>10°
* Chronic colonization or active infection with multi-resistant pathogens
Routine Versus on Demand Removal of the Syndesmotic Screw

The objective of this trial is to demonstrate that the functional outcome of 'removal on demand' of the syndesmotic screw is non-inferior compared to routine removal of the syndesmotic screw in patients with an ankle fracture.


Eligibility Criteria:
Inclusion Criteria:

* Over 17 years of age
* Placement of a metallic syndesmotic screw for an unstable ankle fracture or an isolated syndesmotic injury
* Syndesmotic screw placed within two weeks of the trauma
* Being in such condition that one is able to possibly undergo a second procedure

Exclusion Criteria:

* ISS score \>15
* Injuries to the ipsi- and contralateral side which might hamper rehabilitation
* Other medical conditions which hamper physical rehabilitation
* Incomprehensive understanding of the Dutch language
Safety Evaluation of KX01 Ointment 1% in Japanese Healthy Male Subjects

Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese healthy male subjects

A baseline evaluation of the patch sites will be performed immediately prior to application of the patches to ensure that no conditions, markings, or coloration of the skin will interfere with interpretation of the study results.

A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01KX2-391 ointment 1% and 2 sites for Placebo vehicle ointment. One set (KX01 ointment 1% IP and Placebo ointment vehicle patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions. The distance between the patches will be no less than one centimeter.

The numbering of the test sites will remain the same throughout the study. The sites will be marked with an indelible, surgical marker.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese male adult, whose age 20-65 years old

Exclusion Criteria:

* History of photosensitivity or photoallergy
Dietary Intervention to Improve Health of Cardiovascular Patients

Voed je Beter is a randomized, multicenter, controlled trial to examine whether personalized guidance to increase adherence to the Dutch dietary guidelines, compared to usual care, improves health of cardiovascular patients who receive regular medical treatment.

Voed je Beter is a randomized, multicenter, controlled trial to examine whether a personalized intervention to increase adherence to the Dutch dietary guidelines, compared to usual clinical care, improves health of cardiovascular patients on top of medical treatment.

Patients previously diagnosed with cardiovascular disease are randomized into two parallel groups: the intervention or the usual care group. The intervention consists of personalized guidance from a dietician focussing on improving adherence to the Dutch dietary guidelines during a period of six months. The control group receives usual clinical care.

At baseline, three months, six months, and 12 months measurements will be performed. Primary outcome data will be collected at 6 months. After 12 months, additional data will be collected to assess the prolonged effects of the intervention. The primary outcome of interest is the difference in SMART Risk Score between the intervention and usual care group from baseline till six months.

Secondary outcomes are differences in SMART Risk Score at three months and twelve months; systolic blood pressure, diastolic blood pressure and cardiovascular parameters; diet quality, salt intake, vitamin levels in blood; body weight and waist circumference; renal function; quality of life; sleep; self-efficacy; mental health and medication use. In addition, an economic evaluation is carried out.

Eligibility Criteria:
Inclusion Criteria:

* A previously diagnosed cardiovascular disease, including acute coronary disease syndrome, angina pectoris, coronary revascularization, TIA, stroke, symptomatic aortic iliofemoral atherosclerosis, aortic aneurysm, intermittent claudication or peripheral revascularization.
* Over 18 years of age

Exclusion Criteria:

* Uses medication for treatment of diabetes
* A known hereditary form of cardiovascular diseases
* Chronic kidney disease stage 4 or above (eGFR\<30)
* Participation in another research study of which the outcomes may interfere with the current trial
* Not able to speak and understand the Dutch language
* Unable/unwilling to comply with the intervention
* Active treatment for cancer
A Prospective Post-Market Study to Evaluate the Clinical Utility of IRIS, a Three-dimensional (3-D) Anatomical Modeling Software for Pre-operative Surgical Planning and Intra-operative Navigation for Nephrectomy

This is a prospective, multi-center, post-market study to evaluate the clinical utility of IRIS, a 3D anatomical modeling software, with standard CT scans during pre-operative planning and intra-operative navigation for nephrectomy. The study will be conducted over the course of 21-24 months and enroll approximately 60-120 subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years or older
2. Subject is undergoing robotic-assisted partial or robotic-assisted radical nephrectomy being performed by participating surgeon
3. Subjects who has had or plan to have a CT scan (with IV contrast medium)

Exclusion Criteria:

1. Subject has a solitary or horseshoe kidney
2. Subject has more than two masses in the applicable kidney requiring multiple partial nephrectomies on the same kidney
3. Subject with prior surgery (ex: partial nephrectomy etc.) on the affected kidney excluding endoscopic kidney stone surgery
4. Subject with renal vein tumor thrombus
5. Subjects planned to have a bilateral operation (ex: bilateral partial nephrectomies planned at the same time)
6. Metastatic disease with life expectancy of less than 1 year
7. Pregnant or suspect pregnancy
8. Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
9. Subject belonging to other vulnerable population, e.g, prisoner or ward of the state
Mediterranean Diet Versus Hypocaloric Diet in PCOS

Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women that manifests itself with chronic anovulation, hyperandrogenism and insulin resistance. Available guidelines recommend lifestyle intervention although they do not suggest the best dietetic regimen for the treatment of PCOS. Thus, the purpose of this study is to compare the effectiveness of two nutritional protocols, namely Mediterranean Diet and Hypocaloric Diet in PCOS women.

PCOS is the most common endocrine disorder of reproductive age women, that is often associated with chronic anovulation, hyperandrogenism and insulin resistance. The central importance of insulin resistance in the pathogenesis of the syndrome has been established by several in vivo and in vitro studies. No data are available for the best therapeutical approach for metabolic dysfunction of PCOS. The new guidelines for the management of metabolic risk in PCOS strongly recommended that overweight/obese women with PCOS should lose weight changing their lifestyle. Although calorie-restricted diets are currently recommended to reach the healthy weight, there are still unsatisfied data regarding the best dietetic regimen that should be suggested.

In this study, our purpose is to compare two nutritional protocols in order to find the best dietetic approach for improving clinical, metabolic and hormonal outcomes in pcos women.

Eligibility Criteria:
Inclusion Criteria:

* Polycystic ovary syndrome (using ESHRE/ARSM 2007 criteria)
* BMI \> 25

Exclusion Criteria:

* Age \<18 or \>35 years
* BMI higher than 35
* Pregnancy
* Hypothyroidism, hyperprolactinemia, Cushing's syndrome, nonclassical congenital adrenal hyperplasia, use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic or antiobesity drugs or other hormonal drugs within the previous 6 months
* Subjects with neoplastic, metabolic (including glucose intolerance), hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, or malabsorptive disorders, cephalea)