cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of a Protocol for Muscular Foot Strengthening On a Capacity to Control the Deformation of the DOT Plantar Medial

The human foot allows to perform several functions, rather than providing a Static support for the body, the foot acts dynamically in walking and Movement of the body, requiring adequate biomechanics responsible for Maintenance and posture of the body and harmonic distribution of plantar pressure.

One of the most important structures for this control is the medial plantar vault (MPA), an important structure in the absorption of impact and essential for the function Foot. The deformation of the MPA in the gait support phase absorbs the Energy and propels the limb, to perform this biomechanical function the MPA must Stable from the anatomical point of view, which is conferred by the bone architecture and But also by the performance of the intrinsic and extrinsic musculature of the Feet. The fall of the MPA, decreases the stability of the foot, limits its biomechanical function,

Besides being a risk factor for the development of pathologies such as:

Tendinopathy of the calcaneus tendon and plantar fasciitis. Various Intrinsic Muscles And extrinsic have the function of stabilizing the foot and the MPA, being the main Extrinsic muscles: the posterior tibial, the flexor long of the hallux and the fingers. The Muscles when activated increase the height and decrease the Length of the MPA. Several methods are used to evaluate ALM, such as (AN), Feiss line (LF) and MPA angle (MPAH), in addition to the Baropodometry, which is used to evaluate dysfunctions in the feet, with the principle of Map the pressure of the plantar surface in a static and dynamic way. Based In this information, this study aims to evaluate the influence of the Strengthening of the intrinsic and extrinsic muscles of the feet, for the Of MPA in asymptomatic patients.


Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 18 and 40,
* Seeders (do not practice physical activity regularly)
* No previous injuries to the feet and ankles,
* 12 months without lesions in lower members,
* Without deformities in APM,
* Such as, rigid planar foot
* No history of neurological changes

Exclusion Criteria:

* Individuals who practice physical activities regularly,
* History of pain in the feet,
* Have suffered fractures in the lower limbs,
* Muscular and articular lesions of Lower members in 12 months, -
* Flat foot,
* Valgus of calcaneus above 10º
* History of neurological changes or surgical procedure performed on lower limbs
Study of the Imaging Agent 18F-Var3 in Patients With Breast Cancer

The purpose of this study is to measure the safety of the investigational imaging agent, 18F-Var3 and to determine if it is helpful in providing information about how tumor tissues behave.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or greater
* Biopsy-proven breast malignancy
* \>/= 1 viable lesion, \>/= 1 cm, confirmed on CT, MR, or FDG PET/CT within 4 weeks of protocol enrollment
* Newly diagnosed or recurrent disease, on or off therapy
* ECOG performance of 0-2 \*Note: Lesions are considered viable if they are stable or increasing soft tissue lesions, or if they are FDG-avid bone lesions

Exclusion Criteria:

* Life expectancy \< 3 months
* Pregnancy or lactation
* Biopsy or other surgical procedures within 48 hours prior to receiving study intervention
* Patients who cannot undergo PT/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 400 pounds
Perioperative Changes of Cognitive Function According to Jugular Vein Insufficiency in Robot-assisted Prostatectomy

Internal jugular vein (IJV) is the main pathway of cerebral venous drainage and it has valve system to prevent retrograde blood flow to the brain. Anatomical studies revealed that bicuspid or tricuspid valves were located in both jugular veins 2 cm above the subclavia-jugulars bifurcation and 7-18% of the valves were incompetent. IJVV incompetence (IJVVI) may result in retrograde flow which leads to brain congestion and increase of intracranial pressure, which can cause brain dysfunctions in some patients. IJVVI has been reported to be associated with transient global amnesia (TGA), cough syncope, exertional headache, transient ischemic attack, and air embolism. Demographic data are associated with the development of IJVVI. Akkawi et al. demonstrated that old age over 50 years and male gender are the risk factors for IJVVI. A few physiologic conditions are related with IJVVI including elevated intra-thoracic and intra-abdominal pressure, and pulmonary hypertension. Robot assisted laparoscopic prostatectomy (RLP) is one of the most common robotic surgery because of its significant benefits such as smaller incision, less severe postoperative pain, less intraoperative bleeding, and shorter hospital stay compared to traditional radical prostatectomy. The patients undergoing RLP are mostly over 60 years old, have neurologic, cardiac and pulmonary comorbidities. For RLP, patients are in Trendelenburg position most of the time during surgery, which could cause increases in intra-abdominal and intrathoracic pressure.


Eligibility Criteria:
Inclusion Criteria:

* over 50 years old
* ASA class I or II
* Scheduled for robot assisted laparoscopic prostatectomy

Exclusion Criteria:

* previous neurologic deficit
* history of psychiatric disease, alcoholism or other drug dependency
* Serious hearing or visual impairment or any other comorbidities which would preclude neuropsychological tests
Globus Pallidus Stimulation to Treat Insomnia

Researchers are to determine if turning on an additional unilateral DBS (deep brain stimulation) electrode with stimulation to the globus pallidus externa (GPe) region of the brain will improve insomnia (sleep).


Eligibility Criteria:
Inclusion Criteria:

* 40-80 years of age
* Symptomatic with Parkinsonism for 7-20 years
* Severe insomnia based on ISI score

Exclusion Criteria:

* Clinically significant dementia (MMSE \<23)
* Hoehn \& Yahr \[Hoehn, 1967 #1839\] stage I or V disease
* Other significant neurological or psychiatric disease
* Previous pallidotomy or thalamotomy
* Previous placement of other implantable devices
* Secondary parkinsonism (non-idiopathic parkinsonism)
* Inability to travel to Jacksonville for post-operative study visits
* Severe sleep apnea
* Insomnia due to pain or untreated mood disorder
* Contraindications to 3T MRI
* Circadian rhythm sleep disorders.
* Current use of hypnotics
Assessment of Gastric pH Changes Induced by Ascorbic Acid Tablets

This study evaluates the use of ascorbic acid, vitamin C, to temporary reduce gastric pH in individuals with omeprazole induced hypochlorhydria. All participants will receive ascorbic acid tablets to measure the change in gastric pH.

Elevation of gastric pH in patients with hypochlorhydria can reduce the solubility of weakly basic drugs. This may lead to poor and unpredictable systemic exposure for poorly soluble drugs. For example, extent of absorption of the kinase inhibitors, dasatinib (Sprycel) and erlotinib (Tarceva), is reduced by up to 61% and 46% respectively in patients on acid-reducing agents (ARAs). This pilot study is to evaluate the use of ascorbic acid, vitamin C, to temporary reduce gastric pH in individuals with omeprazole induced hypochlorhdyria. Using pH/impedance testing, we are seeking to determine the magnitude and duration of pH change upon administration of 1000 mg of ascorbic acid in healthy subjects with proton-pump inhibitor induced hypochlorhydria. The results from this study will be used to evaluate the use of ascorbic acid as a drug-drug interaction mitigation strategy.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, young males age 18-30 years with no prior history of gastrointestinal disease or symptoms.

Exclusion Criteria:

* Hypochlorhydria (baseline use antacids, antisecretory medications, or surface agents including proton-pump inhibitors, H2 blockers, or sucralfate).
* Current or previous history of gastrointestinal disease including gastroesophageal reflux disease, Barrett's esophagus, peptic ulcer disease, dyspepsia, gastroparesis, bacterial overgrowth, microscopic colitis, gastric intestinal metaplasia or metaplastic atrophic gastritis, gastric neuroendocrine tumors, helicobacter pylori infection, inflammatory bowel disease (Crohn's disease or ulcerative colitis), celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease).
* History of gastric bypass or other abdominal surgeries excluding cholecystectomy or appendectomy \> 6 months prior to study initiation.
* Radiation therapy to the abdomen.
* Pregnant females.
* Ingestion of any prescription, over-the-counter, or herbal medications which may affect study interpretation.
* Currently a smoker
* Antibiotic use within the last 3 months
A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.

This 2 arm study will compare the pharmacokinetics and safety of Avastin at steady state under 2 different dosing regimens, in combination with XELOX (oxaliplatin + Xeloda) or FOLFOX-4 (oxaliplatin, leucovorin and 5-fluorouracil). Patients randomized to the XELOX arm will receive Avastin (7.5mg/kg iv) on Day 1 of each 3 week cycle; patients randomized to the FOLFOX-4 arm will receive Avastin (5mg/kg iv) on Day 1 of each 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* adenocarcinoma of the colon or rectum, with metastatic or locally advanced disease;
* \>=1 target lesion.

Exclusion Criteria:

* patients who have previously received systemic treatment for advanced or metastatic disease;
* patients who have received adjuvant treatment for non-metastatic disease in past 3 months;
* previous therapy with oxaliplatin or Avastin.
Arimoclomol in Sporadic Inclusion Body Myositis

Inclusion body myositis (IBM) is the most common progressive and debilitating muscle disease beginning in persons over 50 years of age. This study will assess the safety and tolerability of Arimoclomol in IBM as compared to placebo over 4 months of treatment.

IBM is a chronic disorder in which muscles become inflamed (swollen) and cause muscle weakening. The cause is unknown. There is new evidence to suggest that the pathology in IBM results from cellular changes induced by a variety of stressful events and diseases. In response to these stressful events the body's normal response is to increase the levels of Heat Shock Proteins (HSP) to help counteract and stop these cellular changes. In people with IBM this increase does not appear sufficient enough to reverse these toxic cellular changes. Arimoclomol causes the body to make more of this HSP protein. By increasing HSP levels in IBM patients we hope to reverse the toxic cellular changes that might be responsible for the pathology of IBM.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for definite or probable IBM (Griggs 1995)
* Muscle function adequate for quantitative muscle testing
* Age \> 50 years
* Women must be postmenopausal or status post hysterectomy
* For any patient currently taking medication for IBM, they must remain on current dosage for the extent of the study and last dosage change must be \> 30 days previous to enrollment

Exclusion Criteria:

* Presence of any one of the following medical conditions: diabetes mellitus or patients taking anti-diabetic medications, chronic infection, chronic renal insufficiency, cancer other than skin cancer less than 5 years previously, multiple sclerosis or prior episode or central nervous system demyelination, or other chronic serious medical illnesses
* Presence of any of the following on routine blood screening: WBC \< 3000, platelets \< 100,000, hematocrit \< 30%, BUN \> 30 mg%, creatine \> 1.5 mg%, symptomatic liver disease with serum albumin \< 3 g/dl, PT or PTT \> upper range of control values
* Women who are pregnant or lactating
* History of non-compliance with other therapies
* Coexistence of other neuromuscular disease
* Drug or alcohol abuse within the last 3 months
* Inability to give informed consent
* Known bleeding disorder
* Use of potentially renal toxic drugs
* Prior difficulties with local anesthetic
Prognosis and Integrative Assessment of Aortic Coarctation Patients in China

This is a systemic research of Chinese aortic coarctation patients, aiming to determine risk factors and serial biomarkers of aortic coarctation in prognosis.

The goal is to determine how much the left ventricle remodeling pre-operation and how it changes in the following-up duration after surgery, so does in the blood pressure and heart function. Risk factors associated with complications and prognosis are investigated and analyzed. Identification of novel biomarkers is needed to help predicting the prognosis, such as the left ventricle anti-remodeling, heart function and blood pressure improvement, as well as the exercise tolerance post-operation. The findings of this study will help the investigators developping new tests to monitor affected patients and optimize the operation as well as the follow-up procedure.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of isolated coarctation of the aorta, or accompanied with atrial septal defect(ASD), ventricular septal defect (VSD), patent ductus arteriosus( PDA), patent foramen ovale (PFO);
* Patients who can cooperation with study procedures.

Exclusion Criteria:

* Co-morbidities that may independently affect cardiovascular function, including associated complicated congenital heart disease, such as hypoplastic left heart syndrome (HLHS), interruption of aortic arch (IAA), Shone Syndrome, moderate and severe mitral stenosis;
* History of known vasculopathy, genetic syndromes, diabetes mellitus, hyperlipoidemia or other cardiovascular risk factors.
Efficacy of Lutein, Zeaxanthine and Trypan Blue to Stain the Anterior Lens Capsule

Effectiveness of lutein, zeaxanthin and trypan blue to stain the anterior lens capsule during cataract phacoemulsification.

Twenty patients with cataract (nuclear, entumecente, total) and indication for cataract surgery will be selected to participate in this study.

Eligibility Criteria:
Inclusion Criteria

* Patients over 50 years
* Diagnosis of cataract (nuclear, entumecente, total)
* Absence of red reflex
* Indication of cataract surgery

Exclusion Criteria

* Posterior subcapsular cataract
* Any history of eye disease
* Glaucoma
* Eye infection affecting any structure prior ocular
* Any previous ocular surgery
Role of Nutritional Support in Idiopathic Male Infertility

Approximately 100 males with idiopathic infertility and oligo- and/or astheno- and/or and/or teratozoospermia and fertile woman will take a Test dietary supplement (TDS), containing carnitine, vitamins and trace elements (active group) or carotene (control group) for 6 months (50 subjects in active and control groups). Before intake, and 2 and 4 months after the commencement of TDS, all males will have spermogram. After 6-month use of the TDS and during the 12th month of the study, couples will be screened for conception, pregnancy, and a newborn


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent form signed;
2. Age: 21-50;
3. Idiopathic male infertility;
4. Idiopathic oligo- and/or astheno- and/or teratozoospermia;
5. Stated availability throughout the study period and a mobile phone

Exclusion Criteria:

1. Allergy to any component of the dietary supplement;
2. Known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of male infertility;
3. Known genetic, anatomical, endocrine, inflammatory or traumatic testicular cause of female infertility;
4. Inflammatory bowel disease;
5. Known moderate to severe disease of any systems;
6. Known or suspected sexually transmitted diseases;
7. Alcohol or drug addiction of any couple counterpart as suspected by investigator;
8. Difficulty to comprehend study requirements as judged by investigator;
9. Use of any investigational product within the previous 3 months before entering the study;
10. Use of any drugs that stimulate or suppress spermatogenesis within previous 3 months
Repeating LiST for Refractory Non-bacterial Prostatitis/Pelvic Pain Syndrome

The aim of the study is to investigate the efficacy and safety of LiST retreatment for CP/CPPS patients.A total of 50 patients with CP/CPPS diagnosis who were previously treated with 6 sessions of LiST will participate in this study.The primary study parameter is the CP/CPPS-related pain complaints and it will be assessed by the NIH-CPSI


Eligibility Criteria:
Inclusion Criteria:

1. Participant must be between 18-60 years of age.
2. Participant has signed and dated the appropriate Informed Consent document.
3. Participant has had a clinical diagnosis of CP/CPPS defined as symptoms of discomfort or pain in the perineal or pelvic region for at least a three (3) month period within the last six (6) months.
4. Participant has received 6 sessions (1/week or 2/week, energy level 7, Dornier ARIES 2) of LIST the last 12 months for the treatment of CP/CPPS reporting amelioration but without complete remission of CP/CPPS symptoms ( at over 1 UPOINT positive domain).

Exclusion Criteria:

1. Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2).
2. Participant has a history of prostate, bladder or urethral cancer.
3. Participant has undergone pelvic radiation or systemic chemotherapy.
4. Participant has undergone intravesical chemotherapy.
5. Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition associated with LUTS, any neurological disease or disorder affecting the bladder.
6. Participant has undergone prostate surgery or treatment.
7. Participant with penile or urinary sphincter implants.
8. Participant has been diagnosed with cancer during the last 5 years, or had any surgery in the pelvis.
9. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab

Primary Objective:

To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with evidence-based medical and dietary management of dyslipidemia.

Secondary Objectives:

* To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, CHD deaths, CV deaths, all cause mortality).
* To evaluate the safety and tolerability of alirocumab.
* To evaluate the effect of alirocumab on lipid parameters.

18924 number of participants aged \>= 40 years old were randomized in the study.

Eligibility Criteria:
Inclusion criteria :

Recently (\< 52 weeks) hospitalized for ACS.

Exclusion criteria:

* Age \< 40 years.
* ACS event occurring more than 52 weeks prior to randomization visit.
* LDL-C likely to be \<70 mg/dL (\<1.81 mmo/L), and apolipoprotein B (ApoB) \<80 mg/dL (\<0.8 g/L), and non - high-density lipoprotein cholesterol (HDL-C) \<100 mg/dL (\<2.59 mmol/L) with evidence-based medical and dietary management of dyslipidemia.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Early Detection & Intervention of Cerebral Palsy in Ireland

Cerebral palsy (CP) is the most common lifelong physical disability. It is defined as a non-progressive disorder of movement originating from neural lesions in the perinatal period, and is associated with a wide range of common comorbidities in many individuals. These include problems speaking, hearing, seeing, thinking, feeding and controlling their bladder. People with CP often have additional challenges such as behavioural and emotional issues, pain, and poor sleep. Many of these challenges respond well to intervention in early childhood, as brain plasticity is at its greatest in the first 2 years of life. However, in most clinical settings, the age for diagnosis of CP is between 24 to 29 months, after this window of neurodevelopmental opportunity.

This project will aim to improve the Early Detection of Cerebral Palsy in Ireland. This will be achieved by implementing an evidence-based approach to follow-up of High risk infants.


Eligibility Criteria:
Inclusion Criteria:

* Legal guardians must be able and willing to give written informed consent and to comply with the requirements of this study protocol.
* All infants considered high risk for cerebral palsy and neuro-developmental impairment will be eligible, specifically including:

  * All preterm infants born ≤32 weeks Post Menstrual Age or ≤1500 gm birth weight
  * All encephalopathic infants
  * Neurological risk factors (e.g., injury/malformation on neuroimaging, persistently abnormal neurological exam)

Exclusion Criteria:

* Death prior to discharge from the neonatal unit.
Progesterone as Luteal Support in Frozen IVF Natural Cycles

The ProFET study aims to investigate if luteal phase support by vaginal progesterone, is superior to no luteal phase support, in terms of live birth rate per woman after a frozen embryo transfer (FET), in a natural cycle (NC) after in-vitro fertilization (IVF), and if 7 weeks of treatment is superior to 3 weeks duration.

Vaginal progesterone supplementation is routine treatment after IVF with fresh embryo transfer, but it is uncertain whether vaginal progesterone after frozen embryo transfer in natural cycles is efficacious in terms of increasing the chance of a live birth.

The ProFET study is a multicenter, open randomized, controlled trial planning to include 1800 women, intended to undergo a FET in a natural cycle.

Primary objectives are to investigate if luteal phase support by vaginal progesterone, is superior to no luteal phase support, in terms of live birth rate per woman after a frozen embryo transfer, in a natural cycle and if 7 weeks of treatment is superior to 3 weeks duration.

Secondary objectives are to compare groups regarding pregnancy outcomes including biochemical pregnancy, clinical, ongoing and term pregnancy rates, as well as rates of miscarriage, termination of pregnancy, and ectopic pregnancy.

Secondary objectives are also perinatal and obstetrics outcomes, self-reported side effects, adverse events and cost effectiveness.

The investigators will also analyze the effect of S-Progesterone level before FET on the chance of achieving live birth and secondary pregnancy outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Planned for a FET-NC with a blastocyst
* BMI \>18.5 \<35
* Regular menstrual cycles 24-35 days
* Given informed consent
* Understand written and spoken Swedish, English or Arabic

Exclusion Criteria:

* Oocyte donor cycles, preimplantation genetic testing (PGT) cycles. Uterine malformation, submucous myoma and endometrial polyps.
* Hypersensitivity against study medication. Other contraindications according to www.fass.se
* Development of serious disease contraindicating ART or pregnancy.
* Participation or recent participation in a clinical study with an investigational product (past 30 days). Previous participation in this study.