cyrilzakka/clinical-trials huggingface dataset:
Menstrual Phase Endometrial Scratch in IUI Cycles

Patients undergoing treatment with intrauterine insemination (IUI) will be randomized to receive an endometrial scratch or sham procedure during the menstrual phase of the treatment cycle.

Infertility is a common issue faced by many couples throughout the United States. There are multiple fertility treatment options, including in vitro fertilization (IVF) and intrauterine insemination (IUI). Additionally, methods such as endometrial scratch (a modified endometrial biopsy) have been postulated to increase success rate. This prospective, randomized control trial will assess whether performing an endometrial scratch improves cycle outcomes and decreases time to pregnancy following IUI. Each patient will be randomly assigned to receive either an endometrial scratch or undergo a "sham" procedure (speculum insertion but no scratch) during the menstrual phase of the IUI cycle.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing intrauterine insemination procedures between the ages of 18 and 37 who have undergone a complete fertility work up (tubal, uterine, hormonal and sperm assessments) and do not have a current tubal or uterine factor infertility or severe male factor (expected to have \< 10 million total motile sperm on IUI sample) unless using donor sperm.

Exclusion Criteria:

* age \< 18 or \> 37, expectation (prior to randomization) of \< 10 million total motile sperm on IUI sample, tubal factor, uterine factor, incomplete fertility work up.
Effect of Kinesiology Taping on Head and Trunk Control in Children With Duchenne Muscular Dystrophy

Muscular dystrophy (MD) is a group of muscle diseases that results in increasing weakening and breakdown of skeletal muscles over time. The disorders differ in which muscles are primarily affected, the degree of weakness, how fast they worsen, and when symptoms begin. Many people will eventually become unable to walk. Some types are also associated with problems in other organs. The muscular dystrophy group contains thirty different genetic disorders that are usually classified into nine main categories or types.

The signs and symptoms consistent with muscular dystrophy are: progressive muscular wasting, poor balance, scoliosis (curvature of the spine and the back), progressive inability to walk, waddling gait, Calf deformation, Limited range of movement, respiratory difficulty, cardiomyopathy and muscle spasms This study aimed to assess the efficacy of Kinesiology Taping on head and trunk control in patients with Duchenne muscular dystrophy

Duchenne Muscular Dystrophy (DMD) is the most common muscular dystrophy type in childhood. Trunk control is responsible for adaptation during weight transfers, provides and maintains the upright position of the body, organizes postural and correction reactions; and stabilizes the body to perform proximal and distal limb movements, trunk rotations, and making contact between the shoulder and pelvis. In neuromuscular diseases, the trunk is usually ignored both for assessment and treatment as muscle weakness of limbs attracts more attention. Therapists usually focus on activities of lower limb and overhead including standing, walking, climbing, and raising arms to maintain independent mobility in rehabilitation sessions. However, the trunk also gradually gets weaker as the child gets older and this may be associated with movement dysfunction of upper and lower limbs. The Kinesio Taping method is used in the rehabilitation of musculoskeletal disorders, providing either an increase or a decrease in the neural excitation of the muscle, depending on the therapeutic purpose determined after the clinical assessment.

Eligibility Criteria:
Inclusion Criteria:

1. being at the age of 8-12 years
2. being able to cooperate with the instructions of physiotherapist to perform the assessments and procedures.

Exclusion Criteria:

1. having severe contracture at lower extremities
2. having another neurological and/or musculoskeletal disease diagnosis in addition to DMD. c) having a history of any lower extremity injury or orthopedic/neurologic surgery within the past 6 months.
Pentoxifylline in Treatment of Patients With Nonalcoholic Steatohepatitis

The aim of the present study is to evaluate the efficacy and safety of pentoxifylline in the treatment of non-alcoholic steatohepatitis patients.

Nonalcoholic steatohepatitis(NASH) is the progressive form of Non-alcoholic fatty liver disease (NAFLD), is characterized by hepatocellular damage, inflammation, and liver fibrosis that can progress to cirrhosis, in 25% of patients, NAFLD progresses to NASH, which increases the risk for the development of cirrhosis, liver failure, and hepatocellular carcinoma. In patients with NASH, liver fibrosis is the main determinant of mortality.

Pentoxifylline (PTX) is a xanthine derivative drug with a wide range of actions at the cellular and molecular level. PTX possess anti-inflammatory, antioxidant activities. PTX have potential role in improvement of NASH . Also, PTX inhibits a number of pro-inflammatory cytokines including interleukin-1, interleukin-6 and tumor necrosis factor (TNF-α ) which play an important role in the pathogenesis and progression of NASH.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18- 60 years old.
2. Both sexes
3. Patients who have nonalcoholic steatohepatitis (NASH) will be diagnosed by

   1. clinical examination (obese, high body mass index).
   2. radiological criteria of fatty liver (abdominal ultrasonography).
   3. laboratory investigation (elevated liver enzymes aspartate transaminase (AST), alanine transaminase (ALT).
4. The ability to give informed consent
5. Appropriate exclusion of other liver diseases

Exclusion Criteria:

1- Patients with other diagnosed chronic liver diseases as viral hepatitis, metabolic and genetic disorders as Hemochromatosis, Wilson disease, autoimmune hepatitis and drug induced liver disease as well as patients with recent infection and those who refused to be entitled in the study.

2. Patients will be excluded if they had a history of past excessive alcohol drinking for a period longer than 2 years at any time in the past 10 years.

3. Patients also will be excluded if they take medications known to cause steatosis or taking medications that have shown benefits in previous NASH pilot studies, including vitamin E, , thiazolidinedione, and alpha-glucosidase inhibitors.

4. Patients with a history of hypersensitivity to PTX or the methylxanthines (caffeine, theophylline, and theobromine) will be excluded, as well as those with a history of cerebral
A Comparison of Corneal Aberrations in Subjects With Contralateral AcrySof IQ Toric Intraocular Lens (IOL) and AcrySof IQ IOL With Limbal Relaxing Incision (LRI)

The purpose of this study was to evaluate and compare postoperative corneal aberrations and visual parameters in patients contralaterally implanted with an AcrySof IQ Toric intraocular lens (IOL) and AcrySof IQ Aspheric IOL with concomitant limbal relaxing incision.


Eligibility Criteria:
Inclusion Criteria:

Ocular criteria must be met in both eyes.

* Willing and able to understand and sign an informed consent;
* Willing and able to attend postoperative examinations per protocol schedule;
* Have cataracts that require extraction followed by implantation of a posterior chamber intraocular lens and used as an on-label procedure;
* Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and AcrySof IQ Toric package inserts;
* Have regular, bowtie shaped corneal astigmatism and qualify for an SN6AT3, SN6AT4 or SN6AT5 Intraocular Lens (IOL) in both eyes;
* Have the second surgery at least one week following the first eye implant but not later than one month after the first implant.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Previous corneal surgery;
* Planned multiple procedures during cataract/IOL implantation surgery;
* Ocular disease and/or condition that may compromise study results;
* Pregnant or planning pregnancy during course of study;
* Other protocol-defined exclusion criteria may apply.
Pain Control After Arthroscopic Shoulder Surgeries

This study will be conducted to compare the perioperative analgesic efficacy of ultrasound - guided interscalene brachial plexus block versus combined shoulder anterior capsular block and anterior suprascapular nerve block for arthroscopic shoulder surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20-65 years of both sexes, with American Society of Anesthesiologists (ASA) physical status I or II admitted for arthroscopic shoulder surgery.

Exclusion Criteria:

* Patient refusal.
* Uncooperative patient.
* Patient with neurological deficit.
* Patients with respiratory disorders.
* Patient with bleeding disorders.
* Infection at the block injection site.
* Patients with history of allergy to local anesthetics.
Study to Evaluate the Effects of Synthetic Conjugated Estrogens, B (SCE-B) on Nocturnal Vasomotor Symptoms in Postmenopausal Women

This is a multi-center study to evaluate the effects of SCE-B on nocturnal vasomotor symptoms. Study duration will be approximately 16 weeks; this includes a 4-week screening period and approximately 5 scheduled clinic visits. Participants will receive one of two strengths of SCE-B tablets plus matching placebo or placebo only, and will have a physical and gynecological exams that may include transvaginal ultrasound, endometrial biopsy and a pap smear. Participants will be asked to wear a monitoring device for a portion of the study and be asked to complete a daily dairy.


Eligibility Criteria:
Inclusion Criteria:

* Naturally or surgically menopausal
* Minimum 7 daily or 50 weekly moderate-to-severe hot flashes

Exclusion Criteria:

* Any contraindication to hormone therapy
Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion (HIKARI)

This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for macular edema following branch retinal vein occlusion


Eligibility Criteria:
Inclusion Criteria:

* 20 years of age or older
* Diagnosis of macular edema following branch retinal vein occlusion

Exclusion Criteria:

* BCVA ETDRS letter score in non-study eye \< 35
* Known steroid-responder
Portuguese Registry with Meril Myval THV Series - MyPORTuVal Registry

A prospective, single-arm, multi-centre registry to evaluate the safety and performance of Myval THV series using Transcatheter Aortic Valve Implantation (TAVI) procedure in patients with symptomatic severe native aortic valve stenosis.


Eligibility Criteria:
Inclusion Criteria:

1. Patient over the age of 18 years with symptomatic aortic stenosis (severe AS) who underwent TAVI using Myval THV series as assessed by Heart Team and Investigator.
2. Patient has provided written informed consent as approved by the Ethics Committee (EC)
3. Patient is willing to undergo all registry procedures and follow-up requirements

Exclusion Criteria:

1. Patients with hyper sensitivity or allergy to aspirin, heparin, clopidogrel, ticlopidine, cobalt, nickel, chromium, molybdenum or any contrast media.
2. Ongoing infective endocarditis or any similar infection.
3. Pregnant or lactating females.
4. Liver failure (Child-Pugh Class B or C)
5. Patient is currently participating in another clinical investigation where the primary endpoint has not been achieved.
6. Any condition, which in the investigator opinion, would preclude safe participation of the patient in the Registry.
Effects of Immersive Virtual Reality on Balance, Mobility, and Fatigue in Patients With Multiple Sclerosis

Gait disorder, imbalance, and fatigue are the most frequently reported complaints in Multiple Sclerosis (MS), a chronic neurodegenerative disease. The first symptoms in patients with MS are emerging in the age range 20-50 and these patients need long-term rehabilitation. The virtual reality applications developed for these problems which affect the quality of life negatively and cause disability in the following periods may be a good alternative for conventional rehabilitation applications. In this long-term where motivation is important, virtual reality applications in different environments provide patients with the opportunity to do many different tasks amused. In recent years, the vividness has been increased by the 3D virtual reality headsets.

The aim of this study is to investigate the effects of immersive virtual reality on the balance, mobility, and fatigue in patients with MS.

The study was designed as a prospective, randomized controlled study. The patients will be randomly assigned to three groups, the "immersive virtual reality (IVR)" group, the "dynamic balance training (DBT)" group and the control group. The trainings will be twice a week for 8 weeks. In the IVR group, firstly 30 minutes of Pilates training, 10 minutes of rest and then 20 minutes of virtual reality will be applied. In the DBT group, 20 minutes of dynamic balance exercises will be applied after Pilates training. In dynamic balance training, exercises will consist of similar movements required by virtual reality games. The control group will be taught relaxation exercises and will be asked to perform the exercises 2 times for 8 weeks at home.

Statistical analyses will be performed using the SPSS software version 15 (SPSS Inc. Chicago, IL, USA). The pre-training and post-training measurements of groups will be compared with the Wilcoxon Test. The significance level was set at p\< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are ambulatory and volunteer to participate to the study, in a stable phase of the disease, without relapses in the last 1 month, with an EDSS between 0-5,5.

Exclusion Criteria:

* Participants who have orthopedic, vision, hearing, or perception problems
* Patients who have any cardiovascular or pulmonary disease in which exercise is contraindicated
Prevalence of Postpartum Depression in Hospital Jose E. Gonzalez

This research will use the Edinburgh Scale Of Post partum depression to evaluate patients during their 4th to 6th after delivery, and the investigators will compare the results with those found in other countries with population with similar characteristics as ours


Eligibility Criteria:
Inclusion Criteria:

* patients on their 4th -6th week after delivery, who gave birth in our institution

Exclusion Criteria:

* patients with previous diagnosis of psychiatric pathology
Cytoreduction and Intraperitoneal Chemotherapy Versus Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis

The purpose of this study is to see if there is a difference in survival between two different treatment strategies for colorectal peritoneal surface disease. The control arm administered the currently considered standard treatment which is palliative systemic chemotherapy. The experimental arm received the combination treatment cytoreductive surgery and intraperitoneal chemotherapy. The investigators hypothesis is that the combination treatment will improve the overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic disease to the peritoneum from colon or rectum (at least two isolated sites of disease)
* verified primary tumor of adenocarcinoma of the colon or rectum
* Potential resectability as judged by the treating surgeon
* Patient is available for follow-up according to the study protocol
* Signed informed consent

Exclusion Criteria:

* Extraabdominal metastases or liver metastases
* Paraaortic or other inoperable lymph node metastases
* Clear indication for surgery only (such as obstruction, bleeding or peritonitis)
* Prior treatment of either arm in the study
* Clinical or histopathological diagnosis of Peritoneal Pseudomyxoma
* Age \> 80
* Contraindications for chemotherapy
* Pregnancy or breastfeeding
* Ongoing infection
Pharmacokinetics of Glucocorticoids in Children (GLUCOPED)

The purpose of this study is to determine individual susceptibility factors (drug interactions, genetic factors such as enzyme polymorphism...) to explain wide interindividual variability towards corticosteroids (prednisone, prednisolone, methylprednisolone, hydrocortisone) in children, which could establish a base for therapeutic monitoring.

Corticosteroids are widely used in children. A large interindividual variability exists concerning both efficacity and tolerance. Pharmacokinetic is poorly known.

A knowledge of individual susceptibility factors would allow to better adapt therapy in each case.

Drugs evaluated here are used in routine care in children and will be prescribed according to department practices concerning treated disease. Medical checks will be done during usual follow-up. Several features will be collected: reason of treatment, drug chosen and prescription modalities, observance, concomitant treatments, side effects, clinical examination, photography, score... Blood samples will be performed at different interval during usual biological follow-up. Three samples per patient will be required for pharmacokinetic and pharmacogenetic.

170 children under prednisone/prednisolone,130 under methylprednisolone, and 100 children under hydrocortisone will be recruited in four pediatric medical departments: immuno-hematology, nephrology,dermatology, and pediatric neurology.

Eligibility Criteria:
Inclusion Criteria:

* receiving Prednisone or Prednisolone or Methylprednisolone or hydrocortisone
* recruited in Immuno-hematological unit, dermatological unit, in pediatric nephrological unit, pediatric intensive care unit, or pediatric neurology unit
* parental agreement

Exclusion Criteria:

* parental refusal
* inability to take a blood sample
* inhaled corticoids intake in the 3 previous days
* topical corticoids intake in the 3 previous days
Maximizing Benefit of Lung Cancer Screening Incidental Findings of Cardiovascular, Respiratory and Breast Measures

The investigators will implement a patient-centered outcomes tool for participants in lung cancer screening programs that receive clinically important incidental findings relevant to heart, breast and lung health. The study objective is to evaluate participant response and clinical follow-up following implementation of a patient-centered incidental findings communication tool.

A computer assisted personal interview survey will be administered by study personnel to capture information about perceived risk, cues to action and self-efficacy among lung cancer screening participants. Participants eligible for recruitment will have had incidental findings from the low dose CT: moderate to severe CAC, grade 3 or 4 breast density, moderate to severe emphysema, or multiple incidental findings. The interview-administered survey will be conducted by telephone with responses entered by study personnel into a REDCap database. The REDCap questionnaire will be adapted to a given patient's IF status. The survey questions will be based on the Health Belief Model that has been used effectively in the context of secondary prevention. For each participant the survey will be conducted before and after system level implementation of a patient-centered incidental findings communication tool.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for lung cancer screening program
* Presence of one of three incidental findings on low dose CT: coronary artery calcification, extensive breast density (for females), or emphysema

Exclusion Criteria:

* No incidental findings from lung cancer screening low dose CT
Improving the Function of the Foot by Core Foot System (CFS) Exercise Theory in Patients After Hallux Valgus Surgical Procedure

The aim of the study is to identify the impact of CFS foot muscle training on time-space parameters, anthropometric parameters and bioelectrical activity (EMG) of the foot muscles during walking and to develop an algorithm for an effective therapeutic method in patients after hallux valgus correction. Achieving the purpose of the research will contribute to the answer to the following research questions:

* Does the CFS therapy used significantly change the arch of the foot in HV patients compared to the control group?
* Does the CFS therapy used significantly improve gait characteristics after HV surgery in relation to the control group?
* Does muscle stimulation and the moment of their activation differ in groups in which different therapies have been used?
* Will the results of the questionnaires and scale be significantly different in both groups?


Eligibility Criteria:
Inclusion Criteria:

* hallux valgus deformity
* surgical procedure
* voluntary consent to the study

Exclusion Criteria:

* lack of consent to research
* other deformation and operations of the foot
* pain after the surgery which prevents experimental procedure
A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension

A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2307.


Eligibility Criteria:
Inclusion Criteria:

* SUCCESSFUL COMPLETION OF VAA489A2307 CORE TRIAL
* VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg

Exclusion Criteria:

* PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2307 CORE

Other protocol-defined exclusion criteria may apply.
In Vivo Assessment of Silver Biomaterial Nano-Toxicity

Nanotechnology is the controlled generation and manipulation of matter in dimensions less than 100 nm. Silver has been used for its bactericidal properties. The investigators propose to study the American Biotech Laboratory 32 ppm silver solution over a 14-day period in human volunteers to determine the toxicity and to quantify cytochrome P450 enzyme effects of this solution.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be \> 18-80 years old will be included.

Exclusion Criteria:

* Females of child-bearing potential, defined as women physically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means will be excluded unless they are using 2 barrier birth control methods (i.e., diaphragm, condom, intrauterine device, sponge or spermicide) or hormonal contraceptive method.
* Any female subject who is nursing will be excluded. Subject with has a history of heavy metal allergy (including silver) or a history of asthma or COPD or renal impairment defined by a creatinine clearance below 30 ml/min.
* Subjects with symptoms of an active upper respiratory infection at time of consent will also be excluded.