cyrilzakka/clinical-trials huggingface dataset:
Effect of NMES As an Add-On to Exercise Program in Degenerative Meniscus Tears

This randomized-controlled trial aims to investigate the effect of NMES as an add-on to an exercise program in patients with degenerative meniscus tears.

To investigate the efficacy of NMES as an add-on to an exercise program, voluntary patients with degenerative meniscus tears, aged between 40 and 65 years, will be randomly divided into two groups: Group 1 (NMES with Exercise) and Group 2 (Exercise). Interventions will be applied for 16 sessions (twice a week for 8 weeks). The patients will be assessed at baseline and at the end of the 8-week intervention. The pain during activity, at rest, and at night will be assessed with the Visual Analog Scale (VAS). Active range of motion will be assessed with a digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer. The functional status and symptoms will be evaluated by the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Lysholm Knee Scoring Scale. Health-related quality of life will be assessed with the Short Form-12 (SF-12).

Eligibility Criteria:
Inclusion Criteria:

* Being aged between 40 and 65 years
* Having the degenerative meniscus tear in at least one knee
* Having body mass index in the range of 18-30 kg/m2
* Feeling the pain that lasts for at least 2 months
* Having grade 1 or grade 2 degenerative meniscal tear diagnosed by an orthopedic specialist according to the MRI results
* Having the ability to read and write Turkish

Exclusion Criteria:

* Having undergone arthroscopic partial meniscectomy surgery due to degenerative meniscal tear
* Participating in a physiotherapy program for degenerative meniscal tear in the last 12 weeks
* Have received steroid injections in the last 6 months
* Accompanying conditions such as injury to the surrounding ligaments, congenital anomaly in the affected knee, coxarthrosis and spinal stenosis
* Presence of any systemic disorder that may affect assessment parameters
* Failure to cooperate with assessments
The Star Excursion Balance Test: Analysis of Children With Cerebral Palsy

PURPOSE: The investigators estimated the reliability, standard error of measurement (SEM), and minimum detectable change (MDC) of the star excursion balance test (SEBT) in children with cerebral palsy (CP).

METHODS: Eight children with CP (four boys and four girls, sixteen legs) participated in this study. Each child carried out the SEBT and was assessed by two examiners. To determine intra-rater reliability, the investigators calculated the intra-class correlation coefficient (ICC) model (3,3). The investigators also calculated the ICC model (2,3) to determine the inter-rater reliability.


Eligibility Criteria:
Inclusion Criteria:

* were aged between 4 and 12 years,
* had a status above level II on the Gross Motor Function Classification System (GMFCS),
* were able to understand instructions from the rater, and

Exclusion Criteria:

* had history of fracture or sprain of the lower limbs over the previous 12 months.
Multi-strain Probiotic in the Management of IBS-D

1. To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients.
2. To assess the efficacy of a multi-strain probiotic supplement as a treatment option for IBS in a tertiary referral centre

Background: Accumulating evidence supports the view that an imbalance of gut bacteria contributes to IBS, and that increasing the mass of beneficial species may reduce the numbers of pathogenic bacteria and help alleviate symptoms.

Methods: In this double-blind trial 360 adult patients with moderate-to-severe symptomatic diarrhea-predominant IBS (IBS-D) were randomized to treatment with the multi-strain probiotic (Bio-Kult®; 14 different bacterial strains; 8 billion colony-forming units per day) or placebo for 16 weeks. The change in severity and frequency of abdominal pain was the primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed case of IBS using Rome III criteria
2. Absence of red flag sign: anemia, fever, wt loss, per rectal bleeding, nocturnal frequency, family history of inflammatory bowel disease (IBD), cancer
3. Age 18-55 years
4. No probiotics used in prior 3 months.
5. Agreed not to start any other drug unless clinically indicated.
6. No antibiotics in previous 2 months of enrolment.

Exclusion Criteria:

1. Age\<18 or \>55 years
2. Previous treatment with probiotics within last 3 months
3. Pregnant or lactating females
4. Concurrent severe illness (Uncontrolled diabetes mellitus, Renal Dysfunction, Liver disease, hyper and hypothyroidism)
5. Chronic organic bowel disorders e.g. inflammatory bowel diseases, tuberculosis, Diverticular disease etc
6. Any previous gastrointestinal surgery
Comparison of 5 Day Embryo Transfer With 2-3 Day Transfer in Patients With Previous In Vitro Fertilization Failure

The purpose of this study is to determine whether embryo transfer on day 3 versus day 5 shows a significant difference in implantation, clinical pregnancy, live birth, miscarriage and multiple pregnancy rates among women with at least two previous IVF failures

A total of 200 infertile women with at least two previous IVF failures will enroll in this prospective randomized clinical trial study and will randomly be divided into two groups. Random permuted blocks with a block size of 4 will be used to ensure randomization and complete allocation concealment.

The study protocol will be assessed by an independent institutional review board and Royan ethics committee.

Ovarian stimulation protocol will include the use of a GnRH agonist (Superfact; Aventis Pharma Deutshlan, Frankfurt, Germany) administered in the long (down-regulation) protocol and the subsequent addition of FSH (Gonal F, Sereno, Switzerland). Embryos will be initially cultured in G1.V5 medium) Vitrolife-Sweden)TM on day 1 and 2, being transferred from this medium to G2.V5 ) Vitrolife-Sweden)TM on day 3. Embryos will be transferred on day 5, depending on the degree of expansion of the blastocyst.

Main outcome measures will be implantation, clinical pregnancy and live birth rates.

Eligibility Criteria:
Inclusion Criteria:

* Age fewer than 40
* Normal uterine cavity and patent tubes by either hysterosalpingogram or laparoscopy and hysteroscopy
* Two previous or more failed IVF/ICSI cycles

Exclusion Criteria:

* Women with submucous myoma
* Women with intra mural or subserous myoma greater than 3 cm
* Women with Endometriosis or Endometrioma
* Hydrosalpinx
Molecular Diagnosis on Circulating Tumor DNA of Non-Small Cell Lung Cancer

The purpose of this study is to develop an ultra sensitive assay of mutation detection on circulating tumor DNA (ctDNA) for treatment, diagnosis and monitoring disease progression of Non-Small Cell Lung Cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Male or female aged \>= 18 years
* Stage IIIb and IV Non Small Cell Lung Cancer histologically confirmed

Exclusion Criteria:

* Tissue and plasma samples can not be provided for mutation analysis
* Unwilling or unable to provide informed consent
* Any serious medical condition that would interfere with the subject's safety
The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers

To assess the effects of lanthanum carbonate (FOSRENOL) or sevelamer carbonate (RENVELA) on the pharmacokinetics of oral calcitriol (ROCALTROL)


Eligibility Criteria:
Inclusion criteria

* Healthy volunteers age 19-45 years inclusive at the time of consent.
* Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, electrocardiogram (ECG) and laboratory evaluation (hematology, biochemistry, urinalysis) as assessed by the Investigator.
* No current or recurrent disease (e.g. cardiovascular, renal, liver, gastrointestinal (GI), malignancy or other conditions) that could affect the action, absorption or disposition of the investigational products utilized in this study, or could affect clinical or laboratory assessments.

Exclusion criteria

* Current or recurrent disease (eg, cardiovascular, renal, liver, GI, malignancy or other conditions) that could affect the action, absorption or disposition of the investigational products utilized in this study, or could affect clinical or laboratory assessments.
* Current or relevant previous of physical or psychiatric illness, any medical disorder that could have required treatment or made the subject unlikely to fully complete the study, or any condition that presented undue risk from the investigational product or study procedures.
* Current use of any medication with the exception of hormonal replacement therapy or hormonal contraceptives within 14 days of first dose of investigational product.
* History of alcohol or other substance abuse within the last year.
* A positive human immunodeficiency virus antibody screen, Hepatitis B surface antigen or Hepatitis C virus antibody screen.
* Use of tobacco in any form
* Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to receiving the first dose of investigational product.
Curative Image Guided Radiotherapy for Prostate Cancer

The clinical importance of cone beam computer tomography based image guided radiotherapy (CT- IGRT) has not been established. The primary aim of the present trial is to investigate whether CT- IGRT and consequently reduced safety margins reduces the rectal side effects from curative, high dose radiotherapy in prostate cancer. Any impact of the reduced planning target volume in the CT- IGRT arm on biochemical freedom from disease will be evaluated as secondary outcome.

An open randomised phase III trial. The included men will be randomised to receive curative radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and standard safety margins (10-15 mm) or 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm).


Eligibility Criteria:
Inclusion Criteria:

* Biopsy confirmed adenocarcinoma of prostate
* No evidence of nodal or distant metastases (N0M0)
* Intermediate or high risk based on T stage, PSA level and Gleason score
* Informed consent

Exclusion Criteria:

* Previous treatment for cancer last 5 years, except basal cell carcinoma of skin
* Any previous radiotherapy, except KV or electron treatment of skin tumors outside the pelvis
* Metallic hip joint replacement
* Pre-existing intestinal or genitourinary disease with increased risk of side effects
* Any pre-existing condition making the patient unsuitable for radiotherapy
* Any pre-existing condition making the patient unsuitable for hormonal therapy
* Any pre-existing condition making the patient unsuitable for MRI.
* ALAT, GT, ALP, creatinin \> 1.5 x upper normal limit
Trastuzumab and Standard Treatment With Chemo- and Immunotherapy as First Line Treatment for HER2 Positive Esophageal Squamous Cell Carcinoma Patients

The study aims to determine the efficacy of trastuzumab added to standard treatment (fluoropyrimidine/platinum doublet with pembrolizumab) in patients with HER2 positive Esophageal squamous cell carcinoma (ESCC) determined by 6 months progression free survival (PFS) (RECIST 1.1).


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Age ≥18 years
3. Inoperable locally advanced or metastatic squamous cell carcinoma of the esophagus not amenable for curative intended therapy
4. HER2 positive defined as IHC2+ and FISH amplification ratio ≥2 or IHC3+
5. ECOG PS \<2
6. Baseline left ventricular ejection fraction \> 50% measured by echocardiography or MUGA
7. Adequate bone marrow function and organ function:

   1. Hematopoietic function:
   2. Leucocytes \> 3.0 x 109/l, neutrocytes \> 1.5 x 109/l and thrombocytes \> 100 x 109/l
   3. Serum bilirubin \< 1.5 × upper limit of normal (ULN); and AST/ALT \< 2.5 × ULN (or \< 5 × ULN in patients with liver metastases).
8. Creatinine clearance \> 30 ml/min

Exclusion Criteria:

1. Prior systemic treatment with non-curative intent including HER2-targeting drugs. Prior neoadjuvant and adjuvant therapies as well as palliative radiotherapy are allowed
2. Significant medical illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate study treatment
3. Congestive heart failure (New York Heart Association (NYHA) class 3+4); uncontrolled angina pectoris; poorly controlled hypertension (systolic BP \> 180 mmHg or diastolic BP \> 100 mmHg); or high-risk uncontrollable arrhythmias.
4. Patients with severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
5. Patients with known hypersensitivity to trastuzumab or any of the study drugs, murine proteins, or to any of the excipients
6. Symptomatic brain metastases uncontrolled by corticosteroids or carcinomatous meningitis
7. Homozygosity or compound heterozygosity for more than one gene variant of dihydropyrimidine dehydrogenase (DPD) known to cause major reduced metabolism of 5-FU derivates OR plasma uracil \> 150 ng/ml are not eligible. Patients with minor DPD insufficiency are allowed provided that local guidelines for administration of 5-FU are followed.
8. Any other cancer (excluding low risk prostate cancer, carcinoma in situ and radically operated localised squamous skin cancer) with clinical activity within the last 2 years
9. Other current cancer treatments except for anti-hormone and anti-resorptive treatment of bone metastasis.
10. Allopurinol, phenytoin, warfarin treatment is not allowed. Non vitamin K oral anticoagulants (NOAK) and low molecular weight (LMW) heparin is allowed
11. Pregnancy or breast-feeding
12. Positive serum pregnancy test in women of childbearing potential.
13. Subjects with reproductive potential not willing to use an effective method of contraception under and 3 months after participation in this study
A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients

The aim of this exploratory study is to evaluate the rejection rate in patients treated with cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo liver recipients. The blood levels of CsA and CsA micro emulsion will be monitored by C-2h monitoring. In addition, this study will assess the safety of this treatment regimen.


Eligibility Criteria:
Inclusion Criteria

* About to undergo a primary liver transplant (including living donor, split liver).
* Expected to be capable of study participation for full 6 months post-transplantation.
* Allograft biopsies will be possible.

Exclusion Criteria

* The surgery is a multi-organ transplant.
* The patient has previously been transplanted with any other organ.
* The graft derives from a non-heart beating donor.

Other protocol-defined inclusion/exclusion criteria may apply.
Evaluating the Durability of Closure for Venous Leg Ulcers

The goal of this observational study is to determine the durability of closure for venous leg ulcer subjects that achieved closure in the THOR trial.

To determine durability of closure (rate of target wound recurrence) of subjects with a closed venous leg ulcer during the THOR clinical trial comparing subjects treated with Intact Fish Skin Graft (IFSG) plus standard of care (SOC) to subjects treated with SOC alone.

Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects must have participated in the THOR trial and achieved complete closure by the 12-week endpoint.

Exclusion Criteria:

* 1. Subjects who did not participate in the THOR trial. 2. Subjects who participated in the THOR trial and did not achieve complete closure.
Measuring and Predicting Glycemic Response to Food in Patients With Type 1 Diabetes

Personalized medicine methods in the management of type 1 diabetes

This proposal joins together clinical practitioners, biologists, and computer scientists to set up the infrastructure for research that will facilitate, for the first time, the use of big-data, machine-learning approaches in the application of personalized medicine methods in the management of type 1 diabetes mellitus. We will model the clinical, microbial, and nutritional factors underlying the variability in glycemic response to food in this population; develop algorithms for prediction of this response and for the accurate administration of insulin, assisting the clinical management of the disease and discover intervention targets in the gut microbiome aimed at improving glycemic control.

Eligibility Criteria:
Inclusion Criteria:

over one year of diagnostic with T1DM.

Exclusion Criteria:

Drug related diabetes. genetical diabetes.
Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults

This study evaluates whether Ramelteon can prevent delirium, decrease the severity of incident delirium and improve sleep wake cycle in hospitalized elderly surgical patients. Half of the patients will be assigned to Ramelteon, while other half will be assigned to placebo.

Delirium is a common clinical syndrome characterized by acute cognitive dysfunction with core features of inattention, disorganized thinking, perceptual disturbances and sleep-wake cycle disruption. It is typically multifactorial and can be triggered by acute infection, metabolic derangements, surgery, and certain medications. Older adults have a much higher incidence of delirium. Delirium increases in-hospital mortality, length of stay, rate of institutionalization and may cause or exacerbate cognitive impairment. The present pilot study investigates sleep loss as potentially important contributing factors in delirium and an opportunity for intervention. Sleep disruption is prevalent among hospitalized patients. Sufficient sleep is important for recovery from illness, management of pain, wound healing, and a variety of other biologic functions integral to recovery in addition to its putative role in delirium prevention. Melatonin plays an important role in circadian rhythms and sleep-wake cycle regulation. Melatonin secretion is altered in hospitalized older patients in comparison with community-living older individuals. Melatonin and the melatonin-receptor agonist Ramelteon have been studied and have shown promise in delirium prevention, in addition to promoting sleep. We propose to test the use of Ramelteon to decrease delirium and improve sleep/wake cycles in the elderly surgical patients.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older.
* Admitted to BWH vascular surgical service.
* Able to provide informed consent or a surrogate is available to provide informed consent.
* Absence of delirium at time of consent.

Exclusion Criteria:

* Expected stay or life expectancy less than 48 hours
* Unable to take medications orally
* Advanced liver disease (Child-Pugh class B or worse)
* Active treatment with Fluvoxamine
* Active treatment with antipsychotic medications, benzodiazepines or other hypnotic agents (i.e. Trazodone, Mirtazapine, Zolpidem, Zaleplon)
* Known or suspected diagnosis of Lewy body dementia
* Any dermatological condition that may be aggravated by using a wrist sensor.
* Known pre-existing sleep disorder other than insomnia.
A Patient Reported Ocular Comfort Assessment Comparing Bepreve to Lastacaft

The purpose of this study is to evaluate the comfort of BEPREVE compared to LASTACAFT after instillation.

After one drop is instilled subjects will complete a comfort assessment at 1, 3, 5, and 10 minutes after drop instillation.

Eligibility Criteria:
Inclusion Criteria:

Each patient must meet the following criteria to be enrolled in this study:

1. Are male or female at least 18 years of age who are diagnosed with allergic conjunctivitis.
2. Have allergic ocular symptoms within the last three days.
3. Are willing/able to follow instructions from the study investigator and his/her staff.
4. Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study:

1. Have known hypersensitivity to either BEPREVE™ or LASTACAFT® or to any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.).
2. Have active corneal pathology noted in the study eye at the screening visit. Active corneal pathology is defined as corneal pathology that is non stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment.
3. Are pregnant or nursing/lactating.
Treatment of Keratoconus Using Collagen Cross-Linking

The purpose of this study is to determine the effectiveness of collagen cross-linking in the cornea in halting the progression and possibly partially reversing the effects of keratoconus. Keratoconus is a progressive weakening in the cornea that causes irregular astigmatism and thinning of the cornea. The overall effect is reduction of vision, and in more advanced cases, scarring of the cornea that may lead to the need for corneal transplantation. Cross-linking has been shown increase the rigidity of the cornea. The patients would be treated once and then followed over 24 months. .

The goal is for two groups of approximately 66 patients to be included in the study. One eye from the first group will undergo treatment, while the second group of age matched individuals will serve as a control. It will be a prospective, randomized, blinded study. Each patient will be randomized at the beginning of enrollment in the study and will receive a randomization number. The following parameters will be followed: 1. Best corrected spectacle acuity (BCSA) 2. The steepest keratometry measurement (KMax) as measured by computerized corneal topography 3. Apical corneal thickness 4. Corneal mechanical resistance. These measurements will be repeated at 1 month, 3 months, 6 months, 12, 18, and 24 months following treatment.

Eligibility Criteria:
Inclusion Criteria:

* no prior history of ocular surgery
* treatment eye must have a maximum corneal power of between 47 D and 60 diopters
* corneal thickness must be greater than 400 µ
* absence of corneal scarring
* patients must meet the diagnostic criteria for keratoconus, which include one or more of the following features:

  * high myopia
  * corneal ectasia as viewed by slit-lamp exam or measured by pachometry
  * Vogt's striae
  * topographic findings of superior flattening and inferior steepening of the cornea
  * presence of Fleischer ring

Exclusion Criteria:

* history of prior ocular surgery (history of contact lens use is not an exclusion criterion)
* average corneal power \> 60 D
* presence of corneal scarring
* corneal thickness 400 µ or less
* history of herpes simplex virus keratitis
* history of uveitis
* pre-existing glaucoma