cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of Red Grape Seed Extract on Lipid Profile and Oxidized Low-Density Lipoprotein (OX-LDL)

Antioxidants are potent scavengers of free radicals and serve as inhibitors of neoplastic processes. A large number of synthetic and natural antioxidants are known to induce beneficial effects on human health and disease prevention. Cardioprotective ability of grape seed extract polyphenols (GSEP) was studied in animals and humans. It has been suggested that grape seed proanthocyanidins have cardioprotective effects against reperfusion-induced injury of free radicals after ischemia. In another study, it is suggested that proanthocyanidins, the major polyphenols in red wine, might trap reactive oxygen species in aqueous series such as plasma and interstitial fluid of the arterial wall; thereby inhibiting oxidation of low-density lipoprotein (LDL) and showing an antiatherosclerotic activity. The only human model study designed to evaluate the effect of a standardized formulation of a GSEP (leucoselect-phytosome \[LP\]) on the susceptibility of LDL to oxidation in a group of heavy smokers, revealed that the antioxidant potential of GSEP may be effective in oxidative stress (smoking); however more investigational data are needed before wider use in clinical settings. Based on these observations, the investigators decided to evaluate the effect of GSEP in reducing OX-LDL in patients diagnosed with mild hyperlipidemia.


Eligibility Criteria:
Inclusion Criteria:

1. Triglyceride \> 150 mg/dl
2. Total Cholesterol \> 200 mg/dl

Exclusion Criteria:

1. Severe hyperlipidemia (Triglyceride \> 300 mg/dl,Total Cholesterol \> 250 mg/dl)
2. Usage of antilipid drugs
3. Herbivore Diet
4. Alcoholism
5. Heart failure
6. Known cases of any malignancy
7. BMI \> 30 kg/M2
8. Chronic Hepatic Diseases
9. Smoking
10. Chronic Renal Failure
Hips Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients (HipSTHeR)

A registerbased RCT will investigate whether arthroplasty can decrease the reoperation rate compared to internal fixation for patients with an undisplaced femoral neck fracture (Garden I-II).

The aim of this study is to determine whether the treatment of elderly patients with an undisplaced femoral neck fracture (uFNF) can be improved by decreasing reoperation rates through replacing the hip instead of trying to preserve it. Patients ≥75 years with an uFNF will be included and randomized within the Swedish Fracture Register (SFR) platform to internal fixation (screws/pins) or arthroplasty (choice of hemi or total is at the surgeon's discretion). The primary outcome will be a composite variable that combines two variables (reoperations and mortality) into a single variable.

Eligibility Criteria:
Inclusion Criteria:

* Undisplaced (Garden I-II) femoral neck fracture (within 72h)
* treated at participating unit
* informed consent
* amenable for both treatment options

Exclusion Criteria:

* no informed consent
* pathological or stress fracture
* peri-implant fracture
Results of Opening-wedge High Tibial Osteotomy Using Iliac Crest Allograft Compared to Iliac Crest Autograft

The purpose of this RCT is to determine the results of opening-wedge high tibial osteotomy in patients with genovarum deformity using iliac crest allograft compared to the results when using iliac crest autograft.


Eligibility Criteria:
Inclusion Criteria:

* Varus malalignment of knee with of without osteoarthritis: the angle between the articular surface and anatomical axis of tibia\< 82 degrees
* at least 7.5 mm opening wedge is needed in medial proximal tibia to correct the deformity assessed during pre-op planning

Exclusion Criteria:

* symptomatic lateral compartment osteoarthritis of knee
* rheumatoid arthritis or other inflammatory joint diseases
* less than 100 degrees of knee range of motion
* grade III laxity in knee collateral ligaments
* history of surgery or fracture in the limb
* \>15 degrees flexion contracture
* age \<16 or \>60 years
* \>20 degrees varus deformity
* failure to attend follow-up visits
* sever bone loss in medial tibial plateau or medial femoral condyle
* \>1cm joint subluxation
* presence of lateral trust during walking
* presence of patella baja
* skin derangements on medial proximal tibia
* any form of nicotine addiction
Hearing and Balance Disorders in Peripheral Neuropathy

The long term goal of this proposal is to precisely characterize the auditory and vestibular abilities of children with Charcot-Marie-Tooth (CMT) and how these abilities evolve during the progression of the disorder. This information will be used to refine the management methods for hearing loss and vestibular disorders in these patients. Given that the phenotypic severity is variable within the CMT patient population, we predict that not all CMT patients will present with auditory and vestibular dysfunction. We will therefore collect specimens (i.e., buccal swabs and saliva) from study participants so that their DNA can be isolated and used to determine the genetic basis for auditory and vestibular dysfunction in peripheral neuropathies.

Aim #1: Evaluate the prevalence of auditory and vestibular disorders in children diagnosed with Charcot-Marie-Tooth.

We hypothesize that a significant number of children with Charcot-Marie-Tooth (CMT) will develop auditory and vestibular neuropathies, due to the progression of the disorder. We will examine the characteristics of auditory and vestibular abilities of children and how these relate to the type of CMT.

Aim #2: Examine the progression of hearing and vestibular abilities during the course of the disorder.

We hypothesize that the hearing and vestibular abilities of some children with CMT will deteriorate with time. We will repeat the auditory and vestibular testing on a yearly basis to precisely describe the progression of these abilities.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with Charcot-Marie Tooth

Exclusion Criteria:

-
Repair of Flexor Tendon Injuries With Eight Strand Core Stitch Without Postoperative Splinting

Evaluation of early active postoperative mobilisation in flexor tendon injuries without postoperative splinting

Flexor tendon injuries are a common event as the tendons lie close to the skin and so are usually the result of either lacerations such as those from knives or glass, from crush injuries and occasionally they can rupture from where they are joined at the bone during contact sports such as football, rugby and wrestling. Flexor tendon injuries are a challenging problem for orthopaedic surgeons due to three main reasons. Firstly, flexor tendon injuries of the hands are a clinical problem because they cannot heal without surgical treatment, as the two ends need to be surgically brought together for the healing to occur unlike other tendons including the Achilles tendon where it could be placed into plantar flexion to heal. Secondly postoperative management needs to be carefully planned as mobilisation has shown to be essential to prevent adhesions and improve gliding but this can risk rupture. Lastly due to the unique anatomy of the tendons running through flexor tendon sheaths to function, surgeons need to plan preventing increasing the bulkiness of the tendon through its sheath, which is not always possible from scarring as this affects the functional outcome of the tendon

-_ The ultimate goal of surgical intervention has remained constant: to achieve enough strength to allow early motion, to prevent adhesions within the tendon sheath, and to restore the finger to normal range of motion and function.

* The successful repair requires minimal gapping at the repair site or interference with tendon vascularity, secure suture knots, smooth junction of tendon end and having sufficient strength for healing.
* The strength of the core suture is one of the important factors for valid flexor tendon repair. It is obvious that an increased strand number increases repair gap resistance and strength

Eligibility Criteria:
Inclusion Criteria:

1. Adult patient ( \> 16 years)
2. Flexor tendon injuries zones (II,III,IV,V)

Exclusion Criteria:

1. Patients \< 16 years
2. Flexor tendon injuries zone I

2- Fracture of hand,wrist or forearm bones 3- Associated nerve injuries
Clinical, Biochemical, Histological and Biophysical Parameters in the Prediction of Cerebral Palsy in Patients With Preterm Labor and Premature Rupture of Membranes

A major goal of modern perinatal and neonatal medicine is to reduce the rate of developmental disabilities, especially mental retardation. Cerebral palsy is frequently associated with neurologic abnormalities and mental retardation. Improvements in neonatal intensive care have resulted in improved survival of very low birthweight infants but also in an increased frequency of cerebral palsy. Prematurity is a leading risk factor for cerebral palsy. Two thirds of preterm neonates are born to mothers with preterm labor with intact membranes or preterm premature rupture of membranes. A growing body of evidence suggests that these conditions are heterogeneous. This is an observational cohort study designed to identify the mechanisms of disease in patients with preterm labor/contractions and preterm premature rupture of membranes and to describe the relationship between clinical, biochemical, histological, biophysical parameters and the development of infant neurological disorders.

A major goal of modern perinatal and neonatal medicine is to reduce the rate of developmental disabilities, especially mental retardation. Cerebral palsy is frequently associated with neurologic abnormalities and mental retardation. Improvements in neonatal intensive care have resulted in improved survival of very low birthweight infants but also in an increased frequency of cerebral palsy. Prematurity is a leading risk factor for cerebral palsy. Two thirds of preterm neonates are born to mothers with preterm labor with intact membranes or preterm premature rupture of membranes. A growing body of evidence suggests that these conditions are heterogeneous. This is an observational cohort study designed to identify the mechanisms of disease in patients with preterm labor/contractions and preterm premature rupture of membranes and to describe the relationship between clinical, biochemical, histological, biophysical parameters and the development of infant neurological disorders.

Eligibility Criteria:
* INCLUSION CRITERIA:

Consecutive patients admitted with the diagnosis of preterm labor/contractions or PROM.

"Preterm labor/contractions" will be defined as:

1. gestational age: 20-36 weeks;
2. intact membranes; and
3. regular uterine contractions greater than or equal to 8 in 60 minutes.

Preterm PROM will be defined as:

1. gestational age 20-36 weeks; and
2. spontaneous rupture of membranes as diagnosed by sterile speculum examination confirming pooling of amniotic fluid in the vagina, a positive Nitrazine test result, and a positive ferning test result. In cases of suspected but unconfirmed preterm PROM, indigo carmin instillation will be performed. The vaginal leakage of indigo carmin will confirm the diagnosis in these cases.
Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients

The purpose of this pilot study is to examine the effects of combined pharmacotherapy (Zyban/NRT)/behavioral treatment on smoking cessation among methadone maintenance therapy patients.

This is a one-arm, open label pilot study of MMT patients to determine whether bupropion, nicotine replacement therapy, and behavioral counseling is a feasible and potentially effective intervention for smoking cessation. The smoking behaviors of participants will be be followed for 6 months post quit-date to determine effect-size estimates for a future, large scale trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients in long-term methadone maintenance treatment
* Patient smokes at least 10 cigarettes per day, are stable on their use of methadone (phase 2 or higher treatment), smoked for at least 1 year, be willing to participate for 6 months, and not have used bupropion or nicotine replacement therapy for 6 months

Exclusion Criteria:

* Patients who use prescription drug regimens that might affect methadone or bupropion metabolism
* Patients with cardiovascular disease, asthma, COPD
* Patients who are pregnant or breastfeeding
* Patients with regular use of alcohol, other illicit drugs, or other types of tobacco (chewing or pipe for example)
The Türkish Version of the Freezing of Gait Questionnaire

The freezing of gait (FOG) is one of the disabling symptoms in Parkinson's disease. The diagnosis and assessment of the FOG may be diffucult, but it is absolutely necessary. The aim of this study was to develop a Türkish version of the freezing of gait questionnaire (FOG-Q) and assess the validity and reliability of this Türkish version.

The researchers firstly communicated with the developers of the FOG-Q. The permission for Turkish version was received by Giladi. Then, the FOG-Q will be adapted into Türkish using forward-backward translation by three native Türkish-speaking forward translators and one native English-speaking backward translator. The internal reliability of the FOG-Q Türkish version will be assessed using Cronbach's alpha, and item analyses will be conducted by examining the effect on Cronbach's alpha of excluding each of the six FOG-Q items individually. The test-retest reliability will be assessed using intraclass correlation coefficient (ICC).

Convergent validity will be evaluated by means of Spearman rank correlation coefficient (rs). In this section will be determined the correlation between the FOG-Q scores and scores of the UPDRS motor section , Berg Balance Scale, Timed up and go test, Falls Efficacy Scale and Hoehn and Yahr stages.


Eligibility Criteria:
Inclusion Criteria:

* a clinical diagnosis of idiopathic PD
* able to walk with or without a walking device

Exclusion Criteria:

* a diagnosis of other neurological disorders
* any other medical conditions
* not able to take commands.
An Observational Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) And Oxaliplatin in Patients With Colorectal Cancer

This prospective observational study will evaluate the efficacy and safety of bevacizumab in combination with capecitabine and oxaliplatin as first-line treatment in participants with colorectal cancer. Data will be collected from each participant until disease progression occurs (for up to 30 months).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Metastatic colorectal cancer
* Treatment in accordance with current Summary of Product Characteristics and local guidelines

Exclusion Criteria:

* Contraindications according to current Summary of Product Characteristics and local guidelines
Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy

Hypertensive crisis (defined as a systolic pressure \> 160mmHg or a diastolic pressure \> 110mmHg) in patients with a hypertensive disorder of pregnancy is a serious complication with severe and even deadly consequences. The management in this population had been studied, but no consensus has been reached with regards to which treatment is better. Our study will compare two drugs: Hydralazine and Labetalol for the management of hypertensive crisis.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \> 24 weeks.
* Hypertensive Crisis (systolic pressure \> 160 mmHg / diastolic pressure \< 110mmHg).

Exclusion Criteria:

* Known allergy to hydralazine.
* Known allergy to labetalol.
* Severe Bradycardia
Role of Tele-physical Therapy in Patients With Type 2 Diabetes Mellitus Following COVID-19 Infection.

Diabetes mellitus (DM) is a chronic metabolic disease where the body is unable to metabolize carbohydrates properly either due to a lack of insulin production or abnormal insulin function. In recent times, it has been considered a global healthcare concern because of its high prevalence rate (9.2 %) and other associated health consequences. After being infected with Coronavirus disease-2019 (COVID-19), the Type 2 Diabetes mellitus (T2DM) sufferer experiences the following symptoms; reduced exercise tolerance, decreased muscle strength, altered respiratory functions, cognitive impairments and abnormal psychosomatic behaviour, which affects the overall well-being of the patient. To prevent or delay these clinical features and the associated consequences of type 2 Diabetes mellitus, the regular body works out and physical training is suggested either alone or in combination with diet modification. In this study, we tested the hypothesis that 12 months of supervised tele-physical therapy can positively influence patients with type 2 diabetes mellitus following COVID-19 infection. The reports of the study would be helpful for the clinicians and the physical therapists to make this as evidence for using tele-physical therapy in type 2 Diabates mellitus patients.


Eligibility Criteria:
Inclusion Criteria:

* Participants between 18-60 years of age and being diagnosed with COVID-19 with mild dyspnea and type 2 DM and the ability to use smart mobile phones were selected to be included in the study.

Exclusion Criteria:

* Participants who had neurological (radiculopathy, myelopathy and disc problems) and orthopedic problems, cardio-pulmonary diseases (stroke, hypertension and syncope), other metabolic and endocrinal problems, metastasis, pregnancy, taking analgesics or corticosteroids, any contra indications to physical exercises (fracture, instability, osteoporosis, arthropathy and neural symptoms) and cognitive and mental disorder were excluded.
Conditioned Open Label Placebo for Postoperative Pain Management

The primary objective is to evaluate the efficacy of two Conditioned Open Label Placebos (COLP): COLP pill and COLP odor to reduce opioid intake for postoperative (thoracic and spinal surgery) pain management compared to the opioid only usual treatment (TAU).

Patients, eligible for an elective thoracic or spinal surgery, will be randomized into either standard of care, COLP_pill or COLP_odor. Patients in COLP groups will be asked to pair each opioid intake with an open label placebo intake (either a pill or an inhalation) for postoperative (POD) day 0 to 17. From POD 2, patients in the intervention arms will be additionally asked to take OLP alone 3 times a day. Patients will have unrestricted access to pain killers. Patients will daily assess opioid intake, pain intensity, side effects, mobility and sense of agency using a e-dairy.

Eligibility Criteria:
Inclusion Criteria:

* Spinal or thoracic elective surgery for the indications mentioned above
* Able to give informed consent
* Interested in trying COLP as complementary pain management therapy
* Able to fill a e-diary at home

Exclusion Criteria:

* Cognitive impairment (MOCA score \<26)
* Inability to engage in the intervention of the study e.g. inability to communicate in French without a translator, severe hearing impairment without any hearing aid available at the time of intervention, anosmia or intolerance to eugenol.
* Acute psychiatric (e.g. psychotic or suicidal ideation) or somatic (e.g. unstable cardio-respiratory condition) co-morbidity preventing full engagement during intervention
* Opioid use disorder (toxicomania) or contraindication to pain management using opioids (allergy, refusal, ...)
* Intolerance to placebo ingredients
A Study of Real-life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma Who Received at Least 3 Prior Lines of Therapy Including Proteasome Inhibitor (PI), Immunomodulatory Drug (IMID), and Cluster of Differentiation 38 (CD38) Monoclonal Antibody Treatment

The purpose of this study is to assess the safety and clinical response including overall response rate (ORR) of real-life standard-of-care (SOC) treatments under routine clinical practice, over a 24-month period, in patients with relapsed/refractory multiple myeloma (RRMM).


Eligibility Criteria:
Inclusion Criteria:

* Have a documented diagnosis of multiple myeloma according to International myeloma working group (IMWG) diagnostic criteria
* Received at least 3 prior lines of therapy or are double refractory to a proteasome inhibitor (PI) and an immunomodulatory agent (IMID) (induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen). Patients will have undergone at least 1 complete cycle of treatment for each regimen (unless progressive disease was the best response)
* Must have documented evidence of progressive disease based on study physician's determination of response by the IMWG response criteria on or after the last regimen. Patients with documented evidence of progressive disease within the previous 6 months and who are refractory or nonresponsive to their most recent line of treatment afterwards are also eligible
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1
* Must not be pregnant or must not plan to become pregnant within the study period
Cornell Translational Behavioral Science Research Consortium: Asthma Qualitative Study

To explore and illuminate the cultural, social, and psychological factors that either facilitate or serve as barriers to behavioral change in asthma patients.

1. Through a series of open-ended questions we will explore and build a better understanding of how different patient populations view asthma and the difficulties they face in changing behavior. In addition the responses to such questions should help us to better understand and anticipate some of the barriers and issues that participants may face in successfully changing their behaviors.
2. The second objective is to use the responses obtained to inform how an intervention of positive affect induction and self-affirmation should be operationalized and tailored.

Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible for this study if their physicians consider them medically able to participate, if they are 18 years of age or older, and if they have a diagnosis of mild to moderate asthma based on the NHLBI Asthma Expert Panel's classification system which rates symptoms, frequency of exacerbations, nocturnal attacks, activity restriction, use of medications, and pulmonary function.

Exclusion Criteria:

Patients will be excluded from this study for the following reasons:

* If they are unable to walk several blocks for whatever reason;
* If they have musculoskeletal or neurological deficits that preclude increased physical activity;
* If they have other pulmonary diseases;
* If they have cardiac disease or other severe comorbidity;
* If they are unable to provide informed consent because of cognitive deficits;
* If they refuse to participate.
Functional MRI During Resting State in Patients with Eating Disorders

The goal of this observational study is to learn if clinical and neurophysiological characteristics dynamics may follow similar trends in a longitudinal characterization of patients with a diagnosis of an eating disorder.

The primary hypothesis is that the reversal of Functional Magnetic Resonance Imaging (fMRI) baseline alternations is positively associated with symptomatic amelioration.

The secondary hypothesis is that the degree of (f)MRI baseline alternations is positively associated with symptoms.

Participants will be asked to complete psychometric questionnaires, perform a fMRI and be recalled at 12 months for a follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Female sex
* Age between 12 and 40 years old
* Current diagnosis of Anorexia Nervosa or Bulimia Nervosa according to DSM-5-TR.

Exclusion Criteria:

* Previous or current diagnosis of schizophrenia or bipolar disorder,
* Acute psychosis
* Substance abuse
* Severe medical comorbidities (hypercapnia, severe hypertension, cardiac arrhythmia, organ failure)
* incapacity to grant written or verbal consent