cyrilzakka/clinical-trials huggingface dataset:
Comparative Effects of Dual Task and PNF on Balance ,Cognition and Motor Function in Chronic Stroke Patients .

The aim of this study is to compare the effect of dual tasking and proprioceptive neuromuscular facilitation on balance, cognition and motor function in chronic stroke patients. It will be randomized clinical trial.

Stroke is the major cause of disability and mortality worldwide. A stroke is defined as an abrupt neurological outburst caused by impaired perfusion through the blood vessels to the brain. Every year the number of patients affected by stroke is rising thereby putting extra pressure on socioeconomic conditions in developing countries. Major complications of stroke include hemiplegia leading to upper limb dysfunction along with gait abnormalities. This study will be conducted to determine the effects of proprioceptive neuromuscular facilitation exercises versus dual-task training on balance, cognition, and motor function in chronic stroke patients. The randomized clinical trial will be conducted, participants will be selected through Non-probability convenience sampling technique and then randomly allocated into two treatment groups.

Eligibility Criteria:
Inclusion Criteria:

item

* Both male and female
* Age 50-70 years.
* Person should be able to walk 10meter distance with or without assistance.
* Patient should be Cognitively able to perform required task.
* Chronic Stroke patients with strength \>2 on manual muscle testing.

Exclusion Criteria:

item

* Any Gait impairment .
* Patients with comorbidities like cardiac pathologies.
* Patients with dementia .
* History of fall in last 6 months.
* History of Severe Freezing episodes.
* History of Camptocormia (axial deformity.
* Central or peripheral paresis.
Bicalutamide Monotherapy Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer

The aim of this study is to comprehensively monitor the effects of a nonsteroidal antiandrogen in patients requiring hormone manipulation for prostate cancer

Androgen deprivation therapy is the mainstay of treatment for advanced prostate cancer. There is an increasing tendency towards earlier treatment with hormone manipulation. However, luteinizing hormone-releasing agonists decrease serum testosterone to castrate levels within two weeks of commencement.They are associated with loss of libido, loss of muscle bulk and accelerated bone loss. Osteoporotic patients are at high risk of fragility fractures. An alternative is the nonsteroidal antiandrogen bicalutamide which blocks testosterone at the receptor level, allowing androgen deprivation in the prostate without reducing circulating levels of testosterone. This should preserve the desired effects on other androgen-sensitive tissue, resulting in an advantageous side effect profile. The aim of our study is to closely monitor osteoporotic patients commencing bicalutamide for a period of 12 months. Patients will be reviewed in a dedicated prostate cancer clinic every 3 months. Patients will be questioned regarding adverse events. Renal and liver function tests, prostate specific antigen, testosterone, estradiol and bone turnover markers will be measured 3 monthly. Measurement of height , weight, body mass index, quadriceps strength using dynamometry, and skeletal mass using arm anthropometry (mid-arm circumference and triceps skinfold thickness), will be carried out 3 monthly. Quality of life issues will be assessed 3 monthly using the Rand 36-Item Health Survey (SF36) and University of California-Los Angeles Prostate Cancer Index (UCLAPCI). Patients will undergo bone densitometry of the forearm at baseline and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Osteoporotic patients (T score ≤ -2.5) with advanced prostate cancer requiring hormone manipulation, due to biochemical relapse following either radical prostatectomy, radiotherapy, brachytherapy, or biochemical progression after initially being observed with prostate cancer.

Exclusion Criteria:

* Severe hepatic insufficiency, with bilirubin above reference range
* Previous systemic therapy for prostate cancer
* Radiotherapy within 6 months
* Previous other invasive malignancies
* Any severe concomitant disease.
Assessing Best Medical Treatment Patterns of Patients With Symptomatic Peripheral Arterial Occlusive Disease in Germany

This proposed study will be conducted to support real-world-evidence on the extent of best medical treatment for secondary prevention of patients with symptomatic peripheral arterial occlusive disease (PAOD) for prevention of worsening limb symptoms or of major adverse cardiovascular events. The overall objective of this study is to gain a better understanding of patient characteristics, treatment patterns and outcomes in PAOD patients. For this purpose the investigators will analyze a patient population hospitalized either with intermittent claudication (IC) or chronic limb-threatening ischaemia (CLTI) while taking prior PAOD-related diagnoses in the outpatient setting into account. In detail, we study differentials according to age, calendar time, sex, disease severity and hospital procedure. Data were extracted from available German health insurance claims.


Eligibility Criteria:
1. First clinical diagnosis of symptomatic peripheral arterial occlusive disease (according to Fontaine classification, stages II, III and IV) after at least 5 years without such clinical diagnosis
2. At least 18 years of age

   Exclusion Criteria:
3. Incomplete information on sex, age, date of hospital discharge
4. Less than 5 years of insurance membership before index stay
Hemophilia Mobile App Usability Pilot

The purpose of this study is to evaluate the utility and user experience of a smart phone app for people with medical conditions, used in conjunction with an ActiGraph wearable device and a connected scale.

HITLAB will conduct a segmented rapid user acceptance study ("rapid UX study") of a smart phone app and an actigraphy device with a connected scale. During the first segment, of one month's duration, subjects will use the app, actigraphy device, and scale. Next, over an interphase period of up to 6 weeks, subjects will only use the app. During this time, the app will be modified based on data collected during the first segment. Finally, during the second period, also of one month's duration, subjects will use the modified app, actigraphy device, and scale.

Eligibility Criteria:
Inclusion Criteria:

1. You own an iPhone or a Samsung (S5 or higher) smartphone
2. Your age is between 18 and 63 years
3. You reside in the New York metropolitan area
4. You are able to read, write, and speak English
5. You have participated in a concluded clinical trial in the past two years

Exclusion Criteria:

1. You do not own an iPhone or a Samsung (S5 or higher) smartphone
2. Your age is not between 18 and 63 years
3. You do not reside in the New York metropolitan area
4. You are not able to read, write, and speak English
5. You have not participated in a concluded clinical trial in the past two years
A Study of the Effect of BIIB023 on Muscle Atrophy in Healthy Male Volunteers

The primary objective of this study is to determine whether muscle atrophy induced by immobilization of the lower limb can be attenuated by BIIB023 in healthy male volunteers. The secondary objectives of this study in this study population are:

* To determine whether muscle weakness induced by immobilization of the lower limb can be attenuated by BIIB023
* To assess the effect of BIIB023 on the recovery of muscle mass and strength after immobilization
* To assess the effect of BIIB023 on histological markers of muscle atrophy and regeneration
* To assess the effect of BIIB023 on muscle bioenergetics based on oxidative metabolism recovery kinetics
* To evaluate the safety and tolerability of BIIB023


Eligibility Criteria:
Key Inclusion Criteria:

* Deemed healthy as determined by the Investigator based on medical history, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters at Screening, and physical examination at Baseline
* Body mass index (BMI) between 18.5 and 32 kg/m2, inclusive, at the time of Screening
* Willing to abstain from using tobacco and tobacco-containing products during the study
* Willing to limit the intake of alcohol to no more than 2 units per day throughout the study; exceptions are 48 hours prior to Screening, 48 hours prior to Day 1, and during the in-clinic immobilization period when no alcohol will be permitted. One unit of alcohol is defined as 12 fluid ounce (fl oz) of beer, 5 fl oz of wine, or 1.5 fl oz of liquor
* Willing to maintain a regular diet for the duration of the study and a recreational level of physical activity defined as participation in an exercise program or other physical activity at a level of intensity that does not exceed the level prior to study entry
* Practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after the last dose of study treatment.

Key Exclusion Criteria:

* History of or positive test result at Screening for human immunodeficiency virus (HIV).
* History or positive test result at Screening for hepatitis C virus (HCV) antibody or hepatitis B virus (defined as positive for hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\]).
* History of tuberculosis (TB) or a positive QuantiFERON®-TB Gold test. There must be no other clinical evidence of TB on physical examination of the subject.
* Use of tobacco or tobacco-containing products within 3 months prior to Screening
* Known history of thrombophilia, hypercoagulopathy, or prior history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
* History of physical activity consistent with endurance training or resistance training within 6 months prior to Screening
* Any back, leg, knee, or shoulder complaints that may interfere with the use of crutches
* Prolonged travel (more than 6 hours) within 2 weeks prior to randomization.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Sequential Compression Device on Body Temperature

We hypothesized that sequential compression device (SCD) compression system might induce more decreases on core temperature by increasing lower extremity blood flow. And, this study investigated the effects of SCD compression system on body temperature in patients during total intravenous anesthesia (TIVA) with propofol and remifentanil.

Anaesthesia was induced and maintained with propofol and remifentanil. During the surgery, temperature was measured and recorded using oesophageal temperature and the calf-minus-toe skin-surface temperature gradient, respectively.

Eligibility Criteria:
Inclusion Criteria:

* ASA I or II
* 20-65 year
* patient who undergoing elective thyroidectomy

Exclusion Criteria:

* coronary occlusive disease
* peripheral vascular disease
* BMI \> 30 kg/m2
* abnormal thyroid function test
* laparoscopic assisted thyroidectomy
To Evaluate the Performance and Safety of YVOIRE Volume Plus for Improvement of Mid-face Volume

A Study to Evaluate the Performance and Safety of YVOIRE volume plus for Temporary Improvement of Mid-face Volume

This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Performance and Safety of YVOIRE volume plus versus Restylane Lyft with Lidocaine for Temporary Improvement of Mid-face Volume.

Eligibility Criteria:
Inclusion Criteria:

* Male and female aged between 21 to 75 years (inclusive)
* 2 or 3 on the 5-point MFVLRS (Mid Face Volume Loss Rating Scale)
* Desire cheek augmentation to correct volume deficit in the midface.
* Agree to use contraception
* Sign Informed Consent Form

Exclusion Criteria:

* have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers in the midface area
* have undergone temporary facial dermal filler injections with HA-based fillers within 12 months, porcine-based collagen fillers within 24 months prior to screening
* have mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
* have history of anaphylaxis, multiple severe allergies, or allergy to lidocaine, HA products, or Streptococcal protein
* have history of bleeding disorder
* have a tendency to develop hypertrophic scarring or keloid
Vegan Diet in Small Children

Following increased knowledge about climate change and how food production affects greenhouse gas emissions, the interest in vegetarian diets is increasing. In line with this, also vegan diet is becoming more common at all ages, including in young children. But the state of knowledge regarding the effect of this diet on children during infancy and early childhood has been poorly studied and existing literature consists to a large extent of case reports.

With the main hypothesis that vegan diet from the introduction of complementary foods causes reduced bio availability of certain micronutrients important for development, the aim of this study is to examine dietary intake and development during the first years of life in a group of children eating vegan diet and compare with a reference group eating mixed diets.

In an observational study, investigators plan to include 30 children before the age of 6 months during the years 2021-2026, where the parents have decided to offer their child only vegan food. The children are studied in comparison with a reference group of 30 matched cases regarding growth, nutritional status, and dietary intake. Data collection includes monthly dietary records and blood sample analyses and growth at 6, 12 and 24 months. At the age of 3, cognitive developmental assessment (WPSSI-IV) and an DEXA examination of body composition are performed.

The study is expected to contribute to increased knowledge about the risk and benefits of vegan diets and thereby provide a better basis for future recommendations.


Eligibility Criteria:
Inclusion Criteria:

* Planned exclusive vegan diet or mixed diet respectively from 6 months of age until at least 2 years of life
* Exclusively (\>90%) breastfed until 4 months
* Born term (GE 37+0 - 41+6)
* Single birth
* Birth weight \>2500 g
* Apgar score 5 min \> 5

Exclusion Criteria:

\* A chronic disease affecting growth or neurodevelopment
Aorta Calcium Scoring

Calcium scoring of the coronary arteries is use as a predictor of coronary stenosis. The aim of this study is to measure the calcium scoring of the abdominal aorta using an helicoidal fast scan and to correlate this measurement with classical cardiovascular risk factors and newer parameters reflecting vascular rigidity, like pulse velocity measurement.


Eligibility Criteria:
Inclusion criteria :

* Patients with at least one cardiovascular risk factor
* Ambulatory or hospitalized patients

Exclusion criteria :

* Significant cardiovascular complications
Buprenorphine for Prisoners

This five-year study examines the effectiveness of buprenorphine treatment provided to previously-addicted inmates(N=320; 160 males, 160 females) initiated in prison and continued in the community. The study also examines the extent to which the setting of post-release buprenorphine is provided.It is expected that participants receiving in-prison buprenorphine will have superior outcomes compared to participants who did not receive in-prison buprenorphine.

Participants will be randomly assigned, within gender, to one of four treatment conditions: 1) buprenorphine and counseling in prison, with referral for continued treatment at an OTP upon release; 2) buprenorphine and counseling in prison, with referral for continued treatment at a CHC upon release; 3) counseling only in prison, with referral for buprenorphine and counseling at a OTP upon release; and 4) counseling only in prison, with referral for buprenorphine and counseling at a CHC upon release. Participants will be assessed at study entry and at 1, 3, 6, and 12 months following their release from prison. Outcome measures include: treatment entry and retention in the community, heroin use, cocaine use, HIV infection, HIV-risk behaviors, criminal activity, and employment.

Eligibility Criteria:
Inclusion Criteria:

1. pre-release prison inmate with 3-6 months remaining until planned release
2. history of heroin dependence(meeting DSM-IV criteria of heroin dependence at the time of incarceration and manifesting physical dependence during the year preceding incarceration
3. suitability for buprenorphine treatment as determined by medical evaluation
4. willingness to participate in the study
5. having a Baltimore address and planning to live in Baltimore after release from prison -

Exclusion Criteria:

1. evidence of kidney failure
2. evidence of liver failure
3. history of psychosis
4. having a pending parole hearing
5. unadjudicated charges that could result in additional prison time or transfer to another facility -
Placental Transfer of Sugammadex in the Human Placental Perfusion Model

Preclinical research raised concern regarding the foetal effects of using sugammadex during pregnancy. However, to the best of our knowledge, the placental transfer of sugammadex has never been measured. As these data would be critical in assessing the foetal effects after maternal administration of sugammadex, it is warranted to measure the placental transfer of sugammadex. The aim of this project is to measure the placental transfer of sugammadex in the human placenta by using the ex vivo human placenta perfusion model.


Eligibility Criteria:
Inclusion Criteria:

* informed consent signed
* (placenta of a) pregnant women with an uncomplicated pregnancy and delivery

Exclusion Criteria:

* chronic medication use during pregnancy
* maternal diseases during pregnancy (including diabetes mellitus, hypertension, thyroid dysfunction), or any infection (chorioamnionitis and toxoplasmosis, other, rubella, cytomegalovirus, herpes infections, or a positive anti-HIV, anti-hepatitis B virus, or anti-hepatitis C virus serology)
Safety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts

This is a randomised, controlled, open-label study of a single intralesional administration of I-040302 or a single bone marrow aspirate or a single steroid injection (methylprednisolone). Subjects will undergo screening with X-ray and magnetic resonance imaging (MRI) in the diagnosis of a solitary bone cyst.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects 6 - 16 years of age
2. Diagnostic evidence of unicameral bone cysts based on one or more of a combination of any of the following methods:

   * Cyst fluid examination
   * Plain radiographs
   * MRI
3. Subjects with the following types of cysts:

   * Intact cysts that are either growing or at risk of fracture, requiring surgical intervention
   * Persistence of a cyst cavity following cyst fracture that has received conservative treatment/s to repair the fracture
   * Persistence of a cyst cavity despite repeated interventions
4. Subjects with bone cyst volumes \< 30 mL
5. Subjects must be appropriately communicative to verbalise pain.
6. Subjects must be able to understand and be willing to comply with the protocol procedures.
7. Subjects who have provided written informed consent to participate in the study
8. The legally authorised representative of the child must give written informed consent after the child has agreed to participate in the study.

Exclusion Criteria:

1. A history of/or presence of active cancer
2. Family history of retinoblastoma
3. Indication of aneurysmal bone cyst on MRI, cyst aspiration or histology
4. Possible presence of osteosarcoma or uncertain histology
5. Systemic or localised infection at time of surgery
6. Evidence of immune-suppression
7. Evidence of hypercalcemia
8. Cyst volume \> 30 mL
9. Fracture present in the cortical bone surrounding the cyst
10. Evidence of rapid venous drainage from the cyst determined by rapid disappearance of X-ray contrast medium during the surgical process.
11. Suspected or known evidence of allergic reactions towards any of the components of I-040302
12. Known clinically significant organ or systemic diseases such that, in the opinion of the investigator, the significance of the disease will compromise the subject's participation in the study
13. Pregnant or lactating females
14. Participation in another clinical trial within 3 months prior to trial start
Study of Cortisol Metabolism in Familial Partial Lipodystrophy Type 2

Familial partial lipodystrophic syndromes are characterized by an increase in visceral adipose tissue and an atrophy of subcutaneous adipose tissue. They are associated with a severe metabolic syndrome especially when linked to the mutation of the R482 codon of the LMNA gene (Familial partial lipodystrophy type 2, FPL2). Data in lipodystrophy induced by antiretroviral therapy of HIV suggests an increase in the activity of 11β-hydroxysteroid dehydrogenase type 1 (11bHSD1). This enzyme reactivates cortisone in cortisol in adipose tissues and liver and has associated to obesity and type 2 diabetes mellitus. Hence, the hypothesis is that in patients suffering from FPL2 with the R482 codon mutation of the LMNA gene, there is an increase in the activity of HSD11B1 which could participate to the metabolic phenotype of the disease.


Eligibility Criteria:
Inclusion Criteria:

* Familia partial lipodystrophy type 2 (FPL2) with the R482 codon mutation of the LMNA gene
* Social insured
* Ability to give consent

Exclusion Criteria:

* urinary incontinence or inability to collect urine for 24 hours
* moderate and severe kidney insufficiency
* hepatic insufficiency
* history of hypercortisolism or adrenal insufficiency
* treatment interfering with the cortisol metabolism: taking oral or inhaled glucocorticoids within the last 6 months
* pregnant and lactating woman.
Adjunctive Use of Polynucleotide and Hyaluronic Acid-based Gel in Alveolar Preservation After Tooth Extraction

Alveolar ridge resorption after tooth extraction is a physiological process that continues throughout the patient's life due to the loss of the periodontal ligament and lack of mechanical stimulation. Alveolar ridge preservation (ARP) techniques aim to minimize dimensional changes in the ridge after tooth extraction. These techniques involve grafting the socket to fill the bed and/or sealing it with a biomaterial. Currently, there is a polynucleotide and hyaluronic acid-based gel (Regenfast®) on the market that has proven useful in treating residual periodontal defects. Hyaluronic acid-based gels also appear to enhance the regenerative potential of critical bone defects in both in-vitro studies on rats and clinical studies. Therefore, this study aims to evaluate the clinical and histological effects of polynucleotide and hyaluronic acid-based gel in alveolar preservation procedures.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years) who need the extraction of a single non-molar tooth in the mandible or maxilla.
* ASA I or II
* Intact post-extraction socket or with only one wall dehiscence (buccal or lingual) of no more than 50% of the socket.
* The treatment plan must include the replacement of the tooth to be extracted by placing an implant and an implant-supported prosthesis.

Exclusion Criteria:

* Mandibular incisors and molars.
* Acute infection associated with the tooth that needs to be extracted.
* Uncontrolled systemic disease.
* Pregnant patient.
* Patient under treatment with antiresorptives drugs (bisphosphonates or Receptor Activator of Nuclear Factor Kappa-B Ligand (i.e., Denosumab)) or antiangiogenics.
* Smokers (\>10 cigarettes a day).