cyrilzakka/clinical-trials huggingface dataset:
The Correlation Between Outcome and Infarct Growth in Patients With Acute Ischemic Stroke

Previous research has shown there wasn't inevitable relationship between mismatch area and infarct growth according to Volumetric-subtraction mismatch volume.The recently published on Stroke paper has proposed Coregistration mismatch to calculate the mismatch to replace ischaemic penumbra, and it reignites hope for clinical application of the PWI/DWI mismatch. But the correlation between the mismatch, calculated by Coregistration mismatch method,and the clinical outcome of the patients with acute ischemic stroke is still unknown. so the investigators plan to conduct a prospective observational cohort study.

NIHSS,mRS and MR PWI/DWI/MRA are performed within 48 hours of stroke onset and final MR T2/flair image at ≈1 month. And then,Volumetric-subtraction mismatch and Coregistered mismatch will be calculated,respectively.finally,we will assess and compare the Volumetric-subtraction mismatch and Coregistered mismatch, and to clarify which method match the clinical outcome more better.

Eligibility Criteria:
Inclusion Criteria:

* Aged eighteen or above
* Acute middle cerebral artery ischemic stroke
* Stroke onset within 48 hours
* Included a complete set of initial MR images and final outcome MR images up to 1 months

Exclusion Criteria:

* History of stroke in the past 6 weeks
* Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score greater than 3
* CT evidence of the following conditions before enrollment:

Significant mass effect with midline shift Evidence of intracranial hemorrhage

* With contraindication to MR such as severe allergy to contrast media
The Effectiveness of Audiovisual Intervention

The objective of this clinical study is to understand the current status of parent-child bond, parenting role perception and well-being of fathers of preterm infants, and to explore the effect of audio-visual interventions on parent-child bonding, parenting role perception and well-being of fathers of preterm infants. The main questions it aims to answer are:

* After intervention, whether the parent-child connection between fathers and preterm infants in the audio-visual group is higher than that in the audio-visual group and the control group
* After the intervention, whether the father's perception of parenting role in the audio-visual group is higher than that of the vocal group and the control group
* After intervention, whether the father's happiness in the audio-visual group is higher than that in the audio-visual group and the control group The investigators will compare the pre- and post-test methods bwtween the experimental groups and the control group. The fathers of enrolled preterm infants will fill in the structured questionnaires at the time before the intervention (Baseline data) and one month later after the intervention.

This study is a randomized controlled trial, which will compare the pre- and post-test methods between the experimental groups (2 groups) and the control group in an attempt to explore the effect of audio-visual intervention on the parent-child bond, parent-role perception and well-being of fathers of preterm infants.

The total number of participants is estimated as 99. All fathers of preterm infants will complete three questionnaires at the time of 1-3 days , one week, and one month of age of their preterm babies). It will take about 10-20 minutes for questionnaire survey each time. Study participants were randomly assigned to the following three groups (33 in each group):

【Group 1】During the first three days, the researchers will provide a storybook to the father of the premature infant, and the researchers assist in recording the father's voice of the storybook in the form of MP4 recording. At the fourth day, one hour after the baby feeding, the father's voice will be played by the player to the baby, for 2 consecutive days, 2 times/day, 10 minutes/time. The baby's heartbeat, breathing and blood oxygen changes will be recorded and monitored with a physiological monitor. The recording files will be kept by the researcher.

【Group 2】 The intervention will be the same with Group 1 except the following intervention: on the 4th-6th day of the baby's birth, sleeping in the incubator, the baby's reaction behavior will be taken with a mobile phone, 1 time/day, 5 minutes/time, for 3 consecutive days, the image feedback is delivered to the father in person.

【Group 3】This group is a control group. The fathers and preterm infants will not receive interventions conducted in group 1 and 2.

Eligibility Criteria:
Inclusion Criteria:

* father age \> 20
* premature infant born at 29-36 weeks

Exclusion Criteria:

* infant failing the hearing examination
* father and mother are not married
Nutritional Therapy in Late-onset Pompe Disease

RATIONALE: Pompe disease (PD) is a recessive genetic disorder wherein the body cannot break down glycogen due to a mutation in the acid alpha glucosidase (GAA) gene, which encodes for acid alpha-glucosidase. The adult/late onset form (LOPD) leads to glycogen accumulation and autophagic buildup, causing progressive muscle weakness that leads to wheelchair dependence, reduced quality of life and premature death due to cardiorespiratory insufficiency. While nutritional strategies, such as the low carbohydrate/high protein and ketogenic diets, have been used clinically, they are difficult to maintain and have limited benefits. Multi-ingredient supplementation (MIS) allows for targeting of several underlying pathogenic pathways and may be more convenient than traditional dietary strategies, thereby improving both adherence and LOPD pathology.

DESIGN AND INTERVENTION: The present study is a 4-month randomized, double-blind, placebo-controlled clinical trial (RCT) with sampling pre and post intervention in late onset Pompe disease patients undergoing enzyme replacement therapy (ERT) (21-90 years of age). Each patient will be randomized into either a Pompe-Targeted Multi-Ingredient Supplement (PDT-MIS; high-quality proteins, antioxidants, plant extracts, vitamins, and omega-3 fatty acids,) or placebo (PLA; collagen, safflower, and cellulose) group and then undergo four months of daily supplementation with concurrent rehabilitative exercise training (mixed cardio and strength four days/week) and respiratory muscle training (four days/week).

GENERAL RESEARCH AIMS AND HYPOTHESIS: The purpose of this study is to investigate the benefits of PDT-MIS on muscle and blood pathology, muscle function, respiratory capacity, and health-related quality of life (HRQOL) in LOPD patients on enzyme replacement therapy (ERT). It is generally hypothesized that PTD-MIS will mitigate mitochondrial dysfunction, oxidative damage, inflammation and alleviate 'autophagic block' in skeletal muscle of LOPD patients. PDT-MIS may therefore improve muscle pathology by affecting several cell pathways simultaneously, and thereby enhance muscle function, respiratory capacity, and HRQOL of LOPD patients.

Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed LOPD
* Have undergone enzyme replacement therapy for at least three months.
* Physically capable of doing rehabilitative exercise, respiratory muscle training, and the clinical tests described herein.

Exclusion Criteria:

* Dairy protein allergy
* Renal disease (creatinine \> 140)
* Attempting pregnancy or currently pregnant
* Current supplementation
Rest Ventilatory Parameters Predict Morbidity and Mortality in Thoracic Surgery

Cardiopulmonary exercise testing is recommended for preoperative evaluation and risk stratification of lung resection candidates. Ventilatory efficiency (VE/VCO2 slope) has been shown to predict morbidity and mortality in lung resection candidates and has been shown superior to peak oxygen consumption (VO2). Patients with increased VE/VCO2 during exercise also exhibit increased VE/VCO2 ratio and decreased end-tidal CO2 at rest. Our first hypothesis is that rest ventilatory parameters predict morbidity and mortality in patients undergoing thoracic surgery. VE/VCO2 is well correlated with ventilation-perfusion mismatch, therefore it may be useful in hypoxemia prediction during one-lung ventilation during thoracic surgery. Our second hypothesis is that patients with high VE/VCO2 will be prone to hypoxemia development during one-lung ventilation.


Eligibility Criteria:
Inclusion Criteria:

* thoracotomy because of lung infiltration (confirmed or highly suspicious lung tumor)

Exclusion Criteria:

* none
Comparison of MIST With PRF and GBT With PRF in the Treatment of Intrabony Periodontal Defect. A Prospective RCT

The aim is to evaluate in a prospective, randomized, controlled clinical study the healing of a MIST procedure combined with PRF, or GBT combined with PRF. Clinical, radiological evaluation of the regenerative surgical method and the GBT non-surgical therapy in solitaire deep intrabony periodontal defect.

This clinical study aims to clinically and radiologically evaluate the healing response of the periodontal tissues in there is not opened flap design to access the intrabony defect test 1 group where The pre- surgically prepared Platelet Rich fibrine is added into the previously cleaned defect. In the test 2 group a minimally invasive surgical approach is used to access to the intrabony pocket. After opening a flap the same procedure is used to prepare PRF, and added into the pocket. The pockets in the control Group is only cleaned by guided biofilm therapy. Periodontal clinical parameters measured at baseline and at 6 months serves for secondary. After six months the healing is evaluated with a standardized X-ray holder. The primary outcome value is the delta clinical attachment level (gain or loss) The main interest is how the PRF influence the non-surgical healing. Does it any advance of flap opening procedure in comparison with the GBT, if PRF is used.

Eligibility Criteria:
Inclusion Criteria:

* solitaire intrabony periodontal defect at least 4 mm

Exclusion Criteria:

* Periodontitis with intrabony defect (Intrabony component ≥ 4mm, defect radiological angulation \> 25°,
* The patient is able to comply with the study -related procedures (i.e. good level of oral hygiene, follow-up procedures).
* Patients must not be heavy smokers (\<5 cigarettes/day).
* furcation involvement
* Full mouth plaque and bleeding scores (FMPS and FMBS) of \<15% (O'Leary et al. 1972).
* The patient is able to fully understand the nature of the study, signed informed consent.
Biomechanical Assessment of Femoroacetabular Impingement

The purpose of this study is to determine the influence of FAI abnormalities on hip joint biomechanics.

The purpose of this study is to quantify hip biomechanics of subjects with and without FAI.

The results of this study will advance our understanding of how the FAI alters the biomechanics of the hip joint, improving diagnosis and directing treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* Patients who present with hip pain subsequently diagnosed as femoroacetabular impingement
* Subjects who meet the following radiographic criterion of cam or pincer FAI, will be given the opportunity to volunteer in this study.
* Subjects that demonstrate a cross-over-sign or a lateral center edge angle (LCEA) without an alpha angle, will be classified as having pincer FAI.
* Subjects with an alpha angle, without a cross-over sign or LCEA, will be categorized as having cam type FAI.
* Finally, with at least one cam (alpha angle) and pincer sign "cross-over-sign or a lateral center edge angle (LCEA)" will be classified as mixed FAI.

Control Population Inclusion Criteria:

* 12 controls will consist of volunteers in the same age range as the subject groups (18-35 years).
* Control hips will be screened with a standard AP radiograph. Normal volunteers who have radiographic evidence of FAI, dysplasia or other joint deformities will be excluded.

Exclusion Criteria:

* Subjects who have radiographic evidence of osteoarthritis (Tonnis Grade III or IV) will be excluded as this study focuses on the mechanics of hips before prominent cartilage damage.
* Subjects who have had prior procedures to correct FAI or other hip conditions will be excluded (exploratory procedures will be included).
* Minors (under age 18), mentally disabled, persons incarcerated, on parole, probation awaiting trial, or pregnant women are excluded from this study.
* A human Chorionic Gondaotropin (hCG) urine pregnancy test will be performed on all women prior to the study.
* To limit the annual radiation exposure to any participating volunteers, we will exclude anyone who has had a CT scan or participated in a research study involving ionizing radiation in the past 12 months.

Motion Capture Exclusion Criteria:

* Subjects who are unwilling or unable to perform the proposed activities of daily living or undergo the clinical exams will be dismissed.
* Subjects with a BMI less than 30 (www.nhlbisupport.com/bmi/) or those with dense hip musculature/wide hips (maximum of 42 cm of circumferential hip length) will be excluded.

CT Exclusion Criteria:

* Subjects who are unwilling or unable to remain still.
* Subjects who are allergic to contrast agent and/or lidocaine will be dismissed.
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with type 2 diabetes mellitus and treated with either diet or single oral drug therapy
* Diet treated subjects: 7.5% \< HbA1c \< 10%
* Single oral drug therapy subjects: 7.0% \< HbA1c \< 9.5%
* Body Mass Index (BMI): max 40 kg/m\^2

Exclusion Criteria:

* Subjects treated with thiazolidinediones or insulin
* Subjects with any serious medical conditions
OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer

The purpose of this project is to see if weekly carboplatin compared with phenoxodiol in combination with weekly carboplatin, is effective against late stage ovarian cancer and to see what, if any, side-effects of treatment may result.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed ovarian, fallopian, or primary peritoneal carcinoma of epithelial origin
* Recurrent or persistent advanced disease
* Have measurable disease
* Undergone at least two courses of therapy with a platinum drug (cisplatin or carboplatin) and have responded to the first of those courses of therapy as determined by either Response Evaluation Criteria in Solid Tumors (RECIST) or Gynecologic Cancer Intergroup (GCIG) criteria
* Disease relapse as determined by either RECIST or GCIG criteria within 6 months of completion of the second or greater course of platinum therapy using a 2-, 3- or 4-weekly regimen and platinum-free interval of no greater than 6 months at the time of enrollment, being the time taken from the last day of platinum therapy
* Any number of previous courses of platinum therapy or non-platinum therapy
* Likely to survive at least 3 months
* Karnofsky performance score of at least 60%
* Have adequate physiological function without evidence of major organ dysfunction as evidenced by:

  * serum creatinine \< 1.5 mg/dl
  * serum transaminase levels ≤ 3 x the upper limit of normal (ULN) for the reference laboratory and
  * bilirubin level \< ULN
* Have adequate hematological function defined by:

  * platelets \> 100,000/mm3
  * white cell counts (WCC) \> 3,000/mm3
  * neutrophils \> 1,500/mm3
  * hemoglobin \> 8.0 g/dl
* Aged \> 18
* Be able to understand the risks and benefits of the study and give written informed consent to participation.

Exclusion Criteria:

* Patients with mucinous histological type of ovarian cancer
* Patients who have failed to show a clinical response (RECIST or GCIG criteria) to at least one prior course of platinum therapy
* Patients with active infection
* Patients with concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, hypertension, ischemic heart disease, congestive heart failure, etc.)
* Patients with a history of chronic active hepatitis or cirrhosis
* Patients with HIV
* Patients with active central nervous system (CNS) metastases. Patients with known CNS metastases must have received prior radiation therapy, and CNS metastatic disease must be stable for 4 weeks.
* Patients who have not recovered from the acute effects of any prior anti-neoplastic therapy
* Patients with known hypersensitivity to platinum drugs that cannot be managed with concomitant medication.
Title: Comparison of Anti-plaque Efficacy of Natural Honey With Chlorhexidine Mouthwash: A Randomized Controlled Trial

The rationale of our study is to compare the efficacy of natural honey base preparation with other commercially available mouthwashes i.e chlorhexidine base in prevention of dental plaque formation as honey is readily available and cost effective and organic in nature. This study will help to provide the data of our community and positive result may provide a new method of oral hygiene maintenance with fewer side effects. We will be able to deliver the best anti-plaque agent.

In this study, participants will assigned into 2 group those who will fulfilled the inclusion and exclusion criteria. After the informed consent, they were divided into 2 group. Group A will received Chlorhexidine mouthwash and Group B will provided with honey based mouthwash. The participant will blinded as solution will be provided in dark color bottle to mask the study. After which the baseline plaque index will be taken followed by recording plaque index on 7th, 14th, and 21st day. The statistical analysis will be done to compare the mean difference between these 2 groups

Eligibility Criteria:
Inclusion Criteria:

1. Individual aged between 18-25
2. Retained 28 number of teeth excluding wisdom teeth

Exclusion Criteria:

1. Individual with medical illness affecting oral cavity like diabetes, sjögren syndrome, crohn disease etc
2. Multiple extraction , overhang restoration, wearing any appliance
3. Periodontal problem with pocket depth more than 3mm
4. Current or recent history of antibiotic consumption
5. Noncompliance that is unable to maintain their hygiene.
6. Pan, Betel quid and any other oral habit will not be included in study
Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF

This study is a randomized, double-blind, placebo-controlled trial in which eligible IPF subjects will be randomized to receive GBT440 or Placebo orally daily.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of IPF.
* Oxygen desaturation with exercise.
* Completion of the baseline 6MWT
* Weight ≥ 50 kg
* Male or female of child bearing potential willing and able to use highly effective methods of contraception from study start to 3 months after the last dose of study drug.

Exclusion Criteria:

* FEV1/FVC \< 70%.
* Subjects on supplemental oxygen therapy at rest.
* History of other interstitial lung diseases.
* Significant polycythemia.
* Female who is breast-feeding or pregnant.
* Known current malignancy or history of malignancy within the last 2 years prior to screening.
* Use of cytotoxic and/or immunosuppressant medications within 30 days screening.
* Hospitalization due to an exacerbation of IPF within 30 days of screening
* Subject plans to begin or has commenced pulmonary rehabilitation within 30 days of screening
* Corticosteroids (\> 10 mg per day of prednisone or an equivalent) within 30 days of screening.
* Current smoker or history of smoking within 3 months of screening.
* Currently or, in the opinion of the investigator, soon to be listed for lung transplant.
* History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within 6 months of screening.
* Any condition possibly affecting drug absorption.
* Participated in another clinical trial of an investigational drug (or medical device) within 30 days or 5-half-lives, whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device).
* Subject who, for any reason, is deemed by the investigator to be inappropriate for this study.
Subjective Image Quality in Stereoscopic Image Modifications

Humans attain binocular vision from the two retinal images of both eyes through a series of sensory and motor processes that culminate in the perception of stereoscopic depth. Looking at a scene creates two slightly different images on the retinas which is due to the eyes' different positions on the head. This so called binocular disparity provides information to calculate depth and therefore enables stereopsis. Physiologically the two retinal images are superimposed and merge into one stereoscopic image.

If one image is presented to one eye in an experimental setting, and a completely different image is presented to the other eye, the investigators visual system, analogous to diplopic vision, is not able to fuse these image stimuli. Instead, a phenomenon called binocular rivalry occurs. Here, both images are seen alternating and the brain can switch back and forth between these images.

The aim of the present study is to investigate the effects of objective changes to image quality on the investigators subjective stereoscopic perception. This psychophysiological testing is done by looking at different images and thereafter by subjective grading of the image quality.

The investigators hypothesize that overlapping image modifications occurring in both eyes are detected immediately, but changes, that are rotated by 90 degrees against each other, should be suppressed and result in one stereoscopic image, reduced in image quality. Whether this also accounts for more detailed images, such as reading cards, is questionable.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 35 years, nonsmokers
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, emmetropia or ≤ 1 diopter

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug (except oral contraceptives)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day