cyrilzakka/clinical-trials huggingface dataset:
Motor-cognitive Dual-task in Healthy Older Adults and Early Parkinson's Disease Patients

Neuromuscular dysfunction is common in older adults and even more pronounced in neurodegenerative diseases. In Parkinson's disease (PD), a complex set of factors often prevents effective performance of activities of daily living that require intact and simultaneous performance of motor and cognitive tasks. In the current study we aim at employing the Mobile Brain/Body Imaging approach (MoBI) to gain further insides of neuromuscular biomarkers revealing the decrements of older adults with an early PD. The cross-sectional study will be evaluated through the multifactorial mixed-measure design.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for the healthy older participants will be:

* no diagnosis of cognitive or movement disorder,
* score \> 7 for the Short Physical Performance Battery (SPPB),
* living independently in the community,
* age range between 55 and 70 years,
* no color blindness.

Inclusion criteria for the early-stage PD patients:

* diagnosed according to the last MDS criteria (2015),
* duration of the disease less than 5 years,
* positive DATSCAN,
* diagnosed akinetic-rigid or mixed phenotype,
* score of 1 or maximally 2 on the Hoehn and Yahr scale (Hoehn \& Yahr, 1967),
* MoCA score ≥ 24 points,
* score \> 7 for the SPPB,
* age range between 50 and 75 years,
* no color blindness
* living independently in the community.

Exclusion Criteria:

* advanced stages of PD (Hoehn and Yahr score \> 2)
* any acute or chronic diseases, especially of the peripheral and central nervous system, heart failure, respiratory failure, severe osteoarthritis, and major psychiatric illness such as depression
* MoCA score \< 24 points,
* severe disabling tremor,
* recurrent falls,
* impaired vision that is not corrected with e.g., glasses,
* low SPPB score
Low Protein Renal Formula as Meal Replacement in Predialysis CKD Patients

A high energy and low protein renal formula tailored for the specific needs of pre-dialysis CKD patients.

Previous studies indicated that low-protein formula nutritional supplements may improve compliance with an LPD and are beneficial in the management of pre-dialysis CKD patients

This study will evaluate the suitability of the disease-specific enteral formula Fresubin® renal in predialysis chronic kidney disease patients.

Eligibility Criteria:
Inclusion criteria:

* Chronic kidney disease stage 4-5 (eGFR \<30 mL/min/1.73m2)
* Age: 20-80 years
* Patients on low protein diet (0.6-0.8 g protein/kg/d) for at least 3 months
* Written informed consent

Exclusion criteria:

* Dialysis or planned start of dialysis within next 3 months
* Patients awaiting kidney transplantation
* BMI \<18 and \>30 kg/m2
* Malnourished patients with albumin levels less than 3 g/dL who need additional supplementation of calories and nutrients
* Severe liver disease, malignant disease, infectious disease
* Existing gastrointestinal diseases or pathological findings, which do not allow EN, e.g. intestinal atony, ileus, acute upper GI bleeding, shock, or malabsorption, e.g. inflammatory bowel disease, pancreatic disease, or previous surgical GI resection
* Severely impaired gastrointestinal function, i.e. severe constipation or acute diarrhea (≥ 3 loose or watery stools per day)
* Dysphagia or high aspiration risk
* Relevant CNS and/or psychiatric disorders
* Known allergic reaction or intolerance to any of the ingredients of the study product
* Planned surgery or hospitalization during study period
* Suspicion of drug abuse
* Patients unable to follow study instructions or keeping a dietary diary
* Pregnant or lactating women
* Participation in another clinical trial with an investigational product within 30 days prior to start of study or during the study
Spectrum Analysis in Ex-vivo Human Lungs

This study will analyze spectral features of the radiofrequency of lung tumors in ex-vivo human lungs. The resected specimens will be evaluated using the spectrum analysis to determine the localization rate of the targets. Ultrasound measurement and images will be used for correlation of TS mode image findings with pathology by using HE and IHC slides of lung tumor and lymph node.


Eligibility Criteria:
Inclusion Criteria:

* Any patients scheduled for lobectomy of anatomical segmental resection for malignant lung tumors.
* 18 years of age or older

Exclusion Criteria:

* Any patients with inability to give informed consent.
Computer Assisted Relaxation Learning for Dental Offices

This is a randomized study in which two groups will be used to compare the effectiveness of a computerized psychological therapy compared to an information only control group (pamphlet) for reducing fear of dental injections.

This is a randomized study in which two groups will be used to compare the effectiveness of a computerized psychological therapy compared to an information only control group (pamphlet) for reducing fear of dental injections. All patients (96 people with high fear of dental injections) will be tested to assess pre-existing dental fear levels prior to being assigned to study condition. Subsequently, patients in the active treatment group will complete computerized psychological therapy in 1 to 9 weekly 45-minute sessions. Subjects in the control condition will meet with a dental assistant once for approximately 15 minutes to go over a pamphlet. The pamphlet is based on written information developed by a commercial dental web site development company. Following the intervention or control procedures, patients will be reassessed for dental fear using computerized questionnaires. They will also be scheduled to receive a dental injection. Subjects' willingness to complete the dental injection and fear levels during the dental injection will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* High dental injection fear
* Age 18 and over
* Healthy with no untreated systemic conditions
* Able to read and write English

Exclusion Criteria:

* Heart murmur
* Known allergies to lidocaine or benzocaine
* Under 18 year old
* Untreated systemic conditions
* Currently receiving medication for anxiety
Early Initiation of Oral Feeding Versus Traditional Feeding Post Caesarean Section

Early initiation of oral feeding, within 6-12 hours post-caesarean section, has been noticed to be well tolerated by patients and helps them recover fast. Our study aimed to evaluate the tolerability, safety and benefits of early oral feeding post-caesarean section.

BACKGROUND: Early initiation of oral feeding, within 6-12 hours post-caesarean section, has been noticed to be well tolerated by patients and helps them recover fast. However, the traditional method of waiting for 24 hours to commence oral feeding post-caesarean section is still being widely practiced due to the fear of post-operative ileus. Though some studies have shown this fear to be unfounded, early initiation of oral feeding is not yet universally accepted.

OBJECTIVES: To evaluate the tolerability, safety and benefits of early oral feeding post-caesarean section.

STUDY DESIGN AND SETTING: This was a randomized control trial (equivalence) carried out at Alex Ekwueme Federal University Teaching Hospital Abakaliki, Nigeria.

METHODS: Three hundred and six eligible women, randomized into groups (A=early and B=traditional feeding group) were admitted into the post natal ward after elective or emergency caesarean section. Women in group A were commenced on graded oral sips 6 hours post- caesarean section and subsequently soft diets from the 12th hour, after oral sips were well tolerated, while those in group B were commenced on the same regimen as in group A 24 hours post-caesarean section.

MAIN OUTCOME MEASURE: Time of return of bowel sound, time of resuming normal diets, duration of hospital stay, and post-operative complications ANALYSIS: Data obtained were analyzed using the computer software, IBM SPSS version 26. Frequency tables were made and results tested for significance using the t-test for continuous variables and Chi-square test for categorical variables. Relative risk (RR) was also determined, with confidence interval set at 95% and the level of significance determined by p-value \< 0.05

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women included in this study were those booked for elective or emergency caesarean section under spinal anaesthesia, for various indications from antenatal clinic, antenatal ward, labour ward and obstetric emergency unit who met inclusion criteria and consented to the study.

Exclusion Criteria:

* Women with prolonged obstructed labour.
* Women with immunosuppression or HIV/AIDS
* Women with eclampsia.
* Women with medical complications of pregnancy such as:
* Sickle cell anaemia, uncontrolled diabetes, uncontrolled hypertension.
* Women who received general anaesthesia
* Women with previous history of bowel surgery
* Women on drugs that can cause constipation
* Women with previous history of chronic constipation
Seminal Levels of PGK2 and ACRV1 as Predictors of Micro-TESE Results in NOA

* Measurement of PGK2 and ACRV1 levels in the semen of infertile males undergoing testicular sperm extraction (TESE).
* Correlate seminal levels of PGK2 and ACRV1 with sperm retrieval results and histopathology analysis of testicular biopsy samples.


Eligibility Criteria:
Inclusion Criteria:

* Infertile males with normal volume, functional (non-obstructive) azoospermia.
* Age: 18-45 years

Exclusion Criteria:

* Patients with proven obstructive azoospermia.
* Cryptorchidism.
* Testicular Agenesis and testicular atrophy.
* Patient with exposure to gonadal toxins like chemotherapy, radiotherapy, and alkylating agents.
Home Sleep Testing in Neuromuscular Disease Patients

Lay Summary Patients with severe neuromuscular develop hypoventilation, which leads to elevated carbon dioxide levels. Measuring only oxygen saturation levels with pulse oximetry may be inadequate. End tidal carbon dioxide levels or arterial blood gases should be measured periodically, depending on the clinical condition of the patient. A thorough review of systems will help define any problems. Patients who are hypoventilating often have elevated carbon dioxide levels at night and complain of a morning headache, restlessness or nightmares, and poor quality sleep. This may cause daytime sleepiness. Insufficient respiration with hypoxia may occur later, especially if the lung is damaged by chronic aspiration.

We propose to evaluate the use of the Nonin LifeSense monitor in home evaluation of respiration, oxygen level, heart rate, and carbon dioxide level and to develop interpretation of the results that will lead to appropriate interventions for apnea, and insufficient respiration.

Relevance to MDA Fewer than one per cent of the Muscular Dystrophy Association have pulmonologists as co-directors.Late referral of progressive restrictive lung disease leads to invasive support of respiratory failure. Early initiation of non invasive ventilation techniques requires patience on the part of the caregiver and exploration of mask interfaces and ventilation techniques. In addition, the development of new therapies, currently manifested through enhanced diagnostic accuracy, will require new signal for initiation and in the assessment of success or failure.

Aims Aim 1. To assess the utility of a small portable device (LifeSense Monitor Nonin Medical Inc. Plymouth Minnesota) with extended recording capabilty to provide accurate diagnosis of hypoventilation.

Aim 2. To provide an easily interpretable report defining sleep hypoxemia, hypercapnea, and apnea.

Aim 3. To promote early evaluation and treatment of the respiratory problems in centers that do not have pumonologists as these are essential to prognosis, whether of survival or of quality of life, in neuromuscular diseases.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of neuromuscular disease
* Must have home caregivers

Exclusion Criteria:

* No home caregiver
Post-Marketing Safety Study Following Long-Term Prophylactic OptivateTreatment in Subjects With Severe Haemophilia A

Primary objective: To assess post-marketing immunogenicity of Optivate® by monitoring plasma inhibitor levels for at least 100 Exposure Days (EDs) for each subject.

Secondary objectives: To assess efficacy and tolerability by monitoring FVIII recovery and adverse events

The primary efficacy endpoint is to assess immunogenicity of Optivate® by monitoring plasma inhibitor level for at least 100 EDs for each subject.

FVIII inhibitor evaluation FVIII inhibitor screen data will be listed. FVIII quantitative inhibitor results will be listed. Shift tables will present the number of subjects with positive (≥ 0.6 BU) and negative (\< 0.6 BU) results and those for whom the results change during the study. The number of exposure days until development of inhibitors will be summarised.

For the secondary endpoints: Descriptive statistics will be presented on the number of recoveries at each timepoint and for each subject. These will be presented for each visit and for each subject and then for each batch of FVIII/ Optivate® used. All the AE data (from CRF and study diary) will be pooled together and reported in terms of the type, duration, treatment and/or severity.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent or, if less than 18 years of age written assent (where possible) and their parent/guardian's written informed consent.
* Severe haemophilia A (\< 1%# FVIII:C).
* Previously Treated Patients (PTPs) with \> 150 exposure days on prior Factor VIII therapy (of which at least the last 50 EDs or 2 years treatment can be confirmed by way of subject records).
* Immunocompetent with CD4 count \> 200 / µl.
* HIV negative or a viral load \< 200 particles / µl.

  * subjects suffering from severe haemophilia A (\<2%) may be enrolled, but only after approval by BPL. Subjects with a Factor VIII of \<2% may not constitute more than 50% of the total patient population. A separate statistical evaluation will be conducted for the \<1% and \<2% populations.

Exclusion Criteria:

* • History of inhibitor development to FVIII or a positive result on the Nijmegen Bethesda at screening (quantitative result of \> 0.6 BU) prior to the administration of Optivate®.

  * Known or suspected hypersensitivity to the investigational medicinal product or its excipients.
  * Clinically significant liver disease, renal disease, or coagulopathy other than haemophilia A.
  * History of unreliability or non cooperation (including not being able to complete the study diary).
  * Participating in, or have taken part in another trial within the last 30 days.
Exception Cementless Hip Stem

This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study. The objectives of this study are to confirm the long-term safety, performance and clinical benefits the Exception Cementless femoral stem (standard and varized) when used in primary total hip arthroplasty.

Six surgeons have prospectively collected clinical data for patients operated consecutively between January 2008 and September 2012. The patients have been operated based on the indications and contraindications listed in the Instructions For Use (IFUs) of the implant.

This study is an extension of the surgeons' data collection as an attempt from Zimmer-Biomet to fulfill its post-market surveillance obligations by recovering clinical data retrospectively and prospectively.

Study Procedure Flowchart - retrospective data collection: most patients had clinical follow-ups at pre-op, operative, immediate post-op, 3 Months, 1 year, 2, 3, 5, 7 years post-surgery during which their surgeons collected clinical data. This data will therefore only be collected by Zimmer-Biomet after the patients specifically consent to it.

Study Procedure Flowchart - prospective data collection: The informed consent signed by the patient for this study also allow Zimmer Biomet to collect the data of the standard clinical follow-up that will be conducted by the investigators at least 10 years post-surgery.

Eligibility Criteria:
At the time of surgery, the inclusion criteria were based on the indications presented in the IFUs:

* Primary or secondary osteoarthritis
* Inflammatory impairment of the hip, rheumatoid arthritis, etc.
* Fracture of the neck of the femur
* Avascular necrosis of the femoral head
* Sequelae from previous operations on the hip, osteotomies, etc.
* Congenital hip dysplasia.
* Patient is older than 18 years old
* Patient had consented to the original data collection after his/her surgery

At the time of surgery, the exclusion criteria were based on the contraindications presented in the IFUs:

* Local or systemic infections.
* Serious muscular, neurological or vascular deficiencies in the limb concerned.
* Bone destruction or poor quality bone likely to affect the stability of the implant (Paget's disease, osteoporosis, etc.)
* Any concomitant disorder likely to affect the function of the implant.
* Allergy to one of the implant components.
* Patients weighing more than 110 kg.
* Patient incapable of following the recommendations of the surgeon
SWAN: Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)

The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation


Eligibility Criteria:
Inclusion Criteria:

* Infants :

  * Aged ≤ 5 months old
  * fully formula fed
  * with at least 5 episodes of regurgitation per day, for at least a week

Exclusion Criteria:

* Breast fed infants
* Infants presenting symptoms of a complicated gastroesophageal reflux
* Infants presenting intestinal disorders
Dose Defining Study for the Administration of Vitamin K2 Supplements in Hemodialysis Patients

This study aims at finding the optimal dose of Vitamin K2 supplementation in hemodialysis patients.

During the past few years evidence is emerging for a role of Matrix Gla Protein (MGP) as one of the most powerful inhibitors of vascular calcification (Shurgers LJ et al. Thromb Haemost 2008; 100: 593-603). MGP is a Vitamin K dependent protein. This means that he presence of Vitamin K2 is required to promote the gamma-carboxylation process turning MGP in its carboxylated and active form. Recent data show that dp-uc MGP correlates well with Vitamin K status (Cranenburg CM et al. Thrombosis and Haemostasis 2010; 104/4: 811-822).

It is widely recognized that patients with renal insufficiency treated with hemodialysis are prone to accelerated vascular calcification resulting in excess cardiovascular morbidity and mortality (Goodman WG et al. N Engl J Med 2000; 342: 1478-1483).

Consequently, the administration of Vitamin K2 supplements may protect hemodialysis patients against accelerated vascular calcification by enhancing the gamma-carboxylation process of MGP. However, the optimal dose of Vitamin K2 required to achieve these results remains to be defined

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 year
* signed informed consent
* end stage renal disease treated with chronic hemodialysis at least three times a week

Exclusion Criteria:

* coumarin treatment
* known intestinal malabsorption
* inability to take oral medication
* medical conditions with a considerable probability for death within 2 months
Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?

This study aims to explore the potential correlation between decreased ovarian reserve and previous history of early miscarriage.

By investigating the prevalence of low ovarian reserve (LOR) in populations with specific reproductive histories (such as recurrent pregnancy loss, G0, and ectopic pregnancy), as well as the aneuploidy rates of embryos produced with Preimplantation Genetic Testing for Aneuploidies (PGT-A), Investigators can better understand how LOR impacts fertility outcomes in these populations. This information can be used to inform clinical decision-making, such as whether participants with LOR should consider alternative or whether they would benefit from additional interventions to improve ovarian function.

Ultimately, by improving our understanding of how LOR impacts fertility outcomes in specific populations, Investigators can help to improve the overall success rates of infertility treatment, reduce anxiety, and distress, and help participants achieve goals of becoming parents.

Eligibility Criteria:
Inclusion Criteria:

1. All participants with at least 1 previous pregnancy, who are assessed in one of our clinics (ART Fertility Clinics Abu Dhabi, Al Ain, Dubai)

Exclusion Criteria:

1. Severe male factor (azoospermia, cryptozoospermia, severe oligoasthenoteratozoospermia (OAT))
2. Severe Endometriosis and adenomyosis based on positive anamnesis or ultrasound performed in our center during the first consultation
3. Uterine abnormalities (e.g. fibroids, different degrees of uterine septum), diagnosed by ultrasound
4. History of ovarian surgery, chemotherapy, or radiation therapy
5. Known genetic disorder or chromosomal abnormality
6. BMI \>40Kg/m2
7. Currently using hormonal contraception or hormone replacement therapy
Translation of Parkinson's Disease Questionnaire -8 in Urdu Language

Cross cultural analytical study to translate Parkinson's disease questionnaire-8 in Urdu language. Along with the translated version by evaluating its validity and reliability among the patients of Parkinson's disease. No such study has been previously conducted in Pakistan which translate this questionnaire in

Urdu and follows the proper cross- culture adaptation. Condition or disease:

Parkinson's disease. Convenient sampling technique would be used

Parkinson's Disease Questionnaire-8 (PDQ-8) is the brief version of PDQ-39 formulated to reduce the respondent burden and for convenient use in clinical settings in patients of Parkinson's disease. (PDQ-8) is the patient reported outcome measure constructed by taking one question from each of the eight domains of PDQ-39 (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. PDQ-8 will be translated into Urdu language by Beaton et al guidelines for cross cultural adaptation of tool. The validity and reliability of Urdu version of PDQ-8 will be evaluated by calculating Cronbach's alpha, intra-class correlation coefficient and Pearson/spearman rank correlation co-efficient.

Continuous variables will be shown by mean and standard deviation and the categories will be demonstrated in frequency and percentage. Factor structure of the PDQ-8 will be extracted using exploratory factor analysis (EFA), utilizing principal component analysis with varimax rotation.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-65 years
* Both genders
* Patients with diagnosed Idiopathic Parkinson's disease (IPD) by neurophysician
* Patient able to read Urdu Language. Patients who can participate in community, patients with cognitive issue, Patients with MMSE more than 24 will be included

Exclusion Criteria:

* Patients with any other neurological issue
* Patients who undergo brain surgery