cyrilzakka/clinical-trials huggingface dataset:
Effects of Vestibular Training on Postural Control of Healthy Adults Using Virtual Reality

Postural instability is a common symptom of vestibular dysfunction that impacts a person's day-to-day activities. Vestibular rehabilitation is effective in decreasing dizziness, visual symptoms and improving postural control through several mechanisms including sensory reweighting. As part of the sensory reweighting mechanisms, vestibular activation training with headshake activities influence vestibular reflexes. However, combining challenging vestibular and postural tasks to facilitate more effective rehabilitation outcomes is under-utilized. The novel concurrent headshake and weight shift training (Concurrent HS-WST) is purported to train the vestibular system to directly impact the postural control system simultaneously and engage sensory reweighting to improve balance. Young healthy participants will perform the training by donning a virtual reality headset with an overhead harness on and a spotter present to prevent any falls. The investigators propose that this training strategy would show improved outcomes over traditional training methods by improving vestibular-ocular reflex (VOR) gains, eye movement variability, sensory reweighting and promoting postural balance. The findings of this study may guide clinicians to develop rehabilitation methods for vestibular postural control in neurological populations with vestibular and/or sensorimotor control impairment.


Eligibility Criteria:
Inclusion Criteria:

* Able to stand independently (without an assistive device)
* This study requires participants to perform postural assessments including reactive balance following mechanical perturbations.
* Participants will also perform headshake activities and weight shift training in standing for 20 mins will mini breaks.
* Participants must be within the age of 18-35.
* A power analysis revealed that a sample of 24 participants will required for a two-group comparison to detect a significant difference at alpha=0.05 and 0.30 effect size at beta=0.8 (G\*Power, Version 3.0.10)(Faul et al, 2007).

Exclusion Criteria:

* Participants with an evidence of:
* Concussion, vestibular, balance or oculomotor issues for the prior 6 months.
* Neuropathic conditions, particularly affecting the lower extremities. Participants with this issue will have sensory impairments which can affect their sensory assessment.
* Current musculoskeletal deficits including significant postural abnormalities (signs of spinal, pelvic and leg length discrepancies).
* Pain or limitations in neck range of motion.
* Recent (within 6 months) orthopedic surgery that impacts postural training.
* Visual Impairment
* Participants must be able to see and follow targets on the computer monitor. Therefore, subjects must have 20/50 (corrected) vision. Subjects who are blind cannot participate.
Early Oral Feeding vs Traditional Post-operative Care In Emergency Abdominal Surgeries

ABSTRACT BACKGROUND: Enhanced recovery after surgery (ERAS) protocols have been widely studied in elective abdominal surgeries and have shown better outcomes. However the utility of these protocols in emergency abdominal surgeries has not been widely investigated.

OBJECTIVE: To study the outcomes of application of ERAS protocols in patients undergoing perforated duodenal ulcers repairs in emergency abdominal surgeries.

METHODS: This randomized controlled trial was conducted in Surgical Unit 1 BBH from August 2018 to December 2019 with a total sample size of 36 patients with the diagnosis of perforated duodenal ulcer. Patients were randomly divided in two groups. Group A consisted of early oral feeding group and group B consisted of traditional postoperative care group. Outcome results studied were the length of hospital stay, duodenal repair site leak, severity of pain (VAS score) and duration of post-operative ileus. Results were analysed on SPSS version 20 and chi-square and independent t-test were applied.

KEY WORDS: Perforated duodenal ulcer, ERAS protocol, randomized controlled trial, duodenal repair site leak, length of hospital stay, VAS score, post-operative ileus


Eligibility Criteria:
Inclusion Criteria:

* All patients older than 15 years with acute abdominal symptoms admitted in ER department, suspected as perforated duodenal ulcer and operated within 24 hours of admission by emergency department surgeon.

Exclusion Criteria:

* Patients presenting with the following criteria were excluded:
* Refusal to join the study
* Peptic ulcers with both bleeding and perforation.
* Spontaneously sealed off perforations.
* Malignant ulcers
* Concurrent extra-abdominal surgery
* Oral incapacity i.e endotracheal intubation
* Reoperation within a month
* ASA grade III/IV
* Alternative per operative diagnosis.
Respiratory Mechanics and Gas Exchange Characteristics in Patient With SARS-CoV-2

The combination of different ventilatory strategies and its effects on respiratory mechanics and gas exchange in patients under mechanical ventilation with acute respiratory distress syndrome secondary to coronavirus-19 has been scarcely described.

Investigation in mechanically ventilated patients with with acute respiratory distress syndrome (ARDS) secondary to coronavirus-19 (COVID-19) is emerging due to presumed differences with typical ARDS from other origin. Considering these issues, the effects of ventilatory strategies such as positive end expiratory pressure, end inspiratory pause and fraction of inspired oxygen on respiratory mechanics and gas exchange must be studied in order to characterize the behavior of COVID-19 ARDS during invasive mechanical ventilation and choose the best combination of ventilatory settings.

In this study the investigators will evaluate the changes in respiratory mechanics and gas exchange produced by low and high positive end expiratory pressure, low and high inspired oxygen fraction and the application of end inspiratory pause during volume controlled mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old
* less than 72 hs since ARDS diagnosis
* Moderate to severe ARDS
* central venous catheter and arterial line available
* Need of neuromuscular blocking agents
* Supine position
* Informed consent accepted
* Airway opening pressure lower than 20 cmH2O

Exclusion Criteria:

* RASS target higher than -5
* COPD diagnosis
* Pneumothorax
* Intracraneal Hypertension
* Pregnancy
* Cardiac inssuficiency uncompensated
* Chest wall deformity
* Bronchopleural fistula
* Contraindication to use esophageal manometry
The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain

Episiotomy is the intentional incision of the perineum during vaginal birth in order to accelerate the active phase of labor. This study aimed to compare various skin closure techniques in episiotomy repair.


Eligibility Criteria:
Inclusion Criteria:

* Primiparous
* Age between 18 to 45
* Given birth in our labor ward

Exclusion Criteria:

* Multiparous
* having deep vaginal lacerations
* having abnormalities in fetus
* Rheumatologic diseases
* Postpartum bleeding
* Shoulder Dystocia
* Operative Delivery
* Using antithrombotic or anticoagulant medications
Dexamethasone and Pregnancy: Maternal Effects

This study will analyze obstetric, endocrine and metabolic follow-up data in women treated with DEX. It will reveal the prevalence and importance of weight gain, insomnia, edema, stretch marks, arterial hypertension and gestational diabetes, describe pregnancy outcome, and analyze the corticotropic axis during and up to 3 months after pregnancy, with the aim of improving the management of these women and preventing comorbidities.

A few studies suggest problems in women treated with DEX during pregnancy. However, all these studies are retrospective, based on self-questionnaires, and have not evaluated all pregnancy outcomes. Moreover, it would appear that a third of women treated with DEX no longer wish to resume the treatment (8). Compliance with treatment is strongly linked to its efficacy. It is therefore important to start investigating the pregnancy outcomes of women treated with DEX. This project is relevant because it has the potential to improve current clinical practice and recommendations related to this treatment, and thus have a direct impact on future patient care. The results of this study will guide us in the management of women presenting an indication for prenatal DEX treatment, and will help to inform the Order of November 15, 2022.

Main objective:

The main aim of this study was to assess the incidence of metabolic complications (hypertension and diabetes) in mothers treated with DEX during pregnancy.

Secondary objectives:

1. To assess the prevalence and importance of adverse effects of DEX: weight gain, stretch marks, insomnia in mothers treated with DEX.
2. Describe pregnancy outcomes and compare them with a reference population (data from the 2010 French perinatal survey (15)).
3. Analyze the corticotropic axis of DEX-treated mothers during and after pregnancy.

Eligibility Criteria:
Inclusion Criteria:

1. Femme majeure (âge ≥ 18 ans)
2. Grossesse avec indication de traitement anténatal par dexaméthasone (DEX) en accord avec le PNDS :

   * Mutation sévère du gène CYP21A2 chez chacun des parents
   * Fœtus féminin
3. Grossesse unique
4. Ayant commencé un traitement anténatal par DEX depuis au moins 24h

Exclusion Criteria:

1. Contraindication to dexamethasone treatment
2. Objection to use of data
3. Persons under legal protection (curatorship, guardianship), court-appointed guardians
Study Where Pharmaco Magnetic Resonance Imaging (MRI) Effects of AZD6765 Will be Compared to Placebo in Depressive Male and Female Subjects

The purpose of this study is to determine the effect of a single dose infusion of AZD 6765 compared with placebo and ketamine on the blood oxygen level dependent signal using fMRI (functional Magnetic Resonance Imaging) in depressed subjects.


Eligibility Criteria:
Inclusion Criteria:

* Documented clinical diagnosis meeting criteria from the DSM-IV by structured clinical interview,major depressive disorder, single episode or recurrent
* Outpatient status at screening and at randomisation

Exclusion Criteria:

* A major depression disorder which has a major impact on the subjects current psychiatric status
* Subjects not allowed to use mood stabilizers, antidepressants or other antipsychotic or psychoactive drugs
* Subjects with lifetime history of schizophrenia, bi-polar, psychosis and psychotic depression
rTMS for Suicidality in Opioid Use Disorder

This trial is a randomized, double blind, controlled pilot study that will compare bilateral theta burst stimulation (TBS) and sham treatment for patients with opioid use disorder (OUD) and Major Depressive Disorder (MDD) experiencing suicidality.

Repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) is used therapeutically in major depressive disorder resistant to standard treatments, and recently also shown to be effective in reducing suicidality with a bilateral approach. Recently, a new form of rTMS has been developed called theta burst stimulation (TBS) which requires a much shorter daily treatment duration and has been found to be non-inferior to standard rTMS. The investigators propose to conduct a randomized controlled clinical trial of a daily, 20 session course of bilateral TBS versus sham stimulation in the treatment of suicidality in patients with OUD and MDD. The investigators will explore whether TBS can have other clinical effects on decreasing symptoms of MDD, craving for opioids, and rates of relapse to opioid use. The investigators will also examine whether rTMS can engage GABA mediated inhibition using combined transcranial magnetic stimulation and electroencephalography (TMS-EEG) will be assessed before and after intervention. Clinical outcomes measured before, during, at end of treatment, and 4-weeks post treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Capable of providing informed consent and research procedures according to the brain stimulation attending psychiatrist
2. Between the ages of 18-60 years
3. Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of Opioid Dependence and MDD.
4. On a stable treatment regimen without any change in opioid agonist or antidepressant medications or dosages in the last 30 days. Participants will be asked not to change their medication regimen for the duration of the study.
5. Baseline score of \>/=4 on the scale for suicidal ideation (SSI).

Exclusion Criteria:

1. Currently pregnant or intending to be pregnant during the duration of the study
2. Bipolar disorder, any psychotic disorder or current psychotic symptoms
3. Previous rTMS treatment
4. Known active seizure disorder, significant head injury with an imaging verified lesion
5. Unstable medical illness
6. Presence of cardiac pacemaker, intracranial implant, or metal in the cranium
7. Participants taking \> 2 mg lorazepam (or a benzodiazepine at an equivalent dose) or taking any anticonvulsant medication during treatment.
Health-Economic Evaluation of Early Diagnosis of Epithalial Ovarian Cancer Recurrence Using the ROMA Score: a Prospective Multicenter Randomized Trial

In this study, we hypothesize that calculating the ROMA score (CA125 + HE4 blood marker assay) will enable faster, more targeted diagnosis and management of epithelial ovarian cancer recurrence than the CA125 marker assay alone. This early identification of recurrence would then improve patients' quality of life, since it would increase the chances of benefiting from less invasive and less morbid surgery. It would also reduce the cost of patient management following disease progression. If our hypothesis is confirmed, the results of this study will enable us to update the recommendations for post-treatment follow-up of patients in remission from epithelial ovarian cancer, as well as reimbursing the HE4 marker assay (and thus the calculation of the ROMA score).


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 or over and less than 85 years old
* With proven FIGO stage I to IV epithelial ovarian cancer (ovary/tumor/peritoneum)
* Women in remission after first-line chemotherapy, with a normal CA125 less than 4 months old at study entry (end of first-line chemotherapy).
* Woman having completed chemotherapy at least 6 months previously
* Written informed consent
* French social security

Exclusion Criteria:

* Any physical or psychiatric condition that may interfere with the patient's cooperation in data collection
* Patient with normal CA125 at initial diagnosis of epithelial ovarian cancer
* Patient under guardianship
* Patient deprived of liberty
Autologous Tregs for Aplastic Anaemia

This Phase I study will determine the safety and optimal dose of expanded autologous Tregs to treat patients with Aplastic Anaemia (AA) (who have failed, or are considered ineligible for IST (immunosuppressive therapy) / other treatments) using expanded autologous T regulatory cells (Tregs) from AA patients at King's College Hospital, that have been prepared at the licensed Good Manufacturing Practices (GMP) production facility at Guy's Hospital, London

The clinical trial will examine the safety of giving AA patients who have failed other treatment(s), their own ('autologous') expanded Tregs - a form of 'cellular therapy - to treat the AA. The investigators will study the changes in the immune system and determine if healthy bone marrow stem cells recover, thereby improving the blood counts after giving Tregs to patients. Expanded autologous Tregs are currently being looked at to treat other autoimmune disorders such as type I diabetes mellitus, multiple sclerosis, Crohn's disease and systemic lupus erythematosus. Results so far indicate that they are safe to give and do improve these diseases, but significantly this will be the first trial in AA.

Eligibility Criteria:
Inclusion Criteria:

* Acquired idiopathic AA
* No evidence of constitutional/inherited AA based on clinical findings, absence of family history of AA, normal DEB test and normal Kings bone marrow failure gene panel
* Very severe, severe or non-severe AA
* Lack a matched sibling donor (MSD) or matched unrelated donor (MUD), or ineligible for MSD/MUD HSCT
* Transfusion dependent
* Failed or ineligible for a course of ATG and CSA
* Failed / intolerant or inappropriate to treat with Eltrombopag or fails to meet Blueteq approval for use of Eltrombopag using NHS England guidance
* AST \< 3 x upper limit of normal (ULN), bilirubin \< 1.5 x ULN (unless Gilbert's syndrome)
* eGFR \>50mL/min
* Age ≥ 18 years, male or female
* Willing and able to provide written and informed consent
* If female of child-bearing potential, have a negative serum pregnancy test and agree to use adequate contraceptive methods if of reproductive age
* Diffusing capacity for carbon monoxide (DLCO) ≥ 45% predicted corrected for haemoglobin
* LVEF \> 40%.
* Performance status ≤ 2

Exclusion Criteria:

* Constitutional AA
* Age \< 18 years' old
* Have a MSD and are eligible for MSD HSCT
* Have a MUD and are eligible for MUD HSCT
* Hypocellular myelodysplastic syndrome (Hypo MDS) or AA/Hypo MDS overlap
* Uncontrolled ongoing infection
* Active malignancy
* Treatment of cancer in the last 5 years (except in situ carcinoma of the cervix or basal cell carcinoma)
* Unable to give informed consent
* Active or uncontrolled infection not responding to appropriate antibiotics and antifungal agents.
* Human immunodeficiency virus (HIV) sero-positivity, hepatitis B, hepatitis C or hepatitis E infection.
* Abnormal organ function: AST/ALT \>3 x upper limit of normal (ULN), bilirubin \>1.5 x ULN, eGFR ≤50mL/min
* Heart failure (= grade III New York Heart Association)
* Pregnant or lactating women
* Unable or unwilling to comply with the contraceptive requirements
Study in Patients' With Persistent Asthma and Chronic Obstructive Pulmonary Disease

The study is to evaluate the percentage of patients with asthma or COPD achieving disease control

There are no treatment groups or interventions to which the patients can be randomly assigned. Data will be collected in a routine setting on a single occasion during an otherwise normal visit at the physician's office or clinic. Participating physicians will not perform any medical procedures that are outside of their normal daily clinical practice. All treatment decisions are at the sole discretion of the participating physicians and reflect their current standard of care

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years of age who has been diagnosed with persistent asthma or patient ≥ 40 years of age and/or (ex)-smoker with more than 10 pack years of smoking who has been diagnosed with COPD
* Treatment with a stable dose (no change in dose or change by less than 50% in the last 3 months) of a Inhaled corticosteroid (ICS), Long-acting beta2-agonists (LABA), Fixed dose combination (FDC) administered twice daily by Dry powder inhaler (DPI) for 3 months prior to enrollment in accordance with its approved indication
* Patient is willing and able to provide written informed consent;
* Patient agrees to participate in the study and to disclose any medical events to the treating physician;
* Patient is able to complete the questionnaires.

Exclusion Criteria:

• Current enrolment or planned enrolment in an interventional study (patients are allowed to participate in other observational or case-control studies).
Effect of Exercise on Insulin Resistance

The purpose of this study is to evaluate the effect of exercise on Insulin Resistance (IR) in subjects who do not routinely exercise and who are at risk of developing diabetes (prediabetes).

It is estimated that approximately 30-90 people will participate in this study at three study sites in the United States and United Kingdom.


Eligibility Criteria:
Inclusion Criteria

1. Aged 18 to 75 years.
2. Meets one of the three diagnostic criteria listed below (based on screening results or recorded result within one week of enrollment);

   1. Fasting plasma or whole blood glucose (fasting defined as no caloric intake for at least 8 hours): 100 ≤ 125 mg/dL (6.0-6.9 mmol/L)
   2. HbA1c of 5.7% - 6.4% (39 - 46 mmol/mol)
   3. 2-hour plasma glucose of 140-199 mg/dL (7.8-11.0 mmol/L) during an OGTT (as described by the WHO using a glucose load of 75 g anhydrous glucose dissolved in water)
3. No clinically significant adverse exercise response during the maximal graded exercise test

Exclusion Criteria

1. Weight loss diet program or weight change (\>10%) within the past 6 months
2. Daily physical activity of \>10,000 steps per day (as measured during the interval between visits 1 and 2)
3. Participates in deliberate structured exercise
4. Pregnant or intending to become pregnant
5. Cognitive or intellectual disability that prevents subject from providing informed consent or following protocol instructions.
6. Unwillingness to participate in all study procedures
7. Inability to give blood through multiple venous phlebotomies or to have an intravenous catheter
8. BMI greater than 40 kg/m2
9. Concurrent participation in another lifestyle modification trial
10. Diagnosis of diabetes based on any one of the following criteria:

    1. Fasting plasma or whole blood glucose ≥ 126 mg/dL (7 mmol/L)
    2. HbA1c of \>6.5% (\>47 mmol/mol)
    3. 2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during an OGTT
11. Any pre-existing or newly discovered medical condition that is deemed likely to put the subject at risk of injury during this trial. This may include but is not limited to:

    1. Clinically relevant vascular or cerebrovascular event (e.g. stroke, recurrent transient ischemic attack (TIA), deep venous thrombosis or intracardiac thrombi, clinically significant edema within the previous 6 months
    2. Current use of anti-psychotic, anti-convulsant, anti-coagulant, sedative medication, or cognition-enhancing medications
    3. Current use of beta blockers (beta-adrenergic blocking agents)
    4. Current or previous use (within the past year) of the following medications: diabetes related medications or insulin; metformin; growth hormone; glucagon; dipeptidyl peptidase-4(DPP-4) inhibitors (saxagliptin, stigagliptin); glucagon-Like Peptide-1(GLP-1) mimetics (exenatide, liraglutide); sulfonylurea medication or other potential confounding medications
    5. Medical conditon which predetermines insulin resistance (e.g. Marfan syndrome / severe Polycystic ovary syndrome (PCOS) / Cushing syndrome etc.).
    6. Fasting triglycerides \> 1000 mg/dL.
The Effect of the Amino Acid L-Theanine on Alertness and Vigilance

The amino acid l-theanine (the active ingredient in green tea) is considered to have a calming effect without causing sleepiness. This study evaluates whether l-theanine affects blood pressure, heart rate, alertness, and sense of well-being.


Eligibility Criteria:
Inclusion Criteria:

* adult
* able to swallow capsule

Exclusion Criteria:

* none