cyrilzakka/clinical-trials huggingface dataset:
Quantification of Distribution of the Mass Center for a Controlled Force Platform Reaction to the Ground

This study developed a controlled soil reaction force platform that provided controlled mechanical stimuli to quantify the distribution of the center of mass as a function of the angular variation of the ankle in the elderly in the upright position.

Usually the balance evaluation the center of mass displacement for the analysis of postural control is assessed by means of force platforms. However, most of these devices are stationary, that is the patient is the dynamic element which can generate an evaluation with high subjectivity index. Therefore, this study aimed at developed a reaction force to the ground platform which provides mechanical stimuli controlled to quantify the distribution of the mass center as a function of the angular variation in the elderly ankle in the upright position. The construction of the prototype was divided into 3 steps, based on the two-dimensional movement of the ankle joint. In the 1st stage the construction of the mechanical assembly; in the 2nd stage development of the electronics; and 3rd stage the development of the supervisory system (control system). The force plataform was evaluated following the engineering functional tests such as: characterization and calibration of the sensors, the definition of the transfer function and accuracy of tests of angular movements (+ 10 ° and -10 ° to the movements of inversion and eversion, + 15 and -15º to the movements of dorsiflexion and plantar flexion). For the tests with volunteers were selected 30 volunteers.

Eligibility Criteria:
Inclusion Criteria:

* We included in this study individuals male and female
* Age ranging from 20 to 85 years
* Asymptomatic individuals
* Must walk without the use of an attachment
* Do not present motor deficit that makes the study impossible

Exclusion Criteria:

* Decompensated congestive heart failure
* Neurological or neurological diseases that interfere with significant neuromotor
* Individuals who did not agree to participate in the study
Posture and Pulmonary Function of Mouth-breathing Children

The purpose of this study is to characterize the posture and respiratory function of mouth-breathing children.

Mouth-breathing children presents changes in stomatognathic system, which results in head projection, tension augment in scapular belt muscles and postural adaptations. Although thoracic shape and posture can influence ventilatory dynamics, we didn't find studies addressing pulmonary function of mouth-breathing children. This was a transversal study, designed to analyze the posture of mouth-breathing children, and verify the existence of correlation between posture and pulmonary volumes.

Eligibility Criteria:
Inclusion Criteria:

* Nasal breathing (normal subjects group) or mouth breathing (mouth-breathing group), and the age between eight (08) and twelve (12) for both groups.

Exclusion Criteria:

* Prior physiotherapeutic treatment or in process, presence of diagnostic or report on acute or chronic pulmonary disease, neurofunctional or cognitive impairment and alteration of the osteomuscular system.
Dose Escalation Trial of Traditional Chinese Medicine for Irritable Bowel Syndrome (TCM- IBS)

The purpose of this study is to determine whether a 20- herb formulation, as a well characterised extract, is efficacious in treating irritable bowel syndrome (IBS) and also to identify efficacious and safe dosage of the formulation in treating IBS.

The Specific aims of the project are:

1. To determine whether a 20- herb formulation improves pain/ discomfort and disturbed bowel frequency in patients with Irritable Bowel Syndrome who have been disappointed with current conventional Western medicine.
2. To identify an optimal dosage of the 20- herb formulation that is safe and well tolerated for up to 8 weeks of treatment, among 2 dosages. This is determined by relief of symptoms of IBS in a dose escalation, placebo-controlled double- blind randomized clinical trial, in conjunction with indices of safety and tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Age 18- 75
* All IBS patients attending the Gastroenterology Clinic of the Prince Of Wales Hospital of Hong Kong.
* IBS diagnosed by Rome III criteria:

  * Recurrent abdominal pain or discomfort at least three days per month in the previous three months
  * Symptoms onset at least six months prior to diagnose
  * Pain or discomfort associated with two or more of the following:

    1. Improvement with defecation
    2. Onset associated with change in frequency of stool
    3. Onset associated with a change in form (appearance) of stool
* Normal colonic evaluation (colonoscopy or barium enema) in past 5 years
* No "global symptom improvement" as rated by patients (see below) at screening and during the two- week run- in period to baseline
* Normal full blood count, liver function test and renal function test.

  * Informed written consent for participation into study.
  * Ethical approval will be obtained from the Joint CUHK-NTEC Clinical Research Ethics Committee as well as the IRB of UMB.

Exclusion Criteria:

* Past or present history of organic disease of gastrointestinal tract (e.g. colorectal cancer, advanced colonic polyp, celiac disease, inflammatory bowel disease, peptic ulcer and previous gastrointestinal surgery). (Note: those with polyps removed during colonoscopy can be included, as long as no known polyps remained.
* Systemic diseases that cause diarrhea or constipation (e.g. thyroid disease, diabetic neuropathy)
* Lactose intolerance
* Severe liver disease (e.g. cirrhosis, chronic active hepatitis)
* Renal impairment (serum creatinine level \> 150mmol/L)
* Women who are pregnant, lactating or not practicing proper contraception
* Known hypersensitivity to herbal medicine
* Concommitant use of prescription antidepressant medication
* Current alcoholism and drug use
* Current psychiatric illness or dementia
* Fever or severe illness at baseline (week 0).
Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair

Blepharoptosis, inferodisplacement of the upper eyelid, can be congenital or acquired. Acquired Blepharoptosis is usually aponeurotic, due to stretching or disinsertion of the levator aponeurosis. Treatment is surgical and can be performed by three common procedures - Levator advancement, Müller's muscle-conjunctival resection procedure and White line advancement. A number of reports inspected the possibility that Blepharoptosis repair procedures may cause deterioration in dry eye status. The investigators would like to assess whether there is a difference between the different procedures in their influence on dry eye status.


Eligibility Criteria:
Inclusion Criteria:

* Ptosis which indicate surgical repair
* The ptosis must be suitable for repair in any of the procedures

Exclusion Criteria:

* Systemic disease which may cause ocular surface disease (eg Sjogren disease)
* Previous orbital or eyelid surgery
* Significantly dry eyes
Transplantation of Anaerobic Cultured Human Intestinal Microbiota in Irritable Bowel Syndrome

Patients with irritable bowel syndrome (IBS) are treated with microbiota from a human intestinal anaerobic sample cultured for decades. Patients are recruited consecutively with symptoms of IBS and serve as their own controls. After an observation time of 4 weeks, patients are recruited for a 1-week run-in and then given the cultured fecal microbiota by the duodenal route via gastroscopy. Two treatments are given within a 1-week interval. Assessment of symptoms are made before and 4 weeks after the last treatment (at 6 weeks). Additionally, fecal samples are collected for bacterial 16S ribosomal ribonucleic acid (rRNA) analysis and bacterial functional parameters (microflora-associated characteristics).

Diarrhea-dominated irritable bowel syndrome (IBS-D) is studied in subjects by treatment with an anaerobic human intestinal microbiota cultured for 15 years and quality controlled with a specified content of bacterial species regularly over the years. Inclusion criteria is: Diarrheal disease since at least 4 weeks, 18-80 years of age, previously unsuccessful treatment with no symptomatic relief of antidiarrheals or resins, and signed informed consent.

Primary outcome was irritable bowel syndrome-symptom severity scale (IBS-SSS). Secondary outcome was Bristol stool scale (BSS).

Secondary outcome: Changes in fecal microflora distribution and multiplicity as shown by the 16S ribosomal ribonucleic acid (rRNA) analysis of feces.

Once eligible for the study, patients were monitored for a run-in period of one week with the IBS-SSS and the BSS plus fecal samples for analysis of bacterial species using the bacterial specific 16S rRNA differentiation.

Then, the anaerobic cultured human intestinal microflora (ACHIM) was given twice with an interval of 1 week. Thereafter, patients were further monitored over 4 weeks as regards IBS-SSS and BSS. Another feces sample was also collected for bacterial 16S rRNA analysis to evaluate the microbiota diversity.

The study will be evaluated using eligible subjects as their own controls by means of Wilcoxon's matched-pairs test, alternatively t-test for matched pairs.

Power analysis show that 40 subjects are needed to study in order to achieve a power of 80%.

Eligibility Criteria:
Inclusion Criteria:

* IBS according to the Rome III criteria

Exclusion Criteria:

* Pregnancy
* Antibiotic and probiotics within 8 weeks before inclusion
* Unable to give informed consent
* Immunodeficiency (drug- och disease-related)
Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-Ivacaftor

Cystic Fibrosis related diabetes (CFRD), a major factor of morbid-mortality in CF, is characterized by a preclinical phase of glucose intolerance particularly long reaching up to 10 years.

At the physiopathology level, insulin secretion is determinant in the glucose tolerance abnormalities in CF. Indeed insulin secretion is dependent of the CFTR activity at the beta cell surface and inhibition of CFTR leads to a decrease in insulin secretion.

Recently, the combination of the lumacaftor, a CFTR corrector, with Ivacaftor, a CFTR potentiator, was studied in patient with CF homozygous for the Phe508 del CFTR mutation patients and showed an improvement of the respiratory state in comparison with the placebo group.

These data suggests that lumacaftor in combination with ivacaftor in targeting CFTR action may have an early impact on the insulin-secretion and consequently on the glucose tolerance.


Eligibility Criteria:
Inclusion Criteria:

* patients with CF homozygous for the Phe508del CFTR mutation aged 12 years and over
* Combined Lumacaftor-Ivacaftor treatment scheduled or already started
* glucose intolerance in OGTT (ADA criteria) or newly diabetes diagnosed at the OGTT (ADA criteria) or diabetic patients with insulin requirement ≤ 0.3 unit / kg / day or without insulin treatment
* signed informed consent of patient and of one parent OR legal representative for minor subject

Exclusion Criteria:

* hypersensitivity to the active substances or to any of the excipients of Lumactfor -Ivacaftor
* lung and/or liver transplant patient
* Known diabetes with insulin treatment \> 0.3 unit / kg / day
* patient pregnant or wishing to pregnancy
Safety and Effectiveness of COVID-19 Vaccine in Kidney Transplant Recipients

The current study is a noninterventional prospective study examining the efficacy of additional dosage of the coronavirus disease 2019 (COVID-19) vaccine in kidney transplant recipients (KTRs).

In this clinical, prospective, non-interventional study to assess the effectiveness of an additional dose of COVID-19 vaccination, we evaluated the seroconversion rate of KTRs after the booster shot. Consecutive individuals who have completed standard two-doses of COVID-19 vaccination were enrolled. Following consent, demographic and clinical data were collected from participants, including patient/ transplant characteristics and information regarding previous COVID-19 vaccination.

1 Study visit and sample collection Patients were invited to return for up to 2 follow-up visits for sample collection. Whole blood samples were collected two weeks to 1 day before the booster vaccination and 4 weeks after. During the visit for the second blood sample, a survey was conducted to assess booster-related adverse events.

2. Anti-SARS-CoV-2 antibody assay IgG antibodies against the receptor-binding domain (RBD) of the S1 subunit of the spike protein of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) were quantified with SARS-CoV-2 IgG II Quant assay (Abbott).

Additionally, neutralizing antibody was assessed using anti-SARS-CoV-2 GenScript cPass SARS-CoV-2 Neutralization Antibody Detection Kit. The cPass detection kit utilizes the horseradish peroxidase (HRP) conjugated recombinant SARS-CoV-2 RBD protein and the human angiotensin-converting enzyme 2 (ACE2) receptor protein. It detects neutralizing antibodies capable of blocking protein interaction between HRP-RBD and ACE2. The assay was performed according to the manufacturer's instructions.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who received kidney-only transplantation or multi-organ transplantation including kidney before December 31, 2020
2. Patients ≥ 12 years old
3. Patients fully vaccinated with two standard doses of COVID-19 vaccination with the vector vaccine (AZD1222 of AstraZeneca) or the mRNA vaccines (BNT162b2 of Pfizer-BioNTech or mRNA-1273 of Moderna) including homologous and heterologous regimen.
4. Patients with plans of getting an additional dose of COVID-19 vaccine (i.e., booster shot)
5. Patients providing informed consent and willing to comply with the study protocol, including two blood tests and a survey.

Exclusion Criteria:

1. Patients with a previous history of SARS-CoV-2 infection
2. Who had B-cell depleting therapy (e.g., rituximab, bortezomib) or T-cell depleting therapy (anti-thymocyte globulin) within six months
3. Patients who restarted dialysis due to graft failure
Screening for Primary Aldosteronism in Hypertension With 24-hour URinary aLdosterone

This is an observational study compares the positivity rates of two tests for screening for primary aldosteronism: plasma aldosterone renin ratio and 24-hour urine aldosterone in patients with young-onset hypertension with or without other clinical features of primary aldosteronism.

Plasma aldosterone and renin measurements are subject to significant intra-individual variability, including variation related to posture, time of day and sodium balance. Aldosterone secretion is not constant and may be subject to diurnal variation. As such one-off testing of ARR, does not consider the salt status of the individual necessitating repetition of tests to ensure false negative or false positive test results are ruled out. The value of accumulated aldosterone in a 24-hour sample has the advantage that it does not depend on circadian variation. This pilot observational study will help establish the positivity rates of both standard plasma aldosterone renin ratio and 24-hour urine aldosterone, and the degree to which they correlate but will help establish if untargeted screening in young-onset hypertension is feasible and test the robustness of current standard guidelines for primary aldosteronism screening and case confirmation.

Eligibility Criteria:
Inclusion Criteria:

* A patient will be eligible for inclusion in this trial only if all of the following criteria apply:

  * Aged 18 years and above.
  * Meets NICE criteria for a diagnosis of hypertension with an age of onset of hypertension between 18-60 years.
  * For cohort 2 (suspected primary aldosteronism): resistant hypertension, and/or hypertension with spontaneous or diuretic-induced hypokalaemia, and/or hypertension.

Exclusion Criteria:

* • Severe hypertension (sustained blood pressure of \>200/110 mmHg) or a history of known secondary hypertension other than PA.

  * Contraindications to confirmatory testing with saline infusion or oral salt loading test as per standard clinical criteria such as known clinical diagnosis of heart failure, and/or chronic kidney disease stage 3b.
  * Known Pregnancy or breast feeding.
  * Lack of informed consent.
  * Any medical condition deemed unsuitable by investigator for participation in the study
Additional Effect of Pain Neuroscience Education to Orofacial and Neck Exercises in Temporomandibular Disorders

The objective of this study will be to verify the additional effect of Pain Neuroscience Education program to orofacial manual therapy and orofacial and neck motor control exercises for pain intensity and disability and for the secondary outcomes pain self-efficacy, kinesiophobia, and overall perception of improvement in patients with Temporomandibular Disorders (TMD). This study will be a randomized clinical trial comprising a sample of 148 participants. Subjects will undergo a screening process to verify those presenting a diagnosis of painful TMD confirmed by the Research Diagnostic Criteria (RDC/TMD), between 18 and 55 years of both genders, and then the volunteers will be randomized into two groups (G1: Pain Neuroscience Education + Orofacial Manual Therapy/orofacial exercises/neck motor control exercises vs. G2: Orofacial Manual Therapy/orofacial exercises/neck motor control exercises). These volunteers will be recruited at the Dentistry Clinic of the University of São Paulo's School of Dentistry of Ribeirão Preto - University of São Paulo. The intervention will be administered twice a week for 6 weeks by a single therapist lasting 1 hour per session. The primary outcome will be pain intensity and disability and the secondary outcomes will be pain self-efficacy, kinesiophobia and overall perception of improvement. The participants will be assessed immediate after the last session and at one and three-month follow-ups.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of painful TMD Research Diagnostic Criteria for TMD (RDC/TMD)
* A history of orofacial pain at least three months prior to the study (TREEDE et al, 2015)
* age ranging between 18 to 55 years, considering the greater prevalence of TMD associated with this age period.

Exclusion Criteria:

* Patients with illiteracy, severe depression (medical diagnoses), clinical history of tumors in the craniofacial region, patients in the post dental surgery period or submitted to previous physical therapy in the past year or to any health/pain education strategy, pregnant women, infections, whiplash-associated disorders and with chronic degenerative inflammatory or neurologic disorders were excluded from this study. Patients will be instructed to not use pain relief medications during the intervention period of this trial and if any medication be used, participants will be encouraged to report.
In Vitro Myometrial Contractions in Laboring and Non-laboring Women

The purpose of this study is to compare the ability of an isolated sample of uterine muscle tissue (in a tissue bath) to contract in the presence of various drugs. The drugs studied--uterotonics--are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. Amongst common uterotonic drugs, namely oxytocin, ergonovine, prostaglandin F2alpha, and misoprostol, the most effective one to use is unknown.

The investigators will be testing isolated uterine muscle samples to increasing concentrations of these four drugs in three patient populations: non-laboring, laboring without exogenous oxytocin augmentation, and laboring with oxytocin augmentation. Contractile measures will be measured and compared between all groups. The investigators hypothesize that oxytocin alone will have a weaker uterotonic effect in oxytocin-augmented laboring patients, and all four drugs will induce different patterns of contractions.

Postpartum hemorrhage (PPH) is a major cause of maternal mortality and morbidity. In 80% cases of PPH, the primary cause is failure of the uterus to contract after delivery of the baby, which then requires further treatment of the mother with uterotonic drugs (drugs used to contract uterus and thus prevent bleeding).

Patients participating in this study will be asked to donate a very small sample of uterine tissue during Cesarean section, which will be tested in the laboratory for the ability to contract in response to the uterotonics oxytocin, ergonovine, prostaglandin F2alpha, and misoprostol. We will seek to better understand the effects of these drugs by comparing their contractile capability in isolated uterine tissue.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 37-41 weeks
* Patients requiring primary or first repeat Cesarean section
* Cesarean section under spinal anesthesia

Exclusion Criteria:

* Patients who require general anesthesia
* Patient who had previous myometrial surgery or more than one previous Cesarean section
* Patients with placental anomalies
* Patients with multiple pregnancy (twins, etc.)
Safety, Tolerability and Pharmacokinetics of BIBW 2948 BS in Healthy Male Volunteers

Study to investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS


Eligibility Criteria:
Inclusion Criteria:

* Healthy males based on a complete medical history, including physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests:

  * No finding deviating from normal and of clinical relevance
  * No evidence of a clinically relevant concomitant disease
* Aged between ≥21 and ≤50 years
* BMI (Body Mass Index) between ≥18.5 and ≤30 kg/m2
* Provision of written informed consent signed and dated prior to admission to the study in accordance with good clinical practice (GCP) and local legislation

Exclusion Criteria:

* Any finding during the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients)
* Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of study centre