cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study of Anbainuo in Chinese Patients With RA/AS in the Real World

TNF- α receptor inhibitors have been used widely in practice and are well developed in China. Anbainuo is a bio-similar recombinant TNF-α receptor: IgG Fc fusion protein, approved in 2015. Up to now, Anbainuo is well applied in patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS). Although the phase II and III clinical trials both indicated that Anbainuo can effectively control the disease activity with good tolerance and safety in RA and AS patients, there is no sufficient clinical evidence in the real world. Thus, the objective of this study is to evaluate, under the actual conditions of use, dosing patterns of Anbainuo. Investigators plan to recruit 1000 adult patients with RA or AS and to follow them for 48 weeks. It is hypothesized that this study would reflect real clinical conditions (efficacy and safety assessment) of using Anbainuo in RA and AS patients.


Eligibility Criteria:
Inclusion Criteria:

* meet the diagnostic criteria of the American College of Rheumatology (ACR) (1987);
* or meet the diagnostic criteria of ankylosing spondylitis (New York, modified in 1984);
* older than 18;
* Prepare to or already start to use Anbainuo.

Exclusion Criteria:

* any acute or chronic infection or the history of active tuberculosis
* pregnant women or breast feeding women;
* malignant tumor;
* moderate to severe congestive heart failure (New York Heart Association, 3-4 grade);
* allergic to Anbainuo.
Effect of Eriocitrin Supplementation in Subjects With Intermediate Hyperglycemia

First, it will be evaluated whether supplementation of eriocitrin reduces hyperglycemia and insulin resistance, significantly reducing the risk of diabetes. The effects of eriocitrin on the lipid profile, inflammatory, endothelial, hepatic and renal biomarkers will also be evaluated. It is expected that metabolic parameters that constitute risk factors for diabetes and associated chronic diseases are expected to be improved by supplementation with eriocitrin

Volunteers will be invited to appear in a 12-hour fast to measure glucose levels, glycated hemoglobin and to perform the glucose tolerance test, in addition to an individual interview to confirm eligibility according to the inclusion and exclusion criteria. The collection of blood and the glycemic curves will be carried out next to a Laboratory of Clinical Analyzes, commercial, based in the city of Araraquara.

The sample number took into account variances on glycated hemoglobin with a type I error α = 0.05 and a type II error β = 0.2 (80% power) (Mohammad, 2015). The minimum sample size considering an approximately 20% dropout rate, should have 20 individuals per group.

In order to ensure adequate nutrition for the nutritional and energetic needs of volunteers, an individual food plan shall be prescribed, calculated according to the DRI equations. The volunteer will be asked to complete the Food Record for three days at the 3rd, 5th, 7th, 9th and 11th week. Data analysis of energy intake, macronutrients and micronutrients will be performed through the DietBox® . The anthropometric measurements will be performed before the intervention and in the 3rd, 5th, 7th, 9th and 11th week by Nutritionist. Four samples of 30mL of fasting blood each will be obtained before the intervention, in the 4th, 8th and 12th week in the Laboratory of Clinical Analyzes. The blood will be centrifuged to obtain the serum, which will be frozen at -80 ° C until subsequent biochemical analyzes.

Normality and homogeneity will be evaluated by Shapiro-Wilk test and Levine tests, respectively. The T test will be used to compare baseline time between groups. The two-way repeated-measures ANOVA will be used to compare changes within and between the eriocitrin and control groups over the 12-week period. P significant at ≤ 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Glycemia of 6.1 to 7.0 mmol / L
* Glycated hemoglobin with values between 5.7 and 6.4%

Exclusion Criteria:

* use of drugs, vitamins and dietary supplements, alcohol consumption (\> 20 g alcohol/d), and intense physical activity (\> 5 hours/week).
* History of cardiovascular disease, diabetes mellitus, liver or kidney disease
A Multicenter Study to Evaluate the Effects of Switching to Aripiprazole 12 Weeks on the Sexual Dysfunction From Risperidone or Paliperidone in Patients With Schizophrenia Spectrum Disorders or Bipolar Spectrum Disorders

This trial designed to investigate the effect of switching to aripiprazole from risperidone or paliperidone on reverse prolactin level, and consequently improve sexual dysfunction in adult patients with schizophrenia spectrum disorders and bipolar spectrum disorders.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 12-55 years (male), 12-40 (female)
2. Diagnosis: Schizophrenia spectrum disorders \& bipolar spectrum disorders (only Korea) by DSM-IV-TR
3. Receiving RIS or PALI with stable dose for \> 1 month by their physician;
4. Prolactin level Adult: \> 20 ng/ml (male), 25 ng/ml (female) Child/Adolescent: \> 20 ng/ml (male, female)
5. Children and adolescents (age: 12\~17 years) having more than one sexual system dysfunction measured by 5 of the 48 UKU items (galactorrhoea, gynecomastia and erectile dysfunction for male, galactorrhea, amenorrhoea/oligomenorrhoea, and dry vagina for female) or Adults (age: 18\~55 years) who are considered to have sexual/reproductive dysfunction if they had either a total score of 19 or higher; a score of 5 or higher on one question; or a score of 4 or higher on 3 questions.
6. Subjects who have consented to participate by signing an informed consent form.

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Exclusion Criteria:

1. Medical disorder or psychiatric comorbidity or condition known to affect prolactin, sex hormone balance or bone metabolism (i.e., unstable medical disease, Cushing's disease, chronic renal failure, thyroid dysfunction, eating disorder)
2. History of hematological and/or solid malignancies
3. Physical or functional obstruction to food intake or impaired digestive/absorptive function
4. Known hypersensitivity to any study medication (risperidone, paliperidone, and aripiprazole)
5. Insulin requiring diabetes mellitus or poorly controlled diabetes mellitus (HbA1c \> 9% or change of antidiabetics treatment within the 12weeks prior to screening)
6. Uncontrolled hypertension (SBP/DBP 140/90 mmHg), congestive heart failure (NYHA class III or IV), other significant cardiovascular illness (myocardial infarction, unstable angina, cardiac arrhythmia etc.)
7. Baseline QTc interval of \> 450 msec
8. Hepatic and/or renal dysfunction

1) Bilirubin level ≥ 1.5 upper normal limits 2) AST/ALT ≥ 3 UNL or 3) Serum creatinine ≥ 1.5 9. Any patient hospitalized for acute exacerbation of their condition within 2 months of randomization 10. Recent (within the past 1 month) or planned treatment with prohibited medications in the protocol

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INcorporating VoIce AcTivated Communication Aids Into Everyday Communication

Dysarthria is a speech disorder resulting in speech that is slow, slurred and difficult to understand, limiting a person's opportunities to study, work, and develop relationships.

People with dysarthria often use communication aids to help them to communicate creating spoken messages using a keyboard, touchscreen or joystick. Communication aids can increase independence but are often too slow to keep pace with normal conversation.

Developments in speech recognition technology have led to apps which can learn to recognise a set of words or sounds spoken by the individual with dysarthria, and connect these with a clear spoken output. The investigator's previous research provides some evidence that these voice input communication apps may be faster than traditional communication aids. This study aims to find out who can benefit from this technology, and what support they will need to use it successfully. This information can be used by professionals involved in providing communication aids, and will help the investigators to plan further research into their effectiveness.

This research has two phases:

1. 20-30 individuals with dysarthria will be asked to use a voice input communication app for 6 months. The investigator's will collect information on whether VocaTempo improves their communication, and helps participants to reach their goals.
2. Focus groups will be held with professionals involved in providing and supporting people with communication aids, to understand factors affecting their ability to provide the support identified as needed in part 1 of the research.

The investigators have a panel of communication aid users, who are advising and contributing throughout the study, for example, helping the investigators to identify informal support networks to recruit participants from. The investigators will let people know about the findings through support groups used by people with dysarthria, publications read by people involved in providing communication aids, and academic papers and conferences.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Moderately or severely dysarthric (identified using the Frenchay Dysarthria assessment
* Minimum of 2 distinct vocalisations over which they have voluntary control
* Able to give informed consent and take part in interviews with appropriate communication support (scores level 1-3 on consent support tool)
* Communicates predominantly in English

Exclusion Criteria:

* They have significant cognitive impairment and are unable to give informed consent on their own behalf or actively take part in interviews (tested using the Consent Support Tool, scoring at level 4), or are unable to use a communication aid.
* They have no controlled vocalisations.
* They have dysarthria as a result of a progressive condition
Clinical Study to Investigate the Sleep Quality Enhancing Effect of GABA

The purpose of this study is to investigate the efficacy and safety of dietary supplement GABA in subjects with mild, transient sleep disorder.

The subjects will take GABA or placebo capsule once daily before sleep for 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects older than 19 years old
* Who is experiencing mild, transient sleep disturbance (pittsburgh sleep quality index ≥ 5, Insomnia Severity Index ≥ 8)
* Who voluntarily agreed to participate in the study and signed an informed consent form.

Exclusion Criteria:

* Who is suffering from severe sleep disorder including sleep disorders due to psychological or neurologic causes.
* Who has used sleeping pills or sleep related dietary supplements within 4 weeks before study participation
* Who is suffering from obstructive sleep apnea.
* Who has used or is expected to inevitably use prohibited concomitant medications during the study.
* Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.
* Who has dosed other study medications within 30 days before screening.
* Who is determined ineligible for study participation by investigators for any other reasons.
Spinal-Induced Hypotension in Geriatric Patients

The study will be conducted to asses preoperative condition of venous system by VExUS score and it's relation with the incidence of spinal induced hypotension in geriatric patients undergoing surgery with spinal anaesthesia.

An assessment of the intravascular volume deficit prior to the spinal anaesthesia conduction may help to predict the occurrence of a critical decrease in blood pressure, so several indices have been proposed to assess it's status depending on either a fluid challenge or an assessment of heart-lung interaction. Heart rate variability, passive leg raise test, and peripheral perfusion index have revealed good abilities to predict spinal induced hypotension. The inferior vena cava (IVC) collapsibility index provides high diagnostic accuracy in predicting spinal induced hypotension The VeXUS score is a four-staged validated protocol which evaluates the presence and severity of systemic venous congestion in the inferior vena cava (IVC) and organs (liver, gut, and kidneys) by evaluating the (IVC) diameter, venous waveforms of the hepatic vein (HV), portal vein (PV), and interlobar renal veins using colour Doppler (CD) and pulsed wave Doppler (PWD)

Eligibility Criteria:
Inclusion Criteria:

* . Patients aging 65 or older
* Lower body surgeries to be done with spinal anaesthesia
* BMI less than 30 kg/m2.
* Patients with ASA I-III

Exclusion Criteria:

* Patient refusal
* Major bloody surgeries (class c surgeries)
* Patients with a history of cardiovascular disorders including arrhythmias, heart failure, tricuspid or mitral regurgitation, dilated right atrium or ventricle, AF
* Patients with a history of respiratory disorders
* Patients with cirrhotic liver
* Patients with pulmonary hypertension
* Patients with renal diseases
An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer

The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Stage II/III carcinoma of the esophagus or gastroesophageal junction
* Completed pre-operative chemo radiotherapy followed by surgery
* Diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection

Exclusion Criteria:

* Diagnosed with cervical esophageal carcinoma
* Diagnosed with Stage IV resectable disease
* Did not receive concurrent chemoradiotherapy prior to surgery
* Participants who have received a live/attenuated vaccine within 30 days of the first treatment

Other protocol defined Inclusion/exclusion criteria could apply
Local Ketamine Instillation for Postoperative Analgesia

This study aims at exploring the analgesic efficacy, and safety of Ketamine instillation into the wound of total thyroidectomy compared to placebo,and to systemic ketamine administration (I.M. injection of the same dose) with respect to postoperative VAS, first request of analgesia, total opioid consumption, and with respect to possible side effects.


Eligibility Criteria:
Inclusion Criteria:

* patients with thyroid cancer scheduled for total thyroidectomy.

Exclusion Criteria:

1. BMI\>35
2. Unstable ischaemic cardiac disease
3. Increased intracranial pressure
4. Increased intraocular pressure
5. Hypersensitivity or allergy to ketamine, local anesthetic, morphine, or other drugs used in the study.
6. Severe psychiatric disease
7. Unwillingness or inability to use PCA-device
8. Inability to use VAS scale
POEM- Peroral Endoscopic Myotomy for Esophageal Motility Disorders

POEM has recently described as an alternative treatment for achalasia in humans. In this procedure the esophageal sphincter is incised through a submucosal tunnel in the esophagus. In this study we aim to perform POEM on achalasia patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Achalasia whom are candidates for Heller Myotomy

Exclusion Criteria:

* Perforation of LES during dilatation
* Pregnant women
* mentally ill patients
Fecal Microbiota Transplant (FMT) for Relapsing C. Difficile Infection in Adults and Children Using a Frozen Inoculum

Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile-infected recipient, and has long been a successful approach to recurrent/refractory C. difficile. The purpose of this project is to generate a frozen FMT inoculum from well-screened healthy volunteer donors which can be used repeatedly, particularly in those who do not have a healthy intimate partner or other related donor. Delivery of FMT has been performed colonoscopically, by fecal retention enema, or by the nasogastric route. This study will evaluate the safety and secondarily the efficacy of a frozen inoculum administered by nasogastric tube vs administered by colonoscope.

Subjects with recurrent/relapsing C. difficile infection (10 per group) will receive FMT via either:

* colonoscopy
* NGT

The primary endpoint is assessment of safety as measured by clinical events (GI, procedural, systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C. difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a normal bowel status for the individual. Secondary efficacy endpoints include weight, subjective well-being and relative clinical improvement per standardized questionnaire, and subject qualitative assessment of, and satisfaction with, the transplant procedures. Subjects will be monitored for clinical safety by history and standard exams and the follow-up questionnaire as well as followed closely by phone and in person.


Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent or relapsing CDI defined as EITHER(13):

  * At least three episodes of mild-to-moderate CDI and failure of a 6-8 week taper with vancomycin with or without an alternative antibiotic (e.g. rifaximin, nitazoxanide).
  * At least two episodes of severe CDI resulting in hospitalization and associated with significant morbidity.
* Willingness to accept risk of unrelated donor stool
* Willingness to be randomized to NGT vs. colonoscopic delivery.
* Able to consent for self, or parental assent/child assent as age appropriate.

Exclusion Criteria:

* Anatomic contraindication to NGT
* Delayed gastric emptying syndrome
* Known chronic aspiration
* Contraindication to colonoscopy (ASA 4 or more)
* High risk of bacterial translocation (Immunosuppression, cirrhosis etc)
* Pregnant or breastfeeding women
* Acute unrelated infection or comorbid illness exaccerbation
Inhaled Budesonide in Transient Tachypnea of the Newborn

Background: Transient tachypnea of the newborn (TTN) caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid and is a common cause of admission of late preterm and full-term infants to neonatal intensive care units. Infant born by C-section and those with perinatal asphyxia, umbilical cord prolapse or certain maternal condition (asthma, diabetes, or analgesia) are more prone to develop TTN. Conventional treatment involves appropriate oxygen administration and continuous positive airway pressure in some cases. Hastening the clearance of lung liquid should shorten the duration of the symptoms and reduce complications.

Objectives: This study aims to determine the effectiveness of inhaled budesonide in the treatment of this disorder through determining whether it reduces the duration of oxygen therapy and respiratory symptoms and shortens hospital stay in term infants with transient tachypnea of the newborn


Eligibility Criteria:
Inclusion Criteria:

* Late preterm and term infants (post-menstrual age ≥ 34 weeks) delivered by Cesarean section or vaginal delivery
* Diagnosis of transient tachypnea of the newborn
* The need for Continuous positive airway pressure (CPAP) \>6 hours to obtain the oxygen saturation \>92%

Exclusion Criteria:

* Meconium aspiration syndrome;
* Respiratory distress syndrome
* Congenital heart Disease
* Non respiratory disorders causing tachypnea (polycythemia or hypoglycemia) resolving with treatment of the disorder
* Pneumonia by chest x-ray
* Suspected sepsis/bacteremia
* Prenatal steroids
Comparsion Between Intravenous Infusion of Ketofol and Inhalational Anasthetics in Abdominal Cancer Surgeries for Post Operative Analgesia

( post operative pain between intravenous infusion ketofol and standard inhalational general anesthesia in abdominal cancer surgeries )

ketofol, which is a combination of ketamine and propofol, has been increasingly used because the advantages and disadvantages of propofol and ketamine complement each other and increase their effectiveness. Recently, the use of a combination of ketamine and propofol (ketofol) as a sedative has been attracting attention in various clinical fields. Theoretically, the combination of ketamine and propofol can reduce the dose of each drug and compensate for the disadvantages of the other through the antagonistic characteristics of both drugs, resulting in beneficial results for successful sedation

. Most of the time propofol and ketamine have been used as an induction agent in adult surgical patients but propofol may cause cardiorespiratory depression while ketamine increases heart rate and arterial blood pressure. On the other hand, the clinical effects of propofol and ketamine seem to be complementary. Ketofol is most commonly used for procedural sedation hence exploring its effectiveness for induction will be paramount for the clinical care of surgical patients Inhalation anesthetics (nitrous oxide, halothane, isoflurane, desflurane, sevoflurane, most commonly used agents in practice today) are used for induction and maintenance of general anesthesia in the operating room. The volatile anesthetics (halothane, isoflurane, desflurane, and sevoflurane) are liquids at room temperature and require the use of vaporizers for inhalational administration. Nitrous Oxide is already under normal conditions of temperature and pressure. All inhalational anesthetics provide amnesia and immobility, except for nitrous oxide, which also provides analgesia. Inhaled anesthetics are commonly used in combination with IV anesthetic agents. These agents have FDA approval for use as a general anesthetic and sedation agent in the operating room. Inhaled anesthetic agents have also had use in the intensive care unit, but this is not an FDA-approved indication. The primary applications of inhaled anesthetic agents in the ICU are sedation, refractory bronchospasm, and control of status epilepticus unresponsive to anticonvulsant medications.

Eligibility Criteria:
Inclusion Criteria:

* a. Inclusion criteria:

  1. Age group 18 - 60 years old.
  2. Both gender
  3. ASA 1and 2

Exclusion Criteria:

* a. Inclusion criteria:

  1. Age group 18 - 60 years old.
  2. Both gender
  3. ASA 1and 2 b. Exclusion criteria:

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  1. Patient refusal,
  2. History of cardiac or respiratory disease, psychological disorders,
  3. High risk of regurgitation or aspiration based on a history of diabetes,

     hiatus hernia, gastroesophageal reflux, and obesity,
  4. neck pathology,
  5. Predicted difficult airway (history of difficult airway, mouth opening