cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare

To evaluate the safety and efficacy of Genakumab for Injection in patients with gout flare as a first line therapy

Phase 2， randomized, open lable, multi-center, active controlled study. Patients are randomized to Genakumab 200mg single injection group or Etoricorxib 120mg qd po.(until remission or intorlerance, no longer than 8 days) group.

Eligibility Criteria:
1. Male or female, 18 years ≤ age ≤ 75 years;
2. BMI ≤ 40kg/m2
3. Meeting ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout;
4. Start of acute gout flare within 3 days prior to enrolled;
5. History of ≥2 gout flare within 12 months prior to study start;
6. Baseline pain intensity ≥ 50mm on the 0-100mm visual analog scale(VAS)
SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled by Metformin

This is the phase 3 randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and long-term safety of SAL067 in T2DM patients uncontrolled by metformin, comprising 24 weeks of double-blind treatment period followed by an open-label treatment period, making up a total of 52 weeks.

All eligible subjects would enter the 24 weeks of double-blind treatment period and were randomized into the SAL067 group (12 mg once daily) or placebo group at a 2:1:1 ratio. After 24 weeks of double-blind treatment, subjects would enter the extended open-label treatment period. Subjects in the placebo group were to be switched to SAL067 (12 mg once daily) treatment, while patients in the SAL067 groups continued the same treatment until the end of the whole 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes patients who meet the diagnostic criteria for diabetes issued by the World Health Organization (WHO) in 1999;
2. Men or women aged 18 to 75 years old at the day of signing the informed consent;
3. Body mass index: BMI 19kg/m2 to 35kg/m2, \[BMI=weight (kg)/height 2 (m2)\];
4. Subjects treated with metformin≥ 1500mg/day constantly for at least 8 consecutive weeks before screnning;
5. Glycated hemoglobin (HbA1c): Screening period: HbA1c 7.5% to 10.5% (tested by the research center), when randomly enrolled: HbA1c 7.0% to 10.0% (central laboratory test) Measurement);
6. Screening period and random time fasting blood glucose \<=13.9mmol/L.

Exclusion Criteria:

1. Drug compliance during the introduction period \<80% or \>120%;
2. Use other hypoglycemic drugs other than test drugs during the introduction period;
3. The patient may have any contraindications, allergies or hypersensitivity to fuglitagliptin (including study drug and placebo) or its excipients, DPP4 drugs, metformin;
4. Before screening, have any of the following endocrine-related medical history or evidence:

   * Diabetes other than type 2 diabetes, such as type 1 diabetes, single-gene mutation diabetes, diabetes caused by pancreatic injury or secondary diabetes, such as diabetes caused by Cushing's syndrome or acromegaly;
   * diabetic ketoacidosis, hyperglycemia and hyperosmolarity, lacticacidosis and other acute complications of diabetes within 6 months before screening;
   * severe hypoglycemia episodes (such as sleepiness caused by hypoglycemia, unconsciousness, nonsense, and even coma), or a serious history of unconscious hypoglycemia;
5. Before screening, there is a history or evidence of any of the following diseases:

   * Unstable angina, stroke or transient ischemic attack, myocardial infarction, coronary artery bypass graft or percutaneous coronary intervention (diagnostic angiography is allowed of);
   * Decompensated heart failure before screening (New York Heart Association NYHA heart function grades III and IV, persistent and clinically significant arrhythmia;
   * A history of acute and chronic pancreatitis, symptomatic gallbladder disease or history of pancreatic injury, etc. may lead to high risk factors for pancreatitis.
The Effect of Comorbid Psychiatric Conditions on Results of Transforaminal Epidural Steroid Injection

Low back pain (LBP) and radiculopathic pain are a major socio-economic problem affecting all age groups. 70% of people consult a doctor at least once in their life due to LBP. Radicular pain is thought to be caused by inflammation of the spinal nerve roots near the intervertebral disc injury. In this context, fluoroscopic guided transforaminal epidural steroid injection (TFESI) has been increasingly preferred in patients who can not benefit from conservative approach in the treatment of lumbosacral radiculopathic pain due to lumbar disc herniation in recent years.

The assessment of comorbid psychiatric conditions such as depression, anxiety, and somatization disorder and given the detailed and visual information to patients who will be undergone TFESI could affect the result of the treatment in a good way. The pain questionnaire used for objectively evaluating injection outcomes is personality dependent and there are many factors that can affect it.

Although information leaflets given to patients prior to surgical or non-surgical interventions have not yet been used as a standard in each clinic, the effects on patients have been frequently researched in recently. A detailed description of the treatment, the devices to be used and the disclosure of the steps of the procedure may have an effect on the result of the treatment. The aim of the study; (1) the presence of comorbid psychiatric conditions in patients with lumbar disc hernia and radiculopathy, (2) to evaluate the effect of the written and visual informative form given before the injection of the lumbosacral TFESI.

Eligibility Criteria:
Inclusion Criteria:

* lumbar radiculopathy due to lumbar disc herniation,
* unresponsive to conservative treatments,
* duration of pain is less than 3 months,
* patients scheduled for the first time with TFESI.

Exclusion Criteria:

* the cases when fluoroscopy or epidural injection is contraindicated (coagulation disorders, pregnancy etc...),
* underwent epidural injection in the last 6 months,
* to have a history of lumbar spinal surgery,
* inflammatory diseases (rheumatoid arthritis, spondyloarthropathy),
* spinal infection or malignancy,
* to benefit from six-week medical treatment,
* be reluctant to participate in the work and follow up,
* who are illiterate,
* the patients with psychiatric disease
Documenting Toothbrushing Experiences of Caregivers Who Care for Children With Autism Spectrum Disorders

The objective of this study is to examine caregiver reactions to the use of the hum by Colgate Smart Kids Toothbrush and associated app by children with autism spectrum disorder (ASD).

This is a single-center, pretest-posttest, non-randomized, clinical study involving interviews with caregivers prior to utilization of the research toothbrush and after 4 weeks of product use by the child. All participants enrolled will be children ages 5-12 years and their primary caregivers. Participants will be asked to utilize a Hum by Colgate Smart Kids Toothbrush (manual or battery-powered) for four weeks.

To assure that subjects are comfortable with the oral care regime proposed, toothbrushes will be distributed based on the subject's previous oral hygiene habits. Children who are currently using manual brushes will receive the Hum by Colgate Smart Manual Kids Toothbrush, likewise, children who are used to battery-powered toothbrushes will receive the Hum by Colgate Smart Kids battery-powered toothbrush.

All the participants will be offered the electric toothbrush and will have a chance to try it during the first visit.

Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent Form by the child's legal guardian on behalf of the child and from the primary (responsible for child's oral healthcare) caregiver.
2. Caregiver must be able to observe the child using the Hum by Colgate Smart Manual Kids Toothbrush and app twice a day.
3. Caregivers must have a child between the ages of 5-12 years old, who is willing to participate.
4. Child must be reported in good general health and good oral health based on the opinion of the study investigator.
5. Caregiver and child must be available for the duration of the study.
6. Caregiver must have access to Apple iPhone (newer than 8) or iPad (newer than 5th generation) or Android users (running Android 6.0 and up) with access to an Internet Connection.
7. Caregiver must be willing to comply with the study protocol.
8. Caregiver must be willing to download and use app associated with the connected brush.
9. Caregiver must be willing to be audiotaped during key informant interview sessions.
10. English fluency for the child's legal guardian/caregiver.
11. Caregiver must be willing to have a shared brushing experience between themselves and the child.
12. Caregiver's child must be diagnosed with ASD Level I or ASD Level II .

    1. ASD Level I: Requiring support
    2. ASD Level II: Requiring substantial support

Exclusion Criteria:

1. Child undergoing active orthodontic treatment with fixed appliances.
2. Child has obvious signs of oral disease, severe dental caries, or pain as determined by the investigator's judgment.
3. Concurrent participation by child in another clinical study.
4. Child's behavior precludes participation in the study at the investigator's discretion.
5. Current or previous use of the Hum by Colgate Smart Kids Toothbrush by the child.
The Effect of Directional Specific Thoracic Spine Mobilization on Cervical Spine Pain

Hypothesis: There is no difference in directional specific manipulation of the thoracic spine for patients with neck pain.

Patients seeking physical therapy for neck pain routinely have their thoracic spine manipulated. This study seeks to determine if directional limitations in the spine can be specifically determined and treated to decrease neck pain.

Manipulation of the thoracic spine is the most commonly used manual therapy intervention by manual therapists. It is not known whether we can accurately assess and treat directional limitations in the thoracic spine to improve neck pain.

One way is to assess where the limitation is and treat it. Another method is to distract the joint. We want to know if matching the limitation to the manipulation method will give patients with neck pain better results.

The patient lays on their back. The therapist places a hand on the inferior vertebrae of the motion segment. The patient relaxes and the therapist pushes in an anterior to posterior direction either moving the vertebrae into flexion or entension.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Neck Pain; ages 18 - 60

Exclusion Criteria:

* red flags: leg weakness, night pain, history of cancer, upper motor neuron signs, infection, tumors, osteoporosis, fracture (Boissonnault, 2011) (Cleland, 2004) history of whiplash within 6 weeks, cervical stenosis, CNS involvement, signs consistent with nerve root compression, previous surgery, pending legal action
A Plant-Based Whole-Foods Meal Delivery Service for Patients With Multiple Myeloma Undergoing Autologous Hematopoietic Cell Transplant

This clinical trial evaluates the impact of a plant-based whole-foods delivery service on the microbiome in patients with multiple myeloma undergoing an autologous hematopoietic cell transplant. An autologous hematopoietic cell transplant is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Loss of microbial diversity within the intestinal tract has been associated with poor outcomes for patients receiving autologous stem cell transplantation. A plant-based whole meal delivery service may increase the intake of foods high in fiber and nutrients therefore improve microbial health during the peri-transplant period. In this pilot study, study investigators will explore the feasibility of this approach.

OUTLINE:

Patients receive 3 meals per day and snacks delivered twice weekly and meet with dietitian once weekly on days -7 to 28. Patients undergo blood and stool sample collection on study.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent prior to initiation of any study procedures
* Planned first autologous stem cell transplantation for multiple myeloma
* Planned outpatient treatment for the duration of transplantation (if admitted, the investigators will request that caregivers bring the meals/snacks to the hospital as they might with other food prepared at home)
* Access to a refrigerator
* Ability to reheat foods
* Able to consume an oral diet at enrollment
* Able to communicate clearly regarding aspects of the study: e.g. Give feedback on logistics and meals, in order to maximize the operational data the investigators can gather in this pilot study
* At least 18 years of age

Exclusion Criteria:

* Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team
* Planned inpatient transplantation
Anshen Buxin Liuwei Pills for the Treatment of Cardiac Neurosis

This study aims to assess the effect and safety of the traditional Mongolian medicine Anshen Buxin Liuwei Pill for the treatment of cardiac neurosis.

Cardiac neurosis is a group of symptoms characterized by the coexistence of cardiovascular disease related symptoms and nervous system disorders. Anshen Buxin Liuwei Pill is a kind of traditional Mongolian medicine for the treatment of cardiac neurosis. This study aims to evaluate the effect and safety of Anshen Buxin Liuwei Pill for cardiac neurosis in a prospective, randomized, double-blind, placebo-controlled clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old, ≤75 years old;
* Meet the diagnostic criteria for cardiac neurosis: the patient has palpitations, precordial pain, chest tightness, shortness of breath, dyspnea, dizziness, insomnia and dreaminess, cold hands and feet, hyperhidrosis and other cardiovascular symptoms and neurological disorders;
* Meet the diagnostic criteria of Heyisheng type palpitations in Mongolian medicine;
* There is no objective diagnosis of coronary heart disease (in accordance with any of the following): ①The activity flat test is negative; ② Coronary angiography or coronary CTA suggests that the lumen stenosis is ≤50%; ③ Exercise or drug load radionuclide examination results suggest no myocardial ischemia;
* The patient did not take anti-anxiety and depression drugs or psychotropic drugs within 2 weeks before enrollment;
* agrees to voluntarily participate in the study and signs an informed consent form .

Exclusion Criteria:

* Accompanied by organic heart disease, severe cardiopulmonary insufficiency;
* Poor hypertension control (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg after treatment);
* Those with malignant arrhythmia;
* Those who use pacemakers;
* Patients with hyperthyroidism;
* Combined with severe liver and kidney damage (ALT, AST or TBIL\> 2 times the upper limit of the normal reference value, or Cr\> 1.5 times the upper limit of the normal reference value);
* People with serious primary diseases such as hematopoietic system or mental illness;
* SAS≥70;
* SDS≥73;
* Accompanying any other serious diseases or conditions such as malignant tumors;
* Women during pregnancy and lactation;
* People with allergies or allergies to the known ingredients of the research drug;
* Participated in other clinical research in the past 3 months;
* According to the judgment of the investigator, the subject is not suitable for research observation.
Folinic Acid for Prevention of Pemetrexed-induced Toxicity

Objective The main objective is to evaluate the haematological toxicity in patients who use pemetrexed with and without rescue therapy with folinic acid.

Primary endpoint Difference between treatment groups in neutrophil count (\*109/L) at day 8-10 after administration of pemetrexed (nadir).

Secondary endpoints The grade neutropenia (according to the CTCAE version 5, 2017) at day 8-10, the homocysteine plasma levels at baseline (predictor for developing toxicity), the efficacy of chemotherapy treatment based on response CT after cycle 2 and 4 and the incidence of discontinuation, dose delays and dose reductions of pemetrexed.

Trial design The FLEX-trial is a multi-centre, open label, double arm, randomized trial to compare neutropenia in patients with and without folinic acid rescue therapy where subjects are participating for 4 treatment cycles.

Population In total 50 patients (25 in each arm), \>18 years with stage IV non-small cell lung cancer (NSCLC) or mesothelioma treated with pemetrexed (in combination with other chemo- or immunotherapy) are eligible for inclusion.

Interventions Follow-up will take place during the first 4 cycles of chemotherapy with pemetrexed. Patients in the intervention-arm will receive oral folinic acid orally 4 times 45mg / day for 3 days, starting 24 hours after the administration of pemetrexed.


Eligibility Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. ≥18 years old
2. Eligible for treatment with pemetrexed-based chemotherapy based on indication.
3. ECOG performance score of 0-2.
4. Subject is able and willing to sign the Informed Consent Form

A potential subject who meets any of the following criteria will be excluded from participation in this study:

1. Contraindications for treatment with folinic acid in line with the SmPC.

   1. Hypersensitivity to the active substance or to any of the excipients.
   2. Anaemia caused by vitamin B12 deficiency.
2. The presence of clinically relevant drug-drug interactions, according to the current SmPC of folinic acid.
Effects of Portion Size of Multiple Items at a Meal on Food Intake of Adults

This study tests the effect of serving larger portions of all foods in a meal on the outcome of food and energy intake. Using a crossover design, participants are served the meal once a week for four weeks and the portion sizes are varied at each meal. Some of the foods served at the meal are low in calorie density (calories per gram) and some are higher in calorie density. The aim is to determine whether intake in response to larger portions differs depending on characteristics of the subjects or of the foods.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index of 18 to 40 kg/square meter
* Regularly eat three meals per day
* Willing to eat foods served at test meals

Exclusion Criteria:

* Food allergies or restrictions
* Dieting to gain or lose weight
* Taking medications known to affect appetite
* Smoker
* Athlete in training
* Currently pregnant or breast-feeding
* Questionnaire score indicative of depression
* Questionnaire score indicative of disordered eating attitudes
Probiotic Supplementation as Prophylactic for Group B β-hemolytic Streptococcus (GBS) Infection

Streptococcus agalactiae, a Group B β-hemolytic streptococcus (GBS), is the leading cause of severe neonatal infection in developed countries. There is growing scientific interest in probiotic supplementation in pregnancy as possible prophylaxis for GBS infections and urine culture positivity.

There is strong scientific evidence that supports the correlation between bacterial vaginosis (BV), a term used to define a change in the vaginal ecosystem, and spontaneous preterm birth. Antibiotic treatments are recommended to counteract both the presence of S. agalactiae and the onset of BV. The latter, however, are not without risks, as they can in turn cause alterations in the vaginal microbiota and is associated with an increased risk of miscarriage.

Recent research have shown that probiotic treatment can help reduc the risk of preterm birth and positivity of Group B β-hemolytic streptococcus (GBS) infection.

The present study aimed to assess the efficacy and safety of a probiotic iNatal® (probiotic mixture containing 10 ml CFU of Enterococcus faecium L3, 3 billion CFU of Bifidobacterium animalis subsp. lactis BB-12, 3 billion CFU of Lactococcus lactis SP38, 3 billion CFU of Lacticaseibacillus casei R0215) in pregnant wemen in 24 to 36 weeks of gestation as prophylaxis of GBS infections and urine culture positivity.

This was a retrospective, observational, controlled and single centre study.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in 24-36 weeks of gestation period
* History of recurrent genitourinary and/or intestinal problems

Exclusion Criteria:

* Presence of neurological condition
* History of cardiovascular disease
* History of pulmonary disease
* History of renal disease
* Cancer
Speech Analysis as a Diagnostic Tool for Mild Traumatic Brain Injury

The waveform assessment of an athlete's speech production has a high probability of showing abnormalities after brain injury (concussions) which could be used not only for diagnosis of the concussion, but for recovery of the brain. The aim of this study is to investigate this possibility using the Cobweb automated application system for acoustic processing.

Concussions affect cognitive and fine muscle motor control, and these changes will be reflected in the acoustic characteristics of the vowels being produced. The methods to identify and analyze the acoustics of vowels will greatly extend the detailed understanding of vowels produced after a concussion. The identification of the changes in formant frequencies, pitch, and duration will provide the means to use these parameters as an automated diagnostic tool. The waveform assessment of the athlete's speech production has a high probability of showing brain abnormalities immediately after a suspected or diagnosed concussion at the venue of the athletic sport. The aim of this study assessment is to investigate this possibility using the Cobweb system and greatly enhance the ability to diagnose a concussion in a timely manner to remove the athlete from practice or play.

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed or suspected of having a sports concussion seen in a clinical setting
* Ages 6 -21

Exclusion Criteria:

* Patients who have physical injuries to their lips, tongue or oral cavity will be excluded until they have healed.
* Patients with hearing or speech abnormalities who cannot consistently produce the stimulus materials.
* Non-native speakers who cannot read the materials or produce the stimuli consistently.
* Patients who cannot read the materials or produce the stimuli consistently due to their age.
Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B

The purpose of the trial is to evaluate the safety and efficacy of MarzAA for on-demand treatment and control of bleeding episodes in hemophilia A or B patients with inhibitors compared with their standard of care (SOC).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of congenital hemophilia A or B with inhibitors
* Male or Female, age 12 or older
* History of frequent bleeding episodes
* Affirmation of informed consent with signature confirmation and assent for children between ages 12 to 17 before any study related activities

Exclusion Criteria:

* Previous participation in a clinical trial evaluating a modified rFVIIa agent
* Received an investigational drug within 30 days or 5 half-lives or absence of clinical effect
* Known hypersensitivity to trial or related product
* Known positive antibody to FVII or FVIIa detected by central lab at screening
* Have a coagulation disorder other than hemophilia A or B
* Be immunosuppressed
* Significant contraindication to participate