cyrilzakka/clinical-trials huggingface dataset:
Lactobacillus Helveticus in the Treatment of Major Depression

The main objective of the study is to evaluate whether the association of the probiotic Lactobacillus helveticus to standard antidepressant will contribute to the treatment of major depression.

Patients with the diagnosis of major depression according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria will receive one daily oral dose of 1 × 10\^9 colony-forming units (CFUs) of Lactobacillus helveticus or placebo for 8 weeks in addition to conventional antidepressant treatment.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65 years old;
* Diagnosis of major depression
* Agree to sign the informed consent.

Exclusion Criteria:

* Treatment with anti-inflammatory drugs or antibiotics of any pharmacological classes in the month before treatment enrollment;
* Use of dietary supplementation (herbal supplements, other pro- or prebiotics).
A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis

This is a phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of AK111 in subjects with active ankylosing spondylitis.

The purpose of this study is to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis. Subjects will be randomized to receive AK111 or placebo following subcutaneous injection. The study period for each subject will be 25 weeks, including a screening period of up to 35 days, followed by a treatment period of 12 weeks and a follow up period of 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18-75 years old.
* Ankylosing spondylitis has been diagnosed for at least 6 months before screening, with radiological evidence that meets the Modified New York Criteria for Ankylosing Spondylitis.
* Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and Spinal pain score≥ 4 (based on BASDAI question 2).
* Subjects received at least 1 kind of non-steroidal anti-inflammatory drugs (NSAIDs), prior to randomization with an inadequate response or failure to respond.
* Subjects who are regularly taking NSAIDs, weak opioids or oral glucocorticoids as part of their AS therapy are required to be on a stable dose for at least 14 days before randomization.
* Subjects taking methotrexate (MTX) (≤25mg/week) or Sulfasalazine (≤3g/day) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 4 weeks before randomization.

Exclusion Criteria:

* Subjects with total ankylosis of the spine.
* Subjects with progressive or uncontrolled diseases of respiratory, circulatory, digestive, urogenital, endocrine, nervous or mental systems, or with other chronic diseases that are not suitable to participate to the study.
* Subjects with other inflammatory diseases or autoimmune diseases except Ankylosing spondylitis (AS).
* Subjects with any severe systemic or local infection within 2 months before screening.
* Subjects who are using strong opioid analgesics.
* Combined use of Disease Modifying Anti-Rheumatic Drugs (DMARDs) other than methotrexate and sulfasalazine, including but not limited to thalidomide, iguratimod, etc. within 4 weeks before randomization.
* Received any live vaccine within 2 months before screening or planned to receive any live vaccine during the study period.
* Previous exposure to secukinumab, ixekizumab or any other biologic drug directly targeting IL-17 or IL-17 receptor.
* Received Natalizumab or other drugs that regulate B cells or T cells within 6 months before screening.
* Received more than 2 kinds of Tumor necrosis factor alpha(TNF-α) inhibitors before screening.
The Effects of Arm Ergometer Endurance Training and High-intensity Interval Training in Chronic Neck Pain

Neck pain is among the causes of morbidity that causes disability. Although it is not life-threatening, neck pain is one of the most important reasons for a decrease in the workforce. Since there is a close anatomical, musculoskeletal and neural connection between the cervical region and the thoracic spine, neck pain can affect respiratory functions by causing biomechanical changes in the thoracic spine and rib cage. The aim of this study is to investigate the effects of aerobic exercise and high-intensity interval training, which are known to have an effect on both the musculoskeletal system and respiratory functions, on the respiratory parameters and musculoskeletal system disorders and clinical outcomes of people with neck pain when applied with an arm ergometer.

Patients will be divided into 3 groups as randomized controlled. Aerobic exercise will be applied to the first group and HIIT to the second group. The third group will be the control group.

The patients in the first group will be applied an aerobic exercise program with an arm ergometer. Peak workload will be determined by performing an exercise test with an arm ergometer and training will be given for 60-70% of the peak workload for 45 minutes with arm ergometer 3 days a week for 8 weeks.

HIIT with arm ergometer will be applied to the patients in the second group. Peak workload will be determined by performing an exercise test with an arm ergometer, and HIIT will be performed with an arm ergometer for 45 minutes in total, 90-95% of peak workload for 30 seconds, 60 seconds in between, active recovery at 40-50% workload. After the patients receive training for 8 weeks, 3 times a week, post-treatment evaluations will be made.

Only evaluations will be made twice, with an interval of 8 weeks, for the patients in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between the ages of 18-55,
* Having neck pain for more than 3 months,
* Having neck pain ≥3 cm in a 10 cm VAS and
* Patients with non-specific neck pain who score \> 10/50 on the Neck Disability Index will be included.

Exclusion Criteria:

* Pregnant women,
* Smokers,
* BMI\>40
* Those with any cardiovascular or pulmonary disease,
* Those who cannot exercise due to any medical condition,
* Those who have received physical therapy for neck pain in the last 6 months,
* Red flag (malignancy, spinal fracture, etc.),
* Spinal fracture,
* Shoulder fracture,
* Shoulder subluxation,
* Cervical or shoulder surgery,
* Migraine,
* Rheumatological diseases,
* Those with cervical root compression syndrome,
* Those with neurological/inflammatory spinal pathology,
* Those with chronic whiplash and traumatic neck injury,
* Persons with \<24 points on the mini-mental test.
Trans-perineal Repair With or Without Limited Internal Sphincterotomy for Treatment of Type I Anterior Rectocele

Comparison between transperineal repair of rectocele with or without posterior internal sphincterotomy.

Transperineal repair of anterior rectocele is performed in two groups of patients, the first will undergo limited posterior internal sphincterotomy, the second group will not have internal sphincteroromy. The two groups are compared regarding recurrence of rectocele and improvement of symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Patients with anterior rectocele

Exclusion Criteria:

* Pregnant females
* Rectocele with pelvic organ prolapse
* Any patient with previous anorectal surgery
* Pudendal nerve neuropathy
* Anal fistula and sepsis
* Patients with sphincter defect proved by endo-anal sonography
* Patients proved to have colonic inertia either by colon transit time and/or history
* Patients with defecography anomalies causing obstructed defecation other than rectocele (e.g. Anismus).
* Also patients with vascular diseases, scleroderma, malnutrition, and coagulopathy were excluded.
Neurobiology of Alcohol and Nicotine Co-Addiction

This proposal addresses the critical absence of information about the neurobiology of recovery from Alcohol Use Disorder (AUD) in alcohol and nicotine users.

This proposal addresses the critical absence of information about the neurobiology of recovery from Alcohol Use Disorder (AUD) in alcohol and nicotine users. AUD and nicotine use disorder (NUD) are the most commonly abused (non-prescription) substances in the U.S. Co-addiction is particularly high in military veterans. Although nationwide estimates peg the rate of AUD/NUD co-addiction at 80%, the Substance Abuse Treatment Program (SATP) at the Veterans Affairs Portland Health Care System (VAPORHCS) finds that 90% of veterans treated for AUD also meet criteria for NUD. The investigators hypothesize that a support vector machine learning algorithm will be able to use the measures to classify subjects as AUD, NUD both or neither and that the algorithm will predict outcome (sobriety or relapse) at three months.

Eligibility Criteria:
Inclusion Criteria:

* None

Exclusion Criteria:

* None
Ocular Complications of Mpox in the Democratic Republic Congo

This is an observational study in which patients diagnosed with mpox will be enrolled, will undergo standard ophthalmological examinations of their eyes to see if there are any complications of mpox. The study will primarily assess the presence of ophthalmological signs and symptoms at enrollment.

This is an observational study in which patients diagnosed with mpox will be enrolled in two clinics in remote settings in the DR Congo (Tunda and Kole general hospital) where mpox outbreaks are ongoing. After providing informed consent, participants will undergo standard ophthalmological examinations of their eyes to see if there are any complications of mpox. This includes history taking, clinical examination, technical examinations such as a dilated fundoscopic exam, a fluorescein test and a Schirmer test, and a conjunctival swab for tear collection for monkeypox virus (MPXV) detection. Pictures of the anterior and posterior segment will also be taken to aid later verification and interpretation of the study findings. If they are hospitalised for mpox (for clinical reasons or as part of their participation in another ongoing clinical trial at the study sites), they will be followed up for 14 days and examined during an unscheduled visit in the case of new or worsening severe issues. Otherwise, patients are followed up at day 14 (for those hospitalised), day 28 and day 59. Study participants will receive the same supportive eye care as non-study participants. Study participants will be compensated for their time lost and for transportation to the clinic.

The study will primarily assess the presence of ophthalmological signs and symptoms at enrollment, but also aims to describe the complications of mpox that may arise after that point in time.

Eligibility Criteria:
Inclusion Criteria:

* Patient of any age or gender with laboratory-confirmed infection with MPXV
* Laboratory confirmation of MPXV infection less than 48 hours before inclusion
* Patient or culturally acceptable representative is willing and able to give informed consent or assent for participation in the study

Exclusion Criteria:

* Patients for whom, in the judgment of the recruiting physician, participation in the study would interfere with routine optimal clinical care.
Clinical Study on Diagnostics and Outcome of Ruptures of the Subscapularis After Arthroscopic Refixation

The purpose of the trial is to optimize the diagnostics of subscapularis tendon tears and as the circumstances require to found a new classification.

The prime objective is a comparison of the conclusive of the clinic check-up, the sonographic and magnetic resonance tomography findings.

The secondary objective is to detect the correlation of the outcome with the age , the gender, the pathogenesis and attendant injuries.


Eligibility Criteria:
Inclusion Criteria:

* patients, who have turned 18
* suspected subscapularis tendon rupture

Exclusion Criteria:

* disability to understand the trial
* intraoperative intact supbscapularis tendon
* pre-surgical operation of the affected shoulder
* tumor
* infection
the Effect of Monk Fruit and Splenda on Salivary Ph and Streptococcus Mutans Count in Vivo Study

This study aims to evaluate the changes in salivary pH and Streptococcus mutans count by preparing a solution containing these sweeteners dissolved in distilled water and administering it to the participants. Saliva samples will be collected before using the mouth rinse, and salivary pH will be measured using a pH meter, while S. mutans count will be analyzed in the laboratory.

After consuming the solution, salivary pH will be assessed at 1 minute, 15 minutes, and 30 minutes, while the growth of S. mutans will be examined 30 minutes post-rinse.

90 participants who meet the inclusion criteria-having no active caries, aged between 20 and 24 years, and not taking medications that affect saliva-will be included in the study. They will be divided into three groups of 30 participants each based on the type of sweetener used, along with a control group that will receive sucrose.

The solution will be prepared by dissolving 10 grams of the sweetener in 90 mL of distilled water and will be freshly prepared daily. A saliva sample will be collected from each participant before using the rinse, and salivary pH will be measured using a salivary pH meter. Additionally, the Streptococcus mutans count will be determined through incubation and culture.

Participants will use the mouth rinse for one minute, after which saliva samples will be collected at baseline (before rinsing), then at 1 minute, 15 minutes, and 30 minutes post-rinse. The salivary pH will be measured and recorded at each time point. The S. mutans count will be assessed before rinsing and again 30 minutes after using the solution.

Eligibility Criteria:
Inclusion Criteria:

participants aged (20-24) years.

* No active carious lesions or oral diseases.
* Generally healthy individuals without systemic illnesses.
* No prior use of preventive dental treatments

Exclusion Criteria:

* Participants currently undergoing dental treatment.
* Those taking medications that alter saliva flow.
* Presence of painful oral conditions or systemic diseases. Participants have active caries
Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder

This is a single-center, randomized, open-label, single-dose, parallel-group study which will enroll and randomize approximately 48 subjects (to achieve 36 completers) with opioid use disorder (OUD) who are seeking treatment for OUD. The study includes both a Residential (Inpatient) and Non-Residential (Outpatient) Period.


Eligibility Criteria:
Inclusion Criteria:

* Currently meets DSM-5 criteria for moderate or severe opioid use disorder (OUD)
* Is seeking treatment for OUD
* Body mass index: ≥ 18.0 to ≤ 35.0 kg/m\^2
* Females: Female individuals of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative serum pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from Screening through at least 6 months after the last dose of Investigational Medicinal Product (IMP).
* Males: Male individuals with female partners of child-bearing potential must agree to use medically acceptable contraception after signing the informed consent form through at least 6 months after the last dose of IMP. Male individuals must also agree not to donate sperm during the study and for 6 months after receiving the last dose of IMP.
* Have a normal electrocardiogram (ECG) or ECG with no clinically significant findings in the opinion of the Investigator or medically qualified sub-investigator at Screening and through pre-dose on Day 1.
* Agree not to take any buprenorphine-containing products, other than those administered for the current study, throughout the duration of the study.
* Willing to adhere to study procedures and provide written informed consent prior to start of any study procedures.

Exclusion Criteria:

* Current diagnosis, other than OUD, requiring chronic opioid treatment.
* Pregnant or lactating females.
* Have an ECG demonstrating a corrected QT interval using Fridericia's calculation (QTcF) \> 450 msec in males and QTcF \> 470 msec in females upon admission to the residential facility or prior to administration of RBP-6000.
* Currently meet the criteria for diagnosis of moderate or severe substance use disorder, by DSM-5 criteria, for any substances other than opioids, and/or tobacco.
* Had a significant traumatic injury, major surgery, or open biopsy within the 4 weeks prior to signing the informed consent form.
* Used buprenorphine-containing products within the 14 days prior to signing the informed consent form.
* Have a history of suicidal ideation within the 30 days prior to signing the informed consent form or prior to study drug administration
* Have a history or presence of allergic or adverse response (including rash or anaphylaxis) to buprenorphine, naloxone, methadone, or the ATRIGEL Delivery System.
* Individuals who have a positive urine drug screen (UDS) prior to admission to the residential facility for barbiturates, benzodiazepines, buprenorphine, or methadone.
Bubble Continuous Positive Airway Pressure (CPAP) With Conventional CPAP for Extubation in Preterm Infants

The objective of this study is to evaluate whether CPAP delivered by bubble CPAP resulted in a greater proportion of infants being successfully extubated when compared with management with ventilator derived CPAP.

There have been no published randomized trials comparing extubation failure rates of Bubble CPAP with conventional ventilator derived CPAP. Infants of gestation \<32 weeks and of birth weight less than 1500 grams considered by the treating team to be ready for the initial extubation within first week of life were screened for enrolment. All eligible neonates were randomly allocated to bubble CPAP or conventional CPAP.The purpose of this study is to compare whether infants on Bubble CPAP had more chances of successful extubation as compared to infants put on Conventional CPAP.

Eligibility Criteria:
Inclusion Criteria:

* Gestation less than 32 weeks
* Birth weight less than 1500 g
* Age less than seven days
* First extubation attempt.

Exclusion Criteria:

* A neonate having any of the following will be excluded from the study-
* Severe birth asphyxia defined as need for chest compression for more than 30 seconds
* Suspected congenital neuromuscular disorder
* Major congenital malformation
* Grade 3/4 interventricular haemorrhage
* Hydrops.
Comparative Study of Pathophysiological Mechanisms and Bronchial Response in Occupational Asthma to Wheat Flour and Quaternary Ammonium Compounds During Standardized Bronchial Provocation Tests

Occupational asthma (OA) caused by high molecular weight (HMW) substances have been shown to induce predominantly an eosinophilic inflammation. In contrast, OA caused by low molecular weight (LMW) substances results in a neutrophilic inflammation. In addition, data regarding phenotype of lymphocytes in OA caused by HMW and LMW substances are scarce. The use of a new equipment will allow the realization of specific standardized bronchial challenges (BC) to occupational agents. Thus, we propose to study in more detail the cellular mechanisms involved during BC to HMW and LMW occupational agents in a double-blind placebo controlled study.


Eligibility Criteria:
Inclusion Criteria:

For patients with occupational asthma to wheat flour:

* Clinical history,
* A positive skin test to wheat flour and / or specific IgE to wheat flour

For patients with occupational asthma to quaternary ammonium compounds:

-Clinical history,

For two types of asthma:

* Patients must have a worsening of bronchial hyperreactivity during work compared to a rest period assessed by a metacholine challenge
* FEV before challenge (nonspecific and specific) must be\> 70%.

Exclusion Criteria:

Asthmas:

* no occupational asthma:
* secondary to clinically relevant sensitization to an allergen domestic
* aggravated at work.
Promoting a Healthier Lifestyle Among Breast Cancer Survivors

The purpose of this study is to find out if a counseling program the investigators have developed can help breast cancer survivors adopt a healthier lifestyle.

Participants will be randomly assigned to one of two groups. One group of breast cancer survivors will receive general information on how to adopt healthy lifestyle behaviors. The other group of breast cancer survivors will receive counseling on how to increase their level of physical activity.

Participants will have three consultations with a health counselor. The first two consultations will take place in-person and the third consultation will take place via telephone. Participants will also be asked to complete questionnaires assessing their physical and mental well-being, their dietary habits, and their physical activity habits at four time-points: in-person during their first study visit, via mail or through an online survey 6 weeks later, in-person 12 weeks later, and via mail or through an online survey 24 weeks later. Additionally, during their first study visit and 12 weeks later, their level of aerobic fitness will be tested by having participants walk a long hallway for six minutes.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age;
* be capable of speaking and reading English;
* be diagnosed with stage 0-II breast cancer;
* be currently disease free;
* have been treated surgically for breast cancer;
* have completed chemotherapy and/or radiotherapy at least three months but no more than two years prior;
* be physically able to exercise as measured by the Physical Activity Readiness Questionnaire-Revised (Thomas, Reading, \& Shephard, 1992) ;
* be currently physically inactive as measured by the Godin Leisure Time Exercise Questionnaire (Godin \& Shepard, 1985); and
* be contemplating increasing physical activity as measured by the Exercise Stages of Change - Short Form (Marcus, Selby, Niaura, \& Rossi, 1992).
Lansoprazole in Preterm Infants With Reflux

This study is pilot study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux documented by 24hr pH impedance monitoring


Eligibility Criteria:
Inclusion Criteria:

* preterm infant
* documented gastrointestinal reflux by 24hr pH monitoring

Exclusion Criteria:

* unstable vital sings
* congenital anomaly in upper gastrointestinal tract incuding esophagus
* drug history of H2 blocker during last 1 week
* medication of warfarin, carbamazepine, phenytoin, rifampin
* renal or hepatic dysfunction
* inappropriate clinical conditions judged by researchers
Effect of Noninvasive High Frequency Oscillatory Ventilation on Improving CO2 Clearance in COPD Patients

High-frequency oscillatory ventilation (HFOV), as an ideal lung-protecting ventilation method, has been gradually used in neonatal critical care treatment, and is currently recommended as a rescue method for neonatal acute respiratory distress syndrome (ARDS) after failure of conventional mechanical ventilation. . Although its ability to improve oxygenation and enhance carbon dioxide (CO2) scavenging has been repeatedly demonstrated in laboratory studies, its impact on clinical outcomes in these patients remains uncertain. Non-invasive high-frequency oscillatory ventilation (nHFOV) combines the advantages of HFOV and non-invasive ventilation methods, and has become a current research hotspot in this field. It is recommended to be used to avoid intubation after conventional non-invasive ventilation therapy fails. For the treatment of intubation, there is still a lack of large-scale clinical trials to systematically explore its efficacy. The gradual increase in the clinical application of nHFOV has also enriched its use in the treatment of other diseases


Eligibility Criteria:
Inclusion Criteria:

1. Age 40-80, males and females;
2. Stage III and IV COPD and PaCO2≥50mmHg;
3. Similar with non-invasive ventilation;
4. Willing to participate in the study;
5. Able to provide informed consent.

Exclusion Criteria:

1. Bronchiectasis; post-tuberculosis sequelae; rib cage deformities; neuromuscular disorders; and bronchial carcinoma.
2. Intolerant with NIV