cyrilzakka/clinical-trials huggingface dataset:
The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea

The aim of this study is to find the Effects of Anesthetics Used in Hypotensive Anesthesia on Stapes Reflex and Distortion Product Auto Acoustic Emission.

This study was aimed at evaluating the effects of dexmedetomidine and esmolol on stapes reflex and distortion product auto acoustic emission. the stapes reflex and auto acoustic emission are of considerable diagnostic significances in otolaryngology this are objective methods for the assessment of auditory function.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 age
* American Society of Anaesthesiologists physical status classification (ASA)1-2
* tympanoplasty surgery
* patients with normal stapes reflexes

Exclusion Criteria:

* hypertension
* drug allergy
* cardiac problems
* pregnancy
Efficacy of Manual Therapy to Improve Quality of Life and Decrease Pain in Subjects With Endometriosis

This study will compare subjects with a history of pelvic or menstrual pain diagnosed with endometriosis treated at Clear Passage with untreated control subjects. The treatment group will be a retrospective chart review; the control subject group will be a prospective questionnaire based study.

The study will assess the changes in pain experienced by subjects treated with manual therapy at Clear Passage to untreated subjects with endometriosis.

This study has two segments the first is a chart and outcome assessment of patients treated at Clear Passage (CP) with a diagnosis of endometriosis. These patients have completed multiple questionnaires as a standard of care for outcome monitoring in the clinic setting, no new data will be collected. The second segment is a prospective observational, online questionnaire based study of female subjects with a diagnosis of endometriosis not treated at CP. Data on the impact of quality of life (QOL) over time of subjects not treated at CP will be assessed using the same questionnaire used as standard of care in the clinic twice, 30 days apart. This will be accomplished using online forms with subjects able to complete the questionnaires with ease via the internet. The data obtained from the untreated subjects will allow for reporting of overall impact on QOL in this population, as well as provide a control group for assessment of improvement for manual therapy interventions for patients with endometriosis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of endometriosis
* Experience either pain with menstruation or other pelvic pain
* Able to complete the questionnaires online

Exclusion Criteria:

* Currently pregnant
* Cancer diagnosis
* Prior chemotherapy or radiation treatment(s)
* Prior treatment at Clear Passage
Development and Relationship Between Resilience and Anxiety and Depression in Elderly Gastric Cancer Survivors

This study will explore the dynamic interaction between mental resilience, anxiety and depression in elderly patients with gastric cancer 1 year after surgery, in order to better understand the role of these two factors in patients' mental health, and provide accurate insights for clinical practice and targeted psychological support strategies.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with gastric cancer by endoscopy or pathology
* age ≥60 years old
* radical gastrectomy was proposed
* be able to communicate simply in writing and verbal

Exclusion Criteria:

* received preoperative radiotherapy or chemotherapy;
* combined with other sites of malignant tumors;
* combined with severe heart, liver, lung and renal insufficiency;
* recent using hormones, immunosuppressants;
* with physical disabilities.
Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users

The purpose of this study is to examine the relationship between heavy alcohol use, pain, and response to pain medication in older adults.

Potential participants complete a phone screen. If still found eligible, the participant comes in for 1 screening visit (3 hours long). Cognitive/problem solving tests, computerized tasks, CPT, questionnaires and functional measures are administered along with a screening blood lab. If a participant is eligible, he/she comes back for 1 full study day visit (9-10 hours long). A testing battery (similar to the one done during the screening visit) is completed at baseline and again at three timepoints following medication administration. Blood draws, vital signs, and pupil measurements are taken throughout the day. A follow-up phone call is completed within a few days of the full study day visit, during which a questionnaire is given.

Eligibility Criteria:
Inclusion Criteria:

* Age of 35 years old or above
* Mild to moderate pain
* alcohol consumption
* willingness to refrain from taking any sort of pain medication 24 hours prior to study visit as well as refraining from taking sedative-hypnotics, antihistamines, benzodiazepines, sleep aids, NSAIDs/opioid pain medications, alcohol, marijuana
* Cigarette smokers must be willing to refrain from smoking during the all day study visit

Exclusion Criteria:

* current regular use of an opioid or medications that involve the opioid receptor (naltrexone (vivitrol), buprenorphine (subutex), methadone (dolophine)
* abstains from alcohol
* unstable angina or CHF; cerebral vascular accident or recurrent TIAs in the prior 6 months, active cancer requiring current treatment, possible or probable dementia or mild cognitive impairment
* Diagnosis of schizophrenia or schizoaffective disorder, or anxiety disorder requiring regular medication
* History of recreational drug use in the past 1 year, excluding marijuana
* New or increased dose (within last 6 months) of CNS-active medications that may alter neurocognitive and/or psychomotor function: MAO inhibitors, neuroleptics, antidepressants, anticonvulsants, benzodiazepines, sleep aids
* Medications that may alter oxycodone metabolism: St. John's wort, Dilantin, tegretol, corticosteroids, rifampin
* Known hypersensitivity to oxycodone and other opioids;
* Pregnancy
Effect of Two Methotrexate in Sync With the First Adalimumab to Prevent the Immunisation Anti Ada in Spondyloarthritis

Preliminary report have demonstrated that methotrexate induces an anti bio-medicament tolerization whan administrated just before the first administration of the bio-medicament. Once this tolerization is obtained it seems useless to continue the methotrexate because this treatment has no efficacity in cases of spondyloarthritis.

spondyloarthritis are treated in first intention by NSAIDs but in case of inefficacity biotherapies that inhib the TNF are used. Adalimumab is the most used anti TNF in this indication. Monoclonal antibody uses in therapy is immunogene, and there is a clear link between increase of anti drug antibody and in one hand decrease of drug serum concentration and in an other failure of the therapeutic response. With adalimumab there is an apparition of ADAb in 30%. There are reports suggesting that adding methotrexate to the therapy in a specific timeline allow to prevent the immunization. A previous study shows that association in long terms between methotrexate and adalimumab induce less immunized patients. The investigator's goal is to assess if two methotrexate subcutaneous injections at day 1 and 2 could prevent anti adalimumab antibodies formation.

Eligibility Criteria:
Inclusion criteria :

* Patients aged from 18 to 90
* Patients suffering from axial SpA, radiographic or non-radiographic according to ASAS criteria (peripheral involvement and/or Inflammatory bowel diseases could be present).
* Indication for anti TNF treatment: resistance to at least 2 NSAIDs and no contraindication to adalimumab
* No previous treatment with methotrexate in the last 3 months
* Stable dosage of steroids (less than 10mg/day of prednisone equivalent) and/or of NSAIDs for at least 10 days
* Contraception feminine or masculine
* Informed and written consent
* Social insurance

Exclusion criteria :

* Contraindication to methotrexate
* Previous treatment with adalimumab
* Steroids more than 10mg/day of prednisone equivalent
* Previous treatment with:

  * Etanercept in the last month
  * Infliximab, golimumab, certolizumab in the last 2 months (Previous treatment hereafter these dates with anti-TNF except adalimumab or secukinumab are not a counterindication)
* Current immunosuppressive drugs except methotrexate
* Current and proven pregnancy
* Project of pregnancy in the next 3 months following inclusion
* Legal safeguards
* Inclusion in another interventional research project
Clinical Characteristics of Coronavirus Disease 2019 (COVID-19) in Pregnancy: The Italian Registry on Coronavirus in Pregnancy.

The Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease. The number of patients infected by 2019-nCoV in Italy closely followed an exponential trend, and Italy reported the highest number of infected patients and deaths in the world excluding China.

Coronaviruses (CoVs) are the largest group of viruses belonging to the Nidovirales order. They are enveloped, non-segmented positive-sense RNA viruses.1 Coronavirus are believed to cause a significant proportion of all common colds in adults and children. The Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease. The initial cases of 2019-nCoV occurred in Wuahn, China in December 2019.2 A recent review evaluated the potential impact of 2019-nCoV in pregnancy.3 The authors reported published data on CoVs in pregnant women, including 2019-nCoV, severe acute respiratory syndrome (SARS-COV) and Middle East respiratory syndrome (MERS-COV). The review included 12 women with SARS-COV,4 11 women MERS-COV,5 and 9 women with 2019-n-CoV6 in pregnancy. No cases of vertical trasmission were reported, but the authors showed an high rate of preterm birth (45.8%), cesarean delivery (70.8%), maternal admission to intensive care unit (ICU) (63.3%), and maternal death (18.8%).

The number of patients infected in Italy closely followed an exponential trend, and Italy reported the highest number of infected patients and deaths in the world excluding China.7 Therefore, Italy can be a great source of data, including data on pregnant women.

The aim of this study was to evaluate the pregnancy and perinatal outcomes of pregnant women with 2019-n-CoV.

This was a multicenter, retrospective, cohort study. Clinical records and compiled data of all consecutive hospitalized and outpatient pregnant women with laboratory-confirmed 2019-n-CoV Data on recent exposure history, clinical symptoms or signs, laboratory findings, and maternal and perinatal outcomes were collected. All medical recors were sent to the coordinator center at University of Naples Federico II. Data were entered into a computerized database and cross-checked. If the core data were missing, requests for clarification were sent to the coordinators.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with laboratory-confirmed 2019-n-CoV
Antimicrobial Pulpotomy of Primary Molars

There is a lack of evidence of the long-term successful outcomes of antimicrobial endodontic treatment for primary teeth. This study intended to evaluate (by survival analysis) the effectiveness of an antimicrobial pulpotomy (chloramphenicol, tetracycline, zinc oxide/eugenol) in primary molars compared to calcium hydroxide pulpectomy, testing the hypothesis that antimicrobial pulpotomy could be an alternative pulp therapy for primary teeth with pulp inflammation or necrosis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children (ASA PS 1)
* Children presenting one or more primary molar with pulp inflammation or necrosis due to carious lesion and indicated for endodontic therapy

Exclusion Criteria:

* Lost to follow-up
A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

The purpose of this clinical research study is to learn whether dapagliflozin can help reduce blood sugar levels in participants with Type 2 diabetes that is not well controlled on metformin alone. The safety of this treatment will also be studied.


Eligibility Criteria:
Key Inclusion Criteria

* Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic control
* Participants who have been receiving metformin at a total daily dose ≥1500 mg per day for at least 8 weeks
* C-peptide ≥1.0 ng/mL
* Body mass index ≤45.0 kg/m\^2
* Serum creatinine level \<1.50 mg/dL for men or \<1.40 mg/dL for women.

Key Exclusion Criteria

* Aspartate aminotransferase and/or alanine aminotransferase level \>3.0 times the upper limit of normal
* Serum total bilirubin level \>2 mg/dL
* Creatinine kinase level \>3 times upper limit of normal
* Symptoms of severely uncontrolled diabetes
* Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women
* Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic, endocrine, psychiatric, or rheumatic diseases
Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizant™) in Restless Leg Syndrome

The study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin) versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome.

The study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin) versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome. Subjects will be randomized to gabapentin (IR) or Horizant™ (ER). Dosing will be blinded to both patient and study team members. Once study medication dosing has been optimized, subjects will then remain on a stable dose for six weeks until study endpoint, after which subjects will be down-titrated off of study medications.

Eligibility Criteria:
Inclusion Criteria:

1. Outpatients with a diagnosis of primary restless leg syndrome using the International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria8.
2. RLS symptoms ≥ 15 nights of the month prior to study enrollment and for ≥ 4 of 7 consecutive nights in the week prior to study enrollment (if untreated).
3. Age 18 years to 80 years.
4. International Restless Legs Scale (IRLS) Total severity score of ≥ 15 (moderate to severe severity). 8
5. Had significant sleep disturbance on item 4 of IRLS.8
6. Women of child-bearing potential must use a reliable method of contraception.
7. Informed consent. Subject must be willing and able to complete all study procedures.

Exclusion Criteria:

1. Any illness that in the investigator's opinion preclude participation in this study.
2. Subjects with non-RLS-related sleep disorders (e.g., sleep apnea)
3. Subjects with neurological diseases or movement disorders other than RLS (e.g., diabetic neuropathy, Parkinson's disease, multiple sclerosis, dyskinesias, and dystonias)
4. Pregnancy or lactation.
5. Concurrent participation in another clinical study.
6. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini-Mental State Examination scores less than 27).
7. Legal incapacity or limited legal capacity.
8. History of RLS symptom augmentation or early-morning rebound with previous dopamine-agonist treatment.
9. Clinically significant abnormalities in renal function. 3,8,10
10. Presence of severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease.
11. Concomitant treatment with drugs known to affect sleep/wake, RLS or periodic limb movements, including antidepressants. Subjects receiving treatment for RLS at screening will be required to discontinue and wash out for a minimum of 5 half-lives.
12. Body mass index greater than 34 kg/m2.
New Moms Mood Tracking & Wellbeing

New moms can be at risk for perinatal depression (PND). The New Moms Mood Tracking and Wellbeing study is investigating mood changes, risk factors for depression and anxiety and treatment response around the time of delivery. Participants will be asked to complete three sets of online surveys between week 28 gestation and week 20 after delivery, in addition to downloading an app to collect data using their smartphone sensors and brief symptom surveys every other week. Women with elevated symptoms will be eligible to participate in a treatment study. Women who are eligible for the treatment study will be randomized to one of two conditions - Perinatal Psychiatric Care or Screening and Treatment for Anxiety and Depression (STAND). In Perinatal Psychiatric Care, participants will receive appointments with psychiatry clinicians for medication management and supportive therapy. In STAND, participants will be allocated to Online therapy with Coaching or Clinical Care, which includes both psychotherapy and psychiatry appointments. Treatment can last up to 6 months and there will be treatment related assessments for the duration of the 6 months, in addition to brief symptom surveys on a regular basis. Therefore, participation can last between 24 and 52 weeks, as both time of delivery and treatment enrollment timepoint cannot be scheduled in advance.


Eligibility Criteria:
Inclusion Criteria:

* Women who are between week 28 of their pregnancy and 6 months postpartum and are receiving care at a UCLA OB-GYN clinic
* Fluent in English
* Current endorsement of moderate or higher depression on the Edinburgh Postnatal Depression Scale (EPDS, =\> 11 sum score), administered by the treating OB-GYN physician or study staff
* Not currently in individual treatment for a behavioral or emotional problem (e.g., anxiety, depression)
* Willingness to follow study procedures
* Willingness to participate in treatment through the study and follow all study procedures, including provide HIPAA Authorization for research
* Has access to the internet via mobile or desktop device

Exclusion Criteria:

* Are currently receiving treatment by a therapist or a psychiatrist
* Unstable suicidality (e.g., 2 or more suicide attempts or self-injurious behaviors resulting in hospitalization in the last 6 months, combined with high ratings on self-reported negative urgency)
* Current substance use disorder that interferes with treatment: specifically, patients meeting diagnostic criteria for Substance Use Disorder (SUD) will be eligible for inclusion only if they are able to attend sessions while not under the influence of that substance, with the exception of individuals abusing opiates or freebase cocaine, who will be excluded
* Principal diagnosis of psychosis unrelated to depression (unipolar or bipolar)
* Neurological conditions
* Severe uncontrolled medical conditions (e.g., anorexia nervosa, cardiac conditions requiring continuous monitoring)
* Cognitive impairment (e.g., developmental disability, dementia)
A Study of Envafolimab in Subjects With Stage III Non-Small Cell Lung Cancer

This is a prospective, single arm, phase II study to evaluate the efficacy and safety of Envafolimab in subjects with locally advanced/unresectable (Stage III) non-small cell lung cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.

Trial design: This is a single-arm, open-label trial in patients with locally advanced/unresectable (stage III) NSCLC who did not have disease progression after concurrent/sequential chemoradiotherapy to evaluate the efficacy of Envafolimab as a consolidation treatment of the efficacy and safety.

Background:The PACIFIC and GEMSTONE-301 studies have shown the efficacy of immunization as consolidation therapy in stage III NSCLC.

Patients with stage III NSCLC who did not have disease progression after at least two cycles of concurrent/sequential chemoradiotherapy (including platinum) will receive Envafolimab (300mg, Q3W, subcutaneous injection) within 1-42 days after the end of chemoradiotherapy. The maximum duration of Envafolimab treatment is 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Age at least 18 years.
2. Have histologically confirmed locally advanced/unresectable stage III non-small cell lung cancer.
3. The first dose of Envafolimab will be administered within 1-42 days (including 42 days) after concurrent/sequential chemoradiotherapy is completed.
4. ECOG performance status 0-2.
5. Life expectancy ≥ 12 weeks.
6. Adequate organ function.
7. For female subjects of childbearing age, urine or serum pregnancy test shall be conducted before receiving the first study drug administration, and the result is negative.
8. The subject and the subject's sexual partner need to use a medically approved contraceptive measure during the study treatment period and within 6 months after the end of the study treatment period.
9. Willing to participate in this trial; fully understand and informed of this trial, and able to provide written informed consent form (ICF).

Exclusion Criteria:

1. Disease progression after concurrent/sequential chemoradiotherapy.
2. Has received a live vaccine within 28 days prior to the first dose of investigational product.
3. Major surgical procedure (as determined by investigators) within 28 days prior to the first dose of investigational product.
4. Known positive driver gene mutation, such as EGFR sensitive mutation, ALK gene translocation or ROS1 rearrangement.
5. Received any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints), with a washout period of less than 28 days.
6. Known history of human immunodeficiency virus (HIV) infection and/or acquired immune deficiency syndrome.
7. Subjects at active phase of chronic hepatitis B or with active hepatitis C.
8. History of organ transplantation.
9. History of inflammatory bowel disease or active inflammatory bowel disease (for example Crohn's disease or ulcerative colitis).
10. Severe allergic reaction to other monoclonal antibodies.
11. Subjects with other conditions that in the investigator's opinion may influence subject's compliance or make subjects not suitable for participating in this trial.