cyrilzakka/clinical-trials huggingface dataset:
A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), neutralizing antibody and antidrug antibody (ADA) response for TNM001 in infants entering their first RSV season.

This study adopts an adaptive seamless dose selection design and consists of two parts: Part 1 is a phase 2b dose ranging trial which will support to determine the dose for Part 2, the phase 3 trial. The study population includes early and mid-term preterm infants \[gestational age (GA)﹤35 weeks 0 day\] and late preterm infants or full-term infants (≥35 weeks 0 day GA), with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD). A total of approximately 2250 infants will be randomized 2:1 to receive either TNM001 or placebo. All subjects will be followed for 240 days after dosing. This study will be conducted in appropriately 50 sites in China.

Eligibility Criteria:
Inclusion Criteria:

* 1. Early and mid-term preterm infants (\<35 weeks 0 day GA) and late preterm infants or full-term infants (≥35 weeks 0 day GA) under 1 year of age, with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD)，who are entering their first RSV season at the time of screening.

Exclusion Criteria:

* 1. Any fever (\> 38.0°C) or acute illness within 7 days prior to randomization
* 2. History of RSV infection or active RSV infection prior to, or at the time of, randomization
* 3. Drug medication prior to randomization or expected to be treated by medicines during the study period.
* 4. Currently receiving or expected to receive immunosuppressive therapy during the study period.
* 5. Renal impairment or hepatic dysfunction
* 6. Nervous system disease or neuromuscular disease
* 7. Prior history of a suspected or actual acute life-threatening event
* 8. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded.
* 9. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period.
* 10.Receipt of RSV vaccine or mAb
Role of Dopamine Transporter in Glucose Control

Healthy subjects will be enrolled in this study. Each subject will be scanned twice with F18-FP-CIT PET which is commercially available. F18-FP-CIT reflects dopamine transporter availability of striatum. Before each PET scan, subject will be injected either glucose or normal saline. Therefore, PET scan will reflect the changes of dopamine transporter availability after the injection of glucose.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* known neurologic disorder
* known drug addiction
* known endocrine disorder
Latency Antibiotics for Previable Rupture Of Membranes Trial

The purpose of this study is to see if the use of prophylactic antibiotics in the expectant management of PPROM less than 22 weeks significantly reduce the rate of delivery within 7 days and to see if the use of prophylactic antibiotics in the expectant management of PPROM between 20 and 22 weeks decrease composite neonatal morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Preterm premature rupture of membranes at less than 22 weeks.
* Membrane rupture had occurred within 36 hours of randomization.
* Cervical dilatation is 3 cm or less (on visual or clinical examination).
* 4 or fewer contractions in the 60-minute monitoring period before randomization.
* Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age
* Gestational age at randomization less than 22 weeks (≤21 weeks and 6 days) based on clinical information.

Exclusion Criteria:

* Nonreasoning fetal testing
* Vaginal bleeding
* Maternal or fetal indication for immediate delivery
* Cervical cerclage in place
* Receipt of latency antibiotics prior to randomization (azithromycin, ampicillin, or amoxicillin)
* Allergy to Penicillins or Azithromycin
* Febrile illness requiring antibiotics
* Placenta previa
* Multifetal gestation
D4T or Abacavir Plus Vitamin Enhancement in HIV-Infected Patients (DAVE)

The purpose of this study is to determine the best way to treat people on d4T (stavudine) with high levels of lactic acid. Switching from d4T to abacavir will be assessed. Adding riboflavin and thiamine will also be assessed.

Participants will be randomly assigned to one of four groups:

* Group 1 participants will continue to take d4T as part of their antiretroviral (ARV) regimen, and will be given the vitamin supplements
* Group 2 will continue to take d4T without vitamin supplements
* Group 3 will switch from d4T to abacavir and receive the vitamins
* Group 4 will switch from d4T to abacavir without vitamin supplements.

The study plans to involve eighty participants from Canada and Argentina for a treatment period of 16 weeks and a follow-up visit at week 24.


Eligibility Criteria:
Inclusion Criteria:

* Be HIV-positive
* Be 18 years of age or older
* Have a viral load equal to or below 50 copies/mL
* Have been on a d4T-containing multiple drug regimen (at least three agents in total) for at least six months
* Have been on a stable ARV regimen for the three months prior to enrollment
* Have a venous lactic acid measurement above 2.1 mmol/L within the three months prior to enrollment and two consecutive measurements above 2.1 but lower than 6.0 within a two-week period of screening
* Be willing to discontinue L-carnitine and/or coenzyme Q10
* Be willing and able to provide informed consent

Exclusion Criteria:

* Pregnancy or breastfeeding
* Venous lactic acid equal to or above 6.0 mmol/L
* Previous exposure to abacavir
* Virologic rebound while on a previous regimen consisting of dual or triple nucleoside reverse transcriptase inhibitors (NRTIs)
* Use of hydroxyurea within the three months prior to enrollment
* Use of metformin
* Any acute cardiopulmonary illness or infection
* New AIDS-defining illness diagnosed within four weeks of enrollment
* Riboflavin or thiamine supplementation above 20 mg/day within 30 days prior to enrollment
Clinical Trial to Investigate the Efficacy and Safety of NuSepin® in COVID-19 Pneumonia Patients

A randomized, double blind, placebo-controlled, phase 2 clinical trial to investigate the efficacy and safety of 2 doses of NuSepin® intravenous infusion in COVID-19 pneumonia patients


Eligibility Criteria:
Inclusion Criteria

1. Male or female subjects aged between 18≤ and \<80 years old
2. Laboratory-confirmed SARS-CoV-2 infection by PCR test for the first time within 144 hours prior to randomization
3. Diagnosis of pneumonia based on:

   * Radiographic infiltrates by imaging (chest x-ray, CT scan) AND
   * 3 of the following clinical symptoms: new onset cough, fever, fatigue, sputum (all day), tachypnea, dyspnea, pleuritic chest pain AND
   * CRP value \> 10 mg/L
4. Patients with blood leukocyte count \> 4.0 x 109 /L and lymphocyte count \> 0.7 x 109

   * L
5. Patients with SpO2 ≤ 94% on room air or Pa02/FI02 ratio \< 300mgHg at screening
6. Patients capable to give consent and who have signed the informed consent form before any trial related assessment.
7. Medically accepted effective contraception for women of childbearing potential (WOCBP) which should be continued until at least 90 days after the last dose of trial treatment.
8. Patients with NEWS2 score \> 7

Exclusion Criteria

1. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \> 5 times the upper limit of normal.
2. Reduced renal function with estimated glomerular filtration rate (eGFR) \< 30 ml/min or hemodialysis or hemofiltration.
3. Pregnancy or breast feeding.
4. Evidence of multiorgan failure
5. Steroid treatment by any reason within 72 hours prior to enrolment
6. Participation in any other clinical trial of an experimental agent treatment for COVID-19
7. Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
Comparison of Articaine and Prilocaine for Extraction of Maxillary Teeth

Ninety-five patients, aged between 16 and 70 years old, were included in this study. Patients were divided into two groups. Group one received Articaine 4% with 1:00.000 Adrenalines. Group two received Prilocaine with 3% Felypressin (0.03 I.U. per ml). Onset time of anaesthesia was objectively evaluated by using electronic pulp testing.

85 patients in this study had successful local anaesthetic followed by extraction within the study duration time (10 minutes). However, there were six patients with failure anaesthesia (5 in prilocaine group and 1 in articaine group). By application Person's Chi-square test (x2), there were no significant differences in the number of the episodes of the anaesthetic success between articaine and prilocaine groups at time intervals (P-value = 0.5). T- test showed there have been no important variations within the mean onset time of anaesthesia for articaine and prilocaine buccal infiltrations (P-value =0.1).

Eligibility Criteria:
Inclusion Criteria:

* Patients have one or two upper teeth for extraction, subject tooth or its adjacent must be vital, healthy patient or patient with mild systemic diseases (class I or II according to American Society of Anesthesiology).

Exclusion Criteria:

* Patients excluded from this study if they have allergy to local anaesthetic agents or need surgical, or multiple teeth extraction.
Effect of Intraoperative Iloprost Inhalant on Hemodynamic Stability in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery

Considering that the cause of hemodynamic instability during OPCAB is closely related to right ventricular dysfunction with pulmonary artery hypertension, the use of inhaled iloprost (a selective pulmonary vasodilator) in patients undergoing OPCAB maybe beneficial for hemodynamic management. Previous research has showed that inhaled iloprost reduce pulmonary arterial pressure and pulmonary vascular resistance. Therefore, by administering inhaled iloprost before the graft anastomosis might improve cardiac output, mixed venous blood oxygen saturation, and pulmonary oxygenation during the surgery especially during the graft anastomosis.

The objective of our study is to evaluate the effect of inhaled Iloprost on hemodynamic stability in patients undergoing off-pump coronary artery bypass graft surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 20 years and undergoing off-pump coronary artery bypass graft surgery with any of the following condition:
* High risk of hemodynamically unstable (patient in NYHA functional class III-IV, or mean pulmonary-artery pressure ≥ 25 mm Hg or right ventricular systolic pressure ≥ 50mmHg in preoperative echo findings, preoperative left ventricular ejection fraction \< 50%, acute myocardial infarction within 1 month of surgery, ventricular fibrillation)
* History of previous cardiac operation (redo)
* Left main coronary artery disease
* Lesion at all three major coronary arteries

Exclusion Criteria:

* Emergency operation
* Patients undergoing minimally Invasive Direct Coronary Artery Bypass
* Patients with cardiogenic shock or ventricular-assist device (eg. ECMO, IABP)
* Patients with pre-existing infections prior to surgery (eg. sepsis)
* Patients with liver cirrhosis
* Patients with hemorrhagic disease / bleeding risk (history of active peptic ulcer, intracranial hemorrhage, congenital hemorrhagic disease etc.)
* Patients with cerebrovascular event (TIA, stroke) within 3 months
* Patients with symptomatic asthma/chronic obstructive pulmonary disease who are receiving treatment such as inhaler or steroid
* Patient with severe chronic kidney disease (GFR(CKD-EPI) \<30ml/min/1.73m2)
* Patient with acute kidney injury
* Patients who have participated in other clinical studies that may affect prognosis
* Patients who cannot understand the informed consent (eg. Foreigner)
Block Pressor Response to Intubation

Laryngoscopy and endotracheal intubation are necessary for effective control of airway and ventilation, but it has deleterious effects such as hypertension and disrhythmia

Fast-track laparoscopic gynecological surgery usually done under general anesthesia (GA). Laryngoscopy and endotracheal intubation are necessary for effective control of airway and ventilation, but it has deleterious effects such as hypertension and disrhythmia. These hemodynamic changes are due to the reflex sympathetic activity and the magnitude of response is directly proportional to the duration and strength of laryngoscopy. Several drugs and techniques have been tried to attenuate the stress response to laryngoscopy and endotracheal intubation, but none of them have proven to be ideal.

Lidocaine is an amide synthetic local anesthetic, which is used in treatment of ventricular dysrhythmias and as a prophylaxis in ventricular tachyarrhythmia. It has cardio stabilizing action.

Bromage showed that its intravenous (IV) use blunted pressure response to intubation. An IV dose of lidocaine 1.5 mg/kg has been proved to attenuate stress responses during laryngoscopy and intubation.

Dexmedetomidine is a highly selective alpha 2 receptor agonist and possesses the properties of sedation, analgesia, and opioid sparing effect. It has been shown to reduce the laryngeal stress response, reduce the requirement of intravenous (IV) anesthetics, and provides hemodynamic stability.

Magnesium sulphate (Mg SO4) is the fourth most abundant cation in the body and the second most abundant intracellular cation. It activates many of the enzyme system. Mg SO4 inhibits the release of catecholamines from the adrenal medulla and adrenergic nerve endings and is effective in attenuating the blood pressure (BP) response to tracheal intubation. Puri et al showed that MgSO4 50 mg/kg administered before laryngoscopy could attenuate the pressor response to tracheal intubation better than lidocaine.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II
* Age between 23 to 40 years
* With airway of Mallampati grade I and II
* Elective diagnostic laparoscopic gynecologic surgery under general anesthesia with endotracheal intubation

Exclusion Criteria:

* Mallampatti grading III and IV, anticipated difficult intubation
* Body mass index (BMI \> 35 kg/m2), full stomach, pregnancy
* Emergency surgery
* History of cardiac or neurological disease or patient with asthma
* History of Hypersensitivity to the study drugs
* Advanced hepatic or renal failure.
* Patients in whom the duration of laryngoscopy lasted more than 20 seconds
* Patient refusal.
Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Pulmonary Hypertension

This is an open-label non-randomized, pilot study to evaluate the effect of Interleukin-1 blockade on exercise capacity in patients with pulmonary hypertension. Subjects will undergo cardiopulmonary exercise testing at baseline, and after 4 weeks treatment with Anakinra (recombinant human Interleukin-1 receptor antagonist.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Diagnosis of PAH (from prior right heart catheterization), with functional class III symptoms of right ventricle failure despite optimal PAH therapy
* Mean pulmonary artery pressure \>25 mmHg
* Pulmonary capillary wedge pressure \<15 mmHg
* Pulmonary vascular resistance \>3 wood units

Exclusion Criteria:

* PAH due to connective tissue disease (including scleroderma), interstitial lung disease (total lung capacity \<65% predicted value), or cirrhosis (portopulmonary hypertension)
* Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing or baseline ECG changes that limit the ability to detect ischemia (i.e. left bundle-branch block).
* Recent (\<14 days) use of anti-inflammatory drugs (not including NSAIDs), chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, active infection, or any comorbidity limiting survival or ability to complete the study
* Severe kidney dysfunction (eGFR \<30 mL/min)
* Thrombocytopenia (\<50,000/mm3), or neutropenia (absolute neutrophil count \<1,500/mm3)
* Refusal by a woman of childbearing potential (not post-menopausal or surgically sterile) to use a medically acceptable form of birth control (including, but not limited to, a diaphragm, an intrauterine device (IUD), progesterone implants or injections, oral contraceptives, the double-barrier method, or a condom) throughout the duration of the study
* History of hypersensitivity to anakinra or E. coli products
* Latex or rubber allergy
* Inability to give informed consent
Diet and Exercise in Type 2 Diabetes - a Randomized Controlled Trial

The investigators investigate if combined progressive aerobic training and resistance training improve metabolic control and fat mass in patients with type 2 diabetes who are eating a modified paleolithic diet. The investigators randomize 40 participants to two groups: 1) Modified paleolithic diet and exercise under observation 3 sessions/week, 2) Modified paleolithic diet and general advice about exercise.

The investigators primary hypothesis is that in patients with type 2 diabetes decreases fat mass more with progressive exercise under observation and a modified paleolithic diet than with general advice about exercise and a modified paleolithic diet.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes less than 10 years
* BMI 27-35
* women only after menopause
* diabetes treatment with diet and/or metformin
* HbA1c between 45 and 94

Exclusion Criteria:

* nicotine use
* insulin
* betablockers
* estrogens orally
* blod pressure \>160/100
* macroalbuminuria
* malignancy during the past 5 years
* alcoholism
* depression
* cardiovascular disease/stroke
* liver disease
* serious lung disease, GI disease or kidney disease
* more than 30 minutes/5 days a week of moderate exercise during the last 6 months
* resistance training during the past 6 months
* official weight loosing program during the past year
* obesity surgery
* night work
* MADRS-S (Montgomery Asberg Depression Rating Scale) \>20 points
* AUDIT \>14 points for women, \>16 points for men
* not possible to obtain venous sampling
Mindfulness for Breast Cancer

The primary purpose of this study is to evaluate the effects of Mindfulness Based Cognitive Therapy (MBCT) vs. Treatment as Usual (TAU) for depression and anxiety symptoms in breast cancer patients in recovery. Investigators will examine whether MBCT-related improvements in sleep quality, illness-related distress, and rumination (escalating cycles of negative thinking) predict MBCT-related decreases in depression and anxiety symptoms (Aim 2). Exploratory analyses will examine whether demographics (e.g., age, sex, race/ethnicity), individual differences (e.g., perceived stress, social support), clinical characteristics (e.g., stage/severity of diagnosis), and treatment adherence (e.g., sessions attended, hours of weekly practice) help determine for whom MBCT is most effective (Aim 3).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Able to speak and read English
* Diagnosis of breast cancer (any stage) for which active treatment (e.g., surgery, chemotherapy, and/or radiotherapy) has been completed within 2 months to 2 years

Exclusion Criteria:

* Cognitive impairment or mental illness that would impair ability to provide consent or participate in the program;
* Major psychiatric disorder (e.g., psychosis, personality disorder)
* Current suicidal ideation or suicide attempt within past 3 months
* Past participation in an MBCT group
Efficacy and Safety of Oral Misoprostol 25 μg vs. Vaginal Dinoprostone in Induction of Labor at Term

Labor induction is a common medical technique. There is no consensus on which technique is better than the others. Misoprostol is an analogue of Prostaglandin E1 previously used off-label in labor induction. Its low cost, room-temperature storage, and diverse route options have made it an alternative to PGE2 in labor induction. As of 2018, oral misoprostol 25 μg tablet was licensed for labor induction.

Very few studies have been performed on oral misoprostol 25 μg and none compared it with the PGE2s mostly used in induction on unfavorable cervix at term.

The investigators compared the safety and the efficacy between the oral misoprostol 25 μg Angusta® used since 20/02/2020 and the vaginal dinoprostone previously used in gel or diffuser over two consecutive periods from 01/01/2019 to 19/02/2020 for the dinoprostone and from 20/02/2020 to 07/04/2021 for the misoprostol.


Eligibility Criteria:
Inclusion Criteria:

* age of patient\> 18 years
* patients requiring induction of labor with a singleton pregnancy at term, a gestational age greater than 37 weeks of amenorrhea, with a fetus in cephalic presentation and an unfavorable cervix (Bishop score less than six).

Exclusion Criteria:

* intrauterine fetal death,
* preterm pregnancy,
* scarred uterus
* contraindications to vaginal delivery.
Auto-PAP Therapy For Improved Fetal Growth

The purpose of this study is to see whether the presence of night-time breathing disturbances ("sleep-disordered breathing") in pregnant women is related to fetal growth patterns. The hypothesis is that fetal growth slows in the 3rd trimester in women with sleep-disordered breathing. Use of a nighttime breathing therapy called auto-PAP could minimize the slowing in fetal growth.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old;
* no more than 20 weeks pregnant;
* pregnant with one baby;
* found to have sleep-disordered breathing as measured by a sleep study. If you are found to have severe sleep apnea on the sleep study you will be referred for clinical care instead of participating in the study.

Exclusion Criteria:

* more than 20 weeks pregnant;
* pregnant with twins, triplets, or more babies;
* a current smoker, drink alcohol, or use recreational drugs;
* currently using positive-airway pressure therapy for treatment of obstructive sleep apnea;
* diagnosed with certain conditions such as bullous lung disease, a bypassed upper airway, pneumothorax (collapsed lung), pneumocephalus (leak of cerebrospinal fluid, the fluid that the brain and spine float in), if you have had recent trauma, or recent nasal surgery.