cyrilzakka/clinical-trials huggingface dataset:
Effects of Nature Exposure on Smoking Behavior

Smoking continues to be the leading cause of preventable death and disease in the U.S. While smoking is a significant threat to public health in the US in general, the negative effects of smoking disproportionately affect Americans with 12 or fewer years of education and those living below the poverty line. Given these health disparities, it is vital to have widely-available treatments that can be applied in multiple contexts in a cost-efficient way. While numerous methodologies and intervention programs exist, there is a need for improved cessation programs targeted to smokers with low levels of education attainment and income, as these smokers tend to be less likely to receive cessation assistance from a health care provider or have sufficient resources to access treatments. Therefore, the present proposal aims to assess the feasibility of a tool that will improve smoking cessation programs in a short and cost-effective manner: a brief exposure to nature.

The health and wellbeing benefits of nature exposure have been well researched and are widely recognized, and research on the underlying mechanism for nature's positive impact on health has identified a reduction in impulsivity as a mediator of this effect. However, this work has never been directly translated to smoking outcomes, and thus the translational purpose of the present project is to assess the feasibility of a brief and cost-effective nature exposure intervention on smoking cessation outcomes. Prior work demonstrates the validity of the causal links in the nature -\> impulsivity -\> smoking cessation model. Research has shown that nature exposure reduces impulsivity for health-related outcomes, and found that increased impulsivity is linked to all stages of smoking. A necessary step in developing a practical application for this research is the aim of the present project.

Smokers will be recruited online and randomly assigned to either the Nature or Control condition. Participants in the Nature condition will be given a nature-based intervention, while participants in the Control condition will be given a non-nature-based intervention. Participants will be contacted via text message throughout the following 24 hours and asked to report their degree of urgency to smoke and number of cigarettes smoked. Participants will complete measurements of impulsivity, income, socio-economic status, and education, and additional smoking-related constructs.


Eligibility Criteria:
Inclusion Criteria:

* Smoked at least two cigarettes per day for the last seven or more days
* Must be 18 years old or older
* Must have a smart cellular phone that can send and receive text messages and open web links

Exclusion Criteria:

-
Lithium Disilicate Crowns Study

CAD-CAM crowns made of lithium disilicate are placed in patients by using either a dual-curing adhesive or a self-adhesive luting material in combination with total etch/universal bonding agent.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be at least 18 years of age, of either gender, and of any ethnic background.
* Each patient should have at least one carious lesion or defective restoration to be restored on a maxillary or mandibular premolar or molar tooth.
* Each lesion or defective restoration should exhibit sufficient size or loss of tooth structure requiring a full crown restoration.
* The tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact.
* All teeth will test vital and be asymptomatic at the beginning of treatment. No more than two restorations will be placed per patient.

Exclusion Criteria:

* Devital or sensitive teeth
* Teeth with prior endodontic treatment of any kind
* Teeth with a history of direct or indirect pulp capping procedures
* Patients with significant untreated dental disease to include periodontitis and/or rampant caries
* Women who self-report that they are possibly pregnant, pregnant, or lactating, as elective dental treatment is not indicated at these times
* Patients with a self-reported past history of allergies to the materials to be used in the study including composite resin cements or ceramic restorative materials
* Patients unable to return for the recall appointments
Comparison of the Biolimus A9-eluting Stent With the Zotarolimus -Eluting Stent in Multi-vessel PCI

The risk of restenosis in the treatment of coronary artery disease has significantly lessened thanks to the introduction of Drug eluting stent.

Yet, debates on the efficacy and safety of stents in complex lesions or patients have been circulated.

Recently, PCI in multiple lesions is universally performed with the development of effective stents in various kinds in the clinics.

However, a randomized study is rare for multi-vessel coronary artery disease in real procedural environments.

The primary purpose of this study is to evaluate the clinical progress of biolimus A9-eluting stent and zotarolimus-eluting stent in multi-vessel coronary artery disease.

The patients who need multi-vessel stenting with multi-vessel coronary artery disease will be enrolled.Each randomization of the enrolled subjects will be done 1:1 (biolimus A9-eluting stent : zotarolimus-eluting stent). Randomization will be stratified by two factors: Diabetes mellitus and Acute coronary syndrome.Clinical follow-up will occur at the following time points; 1 month, 1 year and 2 years.

Eligibility Criteria:
Inclusion Criteria:

* patients who need multi-vessel stenting with multi-vessel disease
* patients with signed informed consent

Exclusion Criteria:

* known contraindication to any of the following medications: Aspirin,clopidogrel, heparin, contrast agent, Biolimus or Zotarolimus group
* Cardiogenic shock
* Pregnant women or women with potential childbearing
* End-stage diseases with life expectancy shorter than 2 years
* patients with other Drug eluting stents implanted
* Patients requiring modification of antiplatelet agents for planned major surgery within the first 12 months after the enrollment.
Effect of Deep Brain Stimulation on Lower Urinary Tract Function

The precise mechanisms underlying cerebral regulation of lower urinary tract (LUT) function are still poorly understood. Patients with deep brain stimulation (DBS) offer the unique opportunity to investigate the role of different cerebral centers on LUT function.

We hypothesize that DBS has a significant effect on LUT function and that these effects depend on the specific stimulated cerebral center.


Eligibility Criteria:
Inclusion Criteria:

* Patients with deep brain stimulation (DBS)

Exclusion Criteria:

* Pregnancy
* Age \<18 years
Kangaroo Mother Care Implementation Research for Accelerating Scale-up

The implementation research project aims to develop and evaluate models for scaling up KMC in health facilities across India and Ethiopia and thereby develop effective approaches to achieve high population coverage

Kangaroo Mother Care (KMC) is the practice of early, continuous and prolonged skin-to-skin contact between the mother and the baby with exclusive breastfeeding. Despite clear evidence of impact in improving survival and health outcomes among low birth weight infants, KMC coverage has remained low and implementation has been limited. The multi-site project includes formative research to identify barriers and contextual factors that affect implementation and utilization of KMC and design scalable models to deliver KMC across the facility-community continuum. This will be followed by implementation and evaluation of these models in routine care settings, in an iterative fashion, with the aim of reaching a successful model for wider district, state and national-level scale-up. The aim is to successfully provide KMC to 80% or more of babies born in the study area weighing under 2000 grammes

Eligibility Criteria:
Inclusion Criteria:

• All newborns who are less than 2000 gm born within the study facilities during the study period.

Exclusion Criteria:

• Newborns who are sick per predefined criteria will not be provided KMC until they have been stabilized. Criteria for delay of initiation include: critical illness including apnea, decreased respiratory rate \<20 breaths per minute, grunting, cyanosis, severe chest in-drawing, convulsions, unconsciousness, and severe hypothermia \<32°F.
Rapid Detection of Rifampin and Isoniazid Resistance by PCR Before Tuberculosis (TB) Treatment Initiation

French guidelines currently recommend to initiate a 4-drug containing regimen associating isoniazid (INH or H), rifampicin (RIFor RMP or R), pyrazinamide (PZA or Z) and ethambutol (EMB or E) pending the results of drug susceptibility testing (DST). The rationale behind routine use of EMB is to prevent the emergence of resistance to rifampicin (RMP), in case of primary resistance to INH. Hence, early detection of resistance to INH and RIF using molecular testing in Mycobacterium tuberculosis could allow early adaptation of antituberculosis treatment: i) start with a 3-drug containing regimen (i.e. INH, RIF, and PZA); ii) early enforcement of treatment when resistance is suspected, pending in depth susceptibility testings.

the duration of treatment is 6 months or 12 months.

The impact of rapid detection of resistance with PCR has been poorly evaluated in low-endemic countries. In France, primary resistance to isoniazid and rifampicin were estimated at, respectively, 5.2%, and 1.2 %. Based on these estimates, French guidelines currently recommends to initiate a 4-drug containing regimen associating isoniazid (INH or H), rifampicin (RIFor RMP or R), pyrazinamide (PZA or Z) and ethambutol (EMB or E) pending the results of drug susceptibility testing (DST). The rationale behind routine use of EMB is to prevent the emergence of resistance to rifampicin (RMP), in case of primary resistance to INH. Hence, early detection of resistance to INH and RIF using molecular testing in Mycobacterium tuberculosis could allow early adaptation of antituberculosis treatment: i) start with a 3-drug containing regimen (i.e. INH, RIF, and PZA), in patients with fully susceptible isolates (currently 95% of cases); ii) early enforcement of treatment when resistance is suspected, pending in depth susceptibility testings. GenoType ®MTB DR plus sensitivity for RIF and INH resistance detection has been estimated at 100% and 83%, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* with active pulmonary tuberculosis (TB) and positive respiratory samples on microscopic examination for acid-fast bacilli (AFB+,) who are eligible for a standard TB treatment with a 4 drug combination
* PCR (Genotype MTBDR Plus v2.0, Hain Lifescience) result available within the first 7 days of tuberculosis treatment.
* who are seeking care in France (metropolitan or overseas) and accept a follow-up of 18 to 24 months after inclusion.
* who have had a prior clinical examination

Exclusion Criteria:

* Refusal to participate in the study
* Prior history of TB treatment
* For women of child bearing age, pregnancy, willing to become pregnant or breastfeeding
* Patient without healthcare insurance (French social security)
* Patient participating in another clinical trial
* Any condition that might compromise, in the investigator's opinion, patient's compliance with the protocol.
* Results of cultures available at enrollment
* No HIV testing available within the last 3 months prior to inclusion in the study.
Efficacy of Chemotherapy Alone in Patients With Poor-differentiated Early-stage Cervical Cancer

This study is aimed to enroll patients with early-stage cervical cancer (FIGO 2018 IB1-IB2) who undergo radical hysterectomy and the postoperative pathology doesn't meet Sedlis criteria or the "four-factor" model but with poorly differentiated squamous/adenocarcinoma/adenosquamous carcinoma. Patients will be randomly divided into two groups in a 1:1 ratio. The experimental group received 4 courses of paclitaxel and cisplatin (once every 3 weeks) for adjuvant chemotherapy within 4 weeks after surgery, while the control group don't not receive any adjuvant therapy but only received regular follow-up. The disease status of all patients will be evaluated within 4 weeks after the end of all treatment and every 12 weeks thereafter, including gynecological examination, laboratory indicators, imaging evaluation, and the prognosis of the two groups will be compared.


Eligibility Criteria:
Inclusion Criteria:

1. The age of patients is 18-70 years old.
2. Patients with cervical cancer who undergo radical hysterectomy and pelvic lymphadenectomy as initial treatment (including laparoscopic and abdominal surgery).
3. Clinical stage is IB1-IB2 according to FIGO 2018 stage.
4. The postoperative pathological type is squamous cell carcinoma/adenocarcinoma/adenosquamous carcinoma.
5. The degree of tumor differentiation is poorly differentiated.
6. Do not meet the Sedlis criteria or the four-factor model, but meet one of the following factors: ① LVSI (+); ② tumor diameter \> 2cm; ③ Depth of cervical stromal invasion \> superficial 1/3; (4) adenocarcinoma.

Exclusion Criteria:

1. Postoperative pathological stage ≥IIA (according to the 2018 FIGO staging system).
2. Patients with the following high risk factors: ① lymph node metastasis; ② parametrial involvement; ③ positive surgical margin; ④ vaginal involvement.
3. Patients received neoadjuvant chemotherapy.
4. There was evidence of distant metastasis on preoperative imaging examination.
5. Patients received postoperative radiotherapy.
6. History of abdominal or pelvic radiotherapy.
7. Patients with other malignant tumors.
8. Patients with missing or partially missing clinical, surgical, and pathological data were lost to follow-up.
The Effect of Propofol and Remifentanil Sequence on ED50 and ED95 of Rocuronium in Rapid Sequence Induction Anesthesia

Rapid sequence induction (RSI) is a well-known procedure to maintain a safe and rapid airway in patients especially at risk of aspiration. Propofol and rocuronium are generally used agents for RSI. However, the difficult airway scenarios are always valid for these patients, even without predictive signs of difficult airway. Therefore, it is important to decrease the rocuronium dose used in RSI to achieve a rapid recovery of a neuromuscular conduction with the aid of a reversal agent in case of difficult airway. The short acting opioids such as remifentanil may be helpful to reduce the dose of rocuronium in RSI.

Rapid sequence induction is a widely used anesthesia technique to achieve a safe airway control. However, the difficult airway may be expected in these patients as in the others. In the difficult airway situation, cholinesterase inhibitors and sugammadex may be used for the reversal. However, sugammadex is not always available due to its cost in every hospital. In addition to this, it is well-known that cholinesterase inhibitors do not work well in case of deep neuromuscular block. In consideration of these informations, the recovery of the neuromuscular block gain an importance in patients undergoing RSI with difficult airway. Therefore, decreasing the dosage of non-depolarizing neuromuscular agent may be helpful in case of the difficult airway situations. With the aim of decreasing the neuromuscular blocker dosage, opioid analgesics especially remifentanil is preferred combined with propofol to decrease the hemodynamic response to laryngoscopy and intubation. A recent study demonstrated that after induction of anesthesia with remifentanil and propofol, ED50 of rocuronium for acceptable intubation conditions was 0.20 mg/kg. In another study, the authors showed that the administration sequence of propofol and remifentanil for target controlled anesthesia affect the onset time of rocuronium due to change in cardiac output. The authors concluded that the prior administration of remifentanil decreased the cardiac output and delayed the onset time of rocuronium.

The investigators hypothesized that prior administration of remifentanil compared to propofol may increase the ED50 and ED95 of rocuronium for acceptable intubation conditions in RSI.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-II patients
* patients scheduled for elective surgery

Exclusion Criteria:

* suspected or known difficult airway
* a significant renal or hepatic dysfunction
* a known neuromuscular disease
* hypertension
* a known allergy to one of the drugs used in general anesthesia
* a body mass index lower than 18.5 kg/m2 or higher than 30 kg/m2
* intake of any medication that might interact with rocuronium
* patient refusal
Oral Sildenafil in Persistent Pulmonary Hypertension Secondary to Meconium Aspiration Syndrome in Newborns

The purpose of this study is to to study the role of oral Sildenafil in Persistent Pulmonary Hypertension of Newborn (PPHN) secondary to Meconium Aspiration Syndrome (MAS) in newborns and to study risk factors of MAS developing into PPHN.

Design: Randomized control trial Setting: Neonatal intensive care unit in a tertiary care hospital Patients: Patients diagnosed with MAS with PPHN according to clinical criteria. 97 patients with MAS were enrolled in the study over a period of 8 months, out of which 40 patients with PPHN were randomized into two groups.

Intervention: Group A received Sildenafil through a feeding tube (1 mg/kg/dose q6h) for 8 doses. Group B received a placebo. Outcome measures: Improvement in oxygen saturation (SpO2), oxygenation index (OI), duration of hospitalization and mechanical ventilation and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Newborns were diagnosed with MAS if any of the two of the following three criteria were present. (1) Meconium staining of liquor or staining of umbilical cord or skin or nails. (2) Respiratory distress, within one hour of birth. (3) Radiological evidence of aspiration pneumonitis (atelectasis and/or hyperinflation). Newborns with MAS diagnosed with clinical PPHN were enrolled in the study for drug trial. PPHN was determined either clinically by loud P2(second component of second heart sound), 10% or greater pre-/post ductal difference in arterial oxygenation (obtained by acid base gas analysis) or upper limb- lower limb SpO2 difference (obtained by pulse oximetry).

Exclusion Criteria:

* (a) babies with congenital heart disease (b) congenital anomalies particularly those which were incompatible to life or which was the cause for respiratory distress e.g. diaphragmatic hernia (c) Respiratory morbidities such as hyaline membrane disease, congenital pneumonia (d) Babies with PPHN secondary to MAS admitted after 12 hours of delivery (e) Non availability of consent of guardian for interventional procedures
Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients

A multi-centre observational, non-interventional study is to dynamically monitor the changes of circulating tumor DNA (ctDNA) in late stage NSCLC patients under Gefitinib treatment.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Histologically confirmed stage IIIB/IV NSCLC.
* Activating EGFR mutations (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q)
* Able to comply with the required protocol and followed-up procedures, and able to receive oral medications

Exclusion Criteria:

* Histologically confirmed small cell lung cancer or other metastatic tumors
* Patient had received prior chemotherapy or EGFR-TKIs treatment
* Patients who harbor Exon20 T790M mutation
Investigator Initiated Phase 1 Study of TBI-1301

Following pre-treatment with cyclophosphamide and/or fludarabine, NY-ESO-1-specific TCR gene transduced T lymphocytes are transferred to the patients with NY-ESO-1-expressing solid tumors.

Following pre-treatment with cyclophosphamide alone or in combination with fludarabine, NY-ESO-1-specific TCR gene transduced T lymphocytes are transferred to HLA-A\*02:01 or HLA-A\*02:06 positive patients with solid tumors which are 1) unresectable, refractory to standard therapy (chemotherapy, radiotherapy, etc), and 2) NY-ESO-1-expressing. The primary objective is to evaluate the safety and in vivo kinetics, and the secondary is to evaluate clinical effect.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed solid tumors
2. Solid tumor, which is unresectable, refractory to standard therapy (chemotherapy, radiotherapy, etc)
3. HLA-A\*02:01 or HLA-A\*02:06 positive
4. NY-ESO-1-expression by PCR or immunohistochemistry
5. ECOG Performance Status, 0 or 1
6. Age \>=20 years on consent
7. No treatment (surgery, chemotherapy, radiotherapy, etc.) and expected sufficient recovery from the treatment at the time of the lymphocytes collection for gene transfer.
8. Life expectancy \>=16 weeks after consent
9. No severe damage on the major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the following lab value criteria:

   * WBC \>= 2,500/μL
   * Hemoglobin \>= 8.0g/dL
   * Platelets \>= 75,000/μL
   * T. bilirubin \< 1.5 x ULN
   * AST(GOT), ALT(GPT) \< 3.0 x ULN
   * Creatinine \< 1.5 x ULN
10. Ability to understand the study contents and to give a written consent at his/her free will.

Exclusion Criteria:

1. The following serious complications are excluded from the study;

   * Unstable angina, cardiac infarction, or heart failure
   * Uncontrolled diabetes or hypertension
   * Active infection
   * Obvious interstitial pneumonia or lung fibrosis by chest X-ray
   * Active autoimmune disease requiring steroids or immunosuppressive therapy.
2. Serious hypersensitivity
3. Tumor cell invasion into CNS
4. Active multiple cancer
5. Positive for HBs antigen or HBV-DNA observed in serum
6. Positive for HCV antibody and HCV-RNA observed in serum
7. Positive for antibodies against HIV or HTLV-1
8. Left Ventricular Ejection Fraction (LVEF): \<= 50％
9. Percutaneous Oxygen saturation: \< 94％
10. History of serious hypersensitivity reactions to bovine or murine derived substances.
11. History of hypersensitivity reaction to drugs used in this study.
12. Psychological disorder or drug dependency which may have impact on the consent.
13. Pregnant females, lactating females (except when they cease and don't resume lactation) or female and male patients who cannot agree to practice the adequate birth control after the consent during the study
14. Clinically significant systemic illness that in the judgment of the PI or sub-investigator would compromise the patient's ability to tolerate protocol therapy or significantly increase the risk of complications.