cyrilzakka/clinical-trials huggingface dataset:
Atezolizumab Combined With Chemotherapy in Extensive Stage SCLC

CLINATEZO cohort will evaluate overall survival, real world progression-free survival, best response and duration of treatment in patients with advanced, metastatic Small Cell Lung Cancer (SCLC) who received atezolizumab combined with chemotherapy part of the French Early Access Program (ATU). Subsequent treatments (treatment delivered immediately after treatment with atezolizumab and chemotherapy) will be recorded. Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.

Standard-of-care first-line treatment for advanced, metastatic Small Cell Lung Cancer is platinum chemotherapy (carboplatin or cisplatin) with etoposide. Despite response rates of 60 to 65%, limited progress has been made in more than two decades; outcomes remain poor, with a median overall survival of approximately 10 months. Small cell lung cancer has a high mutation burden, which suggests that these tumors may be immunogenic and could respond to immune-checkpoint inhibitors.

Atezolizumab is a humanized monoclonal anti-programmed death ligand 1 (PD-L1) antibody that inhibits PD-L1-programmed death 1 (PD-1) and PD-L1-B7-1 signaling and restores tumor-specific T-cell immunity.

The addition of atezolizumab to chemotherapy in the first-line treatment of advanced, metastatic Small Cell Lung Cancer has been granted access for patients in France part of an Early access program (ATU), in May 2019.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed extensive stage Small Cell Lung Cancer at time of initiation of treatment with atezolizumab and chemotherapy.
* Patients who were informed about the study and accepted for their data to be collected.
* Patients who received at least one dose of treatment with atezolizumab and chemotherapy as part of the French Early Access Program (ATU program) and have been accepted within this ATU program
* Selection period spans from May 6th 2019 until January 31st 2020 for initiation of treatment with atezolizumab and chemotherapy.

Exclusion Criteria:

* Patients enrolled in a clinical trial assessing treatment with a combination of atezolizumab and chemotherapy. (ATU was granted to patients unable to meet eligibility criteria for on-going recruiting trials, unable to participate to other clinical trials, or because other medical interventions were not considered appropriate or acceptable).
* Patients who were included in the French Early Access Program (ATU program) but did not receive any atezolizumab and chemotherapy treatment.
Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection

This study compares the equivalence of hyperpolarized 129Xe MRI as compared to 133Xe scintigraphy for the evaluation of pulmonary function in patients being evaluated for lung resection.

This is a multicenter, randomized, open-label, cross-over Phase 3 study evaluating hyperpolarized 129Xe gas MRI as compared to 133Xe scintigraphy for the evaluation of pulmonary function. This study will enroll subjects being evaluated for possible lung resection surgery (i.e. segmentectomy, lobectomy, or pneumonectomy). Subjects will have both a 129Xe MRI and 133Xe scintigraphy image. The vast differences in technique for obtaining hyperpolarized 129Xe MRI as compared to 133Xe scintigraphy make it impossible to blind study procedures. However, all image interpretation will be performed by personnel blinded to the subject's medical history and all study assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects ≥18 years of age.
2. Subject is being evaluated for possible lung resection (e.g., segmentectomy, lobectomy, or pneumonectomy).
3. Subject is able to undergo MRI imaging and able to fit in the MRI coil.
4. Subject is willing and able to comply with all study procedures.
5. Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study specific assessments or procedures.

Exclusion Criteria:

1. Baseline blood oxygen saturation (SpO2) \<90% at rest. For patients requiring routine supplemental oxygen, SpO2 measurements should be taken with the patient's normal oxygen supplementation.
2. Female subjects of childbearing potential with a positive serum pregnancy test at screening, or who are not taking (or not willing to take) acceptable birth control measures through the Follow-up Period. Adequate birth control methods include with a monogamous partner who was sterilized more than 6 months prior to screening, or measures with a Pearl index of \<1 used consistently and correctly (including intrauterine devices, or implantable, injectable, oral, or transdermal contraceptives). Women are not considered to be of childbearing potential if they meet at least 1 of the following 2 criteria as documented by the Investigator:

   * They have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at a minimum of 1 menstrual cycle prior to signing the ICF; or
   * They are post-menopausal: for women ≥55 years of age, defined as ≥1 year since their last menstrual period, or for women \<55 years of age, defined as ≥1 year since their last menstrual period and have a follicle-stimulating hormone (FSH) level in the laboratory's normal range for post-menopausal phase.
3. Women who are lactating and insist on breast feeding.
4. Subjects who have received any other investigational therapy within 4 weeks prior to Screening.
5. Subjects who require anesthesia or heavy sedation to undergo MRI testing. Mild sedation could be acceptable (i.e. a low dose oral acting anxiolytic medication such as alprazolam) as long as, in the opinion of the investigator, the subject meets Inclusion Criteria #4 and #5.
A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection.

To evaluate the clinical toxicity, safety, and maximum tolerated dose (MTD) of intravenous nystatin in patients with HIV infection. To evaluate the potential anti-HIV activity and clinical pharmacology of intravenous nystatin.

Cohorts of three patients each are treated at escalating doses of intravenous nystatin, administered every other day, until the MTD is reached. Each cohort is observed for toxicity for at least 2 weeks before escalation in subsequent patient cohorts is initiated.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Required:

* Aerosolized pentamidine (300 mg once a month) for PCP prophylaxis in patients with CD4 count \<= 200 cells/mm3. (Patients with CD4 count \> 200 cells/mm3 who are already on aerosolized pentamidine may continue such therapy at the discretion of the investigator.)

Allowed:

* Prophylaxis against Mycobacterium avium Complex in patients with CD4 count \<= 100 cells/mm3.

Concurrent Treatment:

Allowed:

* Local treatment for Kaposi's sarcoma lesions with less than 25 percent increase in measurable disease.

Patients must have:

* HIV antibody positivity.
* Absolute CD4 count \< 500 cells/mm3 on two determinations within 15 days prior to study entry.
* At least 6 months of prior zidovudine (AZT) therapy.
* No active opportunistic infection requiring ongoing therapy.
* Normal neurologic status by standard assessment.
* Life expectancy of at least 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Neoplasm other than basal cell carcinoma of the skin or stable untreated HIV-related Kaposi's sarcoma (provided there is no progression in the Kaposi's sarcoma beyond 25 percent of measurable disease).
* Clinically significant cardiac disease.
* Known hypersensitivity to polyene antibiotics.

Patients with the following prior conditions are excluded:

* History of myocardial infarction or arrhythmias.

Prior Medication:

Excluded within 2 weeks prior to study entry:

* Antiretroviral agents or interferons.
* Biological response modifiers.
* Corticosteroids.
* Cytotoxic chemotherapeutic agents.
* Drugs that can cause neutropenia or significant nephrotoxicity.
* Rifampin or rifampin derivatives.
* Systemic anti-infectives.

Prior Treatment:

Excluded within 2 weeks prior to study entry:

* Radiation therapy. Active drug or alcohol abuse.
THE EFFECT OF LABOR DANCE ON THE LABOR PAIN, BIRTH SATISFACTION AND NEONATAL OUTCOMES

Objective: This research was conducted to determine the effects of labor dance on perceived birth pain, birth satisfaction, and neonatal outcomes.

Design: This research was an experimental study with three groups. The data were collected during the active phase of labor as three groups; Dance Practitioner Midwife Group (DPMG-40 pregnant), Dancing Practitioner Spouse / Partner Group (DPSG-40 pregnant) and Control Group (CG-80 pregnant).

Setting: This research was conducted at Ministry of Health Izmir Urla State Hospital between April 1, 2017 and October 31, 2017.

Participants: The pregnant women in the DPMG danced with the midwives in charge of the delivery room and following the pregnancy, but those in the DPSG danced with their spouse/partners during the active phase of labor. Labor pains were measured before the labor dance was begun (when the vaginal dilatation was 4 cm) and after the labor dance (when the vaginal dilatation was 9 cm) using a Visual Analogue Scale (VAS). In the postpartum period, the first, fifth, and tenth-minute Apgar scores and oxygen saturation levels of the newborns were measured and recorded. The Mackey Childbirth Satisfaction Rating Scale was applied to evaluate the women's birth satisfaction at the end of the first hour. In the Control Group, only routine practices were implemented in the hospital, and data were collected as indicated in the experimental groups.

During a labor dance, pregnant women's hands were wrapped around the neck of the partner (midwife or spouse), the pregnant woman put her head on her partner's shoulder, and they swung left to right accompanied by calming music. During the labor dance, the partner accompanied the pregnant woman's swinging movements and massaged the pregnant woman's sacral area at the same time. The study showed a positive effect of labor dancing on decreasing birth pain and improving satisfaction and neonatal outcomes whether the dance was performed with the spouse or the midwife during the intrapartum period.

Eligibility Criteria:
Inclusion Criteria:

Those who were admitted to the Ministry of Health Urla State Hospital for labor

* Those whose cervical dilatation between 4 and 8 cm.
* Those who had received labor dance training by attending Prenatal Training with their spouses/partners in perinatal period.
* Those who met the inclusion criteria (Volunteering, term pregnancy (37-41 gestational weeks), single foetus, not having any pregnancy complication (oligohydramniosis and polihydramniosis, placenta previa, pre-eclampsia, premature rupture of membrane, presentation anomalies, intrauterine growth retardation, intrauterine death, macrosomic baby, foetal distress etc.)

Exclusion Criteria:

When delivered by cesarean sectio,

* Labor was inducted
* Narcotic analgesics used
Predictive Value of Heart Rate Variability on Cardiorespiratory Events

The aim of this study are to investigate whether heart rate variability (HRV) parameters derived from nonlinear time series analysis at five different time points have prognostic utility for assessing the risk of postimmunisation AOP in very preterm/very low birth weight infants immunised in the hospital.


Eligibility Criteria:
Inclusion criteria for preterm infants:

* Gestational Age (GA) 22+0 to 31+6 weeks and/or birth weight 400 g to 1500 g
* Chronological age \> 7 days
* Written informed parental consent

Inclusion criteria for term healthy control infants:

* GA 37 to 42 weeks, chronological age 3 to 28 days (beyond initial transition after birth)
* Hospitalised in the neonatal rooming-in unit of the University Children's Hospital Basel as healthy co-twin or healthy sibling, or neonate ready to be discharged home after reconvalescence from minor illness such as hyperbilirubinaemia
* Written informed parental consent

Exclusion Criteria:

* Major congenital malformations including neuromuscular disorders, thoracic malformations, major cardiac malformation
* Lack of written informed parental consent
Does Liposomal Bupivacaine Provide Improved Pain Management for ORIF of Midshaft Clavicle Fractures?

To determine whether liposomal bupivacaine wound infiltration decreases pain scores and narcotic use when compared to bupivacaine alone after open reduction internal fixation of midshaft clavicle fractures.


Eligibility Criteria:
Inclusion Criteria:

* Mid-shaft Clavicle Fracture treated with ORIF

Exclusion Criteria:

* Unable to be contacted for 72 hours post surgery
* Other concurrent surgical procedures
* Chronic narcotic user
Olanzapine Versus Aprepitant Based Antiemetic Regimen for High Emetic Chemotherapy

Aprepitant and olanzapine have been recommended for emesis prevention from highly emetogenic chemotherapy. We hypothesized that olanzapine may lead to less nausea compared to aprepitant based on previous study. However, data of combination of olanzapine and ondansetron is scarce.

Aprepitant and olanzapine have been recommended for emesis prevention from highly emetogenic chemotherapy. We hypothesized that olanzapine may lead to less nausea compared to aprepitant based on previous study. However, data on efficacy and adverse effects of combination of olanzapine and ondansetron which is only serotonin antagonist in Thai national essential drug list, is scarce. Also, we aims to assess the efficacy of olanzapine dosage of 5 mg which is more commonly used in Thai patients.

Eligibility Criteria:
Inclusion Criteria:

* pathologically proved of solid malignancy
* receive first cycle of cisplatin \>= 50 mg/m2 or cyclophosphamide/doxorubicin

Exclusion Criteria:

* pregnancy
* patients with episode of vomiting within 24 hours before starting chemotherapy
* uncontrolled brain/ CNS metastasis
* gut obstruction
* receive combination of moderate or high emetogenic chemotherapy during Day 2-5
* Known allergy to ondansetron, olanzapine, aprepitant or dexamethasone
* currently receive olanzapine with other indication and plan to continue the drug
Patient Education Before Orthognathic Surgery

To evaluate the effectiveness in the use of an educational material through: Assessment of knowledge about post-operative orthognathic surgery; assessing levels of anxiety with the survey of Anxiety Inventory-STATE-TRAIT; clinical evaluation of self-care in the management of postoperative signs and symptoms

It is a clinical randomized controlled trial being developed from February 2013 to September 2015, divided into two phases: a pilot study without randomization for impact testing and evaluation of intervention and, in the second time, the clinical randomized study with possible changes after the pilot study.

Will be entered in the study patients undergoing maxillofacial surgery originating at outpatient clinic located in the municipality of São Paulo. The study aims to evaluate the effects of educational material in postoperative education orthognathic surgery, with intervals between pre and postoperative serials.

Recruitment plan of patients: the patients seen in oral and maxillofacial surgery and traumatology clinic located in the municipality of São Paulo with indication for orthognathic surgery will be covered by personally and invited to participate in intervention research. To control the bias will be included in the study patients of the same surgical team, to ensure the same surgical technique and postoperative guidance conduct by the surgeon.

Study variables: it is intended to analyse the socio-demographic variables: sex, age, level of education; independent variables: surgical technique, recovery time, difficulties experienced during the postoperative period, possible surgical complications; dependent variables: signs and symptoms postoperatively (presence or absence) and monitoring of care during the postoperative period; level of knowledge about the post-op of orthognathic surgery and anxiety levels (State-trait anxiety inventory-IDATE).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing orthognathic surgery during the study and with surgical technique:

  * sagittal maxillary bilateral osteotomy;
  * maxillary;
  * vertical osteotomy;
  * Lefort I osteotomy combined with or without mentoplastia and maxillary disjunction.
* Informed consent
* Patients in the maxillofacial outpatient clinic located at Sao Paulo

Exclusion Criteria:

* patients undergoing reoperation of orthognathic surgery;
* with cleft lip-palate.
The Effectiveness of Muscle Energy Technique Combined With Strengthening of Deep Neck Flexors With and Without Core Stability Exercise in Upper Cross Syndrome Patients.

Upper cross syndrome (UCS) is a common muscles related postural disorder which is increasing every new day that is affecting the health related quality of life. It is most prevalent amongst the individuals who work at computers or laptops, or on desks.

The UCS is caused by poor posture. Weak core musculature leads to poor body posture causing chronic degenerative changes and disturbing body alignment and body equilibrium. Core stability exercises (CSE) are a good strategy to improve body posture. The purpose of this study is to determine the effects of muscle energy technique (MET) combined with the strengthening of deep neck flexors with and without core stability exercise to manage Upper Cross Syndrome (UCS) patients.

This randomized controlled trial will be conducted at the Dow University of Health Sciences Ojha campus in Karachi, Pakistan. Those patients who fulfill the criteria will be enrolled in physiotherapy OPD and general OPD. Then they will be randomized into two groups as per the random allocation sheet for treatment. Pre- and post-intervention assessment for pain, functional disability, and range of motions will be done by visual analog scale (VAS), neck disability index (NDI), and goniometer.

Analysis of pre- and post-intervention measure analysis will be performed using SPSS version 21.The Sampling technique will be Nonprobability purposive sampling with Sample size of 70 participants (35 in each group).

Intervention: The Participant will be divided into two groups as per the random allocation sheet for treatment. In Group A, the control group will receive a moist heat pack for 20 minutes then muscle energy technique (MET) of the upper trapezius, levator scapula, and pectoralis muscles (major and minor) and strengthening exercise of deep neck flexors. In Group B, the experimental group will receive the same treatment session as the control group along with the Core stability exercise. There will be 12 sessions for each patient, 6 sessions regularly in the 1st week and then 3 sessions per week for the next 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Participants who were diagnosed or referred with UCS
* The participant with the age of 18 - 45 years old.
* Both male and female.
* Craniovertebral angle less than 48.
* Restricted cervical range of motion.

Exclusion Criteria:

* • Participants who were diagnosed with: Inflammatory/Rheumatoid Arthritis , neurological disorders, History of trauma or fracture with cervical spine, Cervical spine surgery or trauma or any spinal Congenital deformities.
Effects of Expiratory Muscle Strength Training in Adolescent Idiopathic Scoliosis

Adolescent idiopathic scoliosis result in deterioration of core muscles and respiratory system. Core muscles provide trunk stabilization as well as responsible for respiratory system. Especially tr. abdominis, rectus abdominis, external oblic and internal oblic muscle, which are core muscles, highly active during forced expiration while diaphragm muscle also active during inspiration. Thus, expiratory muscle strength training has effect not only respiratory muscle strength but also trunk stabilization. While, effects of expiratory muscle strength training in adolesecent idiopathic scoliosis is a topic that needs to be investigated, this topic has not been investigated until today. Hence, this current study aimed to investigate the effects of expiratory muscle strength training on cobb angle, respiratory muscle strength, core stabilization, functional exercise capacity and quality of life.

A convenience of children with adolescent idiopathic scoliosis, 10-19 years, is going to recruited from Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. Patients will randomly allocate to either a treatment group or control group. The treatments group will receive expiratory muscle strength training at 50% maximal expiratory presssure while, the control group will receive sham expiratory muscle strength training without physiological load. Groups are going to train for a total of 25 breathe/day, 5 days/week, for 6 weeks. Before and after treatment, all of patients progression of scoliosis will be evaluated by calculating cobb angle, respiratory muscle strength using with electronic mouth pressure device, core stability using with Mc-Gill endurance test and the stabilizer biofeedback unit, functional exercise capacity using with six minute walk test (6MWT) and six minute pegboard and ring test (6MPBRT), quality of life using with scoliosis research society -22 questionnare (SRS-22) and daily living activity of upper extremity using with quick-DASH questionnare.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with idiopathic scoliosis,
* aged between 10 and 19 years,
* with a Cobb angle ranging from 10 to 45 degrees.

Exclusion Criteria:

* Individuals who have undergone spinal surgery,
* who have received conservative or surgical treatment for scoliosis,
* individuals with neurological, neuromuscular, systemic, rheumatological, or musculoskeletal disorders, or conditions affecting balance and walking,
* individuals with a history of cardiac or pulmonary diseases that could affect respiratory function and exercise capacity.
Construction of Gynecological Tumor Organoids

This study focuses on the construction of a biological sample library for organoids and tumor tissues in gynecological tumors.

Explore the construction and maintenance of a large-scale queue of gynecological tumor organoids. Beijing Daxiang Technology Co., Ltd. provides corresponding technical support and chip design. Gynecological oncology center provides tumor samples, clinical information, and pathological support, and biological sample library provides technical support, storage space, and quality management.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 18 or older, an informed consent form is provided;
2. The preoperative tumor burden assessment and intraoperative researcher team believe that sampling is feasible;
3. Having relevant requirements for sample library storage;
4. Surgical treatment at Peking Union Medical College Hospital.

Exclusion Criteria:

1. Unable to meet all inclusion criteria;
2. The research team considers any situations or considerations that may hinder normal pathological assessment.