cyrilzakka/clinical-trials huggingface dataset:
Evolutionary Therapy for Rhabdomyosarcoma

This clinical trial will evaluate 4 different strategies of chemotherapy schedules in newly diagnosed participants with metastatic Fusion Positive (alveolar) Rhabdomyosarcoma. The participant and their physician will choose from: Arm A) a first strike therapy, Arm B) a first strike-second strike (maintenance) therapy, Arm C) an adaptively timed therapy, and Arm D) conventional chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a new histologic diagnosis of rhabdomyosarcoma
* Participants must have FISH, PCR or other molecular confirmation of PAX/FOXO1 fusion per institutional standards
* Participants must have sufficient tissue (up to 10 unstained FFPE) for correlative testing
* All participants must have distant metastatic disease; either biopsy positive or PET avid extranodal or distant nodal lesions determined by the investigator to be metastatic disease. Patients with a single distant metastatic site that has been excised prior to study entry are eligible
* No prior systemic chemotherapy
* Participants enrolled to Arm B, maintenance, must be able to take oral cyclophosphamide. Note: enteral administration of cyclophosphamide is allowable.
* Males and females of reproductive potential may not participate unless they have agreed to the use of, at minimum, two methods of contraception during and after treatment or abstinence.
* Women of childbearing potential should adhere to contraception for a period of 4 months after completion of systematic chemotherapy administration
* Men who are sexually active with women of child bearing potential should adhere to contraception for a period of 4 months after completion of systematic chemotherapy administration
* All patients and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent or assent document.

Exclusion Criteria:

* Participants with regional lymph nodes as the only site of disease are not eligible. Distant nodal sites alone are eligible
* Participants who are receiving any other investigational agents for rhabdomyosarcoma are ineligible
* Participants must not be receiving any additional medicines being given for the specific purpose of treating cancer. Alternative medications including, but not limited to cannabis based products would not be a reason for exclusion
* Participants are ineligible if they have uncontrolled intercurrent illness including, but not limited to:

  * ongoing or active infection not expected to resolve with current antibiotic plan
  * cardiac arrhythmia
  * psychiatric illness/social situations that would limit compliance with study requirements
* Patients who are pregnant or breastfeeding are not eligible because there is no available information regarding human fetal or teratogenic toxicities. Females of childbearing potential must have a negative serum or urine pregnancy test within 24 hours of starting protocol therapy.
* Participants who are considered unable to comply with the safety monitoring requirements of the study are not eligible
Patient-controlled Sedation With Propofol Versus Combined Sedation During Bronchoscopy

bronchoscopy - a randomized controlled trial" (EudraCT number: 2015-005274-38, protocol number: "BRONSE") is a phase IV single centre prospective randomized controlled trial with parallel groups. A total of 150 adult outpatients undergo diagnostic bronchoscopy during sedation and are randomized into three sedation arms (1:1:1); sedation with midazolam and morphine-scopolamine as premedication (clinical routine), sedation with propofol using PCS and morphine-scopolamine as premedication, and sedation with propofol using PCS and glycopyrronium bromide as premedication. The study is partially blinded, the bronchoscopist is blinded regarding given premedication for patients given PCS (two sedation arms). The hypothesis is that PCS increase the amount of patients ready for discharge, and further that patient characteristics affect the amount of propofol administered. The endpoints are primarily the amount of patients ready for discharge within 2 hours and secondary assessment of patient recovery and satisfaction as well as bronchoscopist evaluation and doses of administrated drugs. Finally safety variables are collected such as vital signs and interventions performed to maintain cardiovascular and respiratory stability.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥18 years)
* Planned bronchoscopic procedure with sedation in an outpatient setting
* The patient have after receiving information about the study given his/her signed informed consent to participate.
* Women of childbearing potential only if use of effective contraceptive.

Exclusion Criteria:

* Positive pregnancy test S-β-HCG.
* Known/suspected allergy or contraindication\* to any medication within the study.
* Functional disability in both hands which affect the possibility to operate the PCS device.
* Cognitive impairment, unwillingness or language difficulties resulting in difficulty to understand the meaning of participation in the study or to operate the PCS device.
Reliability and Validity of the MINI International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)

The primary aims of this study are to assess:

1. The inter-rater and test-retest reliability of the MINI-KID
2. The validity of the standard MINI-KID interview in relation to the parent rated pencil/paper version (MINI-KID-P) and th longer clinician rated "Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) and "expert opinion" (when available).

Secondary aims will include evaluating the concordance between: The Children's Global Assessment Scale (a required part of the K-SADS) with the clinician-rated Sheehan Disability Scale (to be administered with the MINI-KID) as a measure of illness severity.

The MINI-KID is a short, structured diagnostic interview used to assess the presence of 24 DSM-IV child and adolescent psychiatric disorders as well as the risk of suicide.

To achieve adequate representation of the major psychiatric disorders and sufficient normal controls, we propose recruiting 230 children and adolescents (ages 6 to 17 years 11 months), comprised of 200 subjects identified as having one or more psychiatric disorders and 30 normal controls in the community. These subjects will be from diverse socioeconomic, racial and ethnic backgrounds. We will assess the inter-rater and test-retest reliability of the MINI-KID and examine its validity with the "gold-standard" diagnostic interview for children and adolescents as well as expert opinion.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be between the ages of 6 years and 17 years, 11 months
* All subjects must meet MINI-KID DSM-IV criteria for a least one of the Axis I child psychiatry disorders covered by the MINI-KID.
* Both sexes are included.

Exclusion Criteria:

* Subjects who suffer from mental retardation, significant developmental disorders, congenital abnormalities, delirium, dementia, a language problem, or brain damage will be excluded.
* Subjects with neurological disorders, chronic or life threatening diseases will be excluded.
Comparison of Efficacy of Two Supraglottic Airway Devices: I-gel and the Self-pressurized Air-q in Elderly Patients

Supraglottic airway devices with noninflatable cuff have advantages in omitting the cuff pressure monitoring and reducing potential pharyngolaryngeal complications. Typical devices without cuff inflation available are the i-gel™ and the self-pressurized air-Q™ intubating laryngeal airway (air-Q SP).

The i-gel airway is a supraglottic airway management device made of thermoplastic elastomer, which is soft, gel-like, and transparent. It was designed to create a noninflating anatomical seal of the pharyngeal, laryngeal, and perilaryngeal structures while avoiding the compression trauma that can occur with inflatable SADs.

The i-gel has evolved as a device that accurately positions itself over the laryngeal framework, providing a reliable perilaryngeal seal, and therefore no cuff inflation is necessary. Its advantages include easier insertion, minimal risk for tissue compression, and stability after insertion.

The air-Q is a new SAD intended for use as a primary airway and an aid for tracheal intubation in situations of anticipated or unanticipated difficult airways. The intracuff pressure of air-Q dynamically equilibrates with the airway pressure and adjusts to the patient's pharyngeal and periglottic anatomy, potentially providing improved airway fit and seal.

The anatomical and physiological changes that accompany ageing may have a significant influence on the efficacy and safety of SADs. The distinctive features of the air-Q SP and i-gel may lead to a substantial difference in performance in the elderly, and it is planned a head-to-head comparison of these two devices in patients aged between 65 and 85 years.


Eligibility Criteria:
Inclusion Criteria:

* 65-85 years old
* ASA I-III
* Elective urologic surgery
* Mallampati 1-2

Exclusion Criteria:

* BMI\>35kg/m2
* Operation time more than 2 hours
Effect of FHP on TMJ Proprioception in Postmenopausal Women

anterior protrusion of head in relation to the trunk; It has a high prevalence among old women as increased age is associated with a reduced cervical range of motion (ROM), greater thoracic kyphosis which is associated with greater cervical flexion and greater forward head posture accompanying with greater deficits in cervical ROM of flexion and rotation. So, the aim of the study is to determine the effect of forward head posture on temporomandibular joint proprioception in postmenopausal women

A convenient sample of 100 postmenopausal women will be participated in this study; they are divided into 2 groups according to their cranio-vertebral angle (CVA). The FHP group will be consisted of 50 women, suffer from FHP (CVA was less than 48°). The control group will be consisted of 50 women, are free from FHP (CVA more than 48°).

The participants will be recruited from Faculty of Physical Therapy, Cairo University and Faculty of Physical Therapy, MUST University. Informed consent will be obtained from each participant after explaining the nature, purpose, and benefits of the study, informing them of their right to refuse or withdraw at any time, and about the confidentiality of any obtained information.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women
* their age will range from 50 to 60 years
* their body mass index (BMI) will range from 25 to 28 kg/m2

Exclusion Criteria:

* any identified or acquired dental defects
* existing dental prosthesis use, visual, voice and hearing disabilities
* facial paralysis
* orofacial, neck or shoulder fractures or procedures
* fixed or mobile spinal deformity
* headache
* migraine
* any vestibular or neurological condition that may impair TMJ proprioception.
A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic Fibrosis

This was a Phase IV, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the effect of Pulmozyme on pulmonary function, health-related quality of life (HRQOL), and respiratory symptoms in 3- to 5-year-old children with cystic fibrosis (CF). Approximately 40 patients were planned to be enrolled in this study. However, only 3 patients were eligible for random allocation and received treatment: 1 patient in the Pulmozyme group and 2 patients in the placebo group. All 3 patients completed the study assessments but did not have usable pulmonary function test (PFT) data.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Aged 3-5 years
* Diagnosis of cystic fibrosis

Exclusion Criteria:

* Children taking scheduled inhaled Pulmozyme or hypertonic saline within 56 days prior to Visit 1 or any Pulmozyme in the 28 days before Visit 1
* Involvement in a clinical intervention trial within the 4 weeks prior to Visit 1
* Use of an investigational drug or device within 28 days prior to Visit 1
* Any other condition that might increase the risk of participation to the patient in the judgement of the investigator
A Polypill for Secondary Prevention of Ischemic Heart Disease

Cardiovascular diseases (CVD) are the leading cause of mortality and morbidity worldwide. The most important aspect of CVD secondary prevention is adherence to guideline-indicated pharmacological therapy which globally remains low. In previous studies, a Polypill containing fixed dose combination of essential drugs have improved patient adherence to these drugs. The effect of such a strategy on pharmacological therapy uptake, cost-effectiveness, and CVD recurrence in our setting will be assessed in this study. Participants hospitalized in three referral hospitals in Isfahan, Iran because of an acute myocardial infarction (MI) (ST elevation MI (STEMI) or non-ST elevation MI (NSTEMI)) will be randomized to either receiving Polypill or usual care after MI. Patient recruitment will be carried out at the time of patient discharge from the hospitals.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized because of an acute myocardial infarction (STEMI/NSTEMI) and alive after discharge for at least 1 month
* signing informed consent
* clear indication of receiving all components of Polypill (aspirin, statin, ACE inhibitor/ARB, and beta blocker)
* living in Isfahan city or nearby areas so that they can attend follow-ups
* No mental illness limiting their self-care ability or Severe illness with an estimated lifespan of less than 3 years
* No history of adverse reaction or contraindication to any component of the Polypill
* Not having Secondary hyperlipidemia, serum creatinine ≥ 2, severe heart failure
* No plan for a procedure (CABG, PCI, or another surgical procedures) within following 6 months

Exclusion Criteria:

* Patient unlikely to complete trial
* Need to change or discontinue any of the four principal drugs of the Polypill to achieve better control of the disease or risk factors or because of adverse drug reactions (based on physician's idea)
* Severe illness with an estimated lifespan of less than 3 years
GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma

All subjects will receive GR1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 2 years or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.


Eligibility Criteria:
Inclusion Criteria:

* 1、ECOG score 0-2 2、≥18 years of age 3、Multiple myeloma must be measurable by central laboratory assessment: Serum monoclonal paraprotein (M-protein) level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or

Light chain multiple myeloma without measurable disease in the serum or the urine:

Serum immunoglobulin free light chain (FLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.

Exclusion Criteria:

* 1、Prior treatment with any BCMA-targeted therapy 2、Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma 3、Known allergies, hypersensitivity, or intolerance to the study drug (teclistamab) or its excipients 4、Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
Safety and Efficacy of Sentinel Node Biopsy Omission for Breast Cancer Patients Who Plan to Have Adjuvant Chemotherapy

Eligible patients will be female, ages 18 and older and have a diagnosis of Clinical T1 or T2 invasive breast cancer with no suspicious palpable adenopathy. Patients will undergo standard of care lumpectomy without sentinel node biopsy and whole breast radiation, followed by chemotherapy.

Sentinel node biopsy is also considered standard care when patients have localized breast cancer. Treatment can often be influenced by whether the results of the biopsy show cancer or not. However, the biologic factors of the primary tumor have become more important in determining treatment recommendations in women with clinically node negative breast cancer.

The primary objective of the study is to determine the locoregional recurrence rate in patients with clinically node negative T1 and T2 breast cancer treated with systemic chemotherapy and whole breast irradiation in whom biopsy of the sentinel node is not performed. A locoregional recurrence is defined as any recurrence in the ipsilateral axillary nodes or in the supraclavicular nodes.

After surgery, a patient will receive standard of care radiation on her affected breast and chemotherapy. A physical examination of the affected breast and regional lymph nodes will be conducted every six months for the first two years of follow up and then yearly for the last 3 years of follow up. Imaging of the affected breast will occur every 12 months after surgery per standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Female age 18 and older, not pregnant or lactating
* Clinical T1 or T2 invasive cancer with no suspicious palpable adenopathy
* If abnormal axillary nodes are seen on preoperative imaging, a negative fine needle aspiration or core biopsy is required for study entry.
* Planned treatment with breast conserving surgery and whole breast irradiation
* Chemotherapy required postoperatively based on patient and tumor characteristics at diagnosis

Exclusion Criteria:

* Patients with suspicious palpable axillary adenopathy
* Patients with biopsy demonstrating axillary nodal metastases
* Patients with treatment by mastectomy
* Patients who have undergone neoadjuvant chemotherapy
* Patients with co-morbidities rendering the patient not a candidate for chemotherapy, surgery, or irradiation
* Patients treated with accelerated partial breast irradiation (APBI)
* Patients with contraindication to radiation
Follow-up of Gynecological Cancer Patients, Their Needs and Expectations, A Cooperation Project

Follow-up of cancer patients accounts for a substantial part of outpatient activity, and alternative models of care are developing. In some countries, low-risk follow-up is already done in primary care, mainly in breast, and colorectal cancer. In this study the investigators will explore gynecological cancer patients about their expectations regarding their future follow-up plan. Further, the investigators will ask about the experience and satisfaction among patients who have already attended a follow-up programme for 2-3 years. In addition, the investigators will especially focus on the cooperation aspect between primary and secondary care. The investigators hypothesize that follow-up of selected gynecological cancer patients can be done by general practitioners.

After gynaecological cancer patients have completed their treatment, they are followed up at a gynaecological outpatient clinic for a number of years. The aim of such follow-up is to detect recurrence, improve survival and reduce adverse effects of the treatment. The national guide for oncological gynaecology recommends follow-up by a specialist for five years at intervals depending on cancer type. Several review studies on follow-up of endometrial, cervical and ovarian cancer patients show large international variations in follow-up routines. There are only retrospective studies available, and they indicate that most recurrences are discovered within the first three years after completed treatment, and, in most cases, by the women themselves. More intensive surveillance does not appear to affect the time for discovery of recurrence.

A few randomised controlled studies and retrospective cohort studies have been published that focus on follow-up of colon cancer and breast cancer patients by general practitioners versus by hospital specialists. These studies have not shown any significant differences between the groups in terms of detection of recurrence, incidence of serious clinical events connected with recurrence or health-related quality of life.

The investigators therefore plan to perform a study in which both gynaecological cancer patients and their regular general practitioners are asked about their views on patient follow-up after completed treatment. The investigators especially wish to focus on the collaboration aspect.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* histologically or cytologically proven cancer

Exclusion Criteria:

* Unability to fill out questionnaires (due to language or cognitive barriers)
Study of DT-7012 as a Single Agent and in Combination With an Immune Checkpoint Inhibitor in Participants With Advanced Solid Tumors

This is a phase 1/2, dose-escalation and cohort-expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of DT-7012 (an anti-CCR8 monoclonal antibody) as a single agent and in combination with an immune checkpoint inhibitor in adult participants with selected advanced solid tumors.

This is a phase 1/2, first-in-human, multicenter, open-label clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of DT-7012, administered as monotherapy and in combination with an immune checkpoint inhibitor (ICI), in participants with selected recurrent advanced/metastatic solid tumors.

This study includes:

* a phase 1 Dose Escalation with two planned parts (part 1A which corresponds to a dose escalation of DT-7012 monotherapy and part 1B which will be initiated upon recommendation from the Safety Review Committee based on part 1A data and corresponds to a dose escalation of a combination of DT-7012 with an ICI)
* a subsequent phase 2 Cohort Expansion

The phase 1 aims at determining the recommended phase 2 dose (RP2D) and the maximum tolerated dose or maximum administered dose of DT-7012 as single agent and in combination with an ICI in participants with selected recurrent advanced/metastatic solid tumors.

The phase 2 will assess DT-7012 as monotherapy and/or in combination with an ICI in expansion cohorts of 2-3 specific tumor types.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed solid tumor, among selected cancer types, that is recurrent, locally advanced (i.e., not eligible for curative surgery or radiotherapy) or metastatic, has progressed after at least one line of systemic therapy and has no established curative option.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the local site investigator/radiologist.
* At least 1 tumour lesion accessible to biopsy per treating physician judgement.
* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
* Adequate organ function.

Exclusion Criteria:

* Any unresolved AEs from previous anti-cancer therapies of grade ≥2, with the exception of alopecia.
* Prior severe immune-related AEs (irAEs) leading to immunotherapy treatment discontinuation.
* Major surgery or significant traumatic injury within 4 weeks prior to Cycle 1 Day 1 with unadequately recovered AEs and/or complications from the intervention prior to Cycle 1 Day 1.
* Prior radiotherapy within the 4 weeks prior to Cycle 1 Day 1 or limited field palliative radiotherapy within 2 weeks prior to Cycle 1 Day 1.
* Prior anti-CCR8 monoclonal antibody treatment received in an investigational trial