cyrilzakka/clinical-trials huggingface dataset:
High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma

High-dose chemotherapy and autologous stem cell transplantation (ASCT) as part of the up-front treatment of patients with multiple myeloma has been associated with improved disease-free and overall survival in multiple large randomized controlled trials. Following 3-6 cycles of standard induction therapy with biologic agents, consolidation with high dose Melphalan and ASCT has become the standard-of-care approach for fit myeloma patients up to 70 years of age. Single-agent high-dose Melphalan (200mg/m2) is currently the standard-of-care preparative regimen prior to autologous transplant in Myeloma. Historical studies utilizing Busulfan- or Total Body Irradiation-based preparative regimens have yielded similar results to single-agent Melphalan with higher toxicity.

Myeloma patients, following up-front induction therapy, will receive an ASCT following a high-dose bendamustine-based preparative regimen (BeEAM). The primary endpoint of this trial will be the rate of CR at day 100 post-transplant. Experience from the literature, as well as results from our institution, suggests that following ASCT for the upfront treatment of myeloma, the rate of CR at day 100 post-transplant is approximately 45%. It is hoped that under this protocol, this rate will be at least 65%. Thus we statistically formalize this study by testing the null hypothesis that p, the CR rate is 0.65 or more versus the alternative hypothesis that p is less than 0.45. A sample size of 65 pts gives 90% power with an alpha=0.05, using the formula for a one sample binomial (two-sided) test of a proportion.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 - 70 years
* Karnofsky status ≥ 70%
* Diagnosis of Multiple Myeloma
* Within 9 months of the start of induction chemotherapy and no evidence of relapse or progression.
* Availability of Cryopreserved peripheral blood stem cells with a CD34 dose of at least 2x106/kg.

Exclusion Criteria:

* Poor cardiac function: left ventricular ejection fraction \<40%
* Poor pulmonary function: FEV1, FVC, or DLCO \<40% predicted
* Poor liver function: bilirubin \>2.5 mg/dl (not due to hemolysis, Gilbert's or primary malignancy), AST/ALT \> 3X ULN
* Poor renal function: Creatinine \>2.0 mg/dl or creatinine clearance \< 40 mL/min (calculated creatinine clearance is permitted)
* Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
* Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception
* Patients who have any debilitating medical or psychiatric illness which would preclude their giving informed consent or their receiving optimal treatment and follow-up.
A Scoring System for Difficult Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is the treatment of choice for gall bladder stone disease. Difficult laparoscopic cholecystectomy (LC) is the most common "difficult" surgical procedure performed today, which possesses the potential to place the patient at significant operative risk.The aim of this study was to put a scoring system to avoid difficult laparoscopic cholecystectomy.

Patients with symptomatic chronic calculous cholecystitis based on clinical and radiological correlation undergoing elective laparoscopic cholecystectomy at Assiut University hospitals will be included for the study of 100 patients will operated by single experienced laparoscopic surgeon.The scores are given on history, clinical examination and radiological findings one day prior to surgery on admission.

Eligibility Criteria:
Inclusion Criteria:

* Adults male and female age of or above 18 years
* Symptomatic chronic calculous cholecystitis
* Ultrasound confirmed Gall bladder stones

Exclusion Criteria:

* Complicated chronic calculous cholecystitis
* Malignant Gall bladder
Implant Placement in the Preserved Socket Using Socket Shield Technique With Autogenous Dentin Graft Versus Preserved Socket Using Socket Shield With Alloplast

Alveolar bone resorption and labial bone plate reduction follow teeth extraction due to the deficiency of blood supply, derived from the loss of periodontal ligaments, and hence the socket shield technique with Bone graft was introduced to preserve the periodontal ligaments related perfusion and preserve socket dimensions for new bone formation.

This study aims to compare implants placed in two differently preserved sockets, the first one preserved using Socket Shield technique with Autogenous Dentin Graft while the other socket preserved using socket shield technique with Alloplastic bone graft material


Eligibility Criteria:
Inclusion Criteria:

* One or more of non-restorable (fractured or decayed) tooth/teeth in the upper aesthetic regions (incisors, premolars).
* Intact labial/buccal periodontal tissues.
* Sufficient bone volume to allow placement of an implant.
* Non-Smoker
* Ability to read and sign an informed consent form

Exclusion Criteria:

* A medical history that contraindicates oral surgical treatment (uncontrolled/untreated diabetes mellitus, immunocompromised status,current radio/chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous amino-bisphosponates).
* Untreated periodontal disease. \[15,18\]
* Vertical root fractures on the buccal aspect. \[26\]
* Tooth /teeth with horizontal fractures below bone level. \[26\]
* Tooth /teeth with external or internal resorptions.
Carboxyamidotriazole in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of carboxyamidotriazole in treating patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.

OBJECTIVES:

* Determine the clinical outcome in patients with ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with carboxyamidotriazole.

OUTLINE: Patients receive oral carboxyamidotriazole daily beginning on day 1. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 19-40 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer
* Measurable disease by physical exam, radiography, peritoneoscopy, or laparoscopy

  * No more than 4 weeks since prior peritoneoscopy
* No brain metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 4 months

Hematopoietic:

* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.0 g/dL AND/OR
* Hematocrit at least 27%

Hepatic:

* SGOT/SGPT no greater than 3 times upper limit of normal
* Bilirubin normal

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 50 mL/min

Cardiovascular:

* No history of symptomatic cardiac dysrhythmias requiring medication
* At least 6 months since prior myocardial infarction
* No unstable or newly diagnosed angina

Pulmonary:

* No obstructive lung disease requiring oxygen therapy

Other:

* Not pregnant or nursing
* HIV negative
* Must be able to take oral medication
* No concurrent medical condition (e.g., impending bowel obstruction)
* No grade 2 or greater residual peripheral neuropathy
* No active infection
* No other prior or concurrent invasive malignancy within the past 5 years
* No history of acute visual loss other than that associated with retinal detachment

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior cytokine therapy
* No concurrent cytokine therapy to maintain WBC count

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, carboplatin, or mitomycin)
* No other concurrent chemotherapy

Endocrine therapy:

* At least 4 weeks since prior hormonal therapy
* No concurrent corticosteroids at doses greater than physiological replacement doses
* No concurrent hormonal therapy

Radiotherapy:

* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy

Surgery:

* See Disease Characteristics

Other:

* No more than 3 prior treatment regimens
* At least 1 week since prior systemic antibiotics for infection
* No chronic antifungal treatment with antimycotic imidazoles
* No concurrent alternative therapies
Surgical Emergency Flows and Delays in Admission to the Operating Room

French hospitals treat non-elective surgery according to three organizational models: in a dedicated multi-specialty emergency operative room (OR), in a dedicated OR within a specialized surgical platform or in any available OR from a list of non-dedicated OR. Some triage algorithms for the classification of non-elective surgery have been described but are not routinely applied. The rate of delay in the management of non-elective surgery in France is not known. Reducing this delay decreased mortality and morbidity in urgent surgery (McIsaac D, et al., CMAJ 2017). Optimizing the flow of non-elective surgery represents a major challenge. The main objective of this study is to determine the rate of delay in admission to the OR in emergency surgery through a multicenter prospective observational study in France. All patients requiring urgent surgical management (\<72 hours) will be included. The ideal time for surgery was previously defined by surgeons according to the NEST classification (NEST 1: within minutes; NEST 2: \< 1 hour; NEST 3: \< 4 hours; NEST 4: \< 12 hours; NEST 5: \< 48 hours; NEST 6: \< 72 hours). For each patient, the ratio between the observed time (actual Time To Surgery \[aTTS\] ) and the ideal time (ideal Time To Surgery \[iTTS\]) will be determined. The delay is identified by aTTS/iTTS ratio \>1.


Eligibility Criteria:
Inclusion Criteria:

any patient meeting the Following two criteria

* at least 18 ys old
* decision for unplanned surgery (which should be performed within 72 hours according to the protocol)
* in one of the following hospitals: Lille University hospital, Grenoble University hospital, Strasbourg University hospital, Paris University hospitals (Européen Georges Pompidou, Beaujon, H. Mondor), Lyon University hospital (Hôpital E. Herriot, Lyon Sud), Angers University hospital, Anthony Private hospital).

Exclusion Criteria:

* obstetrics
* interventional radiology
* endoscopies
Study of Laparoscopic Radical Hysterectomy Based on Space Anatomy in Patients With IB3 and IIA2 Cervical Cancer

Radical hysterectomy is an effect treatment for FIGO IB3 and IIA2 cervical cancer patients who refuse to receive radical concurrent chemoradiotherapy. However, due to the large tumor size, both patients and surgeons encountered the risk of substantial bleeding, urinary tract damage, and unsatisfactory resection during surgery. Therefore, the exploration of effective and safe surgical treatments is crucial in enhancing the quality of life and prognosis for patients. Laparoscopic radical hysterectomy (LRH) offers the advantages of reduced bleeding and accelerated recovery, thereby minimizing patient discomfort and enhancing their quality of life. However, the prognosis of patients who received LRH or traditional abdominal radical hysterectomy (ARH) remains controversial. We proposed a modified LRH skill based on new space anatomy concept. In our previous single-center study, the result demonstrates that LRH based on space anatomy leads to less intraoperative blood loss and decreased ureteral injury rate compared with traditional skill. The benefits of this new method for patient survival remain uncertain. In this multicenter retrospective study, we aim to assess clinical prognosis and safety of this new LRH compared with traditional abdominal radical hysterectomy (ARH) in FIGO IB3 and IIA2 cervical cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 20 to 70 years
2. Preoperative clinical diagnosis was FIGO 2018 stage IB3 or IIA2 cervical cancer;
3. Patients who received standard Querleu-Morrow type C radical hysterectomy (including ARH or LRH based on space anatomy) and pelvic lymphadenectomy;
4. no preoperative suspected lymph nodes metastasis, parametrial involvement or lower 1/3 vagina involvement.

Exclusion Criteria:

1. patients who had active double cancer or uncontrolled serious concurrent disease that might compromise prognosis;
2. pregnancy;
3. incomplete radical surgery;
4. follow-up time less than 6 months or lost to follow-up
Study of Capmatinib and Spartalizumab Combination Therapy vs Docetaxel in Non-small Cell Lung Cancer

The purpose of this trial was to evaluate the safety and efficacy of capmatinib in combination with spartalizumab in adult participants with epidermal growth factor receptor (EGFR) wild type (for exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK) rearrangement negative in locally advanced (stage IIIB, not eligible for definitive chemo-radiation) or metastatic (stage IV) Non-small cell lung cancer (NSCLC) after failure of platinum doublet and checkpoint inhibitor treatment.

This was a two-part prospectively designed, multicenter, open-label, randomized phase II study.

Part 1: Run-in. Prior to the randomized part of the study, a run-in to assess the safety and tolerability as well as preliminary efficacy of the capmatinib and spartalizumab combination was conducted. Participants were treated with capmatinib 400 mg twice daily (BID) and spartalizumab 400 mg intravenously (i.v.) once every 28 days. A review was planned to take place after all participants had at least 24 weeks of follow-up. The decision to expand the study to the randomized part was to be based on the safety, tolerability, and preliminary efficacy of the capmatinib and spartalizumab combination.

Part 2: Randomized. Subjects were planned to be randomized to one of the following arms in a 2:1 ratio: 1) combination of capmatinib 400 mg BID and spartalizumab 400 mg i.v. once every 28 days; 2) docetaxel 75 mg/m2 i.v. following local guidelines as per standard of care and product labels. Based on the results obtained in the run-in part of the study, the randomized part was not opened.

For the run-in part of the study, the treatment period began on Cycle 1 Day 1 and continued in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of informed consent, pregnancy, lost to follow-up, or death irrespective of start of new anti-neoplastic therapy. After treatment discontinuation, all subjects were followed for safety evaluations during the safety follow-up period, and the subject's status was collected every 8 weeks as part of the survival follow-up

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally advanced/metastatic (stage IIIB/IV), EGFR wild-type, ALK rearrangement negative, non-small cell lung cancer
* Subject had demonstrated progression following one prior platinum doublet and one prior PD-(L)1 checkpoint inhibitor (either alone or in combination, the most recent treatment regimen must have contained a PD-(L)1 checkpoint inhibitor)
* Subjects must be candidates for single agent docetaxel
* Subjects must have at least one lesion evaluable by RECIST 1.1

Exclusion Criteria:

* Prior treatment with a MET inhibitor or HGF (Hepatocyte growth factor) targeting therapy
* Any untreated central nervous system (CNS) lesion
* Use of any live vaccines against infectious diseases within 12 weeks of initiation of study treatment.

Other protocol-defined inclusion/exclusion criteria might apply.
Low Cost Biological Lung Volume Reduction Therapy for Advanced Emphysema

The clinical utility of bronchoscopic methods for achieving lung volume reduction has been evaluated in patients with advanced emphysema because these procedures are uniformly safer than surgical volume reduction. These include one-way valves, or bronchial occlusive devices to collapse emphysematous regions of lung and bronchial fenestration with bypass stents to improve expiratory flow, wire coils implants that compress the airway and thermal vapor ablation that causes an acute injury with subsequent fibrosis and reductions in volume.

Biologic lung volume reduction (BioLVR): it is a novel endobronchial approach, which uses a Biological agents aiming to reduce lung volume by blocking off the most emphysematous areas with a rapidly polymerizing sealant. The mechanism of action involves resorption atelectasis from airway occlusion, subsequent airspace inflammation, and then remodeling. This remodeling will lead to scarring that induces contraction of lung parenchyma and functional volume reduction can be expected within 6-8 weeks. Biological lung volume reduction occurs independent of the presence or absence of collateral ventilation.

Eligibility Criteria:
Inclusion Criteria:

1. Emphysema determined by HRCT of the chest with:

   * .Persistent symptoms (i.e. a baseline Modified Medical Research Council dyspnea (MRC) score of \>2 despite medical therapy).
   * FEV1 /FVC \< 70% and FEV1 20%-50 % (Sever and very sever airflow limitation according to GOLD 2013).
   * Hyperinflation (total lung capacity (TLC) \> 110% pred and residual volume/total lung capacity (RV/TLC) \> 120% pred.
2. Patients not candidate for or had refused lung volume reduction surgery.
3. Age \> 40 yrs.

Exclusion Criteria:

1. Airflow limitation with FEV1 \< 20%.
2. DLCO \< 20%.
3. Current smoker.
4. Patients not candidate for FOB.
Endoscopic Retrograde Cholangiopancreatography In Patients Older Than 65Years Old With Obstructive Jaundice: Efficacy And Outcome

The incidence of pancreato-biliary disorders ,including malignancy, is increasing in elderly patients. Endoscopic retrograde cholangiopancreatography (ERCP) is a well-known therapeutic tool for these pancreato-biliary disorders.

In general, old age is defined as being more than 65 years of age by the World Health Organization. The increase in the domestic aged population is related to the increasing demand for therapeutic ERCP in elderly patients with pancreato-biliary disorders. Common bile duct stones and cancer account for70 % of all jaundice cases in patients over the age of 65 years . This is related to increasing prevalences of cholelithiasis, choledocholithiasis, and malignancy with advancing age .

Endoscopic Retrograde Cholangiopancreatography(ERCP) represents the gold standard technique for the treatment of biliary or pancreatic tract pathology, and it could be often performed with therapeutic intent by realizing procedures such as insertion of bile duct stents and/or endoscopic sphincterotomy. However, evidence about its safety in the elderly is still controversial.

However, therapeutic ERCP is an invasive procedure and is associated with several complications, such as bleeding, pancreatitis, cholangitis, perforation, and mortality. A higher incidence of periprocedural complications might be expected in elderly patients because of the high prevalence of concomitant medical disorders, such as cardiopulmonary and cerebrovascular diseases, and the poor general condition of this population \[8\].

Despite many previous reports of the safety and efficacy of ERCP in elderly patients, in real clinical practice, there is concern regarding complications of ERCP performed in patients more than 65years old. Also comparative reports of the efficacy and safety of therapeutic ERCP, especially inpatients over 65 years of age, are limited. To investigate this issue, we will evaluate the clinical outcomes such as the technical success rate, procedure-related complications rate, and anesthesia-related adverse events rate of therapeutic ERCP in a older aged group (over than 65 years of age) and control group (less than 65 years of age) at a single tertiary center.

Aim of the work This study aims to evaluate the outcome and safety of ERCP in patients with obstructive jaundice over than 65 years of age.

Eligibility Criteria:
Inclusion Criteria:

* patients with obstructive jaundice older than 18 years old

Exclusion Criteria:

* patients who refuse consent
* patients under 18 years old
AI Models for Non-invasive Glycaemic Event Detection Using ECG in Type 1 Diabetics

This observational study aims to recruit up to thirty T1DM patients from a diabetic outpatient clinic at the University Hospital Coventry and Warwickshire for a two-phase study. The first phase involves attending an inpatient protocol for up to thirty-six hours in a calorimetry room at the Human Metabolism Research Unit under controlled conditions, followed by a phase of free-living, for up to three days, in which participants will go about their normal daily activities without restriction. Throughout the study, the participants will wear commercially available wearable sensors to measure and record physiological signals (e.g., electrocardiogram and continuous glucose monitor). Data collected will be used to develop and validate an AI model using state-of-the-art deep-learning methods for the purpose of non-invasive glycaemic event detection.

The study volunteers will be asked to an attend an 'inpatient' facility for up to 36 hrs dedicated to advanced metabolic measurement (HMRU). They will be asked to consume prepared meals of varying macronutrient content as part of a balanced diet, and performed prescribed physical activity. During this time the volunteers will be measured by instrumentation which will investigate the chemical concentration in respired gases (e.g. whole-body calorimeters, metabolic carts); bloods, saliva and urine samples will be taken. If the participant then wishes, we will ask them to continue to wear the wearable devices in a home setting for a maximum one week.

The data derived from this study will allow new tools and mathematical models to be developed that can be used to analyse and simulate patient metabolic response. It is envisaged this study will give further evidence to support future research into glucose utilisation in diseased metabolic populations.

Eligibility Criteria:
Inclusion Criteria:

The study will be open to all individuals living independently, over 18 years without acute illness or ongoing clinical investigation, or volunteers with a stable medical condition may be included. Volunteers with an ongoing medical condition will only be included after detailed consultation with our clinical and dietetics members of the team; however, it is imperative that volunteers are able to provide written informed consent.

Exclusion Criteria:

Whilst the study employs a deliberately open inclusion criterion, the following exclusion measures will be employed:

* Children (under 18 yrs)
* Any adult who lacks decisional capacity
* Claustrophobia, isolophobia, recent abnormal exercise, radiation exposure within the preceding 24 hours of entering the whole-body calorimeter and feeling unwell in any way.
* Needle phobia
* Any medical/endocrine problem that could affect energy expenditure (e.g. thyroid problems, Cushing's syndrome)
* Chronic inflammatory disorders like rheumatoid arthritis, or long term use of steroids or other immunomodulators like cyclosporine, azathioprine.
* Beta blockers
* Currently actively losing weight
* Depression or any psychiatric illness