cyrilzakka/clinical-trials huggingface dataset:
Combination Chemotherapy in Patients With Zollinger-Ellison Syndrome and Tumors of the Pancreas

Patients with Zollinger-Ellison Syndrome suffer from ulcers of the upper gastrointestinal tract, higher than normal levels of gastric acid, and tumors of the pancreas known as non-beta islet cell tumors.

Prior to the use of drugs to cure the ulcers, patients typically died due to severe ulcers. Because of such effective drugs to treat the ulcers it is more common to see patients dying due to the pancreatic tumors.

The study will observe patients suffering from Zollinger-Ellison Syndrome and non-beta islet cell tumors and determine the effectiveness of combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin.

Heretofore morbidity and risk of death in Zollinger-Ellison syndrome were caused by severe ulcer disease. The advent of specific drugs to cure ulcer disease now extends life until metastases from the non-beta-islet cell tumor cause death. The present study proposes to continue to test the effect of combined chemotherapy with streptozotocin, 5-fluorouracil and doxorubicin in biopsy-proven cases of metastatic non-beta-islet cell tumor in patients with Zollinger-Ellison syndrome. We published our initial experience with this protocol in 1988. An objective response was observed in 40% of patients.

Eligibility Criteria:
INCLUSION CRITERIA

Subjects selected for this study will be patients with Zollinger-Ellison syndrome who are being evaluated under the protocol entitled "Diagnostic Evaluation of Patients with Suspected Abnormalities of Gastric Secretion" (80-DK-0123).

Histologically proven gastrinoma;

Evidence of metastatic disease or locally invasive tumor by angiography, ultrasound, computerized axial tomography, MRI scan or bone scan;

Progression of the tumor during the preceding 6 months.

EXCLUSION CRITERIA

The following pre-existing conditions will exclude patients from the study:

Congestive heart failure;

Proteinuria greater than 1 gram/day;

Serum creatinine greater than 1.5 mg%;

Platelet count less than 100,000/mm3;

White blood count less than 2500/mm3;

Pregnancy.
Gait Training in Patients With Burn Injury

Twenty-four individuals with burn injury will be included in this study. Participants with burn injury will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass index; burn caharacteristics; type of burn injury, degree of burn injury, localization of burn injury and total burn surface area will be recorded. Gait parameters (step length, stride length, base support, step time, cycle time, cadence, velocity, single support, double support, swing ( % of gait cycle) and stance (% of gait cycle). will be recorded via GAITRite system.

Twenty-four individuals with lower extremity burn injury will be included in this study. Participants will be included if they are aged of 18-50, able to walk independently at least 10 meters.

Participants will be divided in two groups; Intervention and control groups. Intervention group: standart rehabilitation program and gait training on the overground will be applied.

Conntrol Group:standart rehabilitation program and gait training on the treadmill will be applied.

Rehabilitation program will applied by physiotherapist during the acute hospitalization. Standart rehabilitation will include active range of motion exercises, functional mobility, balance activities.

Participants will evaluate with the following assessment tools: Demographic datas; age, gender, height, body mass index; burn caharacteristics; type of burn injury, degree of burn injury, localization of burn injury and total burn surface area will be recorded. GAITRite system for gait parameters (step length, stride length, base support, step time, cycle time, cadence, velocity, single support, double support, swing ( % of gait cycle) and stance (% of gait cycle), timed up and go test (TUG) for dynamic balance and six minute walk test (6MWT) for exercise capacity, will be used. These evaluations will be made twice; initial (admission) and final (discharge).

Eligibility Criteria:
Inclusion Criteria:

* participiants who have lower extremity burn injury and able to walk independently 10 meters

Exclusion Criteria:

* f there is a medical condition that prevents the ambulance of the individual and oxygen is needed for ambulance, participants will be excluded.
Comparison of the Effect of A-PRF and L-PRF on Outcomes After Removal of Impacted Mandibular Third Molar

In this study, it was aimed to investigating and comparing the postoperative effects of leukocyte- and platelet-rich fibrin (L-PRF) and advanced platelet-rich fibrin (A-PRF) in terms of pain, swelling on the cheek, and trismus after mandibular third molar surgery. The study included a total of 27 patients with bilateral impacted mandibular third molar which surgically operated at different times. Patients were evaluated in two randomly separated groups. For the first group; A-PRF and for the second group; L-PRF was applied into the tooth socket. The outcomes variables were; pain, swelling, the number of analgesics taken, and trismus. These variables were also assessed on the basis of; 1st, 2nd, 3rd and 7th days following the operation.


Eligibility Criteria:
Inclusion Criteria:

* age≥18
* the presence of bilaterally symmetrically impacted mandibular third molar, which requires an extraction for prophylactic reasons
* absence of systemic diseases
* absence of chronic opioid taken;
* not being pregnant
* not smoking and no alcohol usage
* the absence of allergy to penicillin or any other drugs used during standardized postoperative therapy.

Exclusion Criteria:

* tooth needed to be sectioning during the operation
* operation time exceeding 30 minutes
* the cases with severe periodontal disease or acute pericoronitis,
* the cases using antibiotics for an existing infection
* the cases not capable of following postoperative instructions
Hyperbaric Oxygen Therapy for Acute Domestic Carbon Monoxide (CO) Poisoning

Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric oxygen therapy (HBO) remain controversial. This study aimed at comparing one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy to 6 hours of normobaric oxygen therapy in adult victims of acute domestic carbon monoxide poisoning and without coma.


Eligibility Criteria:
Inclusion Criteria:

* patients older than 15 years of age
* admitted for domestic CO poisoning within 12 hours after the end of CO exposure.
* had transient loss of consciousness (syncope, malaise)
* carboxyhemoglobin level at presentation \>10% or 5%, in smokers and non-smokers, respectively.

Exclusion Criteria:

* poisoning by more than one compound (e.g., CO plus a drug or CO plus other toxic gases such as those found in fire smoke
* suicide attempt
* pregnancy
* coma
* contraindications to HBO (circulatory collapse or pneumothorax)
* technical obstacles to HBO
* non domestic CO poisoning
* difficulty in determining whether the patient experienced initial loss of consciousness or initial coma
* consent refusal.
directSTIM Deep Brain Stimulation System Study

The purpose of this study is to obtain clinical outcome data on safety and effectiveness of the directSTIM DBS system when used on-label, according to the instructions for use.

All participants will undergo bilateral implant in the subthalamic nucleus (STN) and data collected in common practice will be recorded during six months post-implant and analyzed.

directSTIM DBS Therapy for Movement Disorders is indicated for patients with disabling tremor or symptoms of Parkinson's disease.

Subjects selected to participate in the study will be Parkinson's Disease (PD) patients who are eligible for bilateral DBS for STN therapy and meet the inclusion criteria and none of the exclusion criteria.

Primary safety and effectiveness endpoints data will be collected through 6 months of follow-up. The values used for comparison are derived from a review of literature spanning from 2001 to 2019.

After completing the 6 month follow-up, subject will exit the study, and continue to be followed by their physician per usual care.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of idiopathic Parkinson's Disease for 4 years or more according to the United Kingdom Parkinson's disease Brain Bank criteria, with disabling motor complications despite optimal medical treatment.
* Patient is eligible for bilateral DBS for STN therapy according to center's routine criteria and according to the directSTIM DBS system Indications for Use statement.
* Patient who is willing to provide a written informed consent.
* Patient complies with the study follow-up, in particular the follow-up visits, and other study requirements.

Exclusion Criteria:

* Patient is not eligible for DBS per center criteria.
* Patient has a cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to complete study assessments, such as:

  * Active major psychiatric disorder.
  * Dementia (MoCa Dementia Rating Scale score \<26 or otherwise not capable of discernment).
  * Presence of an electrical or electromagnetic implant (e.g. cochlear implant, pacemaker).
  * Previous surgery for the treatment of Parkinson's disease.
  * Previous brain ablation procedure.
  * Epilepsy.
  * Coagulopathies.
  * Abuse of drugs or alcohol.
* Patient is participating in another clinical study that would confound data analysis.
* Patient is pregnant or nursing. As for other DBS systems, the effects of the device on an unborn child are not established.
Dynamic Cardiac SPECT Imaging

The investigators propose a 4 year prospective, observational study of 40 patients yearly, comparing conventional clinically indicated SPECT and PET perfusion with dynamic rest/stress MPI studies with coronary angiography, in some cases performed with quantitative coronary anatomy and flow as well as quantitative 13N-ammonia PET MPI. Methods will also be assessed for their ability to determine myocardial viability by comparing regional wall motion (WM) on clinically indicated serial ventriculography, echocardiography or gated SPECT MPI in those protocol patients with WM abnormalities who subsequently undergo revascularization. Patient studies will begin in the first study year based on those methods already developed and integrate new advances as they become evident.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have had clinically indicated stress MPI with a low pre-test likelihood (0 - 15% ) of coronary disease based on the criteria of Diamond and Forrester.
* Patients who have already had a clinically indicated stress MPI in the last three years with a low likelihood of having active coronary disease with no significantly narrowed coronary arteries.
* Patients whose clinically indicated stress MPI demonstrates clear abnormalities and who are likely to go on to SCA for clinical indications.
* If, after conventional and dynamic MPI some of these patients do not have SCA, they will still be followed for events for up to 3 years following participation in the protocol. To avoid delays and unnecessary procedures among patients in Group II who will have the dynamic imaging protocol studies after SCA, patients will be selected for protocol enlistment only if the decision is made by the patient's physician, based totally on clinical and social factors, that any considered revascularization intervention would not be performed on the day of diagnostic SCA and will be performed electively, at least 4 to 7 days later.
* Patients found at SCA to have lesions of "borderline" clinical significance, preferably in the absence of other associated lesions.

Exclusion Criteria:

* Cannot give informed consent
* Unable or unwilling to return for a second stress imaging study
* Cannot cooperate for adequate SPECT or PET supine and/or prone imaging
* Pregnant females
* Patients under 21 years old
* Active bronchospasm - No theophylline for 48 hours prior to study
* Heart block more severe than Wenckebach block
* Patients with uncomplicated infarction will not be included if they cannot have an exercise test later than 8 weeks of the event or a vasodilator pharmacologic stress test at least 24 hours or more after the event
* Coronary bypass surgery within 8 weeks
* Symptoms of congestive heart failure at rest
* Has had an event or change in drug regimen since the initial stress test.
* Has serious response to or side effect from initial clinical stress test induced ST elevation, hypotension, prolonged arrhythmia, bronchospasm.
* Has had a clinical event since last coronary angiogram, angioplasty, or coronary surgery.
* Has had 201Tl rest SPECT MPI prior to dynamic imaging
Prospective Longitudinal Observational Research in Atopic Dermatitis

Atopic dermatitis (AD) is a frequent chronic relapsing inflammatory skin disorder, characterized by intensely itchy eczema. AD usually starts within the first 2 years of life. In 30 - 60% of children, inflammation spreads onto other body surfaces such as the gastrointestinal tract, the respiratory tract, and the conjunctives within a few years. This sequence is called atopic march.

Atopic dermatitis and associated atopic diseases are more frequent in families, suggesting a genetic predisposition. However, the underlying factors such as genetic phenotype, environmental factors, or life style which cause or worsen an existing allergic disease are not understood yet. Affected people suffer from recurrent flares that result in significantly impaired quality.

This study will collect clinical and laboratory data to elucidate immunotolerance and preventiv stategies with the aim to develop new and individual treatment options of atopic diseases.

Primary Objetive:

In the planned project, the main objective is to identify endogenous (e.g. immunological and molecular factors) and exogenous factors (e.g. environmental, socioeconomic and microbial factors) that influence the course and remission of AD. More specifically to identify factors that are significantly different between patients that have or do not have remission from AD.

Secondary Objective:

(i) To identify endogenous and exogenous factors such as immunological, molecular and microbial factors to separate subgroups of patients (endotypes) with distinct local and systemic inflammatory responses.

(ii) To identify potential biomarkers predicting the individual clinical course of AD and other atopic diseases including asthma, food allergy and allergic rhinitis.

Eligibility Criteria:
Inclusion Criteria:

* Age 0 - 85 years
* Diagnosis of AD and/or another disease of the atopic group (i.e. allergic rhinitis, allergic asthma, food allergy)
* The inclusion of patients in this study is independent from the current therapy. During the study all patients will be kept on a therapy that is medically indicated

The inclusion criteria for healthy controls in this study are as follows:

* Age 0 - 85 years
* No diagnosis or history of allergic disease
* The inclusion of patients in this study is independent from the current therapy. During the study all patients will be kept on a therapy that is medically indicated

Written consent will be obtained after detailed information of the study was given to the participant.

Exclusion Criteria

- Unable to give consent or refusal to participate in the study
TIPS vs. NSBB Plus Endotherapy for the Prevention of Variceal Rebleeding in NSBB Non-responders of Primary Prophylaxis

Variceal bleeding (VB) is a life-threatening complication of cirrhosis with a 6-week mortality of approximately 15%-20%. The 1-year rate of recurrent VB is approximately 60% in patients without prophylaxis treatment. Therefore, all patients who survive VB must receive active treatments to prevent rebleeding. Usually, these patients are submitted to rebleeding prophylaxis with endoscopic band ligation (EBL) combined with non-selective beta-blockers (NSBB). Transjugular intrahepatic portosystemic shunts (TIPS) are reserved for those who failed endoscopic plus medical treatment.

A recent meta-analysis comparing combination therapy to monotherapy with EBL or drug therapy has demonstrated that combination therapy is only marginally more effective than NSBB alone. This suggests that NSBB is the cornerstone of combination therapy. The lowest rebleeding rates are observed in patients on secondary prophylaxis who are hepatic venous pressure gradient (HVPG) responders (defined as a reduction in HVPG below 12 mm Hg or \> 20% from baseline). A recent study demonstrated that patients who have their first episode of variceal bleeding while on primary prophylaxis with NSBB have an increased risk of further bleeding and death, despite adding EBL. These patients possibly require alternative treatment approaches, such as TIPS.

The aim of the present study was to compare the effect of TIPS vs. EBL + NSBB for the prevention of rebleeding in NSBB non-responder for primary prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of liver cirrhosis
* Standard NSBB therapy was used for primary prophylaxis
* At least 5 days after index variceal bleeding
* Child-Pugh score \<13, Model for end-stage liver disease score \< 19

Exclusion Criteria:

* Gastric variceal bleeding (GOV2，IGV1，IGV2)
* History of shunt surgery
* Degree of portal vein thrombosis \> 50%
* Refractory ascites
* Budd-Chiari syndrome
* Hepatocellular carcinoma or other malignant tumors
* Uncontrolled infection
* HIV
* Pregnant or breast-feeding woman
* Poor compliance
Non-interventional Observational Study on WHO-5 Questionnaire Application in Parkinson's Disease

To assess the predictive value of sequential administration of WHO-5 and MDI (Major Depression Inventory) for the clinical management of Parkinson Disease (PD) patients by

* determination of the prevalence of depression in PD patients, based on MDI severity categories and the self-rating scale WHO-5, where poor well being was indicated.
* exploration of influencing factors (PD status, therapeutic status) on the prevalence of MDI depression categories.


Eligibility Criteria:
Inclusion Criteria:

1. PD patients attending one of the participating neurologist practices during 2 fixed weeks in November 2008
2. Idiopathic PD with or without fluctuations
3. Male or female PD patients aged at least 30
4. Ability to reliably complete self-rating scales (WHO-5, MDI) ), according to the physician's judgement.
5. Written informed consent by the patient for study participation.

Exclusion Criteria:

1. PD Patients who only attend the practice to get a prescription and are not seen by the doctor on that day
2. Patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems).
A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer

The purpose of this study is to determine whether treatment with ZACTIMA (vandetanib) in combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients who have failed therapy with an irinotecan and fluoropyrimidine containing regimen.


Eligibility Criteria:
Inclusion Criteria:

* Progression on or following treatment for metastatic colorectal cancer
* Have failed therapy with an irinotecan and fluoropyrimidine containing regimen
* Have World Health Organisation (WHO) performance status 0-2 and life expectancy \>12 weeks

Exclusion Criteria:

* Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR Prior monoclonal antibodies are permitted, (eg, cetuximab, bevacizumab)
* Previous adjuvant therapy with irinotecan within 12 months of randomisation
* More than one prior course of chemotherapy for treatment of metastatic colorectal cancer
A Study to Assess BMS-986207 in Combination With Nivolumab and Ipilimumab as First-line Treatment for Participants With Stage IV Non-Small Cell Lung Cancer

The purpose of this study is to determine the safety and efficacy of BMS-986207 in combination with nivolumab and ipilimumab as first-line treatment for participants with stage IV non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic 1L Stage IV non-small cell lung cancer (NSCLC) of squamous or nonsquamous histology
* No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic NSCLC
* Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or a minimum of 20 unstained slides of tumor tissue obtained during screening or prior to enrollment
* Life expectancy of at least 3 months at the time of first dose

Exclusion Criteria:

* Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutations which are sensitive to available targeted inhibitor therapy. Participants with nonsquamous histology and unknown EGFR, ALK, or ROS-1 status are also excluded
* Participants with known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF) V600E mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown or indeterminate BRAF mutation status are eligible.
* Untreated central nervous system metastases
* Leptomeningeal metastases (carcinomatous meningitis)
* Concurrent malignancy requiring treatment
* Active, known, or suspected autoimmune disease
* Interstitial lung disease
* Uncontrolled or significant cardiovascular disease

Other protocol-defined inclusion/exclusion criteria apply
Gender Differences of Neuroanatomical and Neurophysiological Correlates of Risk-proneness in Early Adolescents

Risk-taking in early adolescence have has been found to be normative and even formative as it might fulfill the youth's needs to experiment different sensations, make independent decisions and learn from their consequences. Several theoretical models have suggested that male and female adolescents differ in risk-taking as a product of individual/contextual factors and neocortical functioning; however, the neurophysiological and neuropsychological correlates of those differences continue to be underexplored. Informed by Evolutionary Neuroandrogenic Theory, the investigators examine the links between gender, risk-proneness, gratification delay, self-control, self-efficacy, executive functions and neurophysiological-neuroanatomical correlates in early adolescents (age 10-12 years). Participants (N=24; 50% females) will complete behavioral measurements on study constructs and perform neuropsychological tests using fMRI scanning (e.g., Go/NoGo continuous performance, stop-signal reaction time, NIH Cognition Battery, delay discounting). Female and male groups will be compared on all outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Early adolescents (age 10-12 years)
* Male and female

Exclusion Criteria:

* Gross impairment of vision or hearing that would prevent the participants from performing neuropsychological tasks
* Inability to read and follow written instructions
* WISC-V IQ score of \< 80
* Physical, neurological or concurrent psychiatric impairments that could affect cognitive and motor functions
* Regular intake of medication that could alter visual, auditory, cognitive or motor functions
* History of head injury that resulted in loss of consciousness / history of brain surgery
* Current / past history of smoking and / or alcohol or drug abuse
* Absolute contraindications to undergo MRI