cyrilzakka/clinical-trials huggingface dataset:
A Longitudinal Study of Multimodal Resonance Imaging in Stroke Patients

Imaging of the ischaemic penumbra with a particular diffusion-weighted imaging (DWI)/ perfusion-weighted imaging (PWI) mismatch is a promising approach to the selection of patients with acute ischaemic stroke for trials of intervention. The investigators want to apply multimodal resonance imaging methods such as functional magnetic resonance imaging ( fMRI), diffusion tensor imaging (DTI), arterial spin labeling (ASL) to guide treatment and predict the prognosis of stroke.


Eligibility Criteria:
Inclusion Criteria:

Time from the onset of stroke till hospital within 24 hours. With clinical characteristics such as hemiplegia, headache. Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Patients must understand the nature of the study and give informed consent.

Exclusion Criteria:

The onset of stroke out of 24 hours. Pregnant women. Patients with intracranial metallic bodies from prior neurosurgical procedure, implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit or ventriculoperitoneal shunt.

Past history of seizures within one year or unexplained loss of consciousness. Family history of epilepsy.
Intensification Therapy of Mature B-ALL, Burkitt and Burkitt Like and Other High Grade Non-Hodgkin's Lymphoma in Adults

All patients are treated according to the same therapy regimen. Therapy duration (number of cycles) and radiotherapy vary according to age group, stage and response. Chemotherapy consists of a pre-phase-treatment (for all patients) and varying A, B and C cycles. Therapy for Patients in the 18-55 Age Group

* Patients in stages III-IV and all patients with mediastinal tumors or extranodal involvement are administered 6 cycles (A1, B1, A2, B2, A3, B3).
* Chemotherapy is stopped after 4 cycles (A1, B1, A2, B2) for patients with stage I/ II if a clear CR has been achieved and there is initially no mediastinal or extranodal involvement.
* In cases of refractory or progressive disease after 4 cycles, study therapy is stopped. These patients are to be given salvage therapy with subsequent stem cell transplantation. Therapy for Patients older than 55 years
* The course corresponds to that of patients in the younger age group, but the regimen is dose reduced (A1\*, B1\*,A2\*, B2\*, A3\*, B3\*). Antibody therapy with anti-CD20 is to be administered on day 1 of each chemotherapy cycle (A, B). After end of chemotherapy (6 or 4 cycles) 2 more cycles of anti-CD 20 are to be administered to reach a total number of 8 resp. 6 cycles antibody therapy.


Eligibility Criteria:
Inclusion Criteria:

* Acute lymphoblastic leukemia of the mature B-cell type (L3-ALL)
* High-grade non-Hodgkin's lymphoma of the following subtypes (WHO classification)

  * Burkitt's lymphoma (including atypical Burkitt's lymphoma)
  * Precursor B-lymphoblastic lymphoma
  * Anaplastic large-cell lymphoma (Ki1+, B-, T- oder Null-cell-type)
  * Mediastinal large B-cell-lymphoma (subtype of diffuse large B-cell lymphoma)
* Age = 18 years
* Patient's Informed Consent

Exclusion Criteria:

* Serious complications caused by leukemia/ lymphoma or by a second illness: e.g.

  * Severe, unmanageable complications such as sepsis, pneumonia with oxygen deficiency,
  * Shock, hemorrhage at the time of diagnosis
  * Renal insufficiency from leukemia/lymphoma-unrelated causes
  * Severe cardiac or hepatic insufficiency
  * Severe obstructive or restrictive lung disease that would compromise patient's treatment with intensified chemotherapy
  * HIV infection
  * Secondary lymphoma following prior chemotherapy/ radiotherapy or an active second malignancy
  * Known severe allergy to foreign proteins
* Cytostatic pretreatment for B-ALL/lymphoma (exceptions: short-term administration of steroids = 7 days, single administration of vincristine or cyclophosphamide, one cycle of CHOP, a single administration in an emergency of other cytostatic agents) for another malignant disease within the last 5 years
* Pregnancy/ nursing period
* Severe psychiatric illness or other circumstances giving ground to the assumption that a patient cannot give his consent to therapy or act co-operatively
* Absence of patient's informed consent
* Participation in another clinical study that would possibly interfere with study therapy
Evaluation of a Cone-beam CT Scanner for Image Guided Radiotherapy

This is a feasibility study investigating the image quality of a new, high-performance cone beam CT (CBCT) used for on-couch imaging during radiotherapy treatments.

This study will examine the image quality generated by a new cone-beam CT (CBCT) imaging system integrated into an external beam radiation treatment delivery platform. Normally, CBCT images are acquired at the start of a daily radiation delivery treatment to align the patient with the images that were used to generate their radiation treatment plan. This alignment increases the precision of radiation delivery. This study will assess whether the improvements in image quality expected from the novel CBCT imaging system are sufficient for the images to be used for more than just patient alignment.

The study will enroll patients who will be treated with external beam radiation therapy for the following conditions: head and neck cancers, stage I lung cancer, stage II to IV lung cancer, cancer in the left breast, tumors in the abdomen, and tumors in the pelvic region. Each patient will undergo one additional imaging session with the novel CBCT imaging system during which 1 or 2 CBCT images will be acquired. The number of novel CBCT images acquired depends on the location and type of the patient's tumor. The additional imaging session will occur on the same day as one of the patient's scheduled treatment delivery sessions to minimize impact on the patient's schedule.

The patient's cancer treatment will not be affected by participation in this study. The methodology for the subject's treatment setup, CT simulation, treatment planning, image guidance and treatment delivery will be determined by the subject's treatment team.

The images acquired by the novel CBCT imaging system will be compared to standard CBCT images acquired as part of the patient's treatment and to the CT simulation images used to define the patient's radiation treatment plan.

Eligibility Criteria:
Inclusion Criteria:

* The patient will be treated with external beam photon radiotherapy at Maastro for head-and-neck cancer, stage I lung cancer, stage II-IV lung cancer, left breast cancer, or tumours in the abdominal or pelvic region.
* Age ≥ 18 years
* Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician
* Provision of written informed consent

Exclusion Criteria:

* Patient is pregnant
Cohort Construction and Prognostic Model Construction for Multiple Myeloma

Multiple myeloma (MM) is a disease caused by malignant plasma cell proliferation disorder. Survival outcomes continue to vary widely even within uniformly treated clinical trial populations. How to construct a clinical prognosis model of MM through real-world data to guide the selection of treatment options, standardize patient management, and improve survival expectations, is a major problem that needs to be solved urgently. It is necessary to build an MM-specific cohort in China to comprehensively understand the characteristics of MM patients, explore treatment options, and improve prognostic factors for survival outcomes.


Eligibility Criteria:
Inclusion Criteria:

Patients were diagnosed as multiple myeloma from January 1, 2008 (the diagnostic criteria are based on "Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (Revised in 2020)").

Exclusion Criteria:

Long-term follow-up information for patients is not available for any reason, such as not being available or having a serious concomitant disease.
Bioavailability of BIBR 953 ZW Under Influence of Food in Healthy Subjects

Study to investigate the relative bioavailability of BIBR 953 ZW after administration of a 150 mg BIBR 1048 HPMC (hydroxypropylmethylcellulose) capsule versus BIBR 953 ZW after administration of a 150 mg BIBR 1048 gelatine capsule, and to investigate the relative bioavailability of BIBR 953 ZW given as BIBR 1048 MS HPMC capsule with food versus without food.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with GCP and local legislation
* Age ≥ 18 and ≤ 55 years
* BMI ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion Criteria:

* Any finding at the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* History of or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* History of relevant orthostatic hypotension, fainting spells and blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of:

  * allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  * any bleeding disorder including prolonged or habitual bleeding
  * other hematologic disease
  * cerebral bleeding (e.g. after a car accident)
  * commotio cerebri
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
* Use of any drugs that might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within 2 months prior to administration or during trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the clinically accepted reference range
* History of any familial bleeding disorder
* Thrombocytes \< 150000/μl
Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting in Ambulatory Surgery

To evaluate the Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting (PONV) in Ambulatory Surgery.

Prospective, randomized, comparative study.

The disease to be studied is Postoperative Nausea and Vomiting (PONV). PONV, described by some as "The Big Little Problem", has a great impact on patient´s satisfaction and the postoperative care needed. Considering the increase of outpatient surgery there is an expanding demand for effective PONV treatment to prevent delays in discharge or unplanned readmissions. The estimated annual costs of PONV in the U.S. per year are 100 million Dollars.

Approximately 75 million patients are anesthetized in the world annually. It is estimated that 20-30% of these patients experience PONV, reaching 80% in patients at high risk. This incidence of PONV has maintained despite the improvement in surgical and anesthetic techniques and advances in antiemetic pharmacology. Increasingly, acupuncture is becoming part of Western medicine as a complementary treatment. Acupuncture has been described to effectively reduce the symptoms of different diseases, including PONV.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, aged 18 years and older.
* ASA I-II patients who will undergo a surgical procedure under general anesthesia in an ambulatory setting.
* Patients who are anticipated to not require admission to the recovery room or intensive care unit.
* Patients who, according to clinical criteria of the acupuncturist physician, are likely to benefit from acupuncture.
* Patients with a sufficient educational level to complete the health questionnaires required in the study.
* Patients who have given their written informed consent to participate in the study.

Exclusion Criteria:

* Patients with any pathology that under medical discretion makes their participation in the study inadvisable.
* Patients who cannot respond to the questionnaires provided during the study.
* Patients with known hypersensitivity to the materials of the ear seeds.
Evaluating the Impact of a Photoaging App Versus School-Based Educational Intervention on Adolescents' Knowledge, and Attitudes Towards Tobacco Use

Tobacco use is a leading cause of preventable morbidity and mortality worldwide. It has been estimated that by 2030, tobacco use will cause approximately 10 million deaths per year worldwide, with 70% of those occurring in low- and middle-income countries. Oman, a country in the Arabian Peninsula, is not immune to this global health problem. Tobacco use is prevalent among young people in Oman, and efforts to prevent and control tobacco use among youth are a public health priority.

This study employs a cluster randomized controlled trial design to assess the impact of a photo-gaining app versus a structured educational intervention on tobacco knowledge and attitudes among adolescents in Sohar, Oman. Boys' public schools serve as clusters, with students in grades 9 to 12 as participants. Schools are randomly assigned to either an intervention or control group. The intervention, facilitated by medical students trained at a local university, involves using the SmokerFace App to demonstrate the effects of smoking via photo-aging technology. The control group receives a standardized educational module endorsed by the World Health Organization. Primary outcomes focus on comparing tobacco knowledge levels between groups, while secondary outcomes examine attitudes towards tobacco use. Pre-intervention and post-intervention assessments are conducted using the modified WHO Global Youth Tobacco Survey. Randomization is implemented in two stages to ensure balance, and efforts are made to maintain blinding among outcome assessors and data analysts.

The proposed study is a cluster randomized trial aimed at evaluating the impact of a photo-aging app versus structured educational intervention on knowledge and attitude towards tobacco use and tobacco consumption habits among Omani adolescents. The results of this study will be important for developing effective strategies for preventing tobacco use among youth in Oman and other countries with similar socio-cultural contexts.


Eligibility Criteria:
Inclusion and Exclusions Criteria:

All Boys' public schools in Sohar, North Al-Batinah Region, from classes 9 to 12, were included in the study. Girls' schools as well as parents and students who declined participation were excluded from the study.
Spinal Manipulation and Neuromuscular Performance on Amateur Cyclists

The present study aims to assess the effects of spinal manipulation therapy on neuromuscular performance.

The present study will follow a parallel, pre-post design. The aim will be to determine the acute effects of spinal manipulation therapy (SMT) on different neuromuscular properties of recreational cyclists. Specifically, the investigators will measure the maximum force production capacity and muscle activation of the knee extensors concomitantly during a maximal voluntary contraction, as well as the maximum and mean power attained during a Wingate cycling test (i.e., 30 seconds 'all out'). Participants will undergo the tests on two different occasions separated by at least 48 hours and a maximum of 2 weeks. The same tests will be conducted in both testing sessions, but participants will be randomly assigned into two groups (sham or actual SMT) immediately before the second testing session.

Eligibility Criteria:
Inclusion Criteria:

* Will be recruited from three different local triathlon and cycling clubs.
* Will have to cycle at least 4 hours per week during the preceding 3 months, and to have a cycling experience greater than 2 years

Exclusion Criteria:

* Having suffered an injury in the month before the study that precluded regular exercise practice
* Having suffered any type of spine injury before the study
* Having previously received Spinal Manipulation Therapy
Epidemiology of Blood Pressure, Insulin, Salt Transport

To determine the roles of insulin, lipids, body weight and ion transport in blood pressure regulation.

BACKGROUND:

Insulin levels are consistently related to blood pressure, obesity, and blood lipids. Insulin level correlation with sodium-lithium countertransport is limited to only one available study done in white, normotensive, predominantly normal weight women aged 45-52. The relationship between cellular sodium-hydrogen exchange activity and hypertension has been studied in rats and in a small study in humans. Correlation of this transport with weight, fasting insulin and lipid levels, and sodium-lithium countertransport was not available in 1989.

DESIGN NARRATIVE:

The study was cross-sectional. Subjects were stratified by weight: plus or minus 10 percent of desirable weight; 11 to 30 percent over desirable weight; and 30 percent over desirable weight; and by diastolic blood pressure: 80; 80-89; 90-99 mmHg. Blood pressure, height, weight, waist and hip girth, skinfold, fasting and post-glucose load insulin, glucose, lipids, creatinine, maximal rates of red blood cell sodium-lithium countertransport and platelet sodium-hydrogen exchange, pH, and calcium concentrations were measured. The strength and independence among these continuous variables were measured by Pearson correlations, partial correlations, and multiple regressions within each stratum, and if appropriate, over all strata. The study examined the hypotheses that: part of the relationship between obesity and blood pressure was due to insulin effects and/or lipid effects on ion transport; the relationship between ion transport and blood pressure was related to an abnormality of sodium-hydrogen exchange, for which the observed increase in sodium-lithium countertransport was a marker; increased blood pressure was related to the alteration of intracellular pH and/or calcium concentration.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Impact of Continuing Medical Education (CME) Insulin Program

The purpose of this study is to determine if a continuing medical education (CME) program can change primary care providers' use of insulin therapy - their confidence in selecting doses and engagement of patients in the decision making as to whether to initiate insulin therapy.

We will determine whether attendees' self-reported confidence and use of insulin with persons with type 2 diabetes changes after they attend the CME program. Specifically, we will address the following questions:

Question 1. Clinical guidelines. Is insulin initiated earlier (at a lower A1C)?

Question 2. Decision-making. Does confidence in selecting a starting insulin regimen change? Does confidence in selecting a starting insulin dose change? Does confidence in adjusting insulin change? Does confidence in discussion nutrition guidelines change?

Question 3. Application. Do more patients start using insulin? Who usually selects starting dose? How is starting dose selected? How often is insulin adjusted?

Question 4. Resources. How available are protocols for insulin use? How available is adequate time to monitor insulin therapy? How available is staff to teach insulin injections? How available is staff to help adjust insulin?

Eligibility Criteria:
Inclusion Criteria:

* primary care provider attending CME training

Exclusion Criteria:

-
Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

The purpose of this study is to investigate the safety and efficacy of four concentrations of DE-117 ophthalmic solution.

This is a 28-day randomized, observer-masked, placebo-and active-controlled, parallel-group, multi-center, study investigating the safety and efficacy of four concentrations of DE-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) and placebo (vehicle of DE-117) in subjects with primary open-angle glaucoma or ocular hypertension.

Eligibility Criteria:
Main Inclusion Criteria:

* Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
* Qualifying intraocular pressure in at least one eye at Baseline
* Qualifying corrected ETDRS visual acuity in each eye
* Qualifying central cornea thickness in each eye

Main Exclusion Criteria:

* Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
* Diagnosis of primary open-angle glaucoma or ocular hypertension due to etiology known to be non-responsive to conventional drug therapy
* Evidence of advanced glaucoma, visual field defect or progressive visual field loss that that do not meet the study criteria
* History of ocular surgery specifically intended to lower IOP
* History of any ocular or systemic abnormality or condition that may put the subject at significant risk, may confound study results, or may interfere significantly with the subject's participation in the study
* Intended or current use of any ocular medications other than study medications during the study
* Use of contact lenses within one week prior to Baseline (Day 1) until end of treatment
* Known allergy or sensitivity to any components of the study medications
* Use of steroids (systemic) within 30 days prior to Visit 1 (Screening)
* Anticipate the need to initiate or modify an existing chronic therapy that could substantially affect IOP or the study outcomes during the study period
* Females who are pregnant, nursing or planning a pregnancy