cyrilzakka/clinical-trials huggingface dataset:
Administration of ARS-1 or Albuterol in Subjects With Persistent Asthma

ARS-1 is being developed for patients as a needleless alternative route of epinephrine administration for the management of refractory asthma symptoms.


Eligibility Criteria:
Inclusion Criteria:

* 1. Is a male or female subject between the ages of 12 and 65 years, inclusive.
* 2. Asthma that has been stable for at least four weeks prior to screening as defined by clinical history.
* 3. Reversible bronchoconstriction.
* 4. Has body weight more than 30 kilogram (kg) and body mass index between 18 and 34 kg/m², inclusive.
* 5. Has no medical history of hypertension and cardiovascular disease in the last 10 years.
* 6. At screening, has stable vital signs.

Exclusion Criteria:

* 1. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition.
* 2. Patients receiving beta blocker.
* 3. Has any clinically significant medical condition or physical exam finding as deemed inappropriate by the Investigator.
* 4. Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram.
* 5. Has mucosal inflammatory disorders.
* 6. Has had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening.
Problem Management Plus for Entrepreneurs

Conflict and unrest over three decades has resulted in significant economic decline in Khyber Pakhtunkhwa (KP) and Federally Administered Tribal Areas (FATA) of Pakistan and these now rank among the poorest regions in the country. The 2009-10 insurgency and subsequent security operations affected both regions and displaced an estimated 2 million people. The severe damage to infrastructure and livelihoods negatively impacted the social and economic fabric of the entire region. As peace has returned to the area, the Economic Revitalization of KP and FATA (ERKF) project, established in 2012 and supported by the World Bank, is working for the rehabilitation of small and medium enterprises (SMEs), with the aim of creation and restoration of jobs. This support is in the form of grants given to individuals who use the funds to establish and run a business in their locality.

Epidemiological studies from the area have shown high rates of common mental disorder (eg., depression, anxiety) in the general population (Husain et al, 2006, Khan et al 2016). Such conditions have a serious impact on the well-being, functioning and productivity of affected individuals (World Health Organization, 2000). For example, in the USA, Depressive Disorders have been estimated to cost the economy over US$210 billion per annum, largely due to reduced productivity (Greenberg et al, 2015). The economic rehabilitation of a population exposed to a humanitarian crisis, and therefore at greater risk of depression, must include interventions to reduce mental morbidity so the individuals are able to function better and potentially improve their long-term productivity.

The Human Development Research Foundation, in collaboration with the World Bank, has adapted a 5-session group intervention from WHO Problem Management Plus program, tailored to the needs of small and medium enterprise owners affected by the prolonged conflict in KP and FATA areas of Pakistan. This intervention (Problem Management Plus adapted for entrepreneurs) is based on established cognitive behavioral strategies previously tested in Pakistan (Rahman et al, 2016). The goal of the intervention is to improve psychological capital,reduce psychosocial distress leading to, increased productivity in the long-term. The intervention will be evaluated using a two arm, single blind randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* All small and medium entrepreneurs, leading SMEs and family businesses in situations of fragility encountered in KP/FATA, Pakistan, who received a cash transfer for rehabilitation of their businesses by Economic Revitalization of Khyber Pakhtunkhwa and FATA (ERKF), Pakistan.

Exclusion Criteria:

-
To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2

This is a single-arm, multicenter phase I/II clinical study to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary consent to participate in the study and signed the informed consent form.
2. Male or female, age 18-75 years (including both).
3. Histologic confirmed non-muscle invasive bladder urothelial carcinoma (NMIBC), and the risk group met the high-risk (including very high-risk) group.

   Note: High-risk NMIBC is a high-grade / G3 tumor meeting any of the following:

   a.Carcinoma in situ (CIS) b. T1 stage c. diameter\>3cm d.Multiple tumors, or recurrent tumors.
4. Absence of resectable disease（Ta and/or T1 disease） after transurethral resection (TURBT) procedures (residual CIS acceptable;
5. The urologist assessed that radical surgery for bladder cancer was not suitable or the subject refused radical surgery for bladder cancer.
6. Tumor tissue samples were detected by immunohistochemistry (IHC) to satisfy HER2 expression of 1+, 2+ or 3+.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
8. Adequate heart, bone marrow, liver, kidney and coagulation function

Exclusion Criteria:

* 1. Invasive bladder cancer (T2 and above) and / or with regional lymph node and distant metastasis.

  2. Combined urothelial carcinoma outside the bladder (i. e., urethra, ureter or renal pelvis).

  3. Any other antitumor therapy received within 4 weeks before study administration, .

  4 Subjects plan to undergo major surgery during the study or within 4 weeks before the first dose.

  5, Known allergic to DV and its components or to any excipients.
Solid Tumor Cancer Surgery With or Without Intraoperative Imaging: A Registry

The study objective is to collect prospective data on cancer patients who undergo surgery and intraoperative imaging. The registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance.

Our objective is to collect prospective data on cancer subjects who undergo surgery and intraoperative imaging. The registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance.

In this protocol, subjects that receive intraoperative imaging will provide us the opportunity to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed. Also, we will monitor any side effects or potential toxicities that may occur. This data can then be used to predict if a subject is more likely to develop a local recurrence due to missed cancer cells, metastatic lymph nodes or synchronous lesions.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>/= 18 years of age.
* Patients presenting with esophagogastric or bladder cancer.
* Good operative candidate as determined by the treating physician and/or multidisciplinary team.
* Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

* Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery.
* Vulnerable patient population.
Corpus Callosum Size in Patients With Pineal Cyst

This study aims to determine size of corpus callosum on midsagittal MR scan in patients with a pineal cyst and to compare it with the control group without a pineal cyst.

A pineal cyst (PC) is a benign affection of the pineal gland, its prevalence in population reaches 1-2 %. Etiopathogenesis of PC is unknown, several hypotheses have been proposed. One of the hypothesis consider perinatal hypoxia as a causative factor for a development of PC in later life. Ozmen et al. showed significantly higher prevalence of PC in patients with cerebral palsy (p\<0.001). Bregant et al. studied presence of PC in patients that suffered from a mild to moderate perinatal hypoxia. Prevalence of PC reached 36 % in these patients and presence of PC was associated with a atrophy of the corpus callosum (p\<0.005). The atrophy of the corpus callosum is considered to be a sign of a periventricular leukomalacia, i.e. an ischemic insult in a perinatal period.

In the present study, we are going to compare an area of corpus callosum on a midsagittal magnetic resonance T2-weighted scan in the group of patients with PC and in the control group without PC. The goal of the study is to determine if there is a relationship between atrophy of the corpus callosum and PC. Such finding would support abovementioned theory of etiopathogenesis of PC.

Eligibility Criteria:
Inclusion Criteria:

* 3T MR examination of the brain including T2 sagittal scans

Exclusion Criteria:

* other intracranial pathology discovered on the MR
* other known neurological disease (e.g. multiple sclerosis, stroke, tumor, etc.)
Aquatic Therapy for Freezing of Gait in Parkinson's Disease Patients

Evaluation of the effectiveness of aquatic therapy for the treatment of freezing of gait in Parkinson's disease patients undergoing a multidisciplinary and intensive rehabilitation treatment.

Freezing of gait (FoG) is an often dramatic, disabling episodic gait pattern that is common in Parkinson's disease (PD). FoG highly impairs mobility, causes falls, and reduces quality of life. Given the limited effectiveness of both the dopaminergic therapy and the deep brain stimulation on this symptom, it represents a challenge in the field of rehabilitation. In the last years, some studies described the effectiveness of aquatic therapy on balance dysfunction in patients with PD, correlating it to the safe conditions offered by the aquatic environment and to the physical properties of water. Nevertheless, the issues concerning the feasibility and the effectiveness of aquatic therapy for the treatment of FoG have never been addressed before. The aquatic environment may act on the sensorial peripheral receptors, thus widely stimulating the proprioceptive system. PD patients show an altered processing of the proprioceptive information that could potentially underline FoG. The investigators aim at investigating the effects of aquatic therapy for the treatment of FoG in PD patients undergoing a Multidisciplinary Intensive Rehabilitation Treatment (MIRT), whose effectiveness on several motor and functional parameters has been already demonstrated.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PD according to Gelb et al;
* Hoehn \& Yahr (H\&Y) stage 2.5-3;
* Presence of FOG confirmed in the patient assessment prior to participation in the study;
* Stable pharmacological treatment for the last 8 weeks and during the rehabilitation period;
* Mini Mental State Examination (MMSE) ≥ 24;

Exclusion Criteria:

* Cardiac, pulmonary, vestibular and orthopedic diseases;
* Urinary incontinence;
* Severe dyskinesias;
* Patients treated with deep brain stimulation;
* Visual deficits;
* Comorbilities other than PD determining reduction of motor autonomy
Effectiveness of Inspiratory Muscle Training in Patient With Stable Angina

Stable angina is a cardiac pathology that adversely affects the quality of life of the patient, which develops as a result of narrowing of the coronary vessels developing in atherosclerotic ground and / or impaired oxygen supply-need balance. Studies widely investigated the effects of exercise training in patients with stable angina. No study investigated the effects of inspiratory muscle training in patients with stable angina.Investigators aimed to investigate the effects of inspiratory muscle training on aerobic exercise capacity, quality of life, depression, peripheral and respiratory (MIP, MEP) muscle strength, pulmonary function, dyspnea, fatigue in stable angina patients.

Patients with stable angina will be included. Primary outcome measurement is inspiratory muscle strength, secondary outcomes are functional exercise capacity, peripheral muscle strength, pulmonary functions, maximal exercise capacity, fatigue, quality of life, depression.

Eligibility Criteria:
Inclusion Criteria:

* No contraindication for pulmonary physiotherapy
* Anjina patients who are clinically stable
* have no other disease that may affect respiratory function
* Individuals who have the good cooperation

Exclusion Criteria:

* Patients under the age of 18
* Pregnancy
* Active infection
* Patients with known malignancies
* patients without consent
* known arrhythmia, dilated or hypertrophic cardiomyopathy, heart failure (EF \<40%)
Cytoreductive Surgery in Platinum-resistant Recurrent Ovarian Cancer

This novel study was specifically designed for platinum-resistant recurrent ovarian cancers with PFI\<6 months and aimed to compare prognosis of patients who received cytoreductive surgery followed by chemotherapy versus chemotherapy alone.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with diagnosis of epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma within 3 lines recurrence;
2. Recurrence occurred within 6 months since platinum-based chemotherapy;
3. R0 ideal debulking in initial surgery; PET-CT indicate the recurrence lesion is almost in abdominal cavity, which is isolated and not exceed 5 sites, and the ascites is less than 500ml;
4. ECOG/WHO Performance score of 0 to 1;
5. Hematology function: Leukocyte≥ 3,5x10⁹/L, neutrophil≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L;
6. No Renal insufficiency: serum creatinine \< 1,5 time the normal limit, creatinine clearance \> 60 mL/min;
7. No hepatic failure: bilirubin ≤ 1,5 time the Normal limit;
8. Patients with good compliance;
9. Patients having read, signed and dated Informed consent before any study procedure.

Exclusion Criteria:

1. Platinum-refractory/uncontrolled epithelial ovarian cancer;
2. Mucous carcinoma or low-grade serous carcinoma;
3. Suffering from other malignant tumors that have not achieved complete remission in the past 2 years;
4. Patients have received abdominal or pelvic radiotherapy;
5. General conditions cannot tolerate cytoreduction;
6. Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any of its excipients;
7. Unable or unwilling to sign the informed consent form;
8. Patients judged by the investigator to be unlikely to follow the research steps, restrictions and requirements.
The Treatment of Patients With Type 1 Diabetes Mellitus With Autologous Tolerogenic Dendritic Cells

The purpose of this study is to determine the safety and tolerability of the administration of tolerogenic dendritic cells in patients with type 1 diabetes mellitus.

The purpose of this study is to determine the safety and tolerability of the administration of autologous monocyte-derived dendritic cells tolerised with Vitamin-D3, co-cultivated with mesenchymal stem cell and primed peptides in patients with type 1 diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Type 1 Diabetes Mellitus
* The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
* Written informed consent

Exclusion Criteria:

* The presence of any malignant tumor within the last 5 years
* Acute or chronic diseases in the stage of decompensation
* Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
* Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
* Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
* Patients are unable or unwilling to give written informed consent and / or follow research procedures
* Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study
Aspirin Dosing in Diabetic Patients

Since diabetic platelets are characterized by an enhanced turnover rate, it may be hypothesized that an increase in the frequency, rather than the dose, of drug administration may be a more effective strategy to inhibit platelet reactivity in diabetic patients as this may enable COX-1 blockade of newly generated platelets. However, how different dosing regimens impact the pharmacodynamic effects of aspirin selectively in diabetes mellitus has been poorly explored. Therefore, the aim of the present pilot investigation was to evaluate how increasing the frequency of aspirin administration, remaining within the daily recommended therapeutic doses, affects antiplatelet responsiveness in diabetic patients with coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Medically treated (taking oral hypoglycemic medication and/or insulin) type 2 diabetes mellitus patients between 18 to 75 years with stable coronary artery disease

Exclusion Criteria:

* Blood dyscrasia or bleeding diathesis
* Oral anticoagulation therapy with a coumadin derivative
* Recent antiplatelet treatment (\< 30 days) with a glycoprotein IIb/IIIa antagonist, thienopyridine (ticlopidine, clopidogrel), cilostazol or dipyridamole Platelet count \< 100 /microL
* History of gastrointestinal bleed within last 6 months
* History of cerebrovascular accident within last 3 months
* History of hospitalization for an acute coronary event or coronary revascularization (percutaneous or surgical) in the past 12 months
* Active bleeding or hemodynamic instability
* Any active malignancy
* Serum creatinine \> 2 mg/dL
* Baseline ALT \> 2.5 times the upper limit of normal
* Pregnant females
* HbA1C \> 10%
* Use of nonsteroidal anti-inflammatory drugs past 10 days.
Drug Interactions With Risk of QT-prolongation in a General Hospital

In this epidemiological point prevalence study, medication profiles of patients with haloperidol treatment will be checked for drug interactions with risk of QT-prolongation. Additional clinical risk factors for developing QT-prolongation and safety measurements will be documented.

Study design: epidemiological point prevalence study

Target population: Patients with haloperidol treatment

The following aspects will be investigated:

* The medication profiles will be checked for drug interactions with risk of QT-prolongation.
* Clinical risk factors for developing QT-prolongation (gender, age, (history of) cardiovascular disease, comorbidity,...) and lab results will be collected.
* Safety measurements (e.g. ECG) will be documented.

Eligibility Criteria:
Inclusion Criteria:

* treatment with haloperidol (started in the hospital)

Exclusion Criteria:

* age \< 18 years
Looking at the Physiological Response of Ergometry in Critical Care Patients

Exploring the physiological and metabolic demands of passive ergometry in the critical ill patient.

This study explores the physiological and metabolic demands of passive ergometry as a step in active rehabilitation and compares two methods of monitoring these changes in critically ill patients.

Eligibility Criteria:
Inclusion Criteria

* already on the Early Mobility Programme (EMP)
* cardiovascularly stable (stable vasopressor dose for two hours)
* stable heart rate (\<140 bpm) and heart rhythm
* presence of a jugular central venous pressure (CVP) line and arterial line.

Exclusion Criteria

* prior rapidly deteriorating neuromuscular disease
* upper limb problem precluding cycle ergometry
* pyrexia (temp \>38 °C)
* raised intracranial pressure
* poor prognostic outcomes
* lack of agreement from clinician
* Next of kin/Legal representative (NOK/LR) not understanding English.
Observational Study of Elizaria® in aHUS Patients

It is a multicenter observational non-comparative study of the efficacy and safety of long-term pathogenetic Elizaria® therapy in patients with atypical Hemolytic Uremic Syndrome

After screening, patients meeting all of the inclusion / non-inclusion criteria and vaccinated against meningococcal infections were treated by Elizaria®.

The study is planned to include at least 50 patients receiving Elizaria® for the aHUS treatment.

The study will consist of a screening period of up to 4 weeks, including, if necessary, immunization with meningococcal vaccine, a treatment period of 52 weeks.

Medication will be prescribed in accordance with routine medical practice. Accordingly to minimize the risks and subjectivity of assessments the methods adopted in the routine practice of treating patients with aHUS will be used.

Investigators enroll patients with aHUS diagnosis who have indications for pathogenetic therapy and who are receiving Elizaria® under the government program. Patients will receive medication in accordance with the established requirements of national standards and protocols for the treatment of patients with aHUS. The registration of the amount of the drug used will be carried out on the basis of information in the Patient Diaries, as well as primary documentation.

Eligibility Criteria:
Inclusion Criteria

1. Written informed consent to study participation.
2. Male and female patients aged 2 months and older with documented atypical hemolytic uremic syndrome (aHUS)diagnosis.
3. By the time of inclusion in the study, Elizaria® should be prescribed as a pathogenetic therapy for aHUS; Exclusion Criteria

1. Intolerance to eculizumab, or other components of the drug.
Video-game Based Therapy in Cerebral Palsy

The video-based therapy applications; will be applied in a non-three-dimensional (with desktop screen) way. In this application, there are different types of exercise programs that will work the upper extremity movements. The video-based therapy applications will be applied to individuals with Cerebral Palsy (CP) who will be included in the study with the Xbox Kinect 3600 (Microsoft, Washington, USA) device.

This study was planned to examine the effect of video-based therapy on upper extremity selective motor control and proprioception in individuals with Cerebral Palsy.

Spastic CP will be participate the study between the ages of 4 and 18 years. Children's classified with GMFCS and MACS. The eligible participants will be allocated two groups, including video-game based therapy group and conventional physiotherapy control group. All the assessments will be performed before and after the therapy in the 8-week therapy groups.The control group individuals will be given a conventional physiotherapy two days per week for a total of 8 weeks (conventional physiotherapy session will last 45 minutes). The video-game based therapy group will receive a conventional physiotherapy and video-game based therapy, two days a week for a total of 8 weeks (15 minutes conventional physiotherapy session+30 minutes video-game based therapy). All sessions will be performed in the clinic with the specialist physiotherapist.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Cerebral Palsy voluntary participation,
* Age between 4-18 years
* GMFCS Level I-II-III
* MACS Level I-II-III

Exclusion Criteria:

* Not voluntary to participate in the research,
* Botox in the last 6 months,
* Upper limb or spine surgeries in the last 6 months