cyrilzakka/clinical-trials huggingface dataset:
An Observational Study of Erlotinib Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer

This observational study will evaluate the impact of rash on survival of patients with metastatic pancreatic cancer treated with erlotinib plus gemcitabine. Further, clinical effectiveness, efficacy and safety will be assessed. Data will be collected for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adults, age \>= 18 years
* Patients with metastatic pancreatic cancer where investigators have decided to give combination therapy of erlotinib and gemcitabine according to Summary of Product Characteristics (SmPC)

Exclusion Criteria:

* Contraindications for erlotinib according to Summary of Products Characteristics (SmPC)
Mechanisms of Orthopnea in Stable Obese Patients

The purpose of this study is to study the role of closing volume as a determinant of orthopnea in stable obese subjects. The investigators hypothesized that: (1) increase in closing volume in supine position would be greater in orthopneic than in non-orthopneic subjects, and (2) the relationship of change in closing volume to change in dyspnea with position would be dependent on expiratory flow limitation in the sitting position.

In stable obese subjects, in sitting and supine positions, the investigators measured Borg dyspnea score, static lung volumes, expiratory flow limitation, and single-breath nitrogen expiration test, from which the investigators determined closing volume and closing capacity, slope of phase III, and opening capacity.

Orthopnea was defined as any increase in the Borg score in the supine position from its value in the sitting position


Eligibility Criteria:
Inclusion Criteria:

* obese (BMI ≥ 30)
* stable condition
* 20 \< Age \< 60 years

Exclusion Criteria:

* other respiratory disorder (COPD)
* left cardiac insufficiency
Postoperative Pain After Breast Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia ( TLA-001 )

The present study aims to investigate the impact of Tumescent Local Anesthesia (TLA) on pain perception following surgeries typical for breast cancer. Previous research has already confirmed the feasibility of conducting operations in TLA for benign breast conditions. In contrast to general anesthesia, Tumescent Local Anesthesia involves local anesthesia of the surgical site, allowing patients to remain awake during the procedure and eliminating the risks associated with general anesthesia. Additionally, if needed, sedatives or further anesthesia can be administered through the vein. Building upon the successful applications of TLA in benign breast surgeries, this follow-up study at the Department of Women's Health focuses on enhancing surgical techniques, pain management, and postoperative care for breast cancer-related procedures. Simultaneously, our goal is to gather scientific data regarding the application of this technique. This research contributes to the continuous advancement of medical practices in the field of breast surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Written informed consent
* Histologically confirmed breast carcinoma or pure ductal carcinoma in situ
* Planned operation:
* Segmental resection/ breast-conserving surgery
* Segmental resection/ breast-conserving surgery with SNB
* Ablatio
* Ablatio with SNB/ axilla exploration

Exclusion Criteria:

* Expected lack of patient compliance or inability of the patient to understand the purpose of the study
* Lack of patient consent
* Pregnancy
* Complete axillary dissection
* Tumour-adapted reduction surgery, implant reconstructions
* Surgeries where technical difficulties are expected under any anaesthesia (e.g. ASA IV, BMI \> 40)
* Bilateral breast operations
* Men

Exclusion Criteria for surgery in TLA:

* Injection phobia
* Psychoses/ previous psychological illnesses
* Advanced dementia
* Language barrier
Training on Using ıInsulin in Patients With Type 2 Diabetes

This study was conducted to evaluate the effect of individual insulin use training given to patients with type 2 diabetes using insulin on safe drug administration, pain level and perception of treatment. The study was conducted between October 2022 and March 2023 with a randomized control group.

Objective: The aim of this study was to examine the effects of individual insulin use training given to patients with Type 2 diabetes on safe drug administration, pain level and treatment perception, and to contribute to both national and international literature.

Method: It was conducted between October 2022 and March 2023 as a randomized controlled study in a pre-test-post-test order to determine the effect of individual insulin use education given to patients with type 2 diabetes on safe drug administration, pain level and treatment perception. The data were collected by the researchers with the descriptive information form of the patients, the Insulin Administration Skill Observation Form, the Visual Analogue Scale and the Insulin Therapy Evaluation Scale.

Data Collection: Face-to-face and individual interviews with patients who applied to the Internal Diseases and Endocrinology Polyclinic and Diabetes Nursing Polyclinics of a state hospital in a city located in the Southeastern Anatolia Region of Turkey, and who were hospitalized in the Internal Diseases, Endocrinology, Physical Therapy and Rehabilitation and Cardiology Services. collected using the method. A pilot study was not conducted before starting the study. Before the study, all patients were informed about the study and their verbal and written consents were obtained.

Eligibility Criteria:
Inclusion Criteria:

Patients included in the study;

* 18 years and over Using insulin injections for at least six months or longer
* Meeting the American Diabetes Association (ADA, 2021) diagnostic criteria for Type 2 diabetes
* No communication and mental problems
* Insulin injection made by himself or his family The patients who agreed to participate in the study.

Exclusion Criteria:

Patients excluded from the study;

* Self or family member health personnel Those with advanced retinopathy, nephropathy, neuropathy
* Diagnosed with type 1 diabetes
* Pregnant or breastfeeding women
* Patients who participated in another clinical trial concurrently or within 1 month prior to the start of the trial.
The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Soft Tissue Sarcomas

This study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for advanced soft tissue sarcomas.

The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-grazytracer PET/CT after 3 cycles of immunotherapy to evaluate response. The imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.

Eligibility Criteria:
Inclusion Criteria:

1. Pathological and clinical diagnosis of advanced soft tissue sarcomas, pathological types include: fibrosarcoma, liposarcoma, undifferentiated pleomorphic sarcoma, epithelioid sarcoma, rhabdomyosarcoma, synovial sarcoma, alveolar soft-part sarcoma, leiomyosarcoma, clear cell sarcoma, malignant schwannoma, angiosarcoma.
2. Consider immunotherapy or combined immunotherapy based on clinical judgement.
3. Signed and dated informed consent form.
4. Commitment to comply with research procedures and co-operation in the implementation of the full research process.
5. Aged 6-80 years old.

Exclusion Criteria:

1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
2. Intestinal perforation, complete intestinal obstruction
3. Pregnant women and women who may be pregnant, women who are breastfeeding.
4. Non-compliant person
Characteristics and Predictors of Progression of an Egyptian Multiple Sclerosis Cohort

Initial recruitment: 1717, 136 (7.92%) were excluded due to missing data that could not be obtained. The diagnosis of multiple sclerosis (MS) was revised according to the 2010 revision of the McDonald criteria.

Patients analyses: 1581 Every patient was registered by his/her 14-digit unique identity numbers, (which is mandatory in Egypt since 1999) to make sure that every registered patient in different centers were counted only once.

Patients' records review procedure and sampling strategies. The medical records, administrative data, laboratory and diagnostic tests reports were screened by 3 authors (HS, NS, AE) and these data were extracted in a standard electronic form according to Kasr Alaini Multiple Sclerosis Unit (KAMSU) registry.

An assigned coordinator from each center was requested to facilitate data collection from site-specific records. In cases of incomplete documentation or unclear information, verification was done by on-site data coordinator either by phone contact or face-to-face interview with the patients, whether during the routine follow up or in an unscheduled visit.

Several measures were taken to ensure the confidentiality of the collected information. No patient names were included in the database presented by site coordinator, and the study staff signed a confidentiality agreement for non-disclosure.

Eligibility Criteria:
Inclusion Criteria:

* All patients with suspecting multiple sclerosis attending 4 tertiary referral centers in Egypt

Exclusion Criteria:

* missing data that could not be obtained
A Study to Determine the Effects of TM30339 on Weight Loss in Obese Individuals.

The purpose of this study is to determine the effects of TM30339 on weight loss in obese individuals after 28 days dosing.

Obesity is a disease with large socioeconomic consequences and many serious health consequences including Type 2 diabetes, dyslipidemia and cardiovascular diseases. The prevalence of obesity is increasing both in developed and developing countries. There is a great need for further medicinal treatments that effectively will support life style changes or surgical procedures in reducing or maintaining bodyweight.

7TM Pharma has identified TM30339 as a clinical development candidate molecule with potential to assist in the control and amelioration of obesity in humans.

Eligibility Criteria:
Inclusion Criteria:

1. Obese males and females with a BMI of 30-40 kg/m2 inclusive and weight in the range of 85 - 135 kg inclusive
2. Age 18-60 years inclusive
3. Stable lifestyle e.g. smoking, exercise and eating patterns and times for at least 6 months, and willing to maintain these habits during the course of the study
4. Stable weight over past 2 months i.e. a change in body weight \< 3 kg as reported by the subject

Exclusion Criteria:

1. Subjects with a history of allergies toward products containing natural rubber (e.g. latex)
2. Subjects with, or with a history of, any clinically significant neurological, gastrointestinal (including bariatric surgery), renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological, or other major disorders
3. Subjects who have a supine blood pressure at screening or Visit 1 higher than 150/95 mmHg by repeat measurements within 15 minutes
4. Subjects who have a QTc (Bazett's correction) interval of \> 450 msec at screening
5. Subjects with bradycardia (heart rate \< 50)
6. Subjects with heart block
7. Clinically significant thyroid dysfunction as evidenced by TSH \> 1.5 X ULN
The Prevalence and Clinical Manifestations of Human Metapneumovirus Among Children With Bronchiolitis.

Sputum specimens will be obtained from children \< 2 years of age and processed by different mode for the HMPV, RSV, Pertussis, Influenza A, B, Parainfluenza 1,2,3, Adenovirus. Clinical and epidemiological data will also be obtained.

The purpose of the study is to asses the various pathogens of bronchiolitis in children and its' clinical manifestations. Prospective study in 3 Medical centers in Northern Israel. Included will be about 200 infants and children \< 2 years hospitalized with bronchiolitis. From each child sputum specimen will be obtained and processed for HUMP - PCR, Pertussis - PCR, RSV - ELISA, DFA, PCR, Influenza A, B, Parainfluenza 1,2,3 - DFA, PCR, Adenovirus - DFA. Epidemiological data will be obtained for every child by structured questioner. Clinical data will be daily obtained by scoring system.

Eligibility Criteria:
Inclusion Criteria:Age 0-24 months, hospitalized children, -

Exclusion Criteria:Previous hospitalization, previous RSV immunization, immunocompromised patient, previous inclusion in this study, inclusion in another study.

-
Dextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With PCIOL.

Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.

Randomized controlled clinical trial assessing the efficacy of DEXTENZA, sustained release dexamethasone 0.4 mg insert when placed within the upper eye lid canaliculus in comparison to the lower lid canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lens implant (CE/PCIOL).

Eligibility Criteria:
Inclusion Criteria:

* Been diagnosed with clinically significant cataract and CE/PCIOL has been planned
* Bilateral cataract surgery with IOL has been planned
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form

Exclusion Criteria:

* Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
* Active infectious systemic disease
* Active infectious ocular or extraocular disease
* Obstructed nasolacrimal duct in the study eye(s)
* Hypersensitivity to dexamethasone
* Patients being treated with immunomodulating agents in the study eye(s)
* History of prior ocular surgery, excluding Lasik or PRK
* History of ocular inflammation or macular edema
* Use of any systemic NSAIDs greater than 375 mg per day
* Patients being treated with immunosuppressants and/or oral steroids
* Patients with a corticosteroid implant (i.e. Ozurdex)
* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Correlation Between Body Mass Index, Manual Dexterity and Handgrip Strength in School Aged Children

The purpose of current study is to investigate the relation between body mass index, manual dexterity and handgrip strength in school aged children having normal weight, overweight and obesity.

The study targeted the normal weight, overweight and obese students (9-11) from both sexes will be selected from governmental primary schools.

Study design:

Cross sectional observational correlational study.

A. Inclusion criteria:

1. The students' age ranges from 9 to 11 years.
2. Normal weight, Overweight and obese students were included
3. both boys and girl will be included.

B. Exclusion criteria:

The students will be excluded from the study if they have one of the following:

1. Congenital abnormalities or medical conditions, which may affect the study.
2. Musculoskeletal problems such as previous or recent orthopedic surgery, fractures, prostheses, inflammation of the fingers, arms, or shoulder.
3. Visual or hearing defects.
4. Motor, behavioral, or neurologic disorders and learning disabilities.

   * All children will be assessed using: the Standard weight and height measuring scale to determine their BMI.
   * Assessment of manual dexterity will be carried out by using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) (Bruininks and Bruininks, 2005).
   * Handgrip strength will be assessed by hand dynamometer.

Eligibility Criteria:
Inclusion Criteria:

1. The students' age will range from 9 to 11 years.
2. Normal weight, Overweight and obese students including both boys and girl.

Exclusion Criteria:

* The students will be excluded from the study if they have one of the following:

  1. Congenital abnormalities or medical conditions, which may affect the study.
  2. Musculoskeletal problems such as previous or recent orthopedic surgery, fractures, prostheses, inflammation of the fingers, arms, or shoulder.
  3. Visual or hearing defects.
  4. Motor, behavioral, or neurologic disorders and learning disabilities.
OverTTuRe: Characteristics, Treatment Patterns and Outcomes of Patients With ATTR Amyloidosis

The overall aim of this observational study is to generate real-world evidence on the pre- and post-diagnosis disease journeys, including baseline characteristics, treatment patterns and selected clinical, economic, and humanistic outcomes (for example Health Related Quality of Life (HRQoL), Neuropathy impairment score, activities of daily living (ADL) assessments) in patients with ATTR amyloidosis, and to better understand how the disease is presented.

This retrospective, observational, longitudinal, multi-country cohort study aims to describe characteristics, treatment patterns, and outcomes in ATTR amyloidosis patients.

Primary objectives: Describe patient characteristics (for example demographics, family history of ATTR, key comorbidities and humanistic outcomes (e.g. Health Related Quality of Life (HRQoL), Neuropathy impairment score, activities of daily living (ADL) assessments), treatment patterns, and disease outcomes. Characterize and quantify the healthcare resource utilization (HCRU) in ATTR amyloidosis patients who will be followed post-index until the end of follow-up.

Secondary objectives: Describe demographics, clinical characteristics and HCRU in ATTR amyloidosis patients prior to diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18 years at study index date AND
* A reported diagnosis code for amyloidosis OR
* A claim for ATTR-specific treatment OR
* A positive biopsy for amyloidosis and positive immunostaining result of biopsy for ATTR

Exclusion Criteria:

* Evidence of primary (AL) and secondary (AA) amyloidosis AND/OR
* At least one claim/procedure code for stem cell transplant or at least two claims/procedure codes for chemotherapy and autoimmune disease drugs which may represent AL (primary) or AA (secondary) amyloidosis treatments
Mirror Therapy and Cross-Education of Muscle Strength

This study was conducted to determine whether mirror therapy has an additive effect on cross-education of the strength of neuromuscular electrical stimulation (NMES) in patients with hemiplegia. As an outcome measure, the ankle dorsiflexion strength of hemiplegic patients was measured.

A total of 29 patients, 7 women, and 22 men were included according to the inclusion and exclusion criteria. The patients were randomly assigned to the control group (n = 14) and the Mirror group (n = 15). Five sessions of neuromuscular electrical stimulation, unaffected side ankle dorsiflexors were applied to the patients in both groups. In addition to the NMES, mirror therapy was applied to the experimental group simultaneously with NMES. Before and after treatment, both ankle dorsiflexor strength was measured with a force sensor. For force measurements, a force transducer (FC2211-0000-0100-L Compression Load Cell, TE Connectivity company, France) was used. Force transducer signals were received with a data acquisition device (POWERLAB® data acquisition system ADInstruments, Oxford, UK) and evaluated offline on the computer. The measurement values were expressed in kilogram.force (kg.f) and this value was normalized according to body weight.

Eligibility Criteria:
Inclusion Criteria:

* Cases with stroke duration ≥ 1 month
* Ability to walk at least 10m (functional ambulation scale ≥3)
* Age range 18-75 years
* Hemorrhagic or ischemic stroke
* Brunnstrom stage ≥4 for lower limb
* Unilateral stroke
* Cooperating with the examination and tests

Exclusion Criteria:

* Mini Mental State Assessment score \<21
* Severe spasticity (MAS = 4) in ankle dorsiflexors
* Have a contracture on ankle joint
* The presence of skin lesions in the application area
* Painful pathologies in the lower extremities
* Having visual field defects
* Active inflammatory, rheumatological or infectious disease
* Parent rhythm / conduction block problem in the heart
* Uncontrollable hypertension (Maxima\> 140, Minima\> 90)
* Presence of lower extremity fracture
* Peripheral nerve lesions such as polyneuropathy, radiculopathy
* Finding or suspected active deep vein thrombosis
* History of deep vein thrombosis and pulmonary embolism
Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy

The purpose of this study is to determine the efficacy and safety of topic ketorolac in treatment for center point thickness secondary to panphotocoagulation in proliferative diabetic retinopathy.

Panphotocoagulation is the standard treatment for proliferative diabetic retinopathy during 3 to 4 sessions within 2 weeks. This treatment reduces the incidence of severe visual loss in the long term. Nonetheless, it induces macular thickness that delays the conclusion of the treatment. This delay could coincide with vitreous hemorrhage which, in turn, may limit additional photocoagulation.

Topic ketorolac could limit the inflammatory reaction cause by panphotocoagulation and produce early benefits in the patient.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* proliferative diabetic retinopathy
* without macular edema
* adequate quality 6 mm fast macular map on the day of treatment
* visual capacity under subjective refraction before treatment
* signed of inform consent

Exclusion Criteria:

* ocular surgery in the last 4 months
* myopia over -6.00 diopters
* allergy to ketorolac or non-steroids antiinflammatory
* previous selective photocoagulation
* using non-steroids antiinflammatory or immunomodulators
* intraocular inflammatory
* any retinal disease different from diabetic retinopathy
* pregnancy
* actual corneal disease
* inadequate quality 6 mm fast macular map after the second visit
* inconsistency after the second visit
* adverse event of the drug
* remove of the inform consent
A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis

This study is a Phase 3, multicenter, open-label, long-term safety extension study of Studies C3291032 and C3291031 in Japanese pediatric and adult participants with mild to moderate Atopic Dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants;
* Who were patients with mild to moderate AD aged 2 years old or older and met eligibility criteria for study C3291032 at the time when entering Study C3291032, and completed treatment period in Study C3291032 without safety issues. Or
* Who were patients with mild to moderate AD aged 1 months to \<24 months and met eligibility criteria for Study C3291031 at the time when entering Study C3291031, and completed treatment period in Study C3291031 without safety issues

Exclusion Criteria:

* Has other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.