cyrilzakka/clinical-trials huggingface dataset:
A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone

The purpose of this study is to assess the efficacy and safety of gefitinib in patients who have progressed on first line gefitinib, comparing continuing gefitinib in addition to cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed combination chemotherapy alone.

A Phase III Randomised, Double blind, Placebo controlled, Parallel, Multicentre Study to Assess the Efficacy and Safety of continuing IRESSA 250 mg in addition to Chemotherapy versus Chemotherapy alone in Patients who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and have progressed on First Line IRESSA.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18 years or older (For Japan only- male or female patients aged 20 years or older)
* Cytological or histological confirmation of NSCLC other than predominantly squamous cell histology with an activating EGFR TK mutation as determined locally
* Patients with documented 'acquired resistance' on first line gefitinib
* Patients suitable to start cisplatin based pemetrexed combination chemotherapy.
* Provision of informed consent prior to any study specific procedures.

Exclusion Criteria:

* Prior chemotherapy or other systemic anti-cancer treatment (excluding gefitinib). Palliative bone radiotherapy must be completed at least 2 weeks before start of study treatment with no persistent radiation toxicity).
* Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
* Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or completely resected intramucosal gastric cancer
* Any evidence of severe of uncontrolled systemic disease Treatment with an investigational drug within 4 weeks before randomization
A Structured Qi-gong Program for Hospitalized Older Adults

The purpose of this study is to test the effects on a number of health outcomes and the feasibility of a structured program of qi-gong, a form of tai-chi which has been previously tested in older populations, in older hospitalized patients. In particular, this pilot study aims to assess changes in quality of life and depressive symptoms after 4 weeks of treatment, with the hypothesis that this intervention will have a positive impact on these two domains, compared to usual care. Adherence will be also monitored in the intervention arm.


Eligibility Criteria:
Inclusion Criteria:

* \>=50 years old
* Preserved ability to move inside the house (also using walking aids or chair)
* Estimation of at least one month of hospitalization (convalescence or rehabilitation)
* Ability and willing to sign informed consent

Exclusion Criteria:

* Moderate to severe cognitive impairment (SPMSQ \>= 4)
Comparison of Brugger's Relief Exercises Versus Kinesio Taping at Craniovertebral Angle on Forward Head Posture

The aim of this research is to compare the effect of Brugger relief exercise versus Kinesio taping at craniovertebral angle on forward head posture. Randomized controlled trials done at we care physical therapy clinic Islamabad. The sample size was 28. The subjects were divided in two groups, 14 subjects in Kinesio taping group and 14 in Brugger relief exercise group. Study duration was of 6 months. Sampling technique applied was non probability purposive sampling technique. Only 20-40 years people with forward head posture having craniovertebral angle less than 50° degrees were included. Tools used in the study is protractor app. Data will be analyzed through SPSS 21

Forward head posture (FHP) is a common condition characterized by abnormal cervical spine, leading to non-specific neck pain (NNP). FHP affects millions of people worldwide, causing pain, reduced productivity and quality of life. Current treatments for NNP associated with FHP include exercise programs and Kinesio taping, but there is limited evidence comparing their effectiveness.

The Brugger relief exercises (BRE) consist of a set of exercises designed to target the cervical spine and adjacent muscles with the goal of enhancing posture, alleviating discomfort, and improving functionality. In contrast, Kinesio taping (KT) is a non-invasive and painless method that involves applying gentle traction to the skin, purportedly leading to the reduction of pain and inflammation. This study aims to compare the effectiveness of BRE versus KT on CVA due to FHP. This research will offer important information on the effectiveness of BRE and KT, guiding healthcare providers and patients in selecting the best treatment for FHP-related NNP. The results will support the creation of evidence-backed protocols for addressing FHP-related NNP, ultimately leading to better treatment results and improved quality of life for those affected

Eligibility Criteria:
Inclusion Criteria:

* Both gender
* Patients whose age lies between 20 and 40
* Forward head posture with craniovertebral angle less than 50° degrees

Exclusion Criteria:

* Individuals with pre-existing musculoskeletal conditions affecting posture e.g. scoliosis, Scheuermann's disease.
* Those currently undergoing physical therapy or other posture correction treatments.
* Pregnant individuals, due to potential physiological changes affecting posture.
* Subjects with a history of significant spinal or neck injuries.
* No neurological disease (e.g. cervical radiculopathy, SCI).
* Patients were excluded who shows positive result to spurling test, ULTT, Allen test.
Turkish Version of the QoR-15 for Emergency Laparotomy

Patient perceived quality of recovery is an important outcome after surgery and should be measured in clinical trials. The QoR-15 was designed to measure quality of recovery postoperatively. It provided an efficient evaluation of the postoperative quality of recovery. The primary objectives of this study is validate the Turkish version of QoR-15 questionnaire for emergency laparotomy. The investigators will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients emergency laparotomy, in the University of Health Sciences, Gülhane Education and Training Hospital Ankara, Türkiye.

Recovery from surgery is a complex process that can vary depending on the patient and the anesthesia used. Most clinical studies are interested in reducing perioperative morbidity and mortality, but few evaluate the overall recovery process. The QoR-15 questionnaire assess recovery after elective surgery. A Turkish translation of the QoR-15 score has been validated for use in scheduled surgery. This scale, regardless of the language in which it is translated, has been developed and validated in patients who have undergone scheduled surgery. Until now, no validated scoring tool has been available to assess recovery after emergency laparotomy.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old,
* Turkish speaking,
* Admitted for any type of emergency laparotomy (time to surgery \< 72 hours)
* Able to answer the questionnaire at hospital admission, alone or with the help of a third party
* And agreeing to participate in the study.

Exclusion Criteria:

* Patients with psychiatric or neurological pathologies that compromise cooperation with the protocol,
* Patients admitted for revision surgery,
* aged \< 18 years old
* not agreed to provide written informed consent to participate
A Single and Multiple Ascending Dose Study of CK-3828136 in Healthy Adult Participants

1. Learn about the safety and tolerability of CK-3828136 after a single dose and multiple doses in healthy subjects.
2. Find out how much CK-3828136 is in the blood after a single dose and multiple doses.
3. Determine the effect different doses of CK-3828136 on the pumping function of the heart.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female participants aged between 18 and 45 years (inclusive) with a body mass index between 18.0 and 30.0 kg/m2 (inclusive), with a body weight \> 50.0 kg.

Exclusion Criteria:

Participants will not be enrolled in the study if they meet any of the following exclusion criteria at the screening visit, unless otherwise stated:

* History of any significant illness or disorder.
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, hernia repair, and/or cholecystectomy will be allowed).
* History or presence of:

  1. additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).
  2. sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or clinically significant conduction abnormalities.
* Clinically significant illness within 4 weeks prior to check in.
* Participants with an inability to swallow tablets.
Effect of Moderate Alcohol Consumption to Cognitive Functioning After Roux-en Y Gastric Bypass

Objectives: Alcohol metabolism is changed in gastric bypass patients, leading to faster resorption and higher alcohol peak concentrations in blood. Because of stronger alcohol effects after gastric bypass we suggest that also general cognitive function is stronger impaired.

Materials and Methods: We included 28 females (12 gastric bypass patients, 8 obese and 8 normal weight subjects) in the study. Each participant had to drink 250 ml white wine. Directly before, 10-30 min after and 45-65 min after wine consumption cognitive functions were tested by test battery for attentional performance (TAP) from Zimmermann and Fimm. During the whole examination breath-alcohol-contents (BACs) were measured every 5 minutes with breathalyser "Dräger Alcotest 7510".


Eligibility Criteria:
Inclusion Criteria:

Gastric bypass group:

* women
* preOP BMI \>35 kg/m²
* time since bariatric surgery \> 1 year
* age 18-60 years
* moderate drinking habits

obese group:

* women
* BMI \>35 kg/m²
* age 18-60 years
* moderate drinking habits

normal weight group:

* women
* BMI 18.5 - 25 kg/m²
* age 18-60 years
* moderate drinking habits

Exclusion Criteria:

* men
* patient does not drink wine
* usage of psychotropic drugs
* alcoholic
* pregnancy
Effect of Omega-3 Fatty Acid on Endothelial Function

Background

Familial hypercholesterolemia (FH) is an inherited disease in which the level of bad cholesterol (LDL-cholesterol) is increased, leading to an increase in coronary heart disease even if adequately treated with cholesterol lowering medication (statins). Polyunsaturated fatty acids (PUFA) including omega-3 is known to affect the risk for coronary disease, however its effect on patients with FH is not known.

The purpose of the study is to assess the effect of PUFA on patients with FH, with regard to inflammation measured in the blood and the effect on the blood vessels'ability to relax (endothelial function) by means of tonometry.

Hypothesis

Treatment with 4 grams of PUFA a day for 4 months will lead to an improvement in the endothelial function, and the treatment will also lead to a decrease in in several markers of inflammation and in lipids in the blood.


Eligibility Criteria:
Inclusion Criteria:

* documented familial hypercholesterolemia
* age 18-60 years
* on statin treatment for at least 12 months

Exclusion Criteria:

* pregnancy or planned pregnancy
* breast feeding
* cancer
* non-compliance
* PUFA/omega-3 \< 3 months before inclusion
Cold Therapy and Cross-Education of Muscle Strength

The aim of this study is to investigate whether a cold application to the contralateral (affected side) extremity in addition to unilateral neuromuscular electrical stimulation (NMES) application has a facilitating effect on muscle strength in post-stroke hemiplegia patients.

In this prospective randomized controlled single-blind study, a total of 25 patients, 16 men, and 9 women were included according to inclusion and exclusion criteria. Patients were randomly assigned to the experimental group (n=12) or the control group (n=13). NMES has applied to the non-affected side ankle dorsiflexors five sessions for a week in both groups. In addition to the experimental group, the cold application was applied on the affected side dorsiflexor muscle skin. The cold application was done on a moist towel for five minutes using a cold pack. A five-minute break was given and a further 5-minute cold application was repeated. The cold application was done simultaneously with NMES. A conventional rehabilitation program was applied to all patients by a physiotherapist. 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
* Brunnstrom stage ≥4 for lower limb
* Unilateral stroke
* Ability to walk at least 10 m (FAC ≥3)
* Cooperating with the examination and tests

Exclusion Criteria:

* Cold allergy
* Active inflammatory, rheumatological, or infectious disease
* Presence of lower extremity fracture
* Severe spasticity (MAS\> 3) in ankle dorsiflexors
* Peripheral nerve lesions such as polyneuropathy, radiculopathy
* Parent rhythm/conduction block problem in the heart
* Uncontrollable hypertension (Maxima \>140 mmHg, Minima \>90 mmHg)
* Have a contracture on the ankle joint
* The presence of skin lesions in the application area
* Finding or suspected active deep vein thrombosis
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses

The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement material compared with standard non-reinforced colorectal, coloanal and ileoanal techniques with respect to the incidence of postoperative anastomotic leakage, anastomotic stricture and time to ileostomy closure, if applicable.

This is a randomized prospective trial that compares the use of GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement (CBSG) to standard stapling techniques in colorectal resections. The potential exists to utilize CBSG as a means of lowering the rate of post-operative anastomotic leakage and bleeding in high-risk colorectal, coloanal, and ileoanal anastomoses.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who will undergo restorative proctectomy or proctocolectomy (\<10 cm from anal verge) with a low circular stapled colorectal, coloanal or ileoanal anastomosis with or without reservoir, including treatment for rectal cancer, ulcerative colitis, familial adenomatous polyposis

  , diverticulitis, perforation of the bowel/trauma.
* Subjects undergoing Hartmann's reversal with restorative proctectomy (\<10 cm from the anal verge).
* Subjects may or may not have a diverting loop ileostomy as a component of their initial surgery.
* Subjects who meet the requirements of number 1 and 2, and are being treated for rectal cancer may or may not have preoperative chemoradiation therapy in the treatment of their rectal cancer.

Exclusion Criteria:

* Subjects being treated for rectal cancer with a diagnosis of inflammatory bowel disease.
* Subjects who have significant intraoperative hypotension or cardiac events.
* Subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine \>1.6 or liver enzymes \> 50% upper limit of normal values).
Relationship Between Acute Phase Markers and Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study

Many patients undergoing laparoscopic cholecystectomy are prone to developing acute and chronic post-operative pain.

The aim of the study is to show a possible correlation between pain and acute phase proteins in order to:

* predict the severity of pain;
* select most suitable pain relief therapy for the patient.

The day after surgery, some serum markers are determined by a blood sample.

The markers analyzed are:

* Leukocytes;
* C-reactive protein (CRP);
* D-dimer;
* Fibrinogen;
* Neutrophil-to-Lymphocyte Ratio (NLR).

Pain level is assessed using the NRS scale at different times:

* 1st post-operative day;
* 7th post-operative day;
* One month after surgery;
* Three months after surgery;
* Six months after surgery.

Other data collected for the study are: gender, age, BMI.

Eligibility Criteria:
Inclusion Criteria:

* patient undergoing laparoscopic cholecystectomy

Exclusion Criteria:

* children
Differentiation of Upper and Lower Respiratory Tract Infections Using Automated Lung Sound Analysis With LungPass Device

This observational study evaluates whether lung sound analysis with LungPass device can be used to differentiate upper and lower respiratory tract infections (URTI and LRTI)

This is a prospective observational study comprised patients presenting with acute respiratory tract infection symptoms in primary care settings. Patients will undergo routine clinical examination including lung auscultation with conventional stethoscope and LungPass device. Moreover, symptoms and anamnesis data, result of diagnostic questionnaire from the LungPass App, complete blood count, C-reactive protein, procalcitonin (PCT) level, SARS-CoV-2 PCR test and X-ray chest examination or CT chest (in case of preliminary clinical suspicion of LRTI). Patients will be followed up within 5-7 days and at the end of the disease in person or by phone for clinical course of the disease assessment to confirm the final diagnosis (URTI or LRTI). Final diagnosis will be considered as Gold standard for accuracy assessment.

Eligibility Criteria:
Inclusion Criteria:

* Adults (over 18 years) and children (3-18 years) of both sexes;
* Patients able and willing to sign an informed consent to participate in the study (parents of children younger than 18 years old will be allowed to give an informed consent on behalf of their children).
* Patients presenting with a new onset of at least two of listed acute respiratory tract infection symptoms within the last 5 days: cough, purulent sputum, breathlessness, core temperature above 38°C.
* Patients who first visit a GP with these symptoms within the first 5 days from the onset of symptoms and was not previously treated with antibiotics during the last month.

Exclusion Criteria:

* Age up to 3 years;
* Patient refusal to participate in the study (or patients' parents);
* Children under full State care (orphans, children left without parental care);
* Treatment with antibiotics during the last month;
* Patients with subcutaneous emphysema, with damaged skin on the surface of the chest, with drainage in the pleural space, patients undergoing mechanical ventilation;
* Presence of other known chronic lung conditions such as asthma, COPD, tuberculosis, cystic fibrosis or bronchiectasis;
* Mental illness, other known acute diseases or known chronic decompensated diseases, such as a known active malignancy or severe heart failure.
* Other known ongoing infection.
Oral Low Doses Tolerance INduction Study for Peanuts

Several protocols have been proposed in scientifis literature, for oral tolerance induction (OIT) protocols for peanuts. A meta-analysis showed that the data in the literature are rather in favor of the exclusion of peanuts, and that OIT doesn't allow to expect significant levels of peanut protein consumed by the patient, and is associated with an increased risk of anaphylaxis and epinephrine use. Also, in most published protocols, patients with a history of anaphylactic shock, severe asthma, or multiple history of anaphylaxis are excluded.

To date, no protocol has been validated for this type of treatment, and each center follows locally validated schemes. In our unit, the investigators use an OIT protocol that starts at low doses (first dose at 2.68 mg peanut protein) and doses increase is scheduled every 4 to 12 weeks (instead of every 2 weeks). The investigators do not exclude patients with asthma or those with a history of peanut anaphylaxis (grade 2 or 3). The investigators have noted that our protocol is associated with a good safety profile and good efficacy, probably due to the fact that the investigators start at low doses and increase the dose with a prolonged delay, compared to previously published protocols. For this reason, the investigators decided to evaluate the results the investigators obtained in our patients and to better analyze the efficacy and safety profile of our protocol.


Eligibility Criteria:
Inclusion criteria:

* Patients evaluated at the Montpellier University Hospital, Allergy Unit ;
* Patients aged 5 years or older;
* Patients with a history of immediate reaction after consuming peanuts
* AND a positive peanut prick test;
* AND peanut positive specific serum IgE (ImmunoCAP®);
* AND a positive oral peanut challenge test OR a clinical history of anaphylaxis AND peanut-specific IgE\> 100 kUA / L (ImmunoCAP®);
* Patients who started peanut OIT between September 2018 and January 2021.

Exclusion criteria:

* Patients in exclusion period determined by a previous study;
* Patients under legal protection, under guardianship or under curatorship;
* Possible poor therapeutic compliance to the OIT protocol;
* Active malignant neoplasia or autoimmune disease;
* Active eosinophilic esophagitis or other gastrointestinal eosinophilic disorders;
* Severe active eczema;
* Pregnancy ;
* Cardiovascular disease and use of beta blockers and / or ACE inhibitors;
* Chronic urticaria;
* Mastocytosis.
Outcomes of the Use of CO2 (Carbon Dioxide) Laser in the Treatment of Chronic Anal Fissure

Outcomes of using CO2 (Carbon Dioxide) laser in the management of chronic anal fissure as an alternative to conventional methods

The use of CO2 laser in management of chronic anal fissure as a new alternative technique. Interventional study of 236 patients. Comparison to other techniques was made with respect to pain scores and healing time.

Eligibility Criteria:
Inclusion Criteria:

* Have chronic anal fissure

Exclusion Criteria:

* Acute anal fissure Pregnancy
Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy

The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18 to 75 years old.
* Type 1 or type 2 diabetes.
* Painful DPN symptoms and signs for at least 3 months.
* Blood glucose controlled with medication.
* Glycosylated hemoglobin not greater than 9.5 or 11%, country dependent.
* Prior analgesic medication.
* Average score of 4 or greater on the 11 point NRS during the last 3 days prior to randomization.

Exclusion Criteria:

* Impaired liver, cardiac or renal function.
* Breastfeeding and pregnancy.
* History of substance abuse, alcohol or medication.
* Chronic gastrointestinal disease.
* History of seizures and or epilepsy.
* History or presence of malignancy.
* Presence of painful medical conditions that are not due to diabetic neuropathy, e.g. rheumatoid arthritis.
* Allergies to opioids, acetaminophen or excipients of the medications.