cyrilzakka/clinical-trials huggingface dataset:
Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours

This study is primarily designed to assess the safety and tolerability of AZD4547 at increasing doses in patients with advanced solid malignancies and for whom no standard medication options are available. It also assesses the blood levels and action of AZD4547 in the body over a period of time.


Eligibility Criteria:
Inclusion Criteria:

* Minimum life expectancy of 12 weeks
* The presence of a solid, malignant tumour that is resistance to standard therapies or for which no standard therapies exist
* In the expansion for the study patients must have a tumour at least 1cm in size that can be measure using a CT or MRI scan, and provide a tumour sample to the sponsor company for testing of FGFR1 and/or 2 amplification
* Expansion, 5 groups of advanced cancer
* Solid tumours,FGFR1 and/or FGFR2 gene amplified
* Squamous NSCLC, FGFR1 gene low \& high amplified
* Gastric adenocarcinoma, including the lower oesophagus/gastro-oesophageal junction, FGFR2 gene low \& high amplified
* Aged at least 25 years

Exclusion Criteria:

* Treatment with any other chemotherapy, immunotherapy or anticancer agents within 3 weeks before the first dose of study
* An inability to be able to take the study medication
* A bad reaction to AZD4547 or any drugs similar to it in structure or class.
Study of the Safety, Tolerability, and PK of PRA-027 Administered to Women of Nonchildbearing Potential

The primary purpose of this study is to asess the safety and tolerability of ascending single oral doses of PRA-027 in healthy women of nonchildbearing potential. The secondary purpose is to provide the initial pharmacokinetic (PK) and pharmacodynamic (PD) profile of PRA-027 in healthy women of nonchildbearing potential, and to evaluate the effect of a high-fat meal on the PK and PD of PRA-027 administered to healthy women of nonchildbearing potential.


Eligibility Criteria:
INCLUSION CRITERIA

* Women of nonchildbearing potential (WONCBP) aged 18 to 60 years. Must have a negative pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or ultrasound scan.
* Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ³50 kg. BMI is calculated by taking the subject's weight, in kilograms, divided by the square of the subject's height, in meters, at screening: BMI=weight (kg)/\[height (m)\]2
* Healthy as determined by the investigator on the basis of screening evaluations.

EXCLUSION CRITERIA

* Any significant cardiovascular, hepatic, renal, respiratory, gynecologic, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* A history of drug abuse within 1 year before study day 1, a history of alcoholism within 1 year before study day 1 or consumption of more than 2 standard units of alcohol per day (a standard unit equals 12 ounces of beer, 1½ ounces of 80-proof alcohol, or 6 ounces of wine). Any positive findings during the urine drug screen for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, and opiates.
* Use of any investigational or prescription drug within 30 days before test article administration. Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day 1. Consumption of grapefruit or grapefruit-containing products within 72 hours before study day 1. Use of any over-the-counter drugs, including herbal supplements (except for the occasional use of acetaminophen and vitamins ≤100% of the recommended daily allowance) within 14 days before study day 1.
Symptom-based Rehabilitation Compared to Usual Care in Post-COVID - a Randomized Controlled Trial

Inpatient, multimodal rehabilitation represents one of the most important interventions in the disease management of post/long COVID. Different professional societies, including the German Society of Pneumology and the European Respiratory Society, recommend rehabilitation intervention to reduce the sequelae of COVID-19. However, from the perspective of science and practice, there are relevant areas that have been insufficiently investigated and are essential for the treatment success of post/long COVID patients:

* Differentiation of rehabilitation effects from natural recovery after COVID-19.
* Lack of personalized and symptom-based treatment approaches that can address the heterogeneity of symptoms in post/long COVID
* Lack of uniform, high-quality rehabilitation standards in post-/long-COVID.

Therefore, post-COVID patients will be recruited at several post-COVID practices around Germany and randomized to receive (A) a rehabilitation program or (B) usual care. The primary objective of this randomized controlled trial (RCT) is to investigate whether a 3-week symptom-oriented, inpatient, multidisciplinary rehabilitation intervention, whose content focus is standardized according to cluster assignment (fatigue, cognition, soma), has a positive effect on the quality of life (primary outcome) in post-COVID syndrome patients compared to a usual care group (standard outpatient care). All study participants will be provided with a continuous telemonitoring system (SaniQ app) throughout the study period. After the interventional phase, there will be a 3 months follow-up assessment to evaluate the maintenance effects of COVID rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Post-COVID Syndrome according to World Health Organisation definition (persistent symptoms for at least 3 months after PCR-test confirmed SARS-CoV 2 infection)

Exclusion Criteria:

* no walking ability
* not able to operate smartphone apps
* rehabilitation program within the previous 6 months
Zinc, Mental Health, and School Performance in Guatemalan Schoolchildren

This study will determine whether supplements of the mineral zinc will improve mental health and school performance among schoolchildren in Guatemala.

Mental health problems are an important cause of dysfunction throughout the world, accounting for 8.1% of the Global Burden of Disease. The need for interventions that can prevent mental health conditions, particularly among children, cannot be overemphasized. This study will determine whether zinc supplementation improves the mental health and school performance among children in Guatemala.

Participants will be randomly assigned to receive daily supplements of either zinc or placebo for 6 months. Participants will be assessed at study entry and after the 6-month treatment. Participants and their parents and teachers will complete questionnaires about the participants' symptoms of depression and anxiety, concentration and activity levels, school performance, and any environmental stressors to which the participants may be exposed to.

Eligibility Criteria:
Inclusion Criteria:

* Attend a public school in specific Guatemalan community and has thorough and up-to-date school records
* Currently in 2nd to 6th grade
* Parent or guardian willing to provide informed consent

Exclusion Criteria:

* Any illness that may affect participants' zinc levels
* Any chronic illness
* History of cancer
Randomized Assessment of Devices Used to Prevent Post-operative Hemorrhagic Risk in Endonasal Surgery

This study evaluates the efficiency and the cost of three medical devices and the abstention of the use of specific product for the post-operative haemostasis in endonasal surgery .

Surgiflo® is a matrix of haemostatic frost of porcine protein origin is the coverage of the post-operative bleeding of which one of the indications is in endonasal surgery.

Floseal® is a haemostatic frost(gel) containing of the thrombin.

Algosteril® is a lint tent of arginate of calcium.

Eligibility Criteria:
Inclusion Criteria:

* endonasal surgery schedule
* Surgical indications:

hypertrophic rhinitis, repeated or chronic infections, extraction of foreign body, polyposes naso-sinusal, benign tumors limited to the nasal pit and in sine,

Exclusion Criteria:

* Pregnant Woman
* Disorder of the haemostasis known or disrupted preoperative biological balance assessment
* Use of treatment disrupting the blood coagulation (anti platelet, anti vitamin K, AINS)
* Unchecked HTA by the treatment and/or preoperative \> mmHg 160/90
* Surgical Act including a septoplasty
* malignant tumoral surgical Indication, or mild overtaking the naso-sinusial system
* Dacryocystorhinostomy
Study Evaluating Sphenopalatine Ganglion Block (SPGB) for Treatment of Postdural Puncture Headache (PDPH)

Postdural puncture headaches (PDPH) are a consequence of spinal and epidural anesthesia in approximately 1% of cases when performed in obstetric patients. The gold standard treatment for a PDPH is currently an epidural blood patch (EBP), which involves placing a needle back into the epidural space of the neuraxium and then injecting 20 ml of the patient's own blood through the needle and into the epidural space to form a clot over the insult in the tissue layer that causes the headaches. The investigators want to test the efficacy of using a less invasive procedure, called a sphenopalatine block (SPGB), for treatment of PDPH. SPGB has been used for many years in the treatment of migraines and cluster headaches, and there are several case reports of its use to successfully treat PDPH as well. SPGB simply involves applying a local anesthetic to the mucosa in the back of each nostril to numb the nerves that cause the headache. The investigators hope that the SPGB will reduce the number of PDPH patients that require and EBP.


Eligibility Criteria:
Inclusion Criteria

* Active postdural puncture headache within 7 days after neuraxial analgesia/anesthesia
* Age ≥ 18 years.
* ASA physical status ≤ 3

Exclusion Criteria

* Known coagulopathy
* Known nasal septal deviation or abnormalities
* Medical conditions contraindicated to bupivacaine or the nasal applicator (according to the product labeling)
A Trial of GFH018 and Toripalimab in Combination with Concurrent Chemoradiotherapy in Stage III NSCLC Chemoradiotherapy in Stage III NSCLC

This is a phase II trial assessing the efficacy and safety of GFH018 and Toripalimab in combination with concurrent chemoradiotherapy (cCRT) in patients with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Newly diagnosed, pathologically (histologically or cytologically) confirmed, locally advanced, unresectable stage III NSCLC
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Measurable disease (according to RECIST v1.1 criteria)
* Life expectancy \> 6 months

Exclusion Criteria:

* Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements.
* Has received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for Stage III NSCLC
* Prior exposure to immune-mediated therapy, including but not limited to, TGFβ inhibitors, anti CTLA-4, anti-PD-1, anti-PD-L1, and anti PD L2 antibodies.
* Known allergy or hypersensitivity to any of the IPs or any of the IP excipients.
* Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 Gy in total (V20) of more than 35% of lung volume.
Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy

Two hundreds and twenty five postmenopausal women undergoing outpatient hysteroscopy and endometrial biopsy will be randomly divided into three equal groups. To ensure blinding the investigators will use the double dummy technique in which group 1 will receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo similar to Celecoxib, group 2 will receive dexketoprofen 25mg (neo ketadex 25, Marcryl, Egypt) in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol and a placebo similar to Celecoxib. All drugs will be given 2 hours before the procedure. An independent person will generate the allocation sequence using computer generated random numbers.

Two hundreds and twenty five postmenopausal women undergoing outpatient hysteroscopy and endometrial biopsy will be randomly divided into three equal groups. To ensure blinding the investigators will use the double dummy technique in which group 1 will receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo similar to Celecoxib, group 2 will receive dexketoprofen 25mg (neo ketadex 25, Marcryl, Egypt) in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol and a placebo similar to Celecoxib. All drugs will be given 2 hours before the procedure. An independent person will generate the allocation sequence using computer generated random numbers.

Statistics:

Quantitative data will be statistically represented in terms of mean ± standard deviation (± SD) while categorical data will be represented as frequency and percentage. Comparison of quantitative data will be done using ANOVA test for independent samples while categorical data will be compared using Chi squared test or Fisher exact test when appropriate. A probability value (p value) less than 0.05 will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Post menopausal women.
* vaginal bleeding.
* Endometrial thickness \>4mm.

Exclusion Criteria:

* Medical disorders like uncontrolled diabetes or hypertension, cardiac, renal, liver disease.
* Gastritis or peptic ulcer.
* Allergy to Tramadol or dexketoprofen.
Kinesiotaping and Post-dry Needling Soreness

Application of trigger point dry needling can induce post-dry needling soreness. This is not a negative experience, but sometimes some patients want to reduce it as much as possible. Different therapeutic strategies targeting to decrease post-dry needling soreness need to be investigated. Since Kinesiotaping has been advocated for decreasing tone in the muscle tissues, it would be a potential intervention for this objective.


Eligibility Criteria:
Inclusion Criteria:

- Generalized neck-shoulder pain with symptoms provoked by neck postures, neck movement, or palpation of the cervical musculature

Exclusion Criteria:

* any contraindication to dry needling
* whiplash injury;
* previous cervical surgery;
* cervical radiculopathy or myelopathy;
* diagnosis of fibromyalgia syndrome;
* having undergone any therapy intervention for the neck are in the previous 6 months;
* fear to needles;
* less than 18 or greater than 65 years of age.
Endoscopic Nasogallbladder Drainage Versus Gallbladder Stenting Before Cholecystecomy

Early laparoscopic cholecystectomy is the current standard therapy for acute cholecystitis, but temporary decompression of the gallbladder (GB) through percutaneous or endoscopic route can be required to alleviate inflammatory process and reach an appropriate time for elective surgery in patients with high operative risk or marked local inflammation or organ dysfunction. Also preoperative endoscopic retrograde cholangiopancreatography (ERCP) is often needed because common bile duct (CBD) stone is accompanied in patients with acute cholecystitis at reported rate from 7-20%.

Two-steps approach of percutaneous transhepatic GB drainage (PTGBD) followed by ERCP or vice versa has been performed for the treatment of acute cholecystitis with concomitant CBD stone who are not suitable for urgent cholecystectomy. However single-step drainage of CBD and GB through ERCP and endoscopic transpapillary GB drainage (ETGD) using nasocystic tube or plastic stent has alternatively been attempted in patients who have contraindications for PTGBD. In clinical practice, many endoscopists have hesitated to perform ETGD because of its relatively low technical success rate and specific concern about post-ERCP adverse event but it minimizes catheter keeping duration, and provides effective clinical improvement via physiologic route.

Currently there are scarce data on if ETGD using nasocystic tube or plastic stent are comparable in terms of clinical efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* grade II or III acute cholecystitis met Tokyo 13 diagnostic criteria
* a high suspicion of CBD stone based on laboratory and imaging study
* informed consent given.

Exclusion Criteria:

* bilo-pancreatic malignancy or surgically altered enteric anatomy
* subsequent elective surgery is expected to be impossible even after GB decompression based on American Society of Anesthesiologist class
Chemotherapy Plus Cetuximab Followed by Surgical Resection in Patients With Locally Advanced or Recurrent Thymoma or Thymic Carcinoma

The main purpose of this study is to find out the good and the bad effects that the combination of cetuximab with the traditional chemotherapy regimen of cisplatin, doxorubicin, and cyclophosphamide has when given to patients with later stage thymoma or thymic carcinoma before surgery. The physicians will also look at changes in genes in the tumor that may relate to the effectiveness of cetuximab


Eligibility Criteria:
Inclusion Criteria:

* Age\>18
* Karnofsky Performance Status (KPS) ≥ 70
* Newly diagnosed or recurrent thymoma - WHO A, AB, B1, B2, or B340, or thymic carcinoma pathologically confirmed at MSKCC, MDACC or City of Hope
* No prior chemotherapy, radiotherapy, or surgical therapy (other than for diagnostic biopsy) for thymoma
* No prior treatment with cetuximab
* Clinical Masaoka Stage II (\>5cm), III, or IVA(See Appendix B), including suspected invasion of mediastinum, pericardium, lung, great vessels or chest wall, and/or pleural metastases Normal marrow function: leukocytes ≥ 4,000/μl, absolute neutrophil count ≥ 1,500/μl, platelets ≥ 160,000/μl
* Adequate renal function, with creatinine ≤ 1.3 mg/dl or calculated creatinine clearance ≥60ml/min by Cockcroft and Gault equation using parameters of age, weight (kg), and baseline serum creatinine (mg/dl)
* Adequate hepatic function: Total bilirubin ≤1.5 mg/dl, AST ≤1.5X UNL, alkaline phosphatase ≤1.5 UN
* Signed informed consent
* Effective contraception
* Medically operable

Exclusion Criteria:

* Evidence of distant metastatic disease (Masaoka stage IVB)
* Thymic carcinoid
* Patients must not be receiving any other investigational agents
* Concurrent or prior malignancy in the last 5 years other than non-melanoma skin cancer and in-situ carcinoma of the cervix
* Known HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with the study drugs. Patients on medications known to alter CYP3A4
* Pregnant or breastfeeding women
Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing

The aim was to determine the wound healing capacity in healthy never smokers and smokers who continue to smoke, or quit smoking using transdermal nicotine patch versus placebo patch.

Two wound healing models were applied: the excisional skin biopsy model to study wound histology and the suction blister model to study epidermal regeneration and skin transudate. In addition blood sampling was made to validate compliance to the study arms and to study systemic markers of collagen metabolism and oxidative stress. In addition, wound infections and wound ruptures were recorded post hoc as complications to the excisional skin biopsy model were not expected to occur.

Eligibility Criteria:
Inclusion Criteria:

* daily smokers smoking between 15-25 cigarettes per day and never smokers

Exclusion Criteria:

* chronic medical disease
* atopic dermatitis or other skin disease
* pregnancy
* menopause
* allergy to dressings or patches
* current or recent medication with corticosteroids or NSAID
Predictive Value of Cognitive Tests Performed for the Diagnosis of Alzheimer's Disease and Related Disorders

The purpose of this study is to determine the predictive value of standardized cognitive tests performed in health examination centres for the diagnosis of Alzheimer's disease and related disorders among adults aged 65 years and older with a subjective memory complaint.

The main objective of this study is to determine the predictive value of standardized cognitive tests performed in health examination centres for the diagnosis of Alzheimer's disease and related disorders among adults aged 65 years and older with a subjective memory complaint.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* Community-dwellers
* Volunteers receiving a free medical examination in Health examination centre
* Subjective memory complaint

Exclusion Criteria:

* Known dementia
* Sensory deficit compromising the cognitive evaluation
* Poor workmanship of the written or oral French language
Drug Interaction Study - Effect of AZD5672 on the Pharmacokinetics of Digoxin

The purpose of the study is to examine the effect of AZD5672 (dosed to steady state) on the pharmacokinetics of digoxin (single dose administration).


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed written informed consent.
* Females should not be of childbearing potential
* Clinically normal physical and laboratory findings as judged by the investigator, including negative drug test and negative tests of Hepatitis B surface antigen, antibodies to Hepatitis C virus and antibodies to HIV.

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate
* Known allergy to digoxin or previous complications to digoxin therapy.
* Participation in any clinical study involving an investigational product in the 3 months prior to enrolment.
List Experiment to Measure Food and Water Insecurity

List experiment to measure food and water insecurity

Food and water insecurity are complex, multi-domain constructs. Given their known association with important health and mental health outcomes, accurate assessment of food and water insecurity in resource-limited settings is paramount. The purpose of this study is to use a list experiment methodology to assess the extent to which there is bias in conventional survey-based means of direct elicitation of food and water insecurity. The list experiment provides an indirect means to measure a particular construct of interest. It is hypothesized that social desirability may cause upward bias in conventional survey-based means of direct elicitation of food and water insecurity.

Eligibility Criteria:
Inclusion Criteria:

* All adults who consider Nyakabare their primary place of residence and who are capable of providing consent

Exclusion Criteria:

* Minors younger than 18 years of age, with the exception of emancipated minors
* Persons who do not consider Nyakabare Parish their primary place of residence, e.g., persons who happen to be visiting Nyakabare at the time of the survey or who own a home in Nyakabare but spend most of their time outside the parish
* Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor)
The General Use of Robots in Stroke Recovery: the Anklebot

The purpose of this study is to determine if isolated robot-assisted training of the ankle joint improves chronic hemiparetic gait in patients after stroke.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior
* Cognitive function sufficient enough to understand experiments and follow instructions
* Some amount of independent ambulation (with orthoses or walker)

Exclusion Criteria:

* Botox treatment within 6-weeks of enrollment;
* Fixed contraction deformity in the affected limb;
* Complete and total flaccid paralysis of all lower extremity motor function;
* Unable to ambulate except with the aid of another person