cyrilzakka/clinical-trials huggingface dataset:
A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis

This study is a randomized, active-controlled, double-blind, phase 3 study to compare the efficacy and safety of CT-P43 to Stelara in patients with moderate to severe plaque psoriasis.

CT-P43, containing the active ingredient ustekinumab, is a human IgG1κ monoclonal antibody that is being developed as a biosimilar medicinal product to the reference product, Stelara. The purpose of this study is to demonstrate similar efficacy and safety of CT-P43 and Stelara in patients with moderate to severe plaque psoriasis.

Eligibility Criteria:
Inclusion Criteria:

- Patient has had diagnosis of plaque-type psoriasis for at least 24 weeks.

Exclusion Criteria:

* Patients diagnosed with forms of psoriasis other than plaque-type.
* Patients previously received ustekinumab or a biosimilar of ustekinumab.
* Patient who has allergies to the active substance or any of the excipients of ustekinumab or study drug, or patients with a hypersensitivity to immunoglobulin products or natural rubber and latex.
Dual Task Training in Spastic Cerebral Palsy

This study aims to investigate the effects of dual task training on gait and balance parameters, gross motor function skills, functional mobility skills, functional independence levels and health-related quality of life o in children with spastic diplegic cerebral palsy. The clinical study's hypothesis is the dual task training programs are superior to conventional physiotherapy programs to improve the parameters in spastic diplegic cerebral palsy.

In this self-controlled study, children with spastic diplegic cerebral palsy, aged 7-16, who were at level 1 or 2 according to the Gross Motor Function Classification System, scored 27 and above from the Modified Mini Mental Test were included.

Children are recruited to the routine physiotherapy program 45 minutes 2 days a week for 8 weeks, and in addition to the routine physiotherapy program dual task training program 45 minutes 2 days a week for the next 8 weeks. The children will evaluate at baseline, after the routine physiotherapy program and after the dual task training program. Children will be evaluate with Gross Motor Function Measurement-88,Modified Ashworth Scale , gait platform, Edinburgh Visual Gait Score, Pediatric Berg Balance Scale,1 Minute Walk Test, Functional Independence Measure, Pediatric Quality of Life Inventory TM-Cerebral Palsy Module.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with spastic diplegic cerebral palsy,
* Being at level 1 or 2 according to the Gross Motor Function Classification System,
* Being at level 1 according to Communication Function Classification System,
* To adapt to the evaluations,
* To get 27 points or above from the Modified Mini Mental Test (MMMT).

Exclusion Criteria:

* Having had injuries such as strains, sprains or fractures of the lower extremity in the last six months,
* Having undergone a surgical intervention or Botulinum toxin in the last six months,
* Having any known chronic systemic problems,
* Having uncontrollable seizures,
* Having vision or hearing problems.
Effect of Kinesio Taping on Pain, Posture and Function in Lower Cross Syndrome

Determine the impact of Kinesio taping on pain, postural alignment and functional outcomes in individuals with lower cross syndrome.

Participants with lower cross syndrome who present to physical therapy department will be screened for eligibility on basis of inclusion and exclusion criteria. Group A will receive the treatment with moist hot pack along with stretching of tight erector spinae, hip flexors and strengthening of weak abdominals and gluteal muscles along with Kinesiotaping using inhibition and facilitation technique for LCS and Group B will receive the treatment with moist hot pack along with stretching of tight erector spinae, hip flexors and strengthening of weak abdominals and gluteal muscles. The patients will receive the treatment sessions 3 days per week for almost 04 weeks. They will be evaluated after the treatment for PAIN, POSTURAL ASSESSMENT, FUNCTIONAL DISABILITY in order to check for the effect of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age- 30 to 50 years.
* Female patients.
* Anterior pelvic tilting \> 7-10 degrees.
* Postural imbalance characterized by anterior pelvic tilt, lumbar hyper lordosis, and associated muscle imbalances.
* Discomfort, pain, or limitations related to the lower back, pelvis, and hips attributed to LCS.
* Willing to provide informed consent to participate in the study.

Exclusion Criteria:

* Musculoskeletal pathologies affecting the lower back, pelvis, hips, or lower extremities (e.g., herniated disc, lumbar radiculopathy, lumbar stenosis, hip labral tear).
* Kinesiotaping interventions for LCS in the past 3 months.
* Allergies to tape materials or skin sensitivities that might prevent safe tape application.
* Pregnant individuals due to potential discomfort.
* Open wounds, infections, or skin conditions at the taping application site.
* Severe cardiovascular, pulmonary, renal, or neurological diseases.
* In other clinical trials involving interventions for LCS.
Persistent Weight Maintenance for 6 Months After 3 Months of Active Weight Loss

This study is intended to report changes in the weight and metabolic indicators of the subjects six months after the end of the study for adults with a risk factor of 27 kg/m2 or higher (formerly the research task name\[clinicaltrial.gov;NCT03675191\]).

There was no special intervention after the previous research intervention. After the previous research was completed, we will check the changes in the body composition and metabolic indicators over six months.

Eligibility Criteria:
Inclusion Criteria:

* Those who have participated in the previous trial (NCT03675191) and have completed the three-month study
* Those who agreed the trial.

Exclusion Criteria:

* Those who have withdrawn the previous trial (NCT03675191)
The Usage of High-resolution Magnetic Resonance Imaging in Patients With Disorders of Consciousness for Early Diagnosis

In this study, high-resolution brain functional magnetic resonance imaging (MRI) was used to evaluate the differences in brain structure and brain function network between patients with different degrees of disturbance of cognition and healthy controls by means of cohort follow-up and control study. The changes of patients' The dynamic changes of learning, to explore its clinical value as an early diagnosis. Combined with neurobehavioral scales and high-resolution brain structure, functional magnetic resonance imaging data to assess the brain structure, functional characteristics and consciousness of patients with impaired consciousness, and initially establish awareness of patients with recovery of consciousness Predictable imaging signs. Twenty eligible controls, 20 VS patients, and 20 MCS patients will be considered for inclusion in the inclusion / exclusion criteria. Informed consent will be obtained as required before starting any registration process.


Eligibility Criteria:
Inclusion Criteria:

(1) no use of centrally acting drugs, (2) no use of neuromuscular function blockers and no sedation within the prior 24 h, (3) periods of eye opening indicating a preserved sleep-wake cycle, and (4) a diagnosis of VS or MCS established according to internationally established criteria

Exclusion Criteria:

Magnetic resonance contraindications
Effects of Endogenous GIP on Postprandial Blood Pressure in Healthy Individuals

The present study investigates the postprandial role of endogenous glucose-dependent insulinotropic polypeptide (GIP) on cardiovascular haemodynamics, hormone responses, and hypotensive symptoms during a tilt test.

The study is an exploratory, randomised, placebo-controlled, double-blinded crossover study comprising four experimental days. Each experimental day consists of a mixed meal test or drinking water, a double-blinded continuous infusion of GIP(3-30)NH2 or placebo or GIP(1-42) or placebo, and three tilt tests. Sixteen healthy men and women will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-40 years
2. BMI between 18.5 and 29.9 kg/m2 (both included)
3. Informed consent

Exclusion Criteria:

1. Allergy or intolerance to ingredients included in the mixed meal
2. History of Orthostatic Hypotension (OH) or Postural Orthostatic Tachycardia Syndrome (POTS) or other autonomic dysfunction at the discretion of the investigators
3. Anaemia (haemoglobin below normal range \<7.3 mmol/L for women and \<8.3 mmol/L for men)
4. Kidney disease (estimated glomerular filtration rate (eGFR) \<90 ml/min/1.73 m2) at screening
5. Known liver disease and/or elevated plasma alanine aminotransferase (ALT) \> three times the upper limit of normal at screening
6. Treatment with antihypertensives
7. Treatment with GLP-1RA (Glucagon-like Peptide-1 Receptor Agonist)
8. Treatment with SNRI (Serotonin and Noradrenalin Reuptake Inhibitor) or treatment within two weeks before the first experimental day
9. Any ongoing medication that the investigator evaluates would interfere with trial participation
10. Any physical or psychological condition that the investigator evaluates would interfere with trial participation, including any acute or chronic illnesses
11. Any concomitant disease or treatment that, at the discretion of the investigators, might jeopardize the participant's safety during the trial
12. Alcohol/drug abuse as per discretion of the investigators
13. Pregnancy or breastfeeding
14. Participation in any other clinical trial during the study period
15. Mental incapacity or language barriers that preclude adequate understanding or cooperation or unwillingness to comply with trial requirements or pr discretion of the investigator
Neoadjuvant Chemotherapy With Carboplatin and Docetaxel in Patients With Advanced Ovarian Cancer-Prospective, Randomized Phase II Clinical Trial

The purpose of this study is to evaluate response to neoadjuvant chemotherapy by imaging and observation of anatomical and biological indicators (i.e. ascites or continuous measurement of tumor marker CA 125). Furthermore the optimal number of preoperative administered cycles of combination chemotherapy with carboplatin and docetaxel should be determined.


Eligibility Criteria:
Inclusion Criteria:

* histological confirmed ovarian neoplasm
* Figo stage IIIC (2cm extrapelvic disease) or Figo IV
* more than 500 ml ascites volume (measured by sonography)
* age \> 18 years old
* ECOG \<= 2
* adequate hepatological, renal and haematological function
* informed consent

Exclusion Criteria:

* concomitant or previous malignant diseases
* debulking procedures on initial surgical approach
* existing peripheral sensoric neuropathy \>= grade 2
* acute infections
* mental disorders, cerebral metastasis
* bowel obstruction
Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation

Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation (CIC)

This was a Phase 3 multicenter, open-label, safety and tolerability extension trial of 10 mg elobixibat daily, with possibility for dose adjustment to 5 mg daily, for 52-week Treatment Period in patients with CIC. A dose adjustment to 5 mg/day was allowed for the remainder of the trial if a patient reported unacceptable treatment-related diarrhoea that occurred within the first four weeks of treatment.

The trial enrolled patients from two lead-in, double-blind efficacy trials (trial codes NCT01827592 and NCT01833065).

Eligibility Criteria:
Inclusion Criteria:

* Has completed double-blind treatment in either of the lead-in efficacy trials, 000079 or 000080.
* The patient reports having understood and has signed the Informed Consent Form (ICF) and is willing to comply with all trial visits and assessments.
* The patient agrees to refrain from making any new, major lifestyle changes that may affect CIC symptoms (i.e., starting a new diet, changing an exercise plan) from the time of signing the ICF through to the last trial visit.

Exclusion Criteria:

* The patient has been withdrawn/discontinued from the 000079 or 000080 trials.
* The patient is not willing to abide by the restrictions for intake of prohibited medication.
* Women of childbearing potential (defined, for the purpose of this trial, as all females post-puberty, not postmenopausal ≥2 years, or not surgically sterile) who have a positive urine pregnancy test at Visit 1, or who do not agree to use one of the following methods of birth control from the day of signing the ICF until 30 days after the final dose of trial drug are excluded:

  1. Transdermal patch
  2. Established use of oral, injected or implanted hormonal methods of contraception
  3. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
  4. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
  5. Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
  6. True sexual abstinence: when this is in line with the preferred and usual lifestyle of the patient.
* The patients is considered by the Investigator to be unsuitable to participate in the trial for any other reason.
Intrathecal Atropine Versus Intravenous Ondasetron in Post Operative Nausea Due to Intrathecal Morphine

To compare between intrathecal atropine versus preoperative administration of IV ondansetron in decreasing incidence of post operative nausea and vomiting related to intrathecal opioids in post operative period in perineal surgery as regard : efficacy and side effects .


Eligibility Criteria:
Inclusion Criteria:

* Age between ( 18 - 45 ) years.
* Body mass index between ( 18.5 - 35 )
* patients undergoing perineal surgery as anal fissure , piles and rectocele
* patients receiving bupivacaine ( 20 mg / 4 ml ) as spinal anesthesia
* Patinets with physical status 1 or 2 according to ASA classification

Exclusion Criteria:

* Patient refusal .
* Any contraindication of neuraxial block as : coagulopathy , skin infection at injection site or bacteremia , hypovolemia and shock , history of allergy to L.A , sever aortic stenosis or mitral stenosis ......... etc
* Patients with physical status other than 1 and 2 according to ASA classification
* Those with history of nausea and vomiting , also those who received anti emetic drugs in last 2 hours of operation .
* Allergy to any of the drug included in this study .
Locally Produced Cloth Face Mask and COVID-19 Like Illness Prevention

The number of cases of COVID-19 is still increasing and transmission of SARS-CoV-2 seems to occur mainly through person-to-person transmission through respiratory droplets, indirect contact with infected people and surfaces. The use of face masks is recommended as a public health measure, but in many settings only domestic cloth made masks are available to the majority of the people. However, masks can be of different quality and very little is known about the utility of cloth face masks at the community level.

In Bandim Health Project's Health and Demographic Surveillance System we will evaluate the effect of providing locally produced cloth face masks on severity of COVID-19 like illness and mortality in an urban population. The locally produced cloth mask is made according to a laboratory certified model and will be provided to the intervention group alongside information of how the risk of transmission can be reduced. The control group will receive information alone.

Follow-up will be implemented through telephone calls and post-epidemic home visits.


Eligibility Criteria:
Inclusion Criteria:

* Household resident
* Age: 10 years and older

Exclusion Criteria:

* Refusal to participate
A Multicenter, Randomized Clinical Trail Evaluate Effectiveness and Security of Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen After the 1st-line Chemotherapy With Capecitabine Combine Regimen in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer(Overstep)

A multi-sites study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine therapy, in metastatic breast cancer patients with HR-positive \& HER2-negative after capecitabine-base chemotherapy.

capecitabine-base chemotherapy must be first-line chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* The age is Above 18 years of age, \<70 years old
* HR-positive \& HER2-negative
* Metastatic breast cancer,incurable.
* No prior chemotherapy for metastatic recurrence, if there is disease progression within 6 months after the end of the adjuvant chemotherapy, adjuvant chemotherapy as first-line treatment for metastatic lesions
* Eastern Cooperative Oncology Group performance status (ECOG PS)=0\~1
* The basic function of normal bone marrow
* Functions of liver and kidney is normal
* Expectation of life is more than 3 months
* Agreed to take contraceptive measures during treatment

Exclusion Criteria:

* Previous toxicity was not recovered to 0-1 degrees
* Central nervous system metastasis
* Pregnancy or lactation
* There are uncontrolled infection, myocardial infarction, thrombosis, etc.
* There are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease;
* Researchers believe that is not suitable for the study
* Patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix;
* Bilateral breast cancer
Dexketoprofen and Ibuprofen in Long Bone Fractures

The aim of this study was to compare the efficacy of ibuprofen and dexketoprofen, two common analgesic drugs used in pain control in patients with long bone fractures.

Long bone fractures are the fractures of long bones (tibia, femur, humerus) in the human body. Such fractures usually occur as a result of trauma and are manifested by symptoms such as pain, swelling, bruising and limitation of movement. Effective control of pain can help the patient relax and facilitate the healing process. Ibuprofen and dexketoprofen, which belong to the class of non-steroidal anti-inflammatory drugs (NSAID), are among the analgesics commonly used in the pain management of all fractures. These drugs are thought to be able to relieve pain, reduce inflammation, and help patients move. However, each patient's individual response and tolerance may differ, so the efficacy and side effects of each drug may vary from patient to patient. This makes it difficult to determine which analgesic is more effective and safe in clinical practice. The fact that it is a subject that has not been done much in the literature has led us to do this study.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years
* Patients under 80 years of age
* Patients who agreed to participate in the study
* One of the tibia, femur and humerus bones is broken
* Patients with a VAS score of 50 and above
* Patients with no other injuries requiring emergency surgery
* Previously known adverse reactions to the active ingredient of the drugs to be used patients with no history
* Conscious patients
* Oriented cooperative patients

Exclusion Criteria:

* Patients under the age of 18 and over the age of 80
* Patients who did not agree to participate in the study
* Patients with vital signs outside the normal limits
* Patients with a history of adverse reactions to known NSAIDs
* Those who cannot determine the severity of pain on the VAS
* Patients with a VAS Score of 50 mm or less
* Those with other orthopedic injuries pregnant women
* Those with advanced systemic disease
* Those with malignancy
* Those with chronic liver and kidney disease
* Those who use neuro-psychiatric drugs with sedative and analgesic effects
* Those with a history of psychological and neurological diseases
* Patients using analgesics 8 hours before the examination
Description of Joint Population and Assessment of Impact on Health Status of Orencia in Patients With Rheumatoid Arthritis in France. A Database Analysis Based on SFR's ORA Long-term Cohort Study

Database analysis:

* To describe how Orencia is prescribed in France in Rheumatoid Arthritis (RA)
* To describe joint population of Orencia
* To assess the impact of the treatment on health status of the treated population as assessed by morbid-mortality criteria
* To describe therapeutic strategies and use of health services

* Observational Model: Historic cohort generated from Société Française de Rhumatologie's (SFR) Orencia and Rheumatoid Arthritis (ORA) registry
* Sampling Method: all physicians and sites taking in charge RA patients received an invitation mailing to participate to ORA
* Minimum Age: 18 years old at Orencia initiation

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Adult outpatients, male or female aged ≥ 18 years old
* Diagnosed with a rheumatoid arthritis according to ACR criteria
* Treated with Orencia according to usual practice conditions from June 1st 2007
* Agreeing to participate

Exclusion Criteria:

* Patients treated by Orencia in the context of clinical trials
Oat Phenolics Bioavailability

A diet rich in whole grain is inversely associated with cardiovascular disease risk and this benefit could be partly attributed to the phenolic acid content of whole grains. The exact absorption, metabolism and excretion of whole grain phenolic acids, however, is not fully understood. In a small human intervention trial, the investigators will investigate to what extent phenolic acids from whole grain oats are absorbed, excreted in urine and how they are metabolised.


Eligibility Criteria:
Inclusion Criteria:

* Males
* 25 to 65 years old

Exclusion Criteria:

* Allergies to oats
* Parallel participation in another research project
* Having flu vaccination or antibiotics within 3 months of trial start
* Taking food supplements within 3 months of trial start
* Past or existing medical history of vascular disease, diabetes, hepatic, renal, gastrointestinal, haematological, neurological, thyroidal disease or cancer