cyrilzakka/clinical-trials huggingface dataset:
Sleep Quality & Spinal Cord Injury

The aim of the study was to evaluate sleep quality in patients with spinal cord injury; to investigate the relationship between sleep and spinal cord level, ambulation status, spasticity, quality of life, daily living activities, depressive status, neuropathic pain

Since survival increases in patients with spinal cord injury, sleep disturbances, which are more frequently observed than the general population and have significant impacts on mortality, impair long-term quality of life.The aim of the study was to evaluate sleep quality in patients with spinal cord injury; to investigate the relationship between sleep and spinal cord level, ambulation status, spasticity, quality of life, daily living activities, depressive status, neuropathic pain Eighty patients with inpatient rehabilitation of spinal cord injury were included in the study.

Demographic characteristics, duration of spinal cord injury, spinal cord injury level, etiology, number of intermittent bladder catheterization (IC), number of night time IC, what time they slept, whether they woke up at night, classification of spinal cord injury were recorded.

Ambulation level with Functional Ambulation Classification (FAC), spasticity with Modified Ashworth Scale (MAS), depressive symptoms with Beck Depression Index (BDI), quality of life with short-form health survey (SF-36), sleep quality The Pittsburgh Sleep Quality Index (PSQI), daytime sleepiness Epworth sleepiness scale (ESS), activity of daily living with Barthel Index (BI), neuropathic pain were evaluated with the Douleur Neuropathique 4 questionnaire (DN4) scale.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age

Exclusion Criteria:

* Noncooperativity
* Traumatic brain injury or other cerebellar-related neurological disease such as hemiplegia.
* Patients with spinal shock
The Efficacy and Safety of Curcuma Domestica Extracts and Ibuprofen in Knee Osteoarthritis

Osteoarthritis of knee is common degenerative musculoskeletal diseases. Non-steroidal antiinflammatory drugs (NSAIDs) are used to decrease pain symptom but someone can not tolerate its gastrointestinal adverse effects. In vitro studies showed that curcumin had an inhibitory effect on substances playing an important role in inflammatory pathway. The mechanisms by which curcumin prevents inflammation are postulated through inhibition of many cytokines, for example, lipo-oxygenase, cyclo-oxygenase, and phospholipase. Therefore, if curcumin is effective as NSAIDs with less side effects, it can be an alternative treatment for those OA knee patients.

Curcumin was demonstrated to be safe and had anti-inflammatory activity in six studies in humans. It may exert its anti-inflammatory activity by inhibition of a number of different molecules that play a role in inflammation.

Our experience in a study of 100 subjects revealed a trend towards a greater effect in OA patients receiving Curcuma domestica extracts. However, studies with adequate sample and dosage of Ibuprofen are recommended to demonstrate the efficacy of C.domestica extracts in alleviating knee pain and improving knee functions.

The objective of the study was to determine the efficacy and safety of C.domestica extracts in pain reduction and functional improvement in patients with knee osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* Primary osteoarthritis
* Knee pain score more than or equal to 5 point (NRS 0-10)
* Age \>= 50 years, not \> 75 years
* Knee crepitus
* Knee stiffness less than 30 minutes
* Urine pregnancy test negative in case of not being menopausal period

Exclusion Criteria:

* History of GI ulcer or melena
* Having hepatic or bile duct diseases(SGOT ≥ 37 u/L, SGPT ≥ 40 u/L)
* Having renal disease or abnormal renal functions (serum creatinine ≥ 1.5 mg/dl)
* Asthma or gout
* Allergy to ibuprofen or curcumin
* History of intraarticular knee injection within 6 months
* Post knee arthroplasty
* History of intermittent claudication
* Unable to walk, for example hemiplegia, severe lung/heart diseases
* Knee x-ray found chondrocalcinosis
* On anticoagulant
Pilot Study Evaluation of 2 Artificial Tears. Evaluation of TBUT, Tear Meniscus Height and Tear Thickness

To determine baseline tear thickness and improvement immediately post installation of two artificial tear solutions:(9582X) and Allergan Refresh Tears.


Eligibility Criteria:
Inclusion Criteria:

1. Normal, healthy volunteers 18 years or older
2. Males or females
3. Any race or ethnic background

Exclusion Criteria:

1. Corneal refractive surgery within 6 months of this study.
2. Contact lens use on day of examination.
3. Corneal ectasia
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)

The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.


Eligibility Criteria:
Inclusion criteria:

1. Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to screening
2. Confirmed prior virological failure with an approved dose of PegIFN/RBV
3. Age 18 to 70 years,
4. HCV RNA (RiboNucleic Acid) = 1,000 IU/mL at screening,

Exclusion criteria:

1. HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection
2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,
3. Decompensated liver disease, or history of decompensated liver disease,
4. Body weight \< 40 or \> 125 kg,
5. Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder
6. Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study
7. Laboratory parameters disorders (thalassemia major, sickle cell anemia or G6PD deficit)
8. Hemoglobin \< 12 g/dL for women and \< 13 g/dL for men
9. Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,
A Study of INCB099280 in Combination With Axitinib in Adults With Advanced Solid Tumors

This study is being conducted to evaluate the safety and tolerability of INCB099280 in combination with axitinib and to assess the antitumor activity of INCB099280 in combination with axitinib. This study will only be open in the UK and EU.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered non-amenable to surgery or other curative treatments or procedures.
* Must have disease progression on or after treatment with at least one prior systemic chemotherapy.
* Eastern Cooperative Oncology Group performance status score of 0 or 1.
* Life expectancy \> 12 weeks.
* Willingness to avoid pregnancy.

Exclusion Criteria:

* Known additional malignancy that is progressing or requires active treatment.
* Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.
* Toxicity from prior therapy that has not recovered to protocol-defined limits.
* Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent; treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL-2, 4-1BB, CAR-T cell).
* Prior therapy with antiangiogenic small-molecule TKIs targeting the VEGF pathway
* Participation in another interventional clinical study while receiving INCB099280.
* Impaired cardiac function or clinically significant cardiac disease.
* History or evidence of interstitial lung disease including noninfectious pneumonitis.
* Presence of gastrointestinal conditions that may affect drug absorption.
* Any autoimmune disease requiring systemic treatment in the past 5 years.
* Diagnosis of primary immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent.
* Active infection requiring systemic therapy.
* History of organ transplantation, including stem cell transplantation.
* Receipt of systemic antibiotics within 28 days of first dose of study treatment.
* Probiotic usage is prohibited during screening and throughout the study treatment period.
* Received a live vaccine within 28 days of the planned start of study drug.
* Laboratory values outside the Protocol-defined ranges.
* Inadequate organ function.

Other protocol-defined Inclusion/Exclusion Criteria may apply.
A Multi-centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery

The purpose of this study is to monitor the performance and determine the metal ion release of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined and undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored.

DePuy decided to close this Study in 4Q 2009. The Study was terminated with effect from December 2010 to allow for the completion of the 5 year follow up assessments.

Please note that subsequent to this decision DePuy voluntarily recalled the ASR products on 24 August 2010. Additional information regarding this voluntary recall and the follow-up of patients affected by the recall can be found at the following links http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON079157 and http://www.depuy.com/countries_list.


Eligibility Criteria:
Inclusion Criteria:

i) Male or female subjects, aged between 18 and 65 years inclusive.

ii) Subjects with current indications for standard metal-on-metal (MoM) hip resurfacing arthroplasty suitable for cementless fixation in the acetabulum. These include pain, deformity, and loss of function, which are not responsive to medical treatment.

iii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iv) Subjects, who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the hospital for all the required post-operative follow-ups.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.

ii) Subjects with proven significant osteoporosis and poor bone quality.

iii) Subjects with compromised renal function.

iv) Subjects with proven metal sensitivity.

v) Subjects with infectious, highly communicable diseases, which may limit follow-up i.e. active tuberculosis, hepatitis, immuno-compromised conditions, etc.

vi) Women who are pregnant.

vii) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

viii) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).

ix) Subjects who are currently, or have been in the last 12 months, participating in a clinical study which involves exposure to ionising radiation.

x) Subjects who are currently involved in any injury litigation claims.
The Effectiveness of Laser Acupuncture and Standard Medication Therapy on Mandibular Post-Odontectomy Patients

Acute toothache is a problem that often occurs in the oral cavity. Toothache can be caused by an impacted tooth, in which the tooth cannot or will not erupt into its normal position. The American Association of Oral and Maxillofacial Surgeons (AAOMFS) states that 9 out of 10 people have at least one impacted tooth, and impacted mandibular third molars have the greatest prevalence. Laser acupuncture is an acupuncture modality that has the benefit of reducing pain after third molar extraction. The goal of this randomized controlled trial is to evaluate the group that received a combination of laser acupuncture and standard medication compared to the group that received the combination of sham laser acupuncture and standard medication alone, in management of post-mandibular odontectomy patients. The main objective of this study is to analyze the combination of laser acupuncture and medication significantly improving the patient's pain intensity, interincisal distance and post-odontectomy swelling compared to the combination group of sham laser acupuncture and medication.

This is a clinical trial study to evaluate the group that received a combination of laser acupuncture and standard medication compared to the group that received the combination of sham laser acupuncture and standard medication alone, in management of post-mandibular odontectomy patients. The required sample was 57 mandibular third molars in male/female subjects post-odontectomy and randomized into 2 groups: (1) combination of laser acupuncture with standard medication and (2) combination of sham laser acupuncture with standard medication. The subjects will receive two times treatment, on day-1 (baseline) and day-3 after odontectomy. The outcome will be assessed on day-1 (baseline), day-3 and day-7 post-odontectomy. Patients and outcome assessors will be blinded to the group allocation.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject
* Age 18 - 40 years
* Classification of Pell and Gregory class I, II and positions A, B, C
* Willing to participate in this research and sign informed consent

Exclusion Criteria:

* Pregnancy
* Have a history of using corticosteroid drugs in the last 3 months
* Have a history of medication with analgesics at least 24 hours before surgery
* Have an unstable systemic disease (such as uncontrolled hypertension and diabetes etc.)
* The patient has a medical emergency / hemodynamically unstable (such as having a hypertensive crisis)
* Wounds or skin diseases at the location of the acupuncture point irradiation
* Patients with a history of epilepsy
* High fever (\> 38oC).
Immunoscore As Decision Guidance for Adjuvant Chemotherapy in Colon Cancer

The overall aim of this study is to prospectively validate the superiority of the Immunoscore as a decision guidance for adjuvant chemotherapy in stage III colon cancer patients, in comparison to the conventional TNM-based high- or low-risk classification.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years of age
* All sexes
* Histologically confirmed stage III carcinoma of the colon
* Medical need for an adjuvant chemotherapy
* Suitable to withstand the course of an adjuvant chemotherapy
* Written informed consent form (ICF) for participation in the study
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Neoadjuvant treatment
* Metastatic disease
* Pregnancy, breastfeeding or expectancy to conceive
* Disagreement of participants with reproductive potential to use contraception throughout the study period and for up to 180 days after the last dose of study therapy
* Uncontrolled or significant cardiovascular disease (myocardial infarction, uncontrolled angina, any history of clinically significant arrhythmias, QTc prolongation in males \> 450 ms and \> 470 ms in females, participants with history of myocarditis)
* Hepatitis B or C
* Human immunodeficiency virus (HIV)
* Immunodeficiency
* Allogeneic tissue or solid organ transplantation
* Systemic steroids or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
* Diagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin and/or curatively-resected in situ cervical and/or breast cancers
* Participants with serious or uncontrolled medical disorders
* Allergies and adverse drug reaction (history of allergy or hypersensitivity to study drug components, contraindications to any of the study drugs of the chemotherapy regimen)
* Other exclusion criteria: Prisoners or participants who are involuntarily incarcerated, participants who are compulsorily detained for treatment of either a psychiatric or physical (i.e. infectious disease) illness
Pemetrexed/Cisplatin With or Without Bevacizumab in Brain Metastases From Non Squamous Non-small Cell Lung Cancer

This is a multi-center phase II randomized controlled study to assess the efficacy of Pemetrexed/cisplatin with or without Bevacizumab on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR wild type by intracranial PFS(iPFS),also PFS ,DCR and OS.The side effect is evaluated as well.


Eligibility Criteria:
Inclusion Criteria:

1. Patient who was confirmed stage IV non squamous NSCLC with EGFR wild type and brain metastases by pathologic histology or cytology
2. Patients who had never received therapy (including chemotherapy,WBRT,and Bevacizumab) after diagnosed brain metastases
3. Appraisable disease, the presence of at least three lesions if longest diameter \<10 mm by brain MRI
4. Adult patients (≥ 18 years and ≤75 years). ECOG Performance Status 0 or 1 Life expectancy of at least 12 weeks.,Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L. Total bilirubin £ 1.5 x upper limit of normal (ULN). ALT and AST \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases. Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula).
5. Patients should be contraceptive during the period of the trial

Exclusion Criteria:

1. Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component.
2. History of haemoptysis
3. Evidence of tumour invading major blood vessels on imaging.
4. Patient was received irradiation of brain. Patient with meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid.
5. Previous radiotherapy.
6. Serious uncontrolled coagulation disorder or thrombi-embolic complications within 6 months prior to study start or history of serious bleeding complications.
7. Major surgical procedures within 4 weeks prior to study entry.
8. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
9. Non-healing wound, active peptic ulcer or bone fracture.
10. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrollment
Estrogen and Platelet Rich Plasma in Treatment of Atrophic Vaginitis

This study is designed to compare the efficacy, acceptability, and safety of vaginal estrogen cream and platelet-rich plasma in pt. complaining of atrophic vaginitis.

Oestrogen deficiency affects many organs such as the genitourinary system. Genitourinary involvement causes untoward symptoms of atrophic vaginitis including dryness, burning, dyspareunia, vulvar pruritus, and discharge For this reason, many investigations have been performed to find out effective, safe, and acceptable therapeutic methods for atrophic vaginitis. Although systemic administration of estrogen can improve the localized symptoms of atrophic vaginitis, women are often reluctant to use systemic hormone replacement therapy and prefer local administration of estrogen. Vaginal application of estrogen has been considered an effective treatment of atrophic vaginitis.

The effects of PRP treatment have been evaluated in many clinical conditions, including wound healing, hair repair, skin regeneration \[9\], vulvar lichen sclerosis, stress urinary incontinence, episiotomy scars, and lubrication aging in the vagina. It can take at least 12 weeks to determine the final effects of treatment with PRP Population of Study It includes 100 pt. complaining of atrophic vaginitis it will be divided into two groups, each group will contain 50 pt

Methodology in detail:

Patients of the first group will receive vaginal estrogen cream one tube every night for 14 nights; then, one tube 2 nights in 1 week (two tubes every week) for 10 weeks.

The second group will receive PRP injection every 3 weeks for 4 times. PRP will be administered to the anterior vaginal wall using 27-G needles once every 3 weeks for 4 times and PRP is mainly injected into the clitoris or the anterior wall of the vagina to increase the tactile sensitivity of the injection site.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women aged 50-70 years old
* with a clinical diagnosis of vaginal atrophy who will not need systemic estrogen therapy for the treatment of vasomotor symptoms or prophylaxis of osteoporosis
* Any parity.

Exclusion Criteria:

* Women with any history of carcinoma of the breast or endometrium,
* abnormal genital bleeding, acute thrombophlebitis, or thromboembolic disorders associated with previous estrogen use,
* or current urinary.
* In addition, women who underwent hormone replacement therapy, treated with systemic or vaginal estrogen within 6 months prior to the study,
* or had any contraindication for estrogen therapy will be excluded from the study.
A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan

This drug-drug interaction study is being conducted to evaluate the potential effect of Dimebon on the pharmacokinetics on dextromethorphan, a probe substrate of the cytochrome P450 2D6 (CYP2D6) enzyme, after multiple dose administration to healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult subjects.
* Extensive or ultra-rapid metabolizers of CYP2D6 substrates, predicted by genotype.

Exclusion Criteria:

* Existence of significant medical conditions that would impact study results or pose unacceptable risks to study subjects.
* Pregnant or nursing females or females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days prior to the first dose of study medication.