cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study to Test Efficacy and Safety of Repeat Doses of CNTX-4975-05 in Patients With Osteoarthritis Knee Pain

This is a randomized, double-blind, placebo-controlled, 2-injection, 52-week study to evaluate the efficacy and safety of intra-articular injections of CNTX-4975-05 in subjects with chronic, moderate-to-severe osteoarthritis knee pain.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female subjects between 40 and 95 years of age (inclusive) at the time of the Screening Visit with the ability to comply with answering the electronic diary using the study- provided tablet computers.
* Confirmation of osteoarthritis (OA) of the knee.
* Confirmation of the OA of the index knee.
* Moderate to severe pain in the index knee associated with OA must be stable for a minimum of 6 months prior to Screening, as assessed by the investigator.
* Body Mass Index (BMI) ≤45 kg/m\^2
* Must have failed 2 or more prior therapies.

Exclusion Criteria:

* Joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 24 months.
* Prior arthroscopic surgery of the index knee within 6 months of Screening.
* Any painful conditions of the index knee due to joint disease other than the OA.
* Periarticular pain from any cause.
* Other chronic pain anywhere in the body that requires the use of analgesic medications.
* Instability of the index knee.
* Misalignment (\>10 degrees varus or valgus) of the index knee on standing.
* Documented history of neuropathic arthropathy or finding of bony fragmentation in the index knee with imaging.
* Physical/ occupational/ chiropractic therapy for the lower extremities or acupuncture for the lower extremities within 30 days of Screening, or need for such therapy during the study.
* Plans to have surgery, other invasive procedures, or IA injections while participating in the study.
* Has used topical capsaicin on the index knee within 90 days of Screening.
* Current use of opioids for any condition other than for OA of the index knee.
* Corticosteroid injection into the index knee within 90 days of Screening.
* Received IA viscosupplementation (eg, Synvisc®, Hyalgan®) within 90 days of Screening.
Trial Of AG-013736, Cisplatin, And Gemcitabine For Patients With Squamous Non-Small Cell Lung Cancer

This study will evaluate whether AG-013736 when combined with cisplatin and gemcitabine shows activity and is safe in patients with squamous type of non-small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically-confirmed diagnosis of squamous NSCLC Stage IIIB with malignant effusion (fluid cytology demonstrating malignant cells required), Stage IV, or recurrent disease after definitive local therapy
* Candidate for primary treatment with cisplatin and gemcitabine
* Presence of measurable disease by RECIST
* Adequate organ function as defined by the following criteria: ECOG performance status of 0 or 1

Exclusion Criteria:

* Prior systemic treatment for Stage IIIB (with malignant effusion) or Stage IV NSCLC.
* One or more lung lesions with cavitation, or any lesion invading or abutting a major blood vessel as assessed by CT or MRI.
* History of hemoptysis \> ½ tsp (2.5 ml) of blood per day for a day or more within 1 week of study treatment, or Grade 3 or 4 hemoptysis within 4 weeks of study treatment
* NCI CTCAE Grade 3 hemorrhage from any cause within 4 weeks of study treatment
* Preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.
* Untreated brain metastases.
* Need for therapeutic anticoagulation, regular use of aspirin (\> 325 mg/day), NSAID or other medications known to inhibit platelet function.
The Effect of Intravenous Glucocorticoids on the Tearfilm in Eyes With Thyroid-associated Ophthalmopathy

Thyroid-associated ophthalmopathy (TAO), also called Graves' ophthalmopathy or thyroid eye disease, is a common orbital disease in adults. Patients with TAO, especially in its active phase, often complain about symptoms of ocular surface discomfort, including excess tearing, gritty sensation, increased sensitivity to light and foreign-body sensation, which are similar to inflammatory ocular surface disorders such as dry-eye syndrome (DES). Incomplete blink, increased proptosis and greater palpebral fissure width in TAO accelerates tear evaporation, which increases the tear fluid's osmolarity, and results in ocular surface damage. The administration of intravenous glucocorticoids can be an effective treatment for TAO.

The rationale of the present study is to assess the effect of intravenously administered glucocorticoids on the signs of DES in patients with TAO with new methods such as measurement of tear film thickness, tear film osmolarity and scattering of the tear film and well established methods for assessment of the severity of DES. Additionally, impression cytology and determination of tear cytokines/chemokines will be performed to obtain information about inflammatory processes on the ocular surface.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 years
* Active thyroid associated ophthalmopathy with clinical activity score (CAS) of each eye more than 3 or recently experienced worsening of proptosis, lid retraction, or ocular motility disturbance.
* Normal ophthalmic findings except symptoms associated with TAO
* Scheduled for treatment with systemic glucocorticoids according to the kahaly-scheme

Exclusion Criteria:

* Chronic inactive TAO
* Previous treatment with oral or intravenous glucocorticoids 3 months preceding the study
* Participation in a clinical trial in the 3 weeks before the screening visit
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
* Wearing of contact lenses
* Intake of dietary supplements in the 3 months preceding the study
* Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants
* Ocular infection
* Ocular surgery in the 3 months preceding the study
* Sjögren's syndrome
* Stevens-Johnson syndrome
* Pregnancy, planned pregnancy or lactating
CHP-BV Followed by Consolidation With High-dose Therapy / ASCT as Frontline Treatment of Patients With EATL Type 1.

It has been recently reported that EATL type 1, but not refractory coeliac disease, strongly expressed CD30 and might benefit from brentuximab vedotin. Since the safety profile of the combination brentuximab vedotin and CHP is known and since the role of etoposide as part of induction regimen is not demonstrated, the investigator will assess the efficacy and toxicity of the combination brentuximab vedotin and CHP followed by HDT/ASCT, as frontline treatment of EATL.

Brentuximab vedotin is an anti-CD30 monoclonal antibody conjugated to the cytotoxic drug monomethyl auristatin E. It is currently evaluated in combination with multi-agent chemotherapy as frontline treatment of systemic ALCL (sALCL) and other CD30-positive mature T cell and NK cell lymphomas. Preliminary results of this phase 1 study have been presented at the 2012 ASH Annual Meeting: 26 patients have been treated with combination brentuximab vedotin and CHP. Nineteen of 26 patients had a diagnosis of sALCL and 7 patients had a diagnosis of another mature Tor NK-cell lymphoma (EATL, n=1). The maximum tolerated dose of brentuximab vedotin in combination with CHP was not exceeded at 1.8 mg/kg IV. Adverse events were manageable. All patients achieved an objective response, with 23 patients (88%) achieving a complete response (CR). All 7 non-sALCL patients achieved a CR.

Finally, it has been recently reported that EATL type 1, but not refractory coeliac disease, strongly expressed CD30 and might benefit from brentuximab vedotin. Since the safety profile of the combination brentuximab vedotin and CHP is known and since the role of etoposide as part of induction regimen is not demonstrated, the investigator will assess the efficacy and toxicity of the combination brentuximab vedotin and CHP followed by HDT/ASCT, as frontline treatment of EATL.

Eligibility Criteria:
Main Inclusion Criteria:

1. Histologically confirmed diagnosis of EATL based on criteria established by the World Health Organization (WHO) 2016 Classification of Tumors of Haematopoietic and Lymphoid Tissues.
2. EATL should be CD30-positive with a threshold of 10%.
3. Patients aged ≥ 18 years and \< 70 years at the time of study entry.
4. ECOG performance status 0 to 3 at time of study entry.
5. Left Ventricular Ejection Fraction (LVEF) ≥ 45% measured by bidimensional echography or radionuclide ventriculography (MUGA scan).

Main Exclusion Criteria:

1. Participants must not have been treated with any prior chemotherapy for EATL. Patients with previous treatment for refractory celiac disease (i.e., immunosuppressive or immunoregulatory drugs) may be included.
2. Known central nervous system involvement by EATL.
3. Active chronic hepatitis B or C.
4. HIV positive serology.
5. HTLV-1 positive serology.
The Natural History and Outcome of Sleep Disordered Breathing in Children

Sleep-disordered breathing in children is characterized by recurrent events of partial or complete upper airway obstruction during sleep, resulting in disruption of normal gas exchange (intermittent hypoxia and hypercapnia) and sleep fragmentation. The major symptom is snoring or noisy breathing. Sleep Disordered Breathing (SDB) is a wide spectrum of disorders that includes primary snoring, UARS and OSA. The main etiology for SDB in children is enlarged tonsils and adenoids and therefore the first line of treatment in pediatric SDB is adenotonsillectomy.

The objectives of this study are:

1. To investigate the natural history of primary snoring
2. To investigate the effect of seasonality on SDB severity
3. To compare the effect of adenoidectomy to adenotonsillectomy in the treatment of SDB in children
4. To characterize the children referred for repeated PSG following adenoidectomy or adenotonsillectomy and the indications for second PSG evaluation.


Eligibility Criteria:
Inclusion Criteria:

* healthy normally developing children that underwent PSG evaluation at the Tel Aviv Medical center between 2005-2010

Exclusion Criteria:

* Chronic medical and neurodevelopmental conditions.
* Congenital anomalies.
Interest of Cervical Dilators in Second Trimester Termination of Pregnancy

The purpose of this study is to evaluate whether the use of cervical dilators for cervical ripening in case of second trimester medical termination of pregnancy (TOP) is effective to reduce duration of labor.

Termination of pregnancy is a distressing and painful procedure for women. The use of cervical dilators could shorten the duration of labor but can generate more pain. The investigators will compare two procedures of induction of labor for second trimester termination of pregnancy: one with the use of oral prostaglandins (misoprostol) only and one with the exact same procedure preceded by cervical ripening with hygroscopic cervical dilators. Epidural analgesia will be effective previously to the placement of cervical dilators and the first tablet of misoprostol. Efficacy will be determined based on the proportion of women achieving vaginal delivery within 12 hours. The beginning of labor will be defined as the first administration of misoprostol tablets in both groups.

The investigators will also evaluate safety by collecting hemorrhage endometritis, cervical tear. The investigators will compare psychological impact of these procedures, measured by the impact of event scale and acceptability 1 to 4 months later.

Eligibility Criteria:
Inclusion Criteria:

* Termination of pregnancy requested by the patient and accepted by the weekly multidisciplinary counselling of fetal medicine
* gestational age between 15 and 27 weeks and 6 days,
* single pregnancy,
* major patient,
* French-speaking woman,
* Patient with health insurance.

Exclusion Criteria:

* Termination of pregnancy by surgical technique
* cicatricial uterus
* premature rupture of membranes
* chorioamnionitis
* multiple pregnancy
* placenta praevia
* myoma praevia
* uterine malformation
* unstable maternal pathology
* psychiatric pathology
* contraindication to mifepristone: severe asthma, adrenal insufficiency, porphyria, corticotherapy.
* contraindication to misoprostol: hypersensitivity to prostaglandins.
* contraindication to epidural analgesia: hemostasis disorder, spinal or medullary anomaly.
* Bishop score \> or = to 7 at arrival in birth room
Active Somatosensory Exercise for Chronic Stroke

The current work aims to examine whether the proposed rehabilitation training or exercise will eventually yield improvements in both motor and somatosensory aspects at one goal. Here, the word 'somatosensory' refers to bodily sensations associated with proprioception or kinesthesia, not the sensation of touch, pain, and temperature. The study focuses on upper limb retraining for community-dwelling stroke survivors using a robotic device. At the end of training, both movement accuracy and somatosensory acuity in chronic stroke survivors are presumed to improve, and such paradigm is expected to provide reliable benefits as compared to conventional intervention alone.

Long-term disability is common sequela among people with stroke. On top of motor impairment, many stroke survivors suffer from somatosensory impairment of their paretic arm, leading to their inability to perform activities of daily living using upper limb. In this respect, recent research on motor recovery following stroke has begun to place more emphasis on the inclusion of somatosensory retraining in stroke rehabilitation program. Although evidence is still scarce, training paradigms that simultaneously combine both somatosensory and motor aspects are considered useful for motor recovery in stroke survivors. Principally, studies focusing on such form of training paradigm sought to employ robotic technologies to assist in the retraining of both motor and somatosensory function in stroke survivors. Robotic technologies have gained popularity recently for assessing somatosensory function in clinical setting due to its objective quantification of patients' performance and high inter-rater reliability. Thus, with the purpose of improving both motor and somatosensory functions in chronic stroke survivors, this proposed study will provide an intensive robotic-based behavioral training intervention to chronic stroke survivors from the community. The intervention will require active participation of the patients through an exploratory strategy.

Eligibility Criteria:
Inclusion Criteria:

* First-time ischemic or haemorrhagic stroke survivors;
* Patients of at least 6-month post-stroke;
* Patients with severe to moderate sensory impairment as assessed by Erasmus Nottingham Sensory Assessment (≤ 6/8);
* Patients with arm motor impairment, shoulder abduction and elbow extension Medical Research Council (MRC) motor power grade 3-5;

Exclusion Criteria:

* Patients with bilateral impairment;
* Patients with high upper-limb spasticity (Ashworth scale \> 2);
* Patients with unilateral neglect as assessed by Star Cancellation Test (score \< 44);
* Patients with cognitive impairment as assessed by a 2-step instructions from the modified Mini Mental State Examination;
* Patients with a known history of mental disorders;
* Patients with the inability to perform upper arm activity due to excessive pain
Symptom-driven Referral for Evaluation of Chronic Thromboembolic Disease or Pulmonary Hypertension in Patients With Previous Acute Pulmonary Embolism

Aim: To investigate if a symptom driven referral for chronic thrombosis in the lungs after acute pulmonary embolism is better than the current approach.

Background: A number of patients with chronic thrombosis in the lungs after acute pulmonary embolism have dyspnea and reduced functional capacity without elevated pulmonary arterial pressure at rest (CTED). However, current guidelines for follow-up after acute pulmonary embolism will miss all patients with CTED, as referral for further examination is based on elevated pulmonary arterial pressure on echocardiography. Thus, the prevalence of CTED is unknown. The hypothesis is, that a symptom-driven referral of patients with previous acute pulmonary embolism is more sensitive in diagnosing CTED than the current approach.

Methods and materials: Patients diagnosed with acute pulmonary embolism in Region Midt (approx. 350 per year) will be screened for non-recovery or persistent pulmonary embolism related symptoms during their 3-6 months follow up at their local outpatient clinic. If the patient has persistent symptoms they will be referred to a scintigraphy. If CTED is suspected from the scintigraphy, the patient will be referred for full CTED work-up. The investigators expect to screen 300 patients for persistent symptoms with an expected study time of 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Acute PE diagnosed by CT or V/Q-scan within the last year.
* Non-recovery or persistent PE related symptoms assessed by a MRC breathlessness score or WHO functional class.
* Age \>= 18 and \< 80

Exclusion Criteria:

* Contraindications or unable to perform 6 minutes walk distance (6MWD) and/or cardiopulmonary exercise test.
* Contraindications to CT pulmonary angiography.
* Congestive heart failure (LVEF \<40%).
* COPD or restrictive lung disease, severe or worse (FEV1 \<50% and \>=1 exacerbation causing hospital admission per year (GOLD grade 3 and 4 class C and D)).
* Lactating or pregnant.
* Unable or unwilling to provide written informed consent.
* Paroxysmal or persistent atrial fibrillation.
* Other known cause of PE related symptoms.
Treatment of Constipation in Functional Dyspepsia

Background. Functional dyspepsia is characterized by symptoms that apparently originate in the stomach without detectable cause by conventional diagnosis test. The pathophysiology of functional dyspepsia is not known, but a number of data indicate that dyspeptic patients have increased sensitivity of the digestive system, so that physiological stimuli may induce their symptoms. Some patients with functional dyspepsia have also functional constipation and the investigators hypothesize that in them constipation triggers or facilitates dyspeptic symptoms, and consequently, correction of constipation relieves dyspeptic symptoms.

Objective. To demonstrate the superiority of biofeedback versus a fiber supplement for the treatment of dyspeptic symptoms in patients with constipation due to functional outlet obstruction.

Design. Randomized, controlled parallel trial performed in a referral center. Participants. Consecutive patients complaining of symptoms of functional dyspepsia and functional outlet obstruction.

Interventions: Patients will be assigned to experimental (biofeedback for functional outlet obstruction) and active comparator (fiber supplementation) arms. Biofeedback for functional outlet obstruction: sessions of biofeedback guided by anorectal manometry (performed during the first 3 weeks of the intervention period) combined with instructions for daily exercising for 4 weeks. Fiber supplementation: 2.5 g plantago ovata per day for 4 weeks. Main outcome and measures. Clinical symptoms of functional dyspepsia measured by daily questionnaires for 7 consecutive days before and during the last week of intervention.

Relevance. Functional Dyspepsia, defined by purely clinical criteria, brings together a diverse group of conditions with different pathophysiology. As a result, the treatment is empirical and globally inefficient. This study will identify a subset of patients with a common pathophysiological mechanism of dyspeptic symptoms (functional outlet obstruction) which respond to specific treatment (biofeedback).


Eligibility Criteria:
Patients with functional dyspepsia and functional constipation.

Inclusion Criteria

* Rome IV criteria for functional dyspepsia type of postprandial distress syndrome.
* Rome IV criteria of functional constipation
* Anorectal manometry showing defective sphincter relaxation during the defecatory manoeuver.

Exclusion Criteria:

* History of organic gastrointestinal disorders
* Cognitive impairment.
Abdominal Wall Function and Quality of Life and Before and After Incisional Hernia Repair

The primary objective of the present study is to investigate a possible correlation between abdominal wall function and subjective measures of QoL before and after laparoscopic repair of small- to medium sized incisional hernia.

This prospective study includes 25 patients undergoing laparoscopic incisional hernia repair. Abdominal wall function is examined by determination of maximal truncal flexion and extension with a fixated pelvis using a Goodstrength dynamometer (Metitur Ltd., Jyväskylä, Finland). Subjective scores of QoL (HerQLes), pain (visual analogue scale) and physical activity (International Physical Activity Questionnaire) are assessed. Patients are examined before, one month after and three months after the operation. Furthermore, pulmonary function is examined preoperative and three months postoperative by standard spirometry (forved vital capacity, peak expiratory flow, forced expiratory volume in 1 second) as well as maximum in- and expiratory pressure is measured.


Eligibility Criteria:
Inclusion Criteria:

* Elective laparoscopic repair for one or more incisional hernias in the midline (at least 5 cm caudal to the xiphoid process and at least 5 cm cranial to the pubic bone), using a synthetic mesh
* Horizontal fascial defect between 3 and 8 cm
* Age between 25 and 75 years
* American Association of Anesthesiologist score between I and III
* Body mass index \< 33 kg/m\^2

Exclusion Criteria:

* Severe musculoskeletal, neurologic or cardiopulmonary disease preventing the patient from climbing stairs or shopping for groceries
* Existing stoma
* Postoperative complications requiring intervention
3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs

This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis


Eligibility Criteria:
Inclusion Criteria:

* Women who have received the 4th and 6th dose of zoledronic acid in study CZOL446H2301E1

Exclusion Criteria:

* Poor kidney, eye, liver health
* Use of certain therapies for osteoporosis in study CZOL446H2301E1
* Abnormal calcium levels

Other protocol-defined inclusion/exclusion criteria may apply
Special Drug Use Investigation for ZEFIX (Lamivudine) Tablet (HBV Cirrhosis)

The purpose of this study is to confirm efficacy and safety when administering lamivudine tablet alone in subjects with hepatitis B virus-induced liver cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with hepatitis B virus-induced liver cirrhosis, in whom lamivudine tablet was administered alone for 6 months or longer, or those in whom lamivudine tablet was expected to be administered alone for 6 months or longer

Exclusion Criteria:

* Subjects previously enrolled in Drug Use Investigation or Special Drug Use Investigation of lamivudine tablet
* Subjects with a history of hypersensitivity of the ingredients of lamivudine tablet