cyrilzakka/clinical-trials huggingface dataset:
Labor Induction and Pain Relief With Paracetamol Versus Placebo

Single-blind study conducted on 2 randomly selected groups of pregnant women carrying a single fetus (from week 37 onward). One group will receive paracetamol 1 gr I.V. prior to insertion of balloon catheter and the control group will receive 100 ml sodium chloride 0.9% I.V prior to insertion of balloon catheter. An assessment of pain management will be conducted using various assessment tools. additionally, mode of delivery and time from catheter insertion to delivery will be assessed.

Single-blind study conducted on 2 randomly selected groups of pregnant women carrying a single fetus (from week 37 onward). One group will receive paracetamol 1 gr I.V. prior to insertion of balloon catheter and the control group will receive 100 ml sodium chloride 0.9% I.V prior to insertion of balloon catheter.

assessment of pain during catheter balloon insertion will be assessed using visual analogue scale (VAS) instrument with scores 1 to 10.

An assessment of pain management will also be conducted using various assessment tools:

1. Brief Pain Inventory short form (BPIsf) - before balloon insertion and at various time intervals.
2. Hospital Anxiety and Depression Scale (HADS) - 1 hr. before balloon insertion and immediately upon removal of catheter.
3. Patient Experience Questionnaire - upon transfer to delivery room.
4. Socio-demographic Questionnaire

Additionally, obstetrics outcomes will be recorded including time from catheter to delivery, mode of delivery. these parameters will be compared between the two groups (those who recieved paracetamol versus normal saline 0.9%).

Eligibility Criteria:
Inclusion Criteria:

Women from 18-44 yrs of age 37 weeks pregnant and onward singleton pregnancy induction of labor using a balloon catheter Nulliparity

Exclusion Criteria:

1. Sensitivity to paracetamol.
2. Past Cesarean section
3. Multiple pregnancy
Registry AutoLog Lipid Removal and Blood Component Characterization

The purpose of this study is to show the success of the AutoLog System in removing lipids to less than 10mg/dl in vivo. The Autolog registry has two objectives:

1. to determine the lipid removal capabilities of the Medtronic AutoLog System.
2. to obtain in vivo data on blood component removal and washing capabilities of the Medtronic AutoLog System.

Since the in house data strongly suggest that the Medtronic AutoLog is uniquely high performing in lipid removal in-vitro, the Registry AutoLog Lipid Removal and Blood Component Characterization is initiated to determine if the AutoLog system is successful in removing lipids in vivo as it is in-vitro. Therefore, it is expected that the lipid amounts after washing will be less than 10 mg/dl.

The study is designed as a multi-center, non-randomized, non-interventional, post market release study (a registry). The study has a single arm, without controls, as it is descriptive in nature.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an indication for surgery procedures in which the hospital treatment protocol requires the routine use of an autotransfusion system are eligible for participation.

Exclusion Criteria:

* The use of citrate-based anticoagulant in patients with impaired liver function
* Gross contamination and/or septic procedures
* Surgery within the malignant area that may allow dissemination of tumor/malignant cells, if aspirated, into the autotransfusion system
* Caesarean sections in presence of amniotic fluid
* Presence of high concentrations of prostatic fluid
* Contamination of salvaged blood with drugs not intended for intravenous administration
* Use of collagen-based haemostatic agents and gel foam used in combination with any autotransfusion system
* Coagulopathy
* Not willing to sign a Patient Informed Consent/Data Release Form
Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery

To assess the analgesic efficacy and general safety of 2 dosing regimens of valdecoxib compared to placebo on the first post-operative day in patients with moderate or severe pain following bunionectomy surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent an uncomplicated primary unilateral first metatarsal bunionectomy surgery (with or without ipsilateral hammer toe repair) requiring open manipulation of bone with periosteal elevation under regional anesthesia (Mayo block)
* Patients had a Baseline pain intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS

Exclusion Criteria:

* Patients who were scheduled to undergo other surgical procedures that would be expected to produce a greater degree of surgical trauma than the orthopedic procedure alone
* Patients treated with patient controlled analgesia (PCA) subsequent to the end of anesthesia
* Patients treated with long-acting local anesthetics or local anesthetics coadministered with epinephrine injected into the index joint space
* Patients expected to require analgesics or other agents other than study medication during the 8 hours preceding administration of study medication through the end of the treatment period, that could confound assessment of the analgesic response, specifically excluded were tricyclic antidepressants, tranquilizers, neuroleptics, neuroleptic antiemetics, cyclooxygenase-2 inhibitors, nonsteroidal antiinflammatory drugs, and corticosteroids
Iron Supplementation and Intestinal Health

This is a randomized double-blinded study of enteral iron supplementation in Very Low Birth Weight infants. The subjects will be randomized into low dose (2 mg/kg/day) and high dose (6 mg/kg/day) of daily iron supplementation. The primary outcomes are intestinal health including microbiome, inflammation, and barrier function.

Infants and mothers will be recruited at a single academic level III NICU at Tampa General Hospital, Tampa, FL. Inclusion criteria infants: \<1500 g at birth, expected to live beyond 2 weeks, not yet started on oral iron supplementation (OIS), and parental consent. Exclusion criteria infants: congenital intestinal defects, history of intestinal infection or perforation before OIS. Infants who require epogen for religious reason to prevent them from getting blood transfusions will be excluded from the study.

Intervention: Participants will be randomized to either 6 mg/kg/day or 2 mg/kg/day total of elemental iron once a day when they are consuming 150-160 ml/kg/day of enteral feeds and are at least 14 days old. The total iron doses will be provided by fortification of feeds and liquid iron sulfate and will be weight adjusted once a week. The participants will receive the study OIS doses until 36 week corrected gestational age or discharge, whichever comes first.

Sample collection and testing:

1. Stool and urine collection: We will collect weekly stool and urine samples non-invasively starting at enrollment until study completion. Samples will be collected from soiled diapers.
2. Blood tests: We will collect C-reactive protein (CRP) and ferritin level at 4 weeks after birth at the same time as other routine labs (complete blood count, reticulocyte count, and liver function test).
3. Monaural auditory brainstem response (ABR): for each ear will be performed at 36 weeks corrected gestational age or at discharge under the supervision of an audiologist who is blinded to the infants assigned iron doses and test results (stool microbiome, blood and urine tests).

Monitoring: iron supplementation dose will be increased by 2 mg/kg/day if ferritin level \<100 mg/dL and the dose will be held if ferritin level \>400 mg/dL. Ferritin level will be rechecked every 2 weeks until normalized. Hematocrit and reticulocyte count will be monitored by the medical team.

Eligibility Criteria:
Inclusion Criteria:

* \<1500 g at birth, expected to live beyond 2 weeks, not yet started on oral iron supplementation (OIS), with mother at least 18 years of age, and parental consent.

Exclusion Criteria:

* congenital intestinal defects, history of intestinal infection or perforation before OIS. Infants who require epogen for religious reason to prevent them from getting blood transfusions will be excluded from the study.
Study of KB004 in Subjects With Hematologic Malignancies (Myelodysplastic Syndrome, MDS, Myelofibrosis, MF)

This is a global, multicenter, open-label, repeat-dose, Phase 1/2 study consisting of a Dose Escalation Phase (Phase 1) and a Cohort Expansion Phase (Phase 2). In both phases, KB004 will be administered by IV infusion once weekly as part of a 21-day dosing cycle.

The purpose of Phase 1 is to determine a maximum tolerated dose (MTD) for KB004 when administered to subjects with hematologic malignancies who meet the entry criteria. Phase 1 has completed enrollment July of 2014, the recommended Phase 2 dose is 250 mg. AML 20 mg Cohort completed enrollment Dec 2014.

The purpose of Phase 2 is to characterize preliminary clinical activity. The Phase 2 portion of the study consists of two parts:

* Part A: Subjects with AML or MDS who meet the entry criteria
* Part B: Subjects with MF who meet the entry criteria

Eligibility Criteria:
Key Inclusion Criteria (Phase 1):

- Confirmed hematologic malignancy, including Acute Myeloid Leukemia (AML), Chronic Lymphocytic Leukemia (CLL), Chronic Myelogenous Leukemia (CML), Acute Lymphocytic Leukemia (ALL), Myelodysplastic Syndrome (MDS), Multiple Myeloma (MM), Myelofibrosis (MF), Myeloproliferative Neoplasms (MPN) or MDS/MPN overlap diseases. (Once Phase 2 has started subjects with AML will be eligible for inclusion in the Phase 1 portion of the study only if their malignancy has been shown to have c-Cbl mutation, trisomy 3, trisomy 11, inv(16), or elevated FLT3. \[Other AML and subjects with MDS will no longer be eligible for inclusion in the Phase 1 portion of the study\]).

Key Inclusion Criteria (Phase 2):

* Part A: AML or MDS patients with an acceptable level of EphA3 expression
* Part B: MF patients with an acceptable level of EphA3 expression

Key Inclusion Criteria (Both Phases):

* Confirmed hematologic malignancy refractory to or progressed following standard treatments, or subjects not considered medically suitable to receive standard of care treatment or who refuse standard of care treatment
* Acceptable level of EphA3 expression
* Eastern Cooperative Oncology Group (ECOG) ≤1
* Acceptable laboratory results

Key Exclusion Criteria (Both Phases):

* For subjects with AML, more than 2 prior therapies for AML (induction and consolidation with or without a hypomethylating agent given in a maintenance setting are considered 1 therapy)
* History of or current central nervous system (CNS) involvement that may increase risk of bleeding
* Recent major surgery
* Ongoing surgical or wound healing complications
* Active clinically significant bleeding
* Uncontrolled hypertension
* Significant intercurrent illness
* Known history of prolonged bleeding times or platelet dysfunction
* Active infection requiring IV antibiotics, IV antifungals, or IV antivirals within 2 weeks prior to Cycle 1, Day 1
Prospective Study on the Efficacy of Exclusive Odontological and Medical Treatment in Chronic Dental Maxillary Sinusitis

The study will be offered to patients for whom chronic maxillary sinusitis will be diagnosed in the first ENT (ear, nose and throat) consultation. These patients will then be seen in a stomatology consultation to determine whether or not a dental cause is objective

Chronic maxillary sinusitis is an inflammatory condition and/or infectious diseases of the maxillary sinus, which last longer than 12 weeks. Those whose the origin is dental, are well described, and yet under-diagnosed most of the time due to a lack of well-defined diagnostic criteria and literature. There is controversy in the various studies about their prevalence. Their management and in particular the therapeutic sequence, is not the subject of any recommendation and involves only a few clinical studies. Their consequences on the patient's general health and quality of life are important. The lack of knowledge about them often leads to diagnostic errors and therefore to a persistence of symptomatology. Moreover, their complications when they are not or incorrectly treated, although rare, can be dramatic (occulo-orbital or endo-cranial complications for example).

Preliminary work in the form of a retrospective study was carried out within of the Centre Hospitalier intercommunal de Créteil in 2015. In view of the results the investigators wanted to set up a clinical trial with the following objectives measure the prevalence of chronic maxillary sinusitis of dental origin and measure the effectiveness of exclusive dental and medical treatment, which could avoid surgical intervention under general anaesthesia, at the higher morbidity.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Signed Informed Consent
3. Patient with chronic maxillary sinusitis diagnosed by examination of the patient and ENT examination by naso-fibroscopy
4. Sinus imaging to confirm the diagnosis (facial mass scanner or cone beam CT)
5. Affiliated or beneficiary of a social security scheme

Exclusion Criteria:

1. Fungal bullet sinusitis
2. Naso-sinus polyposis
3. atelectasic sinusitis
4. Systemic damage that may affect the maxillary sinuses (muciviscidosis, primary ciliary dyskinesia, vasculitis, granulomatosis, history of radiotherapy of the facial mass, pregnancy)
5. Long-term immunosuppressive treatment (chemo, anti-rejection)
6. Rhinosinusian tumor process
7. Fronto-ethmoidomaxillary sinusitis with risk of orbital or meningeal damage in the short to medium term.
8. Refusal of consent
9. Simultaneous participation in another intervention research
10. Patient under guardianship, curatorship or justice protection
Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer

The primary objective of this study is to determine the overall response rate (complete response + partial response) to a combination of bavituximab plus carboplatin and paclitaxel in patients with previously untreated locally advanced or metastatic non-small cell lung cancer.


Eligibility Criteria:
Key Inclusion Criteria:

* Adults over age 18 years of age with a life expectancy of at least 3 months
* Histologically or cytologically confirmed non-small cell lung cancer at stage IIIB (with pleural effusion), stage IV, or recurrence
* Measurable disease on cross sectional imaging at least 2 cm in longest diameter (1 cm if measured by spiral CT)
* Adequate hematologic (ANC ≥ 1500 cells/µL; Hemoglobin ≥9 g/dL; platelets ≥100,000/µL and ≤500,000/µL ), renal (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min), and hepatic function (bilirubin ≤ 1.5 x ULN, ALT ≤ 3 x ULN, AST ≤ 3 x ULN)
* D-dimer ≤ 2 x ULN

Key Exclusion Criteria:

* Small cell or mixed histology
* Known history of bleeding diathesis or coagulopathy
* Any current evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or GI bleeding
* Any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism)
* Prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
* Radiotherapy within 2 weeks preceding Study Day 1
* Symptomatic or clinically active CNS disease or metastatic lesions
* Major surgery within 4 weeks of Study Day 1
* Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
* Any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
* A history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin. Anti-platelet agents are prohibited during the study.
* Requirement for chronic daily treatment with NSAIDs, anti-platelet drugs, or steroids
Observational Study on the Patients With Pain Medications

The purpose of this study is to describe the use of pain treatments in Taiwan, the demographics, clinical characteristics of patients requiring pain treatments, current treatments, outcomes of treatments and the reasons for changing pain medication during treatment.

This is a Phase IV, multi-center, observational study to describe the use of pain treatments, the demographics, clinical characteristics of patients requiring pain treatments, current treatments, outcomes of treatments and the reasons for changing pain medication during treatment. The study is conducted in an effort to understand the status of pain control in Taiwan. Currently in Taiwan, there is no approved documentation showing the most effective standard medication for treatment of patients in pain. Observational study with no study medication administered.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients only
* Patients must have pain, previously treated with and without medication and have a VAS (Visual analogue scale) score recorded at the enrolment time
* Patient must have a VAS score \>4

Exclusion Criteria:

* Patients who are receiving any investigational drug during the study
* Patients with known or suspected psychotic disease or mental retardation.
Comparison of Deproteinized Bovine Bone Mixed With Injectable Platelet Rich Fibrin Versus a Sole Deproteinized Bovine Bone "TUTOGEN BONE" in Sinus Floor Elevation With Simultaneous Implant Placement. A Randomized Clinical Trial

28 recruited patients indicated for sinus floor elevation with simultaneous implant placement . they were divided into two groups. first group was assigned for placement of deproteinized bovine bone solely, while the other group was assigned for the placement of mixture of injectable platelet rich fibrin with deproteinized bovine bone into the sinus after implant placement.


Eligibility Criteria:
Inclusion Criteria:

Patients requiring implants in maxilla and have atrophic bone regarding the length due to sinus pneumatiztion. Length 3: 7 mm .

Exclusion Criteria:

1. General contraindications for implant
2. Systemic diseases that might affect the healing of bone
3. Patients with sinus pathology
Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Alcohol Use Disorder

The objective of the current study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) on self-reported negative affect, cerebellar brain activation and alcohol use outcomes in alcohol use disorder (AUD).

To achieve study aims, 34 treatment seeking adults with AUD will be recruited from local intensive outpatient (IOP) treatment programs and randomized to treatment with either inhibitory 1Hz rTMS to cerebellar vermis given daily for 2 weeks (total of 10 sessions) or sham. Alcohol use outcomes, self-reported negative affect, and craving will be obtained at baseline, 1 day, 1 week and 6 weeks following rTMS termination. An fMRI scan during a Stroop task will be obtained at baseline and 1 day after the final rTMS session.

Eligibility Criteria:
Inclusion Criteria:

* Males and females age 18-65 meeting DSM-V criteria for moderate or severe AUD in the past year;
* Interested in cutting down or quitting drinking;
* Able to provide voluntary informed consent;
* Have at least 4 heavy drinking days (≥ 5 drinks per day for men, and ≥4 for women) in the past 60 days;
* Currently receiving treatment for alcohol use disorder.

Exclusion Criteria:

* Severe neurological conditions (TBI/stroke/history of a seizure/dementia and other significant cognitive illnesses);
* Other urgent medical problems, as determined by the study physician from the history and physical exam;
* Schizophrenia, schizoaffective disorder, bipolar I disorder
* Suicidal thoughts (intent or plan) in the last month;
* Current moderate or severe other SUD (except nicotine or marijuana) or other drug (except nicotine or marijuana) use in the past month;
* Active legal problems with the potential to result in incarceration;
* Pregnancy or lactation, or child bearing age and sexually active but not on birth control (barrier methods allowed);
* Current daily use of anti-craving medications, antidepressants (at doses considered therapeutic for depression), benzodiazepines, antipsychotics (at doses considered therapeutic for psychosis or mood stabilization), mood stabilizers (at doses considered therapeutic for mood stabilization);
* Have previously undergone rTMS (to assure the blind is effective);
* Personal or familial (in first degree relatives) history of epilepsy;
* Any contraindication for Magnetic Resonance Imaging (MRI) or TMS including metal shards or certain implants (pacemakers etc.) in the body.
To Explore the Treatment Effect of Various Commercially Available Statins on Patients With Hyperlipidemia

The primary objective is to survey the efficacy of various commercially available statins (a class of lipid-lowering agents, for example, rosuvastatin, atorvastatin, simvastatin, lovastatin, pravastatin and fluvastatin) under local clinical practice in treating patients with hyperlipidemia. Surveillance data (Lipid Profile) will be collected during course of usual clinical practice or captured upon its availability.


Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with hyperlipidemia
* Patients who are just starting a statin treatment, who need to switch from current therapy to a statin medication, or who are receiving dosage adjustment of statin as judged by the physicians
* Patients who are willing to participate in this study and who sign an informed consent form

Exclusion Criteria:

* Pregnancy or breast feeding
* Patient are illiterate or unable to fill the questionnaire for any reason
* Patients with contraindications to the use of certain statins as needed prescribed by physicians (as per commercially available statins package insert) including the use of rosuvastatin.
* Any clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications
BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)

TNX-102 capsules \[formerly known as very low dose (VLD) cyclobenzaprine\] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary Fibromyalgia (ACR criteria)
* Male or female 18-65 years old
* For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressent therapy
* Willing and able to withdraw specific therapies (ask PI)
* Medically acceptable form of contraception (female only)
* Signed informed consent

Exclusion Criteria:

* Arthritis, lupus and other systemic auto-immune diseases
* Regional or persistent pain that could interfere with assessment of fibromyalgia pain
* Bipolar and psychotic disorders
* Increased risk of suicide
* Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities.
* Inability to wash-off specific medications (ask PI)
* Known hypersensitivity to cyclobenzaprine
* Others: seizure disorders, sleep apnea, continuous positive airway pressure (CPAP) use, BMI\>40