cyrilzakka/clinical-trials huggingface dataset:
Special Investigation of Humira® (Adalimumab) on Long-term Treatment in Patients With Rheumatoid Arthritis

The purpose of this study was to collect data on the incidence of adverse drug reactions, infections and malignant tumors, as well as factors that might affect the safety and effectiveness of Humira® (adalimumab; 40mg/0.8 mL) in Japanese participants who received the drug for the treatment of rheumatoid arthritis.

Rheumatoid arthritis is a chronic autoimmune disease which requires long-term treatment. Due to the need of long-term safety data in Japanese participants and to fulfil the conditions of approval of adalimumab by the Japanese regulatory authority, this post-marketing observational study (PMOS) was conducted. The study investigated the long-term safety of adalimumab, particularly associated with the development of infections and malignant tumors. Data was collected once every 6 months up to 3 years.

Eligibility Criteria:
Inclusion criteria:

1. Participants who received adalimumab in accordance with its indications for treatment and dosage regimens.
2. Participants who used adalimumab continuously.
3. Participants without current or past history of malignant tumors.
4. Participants evaluated for Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR).
5. Participants evaluated by Health Assessment Questionnaire (HAQ) or Modified Health Assessment Questionnaire (MHAQ) prior to the initiation of adalimumab treatment in the all-case PMOS.

Exclusion criteria:

1. Contraindications according to the package insert.
2. Participants with serious infections.
3. Participants with tuberculosis.
4. Participants with a history of hypersensitivity to any ingredient of adalimumab.
5. Participants with demyelinating disease or a history of demyelinating disease.
6. Participants with congestive cardiac failure.
Intensive Stress Coping Intervention Week - A Secondary Prevention For Real World Affective Disorder Patients

This study intents to determine who will benefit from an intensive brief stress coping intervention week (ISCIW) as secondary prevention for real world affective disorder patients.

Affective disorders are associated with a substantial personal and socio-economic burden. This study evaluates an intensive brief stress-coping intervention week (ISCIW) as feasible follow-up treatment for real world patients who suffer from this highly prevalent and chronic stress-related disorders. Stress-associated blood (Interleukin-6, Homocystein, Myeloperoxidase), saliva cortisol and psychosocial screening parameters will be analyzed to determine who will benefit from the ISCIW. All patients were identified in a preventive medical screening before pre-treatment for at least three month as outpatient and the following inclusion to the follow-up ISCIW-trial at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria. For the three planed groups and interventions see interventions and arms.

Eligibility Criteria:
Inclusion Criteria:

* Affective or anxiety disorder DSM-IV diagnosis (structured interview, M.I.N.I. International Neuropsychiatric Interview )
* Minimum 3-weeks previous therapeutic treatment as outpatient at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria
* Clinical Global Impression - Severity (CGI-S) score \> 2 points
* Minimum improvement of 1 CGI-S points as outpatient
* Written informed consent

Exclusion Criteria:

* More than 60 days away sick per year in the last year before intervention
* Therapy adherence as outpatient at the Health and Prevention Center, Sanatorium Hera, Vienna, Austria
* Work Ability Index (WAI) score \< 25 points
* Major neurological or cognitive deficits
* Current psychotic symptoms
* Current or previous DSM-IV diagnosis of substance dependence, except for nicotine or current substance abuse
* Failures to comply with the study protocol or to follow the instructions of the study team
* Currently requested application for retirement
* Middle to high suicidal tendency in the M.I.N.I.-examination
Effect of Preoperative Oral Carbohydrates on Quality of Recovery in Laparoscopic Colorectal Surgery Patients

Preoperative midnight NPO is a traditional method for preventing aspiration during general anesthesia. However, recent studies reported that drinking carbohydrate beverage, three hours prior the surgery helps reducing patients starving, uncomfortment, and fatigue without other complication. QOR 40 is developed for evaluating patients' recovery condition regarding physical, psychological, and social aspects. Enhanced Recovery After Surgery(ERAS) is a concept for reducing patients' hospital stay and helping recovery. Studies showed that drinking carbohydrate beverage made better recovery of bowel function and shorter hospital stay in colorectal surgeries. However, the effect of carbohydrate drink for laparoscopic surgery is not yet proved. Therefore, the investigators will show the effect of carbohydrate drinking through this study.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing laparoscopic colorectal surgery,
* 20\~85 year-old patients

Exclusion Criteria:

* diabetes mellitus
* Inability to consume clear fluids
* GERD or gastrointestinal obstruction
* Liver cirrhosis
* corticosteroid treatment
* ASA\>4
* starting surgery five and more hours after drinking carbohydrate beverage
* pregnancy
RCT of CBT for Insomnia With PLWHA

The proposed study will consist of a randomized controlled trial (RCT) comparing a known efficacious treatment for insomnia (CBT-I) to a sleep hygiene (SH) comparison condition.

The purpose of this study is to test whether a group cognitive-behavioral treatment program for insomnia (CBT-I) will help adults diagnosed with HIV to improve the quantity (number of hours) and the quality of their sleep. The PI will compare adults who participated in the CBT-I program to adults who participated in a Sleep Hygiene group, a common treatment for insomnia. The PI will look at the overall quality of life, and number of hours and quality of sleep of adults who participated in the CBT-I program versus adults in the Sleep Hygiene group. Also, the PI will draw blood to compare how the body responds to medical illnesses between adults in the CBT-I program to adults in the Sleep Hygiene group.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking individuals
* over the age of 18 years old with a diagnosis of HIV or AIDS who is receiving medical care at the Grady Health System's Infectious Disease Program (IDP)
* study subjects must meet the criteria for primary or secondary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision
* must experience difficulty initiating or maintaining non-restorative sleep for at least l month (DSM- IV-TR)
* the sleep disturbance causes clinically significant impairment or distress in important areas of functioning
* sleep efficiency of less than 85%, sleep disturbances that occur three or more days per week, and sleep latency (i.e., time awake after sleep onset greater than 30 minutes)

Exclusion Criteria:

* current substance dependence (within the past six months)
* active psychosis
* Bipolar I and II disorders
* neurocognitive impairment and/or a current diagnosis of dementia
* lack of independent housing
* previous participation in a CBT-I program
* employment in a job requiring shift work that impairs the ability to establish a regular sleep schedule
Computer Guided Simultaneous Implant Placement With Tri-cortical Ridge Augmentation Using Chin Cortical Bone Struts in Anterior Atrophic Maxilla: A Case Series

10 patients having deficient anterior maxilla will be recruited and a preoperative CBCT will be done to evaluate the vertical and horizontal dimensions of the intended alveolar ridge. pre-operative manufacturing of the digital surgical guides performed for Harvesting of the chin cortical bone struts from the symphysial area in the donor site and for Placement of the grafted cortical bone struts and the implant in the recipient site. Intra operatively the donor site (Chin) will be prepared to harvest autogenous bone from the chin aided by the patient's prefabricated bone harvesting guide. The recipient site (Maxillary anterior defect) will be prepared to receive the chin grafts. Grafts will be screwed in position and implants will be screwed in its preparation until it gains primary stability from basal bone, using the prefabricated bone fixation-implant placement guide. Any gaps will be filled with autogenous bone particulates from the chin. A healing tie base Abutment will be screwed into the implant through the third cortex.

Primary stability will be assessed using Osstell device. An immediate postoperative CBCT will be done and superimposed on the preoperative CBCT to measure accuracy of plan transfer to make sure the planning was followed accurately.

Follow up after 6 months and CBCT will be done for bone formation and density assessment and implant exposure for implant stability measurement-using osstell and removal Healing abutment and consecutive prosthetic loading.


Eligibility Criteria:
Inclusion Criteria:

* Patients with single or Multiple missing Maxillary Anterior Teeth with vertically and horizontally defective ridges having adequate soft tissue ample.
* Patients who gave their consent for this trial.
* Males and females will be included.

Exclusion Criteria:

* Patients on bisphosphonates or drugs altering bone metabolism, within 2 months before initiating the study.
* Subjected to irradiation in the head and neck area less than 1 year before implantation.
* Patients allergic to drugs used in the study.
* Patients having a history of a major medical condition (ASA 3,4)
* Untreated periodontitis.
* Poor oral hygiene and motivation.
* Uncontrolled diabetes.
* Pregnant or nursing.
* Substance abuse.
* Psychiatric problems or unrealistic expectations.
* Severe bruxism or clenching.
* Immunosuppressed or immunocompromised patients.
* Treated or under treatment with intravenous amino-bisphosphonates.
* Active infection or severe inflammation in the area intended for implant placement.
* Unable to open mouth sufficiently to accommodate the surgical tooling.
* Patients participating in other studies, if the present protocol could not be properly followed.
* Referred only for implant placement or unable to attend a 5-year follow-up.
Does the Deep Layer of the Deep Temporalis Fascia Really Exist?

It has been widely accepted that a split of the deep temporal fascia occurs approximately 2 to 3 cm above the zygomatic arch, named the superficial and deep layers. The deep layer of the deep temporal fascia lies between superficial temporal fat pad and the temporal muscle. However, during the investigators' previous surgeries, the investigators did not find the deep layer of the deep temporal fascia between superficial temporal fat pad and the temporal muscle. This study was conducted to clarify the presence or absence of the deep layer of the deep temporal fascia. And the investigators' clinical study has confirmed the absence of the deep layer of the deep temporal fascia between superficial temporal fat pad and the temporal muscle.

The anatomic layers of soft tissues of the temporal region, with regard to the deep temporalis fascia, was investigated in 169 cases operated upon with zygomaticofacial or craniofacial fractures using the supratemporalis approach from June 2013 to June 2017. Among 167 surgeries, this so-called "deep layer of the deep temporalis fascia" was not observed. In fact, the superficial temporal fat pad is closely attached to temporal muscle above the zygomatic arch.

Eligibility Criteria:
Inclusion Criteria:

Clinical and imaging diagnosis of zygomaticofacial or craniofacial fractures A need to operate using the supratemporalis approach No previously surgical treatment

Exclusion Criteria:

unobvious displaced fracture disagree with the surgical treatment previous unsuccessful surgery at the temporal region
Efficacy of Buccal Pad of Fat, Advanced Platelet Rich Fibrin, Fibrin Glue and Oxidized Cellulose Plug in Management of Oro-Antral Communication, Comparative Clinical Study

Evaluation of the efficacy of different treatment protocols in the management of Oro-Antral Communications.

the current study was carried on 24 patients suffering from Oro-Antral Communications. All patients were divided into 4 equal groups.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from oroantral communications
* patients suffering from oroantral fistula.
* The Diameter of the opening ranged from 4-9 mm,
* communication resulted from recent extraction,
* foreign body; or
* cyst enucleation

Exclusion Criteria:

Patients suffering from any systemic diseases were excluded from the study.

* diabetes,
* autoimmune diseases,
* cancers,
* nephropathy,
* coagulation disorders
Treatment of Menstrual Migraine With Sequential, Transdermal, 17-Beta-Estradiol. A Double-Blind, Randomised, Cross-Over Trial.

The purpose of this study is to determine whether transdermally administered 17-beta estradiol sequentially could reduce the number of, and severity of, menstrual migraine attacks.

During the fertile ages, migraine is more common in women than in men (3:1). Hormonal factors has been proposed to affect this difference and it has been shown that a rapid decrease in serum concentrations of estrogens might trigger an attack.About 15 percent of all women with migraine suffer from menstrual migraine which means that the attacks only come during the menstrual period and start +/- 24 hours of the bleeding start, i.e when there is a rapid decrease in serum concentrations of sex hormones.

Stabilizing the serum concentrations of estrogens seems to be crucial in the prophylactic treatment of menstrual migraine. A number of studies have focused on treatment with estradiol during the menstrual cycle but results are conflicting and doses and control groups have varied a lot. other studies have tried to reduce the exposition of estrogens by treatment with, for example, GnRH analogues. This treatment stabilizes the woman's serum concentrations of sex hormones on a very low level, like during the menopause, and it seems to be effective but there are a number of side-effects and the treatment is expensive.

Comparison: In a double-blind, randomized cross-over trial women with strictly defined menstrual migraine will receive treatment with 100 microg 17-beta estradiol/placebo transdermally one week before the estimated start of the menstrual bleeding and twoo weeks on. After three cycles and a wash-out period the treatment will be repeated but now with the tratment the woman did not have during the first treatment period. The women serve as their own controls.

Eligibility Criteria:
Inclusion Criteria:

* Migraine only during the menstrual period
* Migraine attacks each menstrual period during the last year
* Regular menstrual cycle

Exclusion Criteria:

* Migraine other times than during the menstrual period
* Use of hormonal contraceptives (other than depo-provera)during the last three months.
* Depo-provera injection the last year
* History of Thrombo-embolism
* Liver disease
* History of malignancy
* Breast-feeding during the last two months
* Abortion/miscarriage during the last two months
* Pregnancy
Efficacy Mydrane ® for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma.

The aim of this study is to compare Mydrane ®, mydriatic eye drops and Mydriasert ® in terms of pupil site stability, surgical time, visual field and anterior chamber configuration modifications among primary open angle glaucoma (POAG) patients during cataract extraction surgery.

60 patients with coexisting POAG and cataract who underwent elective cataract extraction. All patients underwent ophthalmic routine examinations including automatic visual field examination, anterior chamber configuration, specular microscopy and arterial blood pressure measurement prior to surgery, 24 hours and 30 days postoperatively. All cataract surgeries were videorecorded, and all measurements were performed using media player. 20 patients received topical mydriatic eye drops, 20 patients received Mydriasert ® whereas 20 patients received intracameral injection of Mydrane ® just after the first incision.

Eligibility Criteria:
Inclusion Criteria:

* patients \>18 years of age
* diagnosed with age-related cataract with concomitant POAG well controlled by pharmacological therapy (IOP within its target during the entire day in a minimum of 12-month follow-up with constant use of anti-glaucoma medications)
* required cataract extraction under local anesthesia
* no history of previous surgery in the study eye

Exclusion Criteria:

* patients with POAG requiring glaucoma surgery
* ocular trauma or infection
* other forms of glaucoma
* pseudo-exfoliation and exfoliation syndrome
The Effect of Vitamin K2 on Bone Turnover

To investigate the effect of menatetrenone on bone turnover in postmenopausal patients with osteoporosis. One month of menatetrenone therapy enhanced the secretion and gamma-carboxylation of osteocalcin. Moderate increases of bone resorption and formation markers were observed after 6 months. These changes may contribute to fracture prevention in patients with osteoporosis.


Eligibility Criteria:
Inclusion criteria:

* A diagnosis of osteoporosis was made according to the Year 2000 version of the Diagnostic Criteria for Osteoporosis proposed by the Japanese Society for Bone and Mineral Research.
* These criteria state that patients with a lumbar bone mineral density (BMD)\<70% of the young adult mean or patients with pre-existing osteoporotic fractures and a lumbar BMD\<80% of the young adult mean can be diagnosed as having osteoporosis.

Exclusion criteria:

* Patients with secondary osteoporosis (e.g., due to major gastrointestinal surgery, steroid therapy, rheumatoid arthritis, premenopausal bilateral oophorectomy, renal dysfunction, and thyroid dysfunction ).
* Patients taking medications that could affect bone turnover (such as bisphosphonates, estrogen, calcitonin, SERM, active vitamin D3, or Warfarin) were excluded.
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy

The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45%

The Impulse Dynamics OPTIMIZER Smart Pre-Market Application (PMA) clinical data confirmed that CCM therapy delivered with the Optimizer meaningfully improved health outcomes in patients with NYHA class III heart failure symptoms and left ventricular ejection fraction of 25-45%. CCM has shown significant improvements in quality of life measures, with an average improvement of \>11 points in MLHWFQ incremental to the improvement of a randomized control group with no device. Six minute hall walk and functional class also showed improvements in the PMA data. The post-approval study (PAS) protocol has been designed to evaluate long term safety and efficacy of the OPTIMIZER Smart in a real-world setting.

Eligibility Criteria:
Inclusion Criteria:

1. Patient provides written authorization and/or consent per institution and geographical requirements
2. Male or non-pregnant female, aged 18 or older
3. Left ventricular ejection fraction of 25-45% (inclusive, per site assessment)
4. NYHA Class III heart failure symptoms
5. Stated willingness to comply with all study procedures and availability for the duration of the study
6. Patient has been treated with guideline-directed medical therapy

Exclusion Criteria:

1. Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant
2. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant
3. Myocardial infarction within 90 days prior to implant
4. Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant
5. Prior heart transplant or ventricular assist device
6. Mechanical tricuspid valve
7. Receiving cardiac resynchronization therapy (CRT) or has a Class I indication for CRT implantation according to the ACCF/AHA/HRS guidelines for device-based therapy
8. Participating in a cardiac investigational study at the same time
9. Patient is in a vulnerable population (such as significant mental disability, prisoner) that in the judgement of the PI impedes ability to provide informed consent.
Navigated Brain Stimulation in Diagnosis of Minimally Conscious State

It has already been demonstrated that mental imagining of the complex motor act, such as limb lifting, can evoke the activation of the involved motor centres even if it doesn't result in movement due to paresis. Aim of the study: using the navigated brain stimulation system create a new diagnostic model for the differential diagnostics between the vegetative state and the minimally conscious state. If the investigators could get from patient the efferent motor response after a verbal command, his level of conscious should not be defined less than the minimally conscious state.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed vegetative state
* age 20-85

Exclusion Criteria:

* oncological history
* cardiac pacemakers and other metal implants
* Modified Ashford Scale scores 3 and more
* predisposing disease with motor neurologic impairment
Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis

The primary objective of this study was to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) participants with relapse.

The secondary objective was to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.

Participants completing the EFC6049 (HMR1726D/3001) study were given the opportunity to continue in the extension study;

* participants receiving teriflunomide 7 mg or 14 mg were blindly maintained on the same dose of teriflunomide.
* participants receiving placebo were randomized at a 1:1 ratio to teriflunomide 7 mg or 14 mg.

The study period per participant was broken down as follows:

* Double-blind treatment: up to a maximum of 288 weeks or until teriflunomide was commercially available in the country where participant lived,
* Post-washout follow-up: 4 weeks after last treatment intake. No post-washout follow up if participant continued on teriflunomide treatment by obtaining its commercial form after end of the study.

The total duration of the extension was 292 weeks (about 6 years) from the first participant enrolled or until teriflunomide is commercially available in the country where participant lived.

Eligibility Criteria:
Inclusion Criteria:

* Participant who completed the previous double-blind placebo-controlled study EFC6049 and who did not meet criteria for treatment withdrawal.
* Willingness to participate in a long-term safety/efficacy trial.

Exclusion Criteria:

* Any known condition or circumstance that would prevent in the investigator's opinion, compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.