cyrilzakka/clinical-trials huggingface dataset:
The Effect of Gum Chewing on Bowel Function After Cesarean Section

This study is a randomised controlled trial that included 150 pregnant women undergoing cesarean in Sisli Ethal Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey. It was carried out in the period from October 1, 2015 to December 31, 2015. After operation, the participants are going to randomly assigned into two groups by using cards. The patients are going to randomized into two groups by using a sealed enveloped system.The patients in the study group, will chew one sugar less gum for 30 minutes in postoperative 3., 5. and 7. hours. The control group will be followed without chew gum. All patients will note the time of first rumbling of the stomach, first feeling of hunger and the first gas outlet.

For elective cases, all participants are going to given nothing by mouth since midnight before surgery, and all operations are going to perform in the morning. For those who had emergency cesarean section, nothing is going to given per oral for at least 4 hours before the start of the operation. Operation data is going to recorded including surgical setting, type of cesarean section, previous surgery, adhesion and operation time.

After operation, the participants are going to randomly assigned into two groups by using cards. The patients are going to randomized into two groups by using a sealed enveloped system. A blue card and an orange card are going to sealed in separate envelopes. Blue card means patients will chewgum.

The patients in the study group, will chew one sugar less gum for 30 minutes in postoperative 3., 5. and 7. hours. The control group will be followed without chew gum. Both patient groups will be mobilized in postoperative 6 hour and 8 hour after the operation, juicy food will be given. It will be introduced to solid foods after bowel movements and gas output occurs. All patients postoperatively 4, 6, 8, 10, 12, 24 and 48 hours will be examined and bowel sounds will be oscult. Gas evolution is still not, enema will be applied. All patients will note the time of first rumbling of the stomach, first feeling of hunger and the first gas outlet.

Eligibility Criteria:
Inclusion Criteria:

1. pregnant women who is at least 18 years of age
2. pregnant women whose body mass index is under 35
3. pregnant women who is going to have cesarean section.

Exclusion Criteria:

1. cesarean hysterectomy,
2. surgical management of severe postpartum hemorrhage
3. previous bowel surgery
4. women with history of drug consumption,especially opioids
5. water and electrolyte disturbances
6. pancreatitis or peritonitis
7. inability to chew gum
8. diabetes, pregnancies accompanied by coagulopathy like pre-eclampsia, hypothyroidism, muscular and neurological disorders
9. postoperative admission to intensive care unit
10. history of abdominal surgery except cesarean section
11. history of postoperative ileus
12. patients with drains
CARTO-Finder Guided Ablation Versus Multiscale Entropy Guided Ablation in Persistent Atrial Fibrillation

This is a randomized control trial to compare the efficacy and safety of CARTO-Finder-guided ablation plus pulmonary vein isolation versus multiscale entropy (MSE)-guided pulmonary vein isolation in patients with persistent atrial fibrillation.

This is a randomized control trial. Patients with persistent atrial fibrillation are enrolled and randomized to CARTO-Finder-guided ablation plus PVI group or MSE-guided ablation plus PVI group. Postoperative recurrence rate and other indicators are analyzed to compare the efficacy and safety between CARTO-Finder-guided ablation plus PVI and MSE-guided ablation plus PVI in patients with persistent atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 80 years old
2. Persistent AF
3. Nonresponse or intolerance to ≥1 antiarrhythmic drug

Exclusion Criteria:

1. With uncontrolled congestive heart failure;
2. Having significant valvular disease;
3. Having moderate-to-severe pulmonary hypertension;
4. With myocardial infarction or stroke within 6 months of screening;
5. With Significant congenital heart disease;
6. Ejection fraction was \<40% measured by echocardiography;
7. Allergic to contrast media;
8. Contraindication to anticoagulation medications;
9. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
10. Left atrial thrombus;
11. Having any contraindication to right or left sided heart catheterization
Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment

This study will evaluate the efficacy and safety of AKST4290 in subjects with Parkinson's Disease who are currently on stable dopaminergic treatment.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of clinically established or clinically probable PD according to MDS-PD criteria with at least 1 year of PD symptoms.
* Modified Hoehn and Yahr ≤2.5.
* Have notable motor worsening during off-medication state.
* Clear-cut improvement of motor response to levodopa medications, as assessed by the investigator.
* Must be on stable dopaminergic therapy (e.g., levodopa, dopamine agonists, monoamine oxidase inhibitors, catechol-O-methyl transferase inhibitors, amantadine), for at least 8 weeks prior to enrollment and remain on stable dose during the 12-week treatment period.
* Female subjects must not be pregnant or breastfeeding. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening. WOCBP must agree to use highly effective contraception prior to study entry. Male subjects must be willing to use a barrier method of contraception.

Key Exclusion Criteria:

* Secondary or atypical parkinsonian syndromes, for example, patients with parkinsonism from encephalitis, metabolic disorders, vascular parkinsonism, drug-induced parkinsonism, multiple system atrophy, corticobasal ganglia degeneration, progressive supranuclear palsy, Lewy body dementia.
* History of any brain surgery for PD (e.g., pallidotomy, deep brain stimulation, or fetal tissue transplant).
* Conditions affecting the peripheral or central nervous system, unless related to PD, that would affect the ability to adequately perform the MDS-UPDRS and motor assessments: i.e., severe sensory neuropathy affecting arm or leg function, or stroke affecting motor or gait function.
* Significant alcohol or drug abuse within past 2 years.
* Based on ECG reading, subjects with a risk of QT prolongation.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Role of the Gut Microbiome in Complex Regional Pain Syndrome

The objective of this prospective, observational study is to determine the association between the composition of the gut microbiota and the severity and persistence of Complex Regional Pain Syndrome symptoms (Study A). The objective of Study B, a longitudinal study of microbiota biomarkers of patients with newly diagnosed CRPS is to determine if the researchers can predict which patients are more likely to recover compared to those who do not. A secondary objective of both studies is to examine cognitive flexibility in relation to outcomes (study A and B).


Eligibility Criteria:
Study A: Cross-sectional study

Inclusion criteria, cases:

* Adults over the age of 18
* Current (\< 1 year duration) or former (\> 1 year) diagnosis of Complex Regional Pain Syndrome by the Budapest criteria
* English as primary language
* able to consent

Inclusion criteria, controls

* Adults over age of 18
* Cohabitant of person with current or former diagnosis of CRPS

Study B: Longitudinal Study

Inclusion criteria, cases:

* Adults over the age of 18
* Recent diagnosis (\<6 months) of Complex Regional Pain Syndrome by the Budapest criteria
* English as primary language
* able to consent

Inclusion criteria, controls

* Adults over age of 18
* Cohabitant of person with diagnosis of CRPS

Study A and B: Exclusion criteria, cases and controls:

* Unwilling to participate in the study
* Lives alone
* Current use of probiotics and unwilling to stop for 1 week prior to stool sample
* Pregnant or lactating
* Vegan diet
Barley Bread and Metabolic Disease

The aim of this study was to compare the metabolic effects of consuming whole barley bread and whole wheat bread, in healthy subjects. Also, to investigate the effect of whole grain flour on mineral status.

Generally, diet can be improved in order to lower diet-related diseases risk. However, the increasing prevalence rates of diet-related diseases indicate that, in practice, people's diet does not follow the recommendations. The intake of whole flour foods is consistently associated with reduced risk of type 2 diabetes and cardiovascular diseases in epidemiological studies, although the mechanisms of this association are unclear. Here the aim is to compare the metabolic effects and mineral status of consumption of diet containing wholemeal barley bread versus whole meal wheat bread in healthy subjects.

The intervention was designed as a randomized, cross over trial of 3-weeks duration. A total of 14 participants was included in the study. In one period subjects received WBB bread; in the second period, subjects received WWB bread. This bread is based on the recipe of Egyptian Baladi bread but formed in Danish buns form. Participants incorporated this bread into their normal habitual diet with regard to the study restrictions about other cereal food products. At the beginning and end of each intervention period blood was drawn and urine collected and stored for later analysis.

The primary outcomes of this study are evaluation of LDL-c, insulin and glucose levels evaluated by analysis of fasting blood samples. Furthermore, selected measures to evaluate SCFA level in blood is to be evaluated. Secondary outcomes include mineral status.

Eligibility Criteria:
Inclusion Criteria:

* Like and tolerate wheat/ barley bread products.
* Age: 20 - 53 years
* Body mass index (BMI): 23 - 30 kg/m2
* Weight stable (\<3 kg weight change during the last 6 months)
* Apparently healthy
* Informed consent signed
* Freezer capacity for 1 week bread provision
* Can attend all visits required for the study

Exclusion Criteria:

* Wheat/gluten or barley intolerance
* Smoking on a daily basis
* Lactating (or lactating within 6 weeks prior to study start), pregnant (or pregnant within 3 months prior to study start) or wish to become pregnant during the study
* Diagnosed with any form of diabetes or cardiovascular disease
* Reported chronic gastrointestinal disorders
* Taking dietary supplements during or one month prior to the study
* Lack of cooperation and adherence to the protocol
* Use of prescription medication will be evaluated on an individual basis
* Blood donation within 3 months prior to study start or during the study
* Participation in other clinical trials
Safety and Tolerability of Repeat Courses of IM Alefacept

The purpose of this study is to determine whether repeat courses of alefacept, administered intramuscularly, are safe when given to chronic plaque psoriasis patients who are receiving standard dermatology treatments.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* At least 16 years of age.
* Diagnosed with chronic plaque psoriasis and require systemic therapy.
* CD4+ lymphocyte counts at or above the lower limit of normal for Covance Central Laboratory Services, Inc., unless on a stable dose of prednisone (counts must be at or above 300 cells/mm3).

Exclusion Criteria:

* Unstable erthrodermic or pustular psoriasis.
* Diagnosis of guttate psoriasis.
* Serious local infection or systemic infection within 3 months prior to first dose of alefacept.
* Positive for HIV antibody.
* Known invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded.
* Evidence of active tuberculosis.
* Current treatment for active tuberculosis or tuberculosis prophylaxis.
* Female patients unwilling to practice effective contraception as defined by the investigator.
* Female patients who are pregnant or breast-feeding.
* Current enrollment in any other investigational drug study.
* Previous participation in this study or previous alefacept studies.
Study of INV-102 Ophthalmic Solution in Adults With Moderate to Severe Dry Eye Disease

Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during 4-week repeat dosing in subjects with moderate to severe dry eye disease.


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects ≥18 and \<75 years of age
* Presence of moderate to severe dry eye disease (DED) in at least one eye

Key Exclusion Criteria:

* Presently using prescription eyedrops, except those used for dry eye disease, which must be discontinued 4 weeks prior
* Use of over-the-counter (OTC) eyedrops except for lubricant eyedrops or artificial tears, within 1 week prior to initiation of study drug dosing
* History or evidence of ocular infection within the previous 30 days
* Blepharitis or meibomian gland disease requiring the use of either topical or systemic antibiotics within 2 months
* Allergic conjunctivitis requiring treatment within 30 days
* Unable to discontinue contact lens wear for 2 weeks prior and for the duration of the study
Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease

The purpose of this study in healthy adult males is to investigate safety and pharmacokinetics of single and multiple oral doses of KDT-3594.

The purpose of this study in patients with Parkinson's disease is to investigate safety and pharmacokinetics of single and multiple oral doses of KDT-3594. The exploratory efficacy of KDT-3594 will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer part

  * Healthy Japanese males aged 20 to 35 years, inclusive
* Patient part

  * Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria
  * Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale
  * Male patients with Parkinson's disease aged 20 to 74 years inclusive, post-menopausal female patients with Parkinson's disease aged 50 to 74 years inclusive

Exclusion Criteria:

* Healthy volunteer part

  * Subjects with any abnormal findings in physical examination vital signs, 12-lead ECG, clinical laboratory tests, ophthalmic examinations and electroencephalography
* Patient part

  * Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease
* Healthy volunteer part and patient part

  * Subjects who do not agree to avoid dangerous works such as driving, mechanical operation and high-place work until completion of the follow-up examination
The Effects of Virtual Reality on Upper Extremity Function in Hemiplegic Cerebral Palsy

The investigators have planned a research on the effects of virtual reality therapy and home exercise program on hand functions in children with hemiplegic cerebral palsy in Istanbul University Istanbul Faculty of Medicine in the Department of Physical Medicine and Rehabilitation. The eligible patients will be randomized into two groups. The patients in intervention group will participate in a computer based virtual reality exercise program for a period of 8 weeks supervised by the investigators. In addition, these patients will receive a home exercise program. The patients in the control group will receive only a home exercise program for 8 weeks. All patients will be evaluated before treatment, immediately after treatment, and 3 months after the end of the treatment.

The current study is a prospective, randomized controlled interventional trial, which will conduct in the Istanbul University Istanbul Faculty of Medicine in 2016. The study was approved by the Ethics Committee in conformity with the Declaration of Helsinki. Prior to data collection, all participants will provide informed consent. By the order of application to the outpatient clinics, the eligible participants will randomly allocated to two groups using the computer-generated random numbers: intervention group (n=17) and control group (n=17). Information on demographic characteristics (age, gender, body mass index, educational level), pre-natal history, parent educational level and past medical history will obtain at baseline assessment. After baseline assessment, the patients in intervention group will participate in a computer based virtual reality exercise program with HandTutor equipment. The supervised intervention program consists of a forty-minute exercise session three times a week for 8 weeks. In addition, these patients will receive a home exercise program. The patients in the control group will receive only a home exercise program for 8 weeks. The home exercise program consists of different games and exercises such as range of motion, stretch, and strengthening exercises for hand. All patients will be evaluated before treatment, immediately after treatment, and 3 months after the end of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Children with hemiplegic cerebral palsy diagnosed by the specialist
* Active wrist extension ≥ 20 °
* Gross Motor Function Classification System score: 1-2
* Manual Ability Classification System score: 1-3
* The ability to follow simple commands and participate in the task

Exclusion Criteria:

* Contracture in upper limb
* Absence of vision and hearing problems
* Uncontrolled seizure
* Lack of movement in the hemiplegic upper limb
* History of orthopedic surgery (tendon transfer / tendon lengthening) to the affected upper extremity
* Any treatment for upper limb in the last 6 months including BTX-A or orthopedic interventions
Effects of Cognitive-motor Training on Cognition, Depression and Daily Functioning in Patients With Mild Cognitive Impairment (MCI)

This randomized controlled trial evaluated the effectiveness of an immersive virtual reality (IVR) application (focused on a daily activity) to train cognitive functions and its impact on depression and the ability to perform activities of daily living (ADL) in patients with mild cognitive impairment (MCI). With a dose of two sessions per week during six weeks, the study showed significant improvements in cognitive functions and reduction in depression, with notable effects in the experimental group. This underscores the potential of IVR as a valuable tool in the management of MCI.

Background:

The increase in cases of MCI underlines the urgency of finding effective methods to slow its progression. Given the limited effectiveness of current pharmacological options to prevent or treat the early stages of this deterioration, non-pharmacological alternatives are especially relevant.

Aim: The study aimed to evaluate the effectiveness of an immersive virtual reality (IVR) application, focused on an activity of daily living (ADL), to train cognitive functions and its impact on depression and the ability to perform ADL in patients with MCI. IVR is presented as an innovative tool with the potential to offer a promising non-pharmacological approach.

Methods:The researchers implemented a 40-minute-long intervention, twice a week for six weeks (totaling 12 sessions), using the cupboard task (based on IVR). The study included the participation of individuals with MCI, randomly distributed into control (n=12) and experimental (n=14) groups. The majority in the control group were women (75%), with a mean age of 77.67 years, and in the experimental group, women represented 57.14%, with a mean age of 74.86 years. Cognitive functions, depression, and the ability to perform ADLs were assessed. The scales used were: the Spanish version of the Montreal Cognitive Assessment (MoCA-S), the Short Geriatric Depression Scale (SGDS-S) and the Instrumental Activities of Daily Living Scale. (IADL-S), respectively.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 or older
* Community-dwelling, not in nursing homes
* Physically functional
* Understanding and voluntary consent
* Mild Cognitive Impairment (MCI)
* MoCA score of 19-25

Exclusion Criteria:

* Clinical dementia diagnosis
* MoCA ≤ 18 indicating probable dementia
* Neurological disorders including stroke or TBI in the last year
* History of mental/psychiatric disorders
* Substance abuse
* Difficulty using VR headset and controllers
* Medical conditions affecting trial participation
* Visual/hearing impairments
* Communication difficulties
Registry to Evaluate Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting

The objective of this study is to evaluate the safety and long-term effectiveness of coronary stenting with the everolimus-eluting stent (EES) and to determine clinical device and procedural success during commercial use of EES in the real world.

The investigators will compare EES (Xience/Promus, prospective arm) with sirolimus-eluting stent (SES, Cypher, retrospective arm).


Eligibility Criteria:
Inclusion Criteria:

* The patient agrees to participate in this study by signing the informed consent form.
* Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.

Exclusion Criteria:

* There are no exclusion criteria for this registry.
Phase II Study of Brivanib (BMS-582664) to Treat Multiple Tumor Types

The purpose of this study is to determine if gastric/esophageal, lung, pancreatic, bladder and sarcoma patients show benefit from brivanib treatment. Patients who clearly do, stay on treatment. Those in which it is unclear will be randomized to continue or withdraw treatment to determine whether that benefit is related to brivanib


Eligibility Criteria:
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

* Life expectancy at least 3 months
* Diagnosis of a solid tumor which is unresectable in which no approved effective therapy exists or for subjects who are intolerable to such therapy. The initial enrollment will focus on non-small cell lung, gastric/esophageal adenocarcinoma, soft tissue sarcoma, transitional cell carcinoma, and pancreatic cancer including ampulla of Vater tumors
* Adequate tumor sample
* Adequate recovery (baseline or Grade 1) from recent therapy. At least 1 week must have elapsed from the time of a minor surgery, and at least 8 weeks for major surgery or radiation therapy

Exclusion Criteria:

* Subjects with known brain metastasis.
* Subjects with signs or symptoms suggestive of brain metastasis are not eligible unless brain metastases are ruled out by CT or MRI

Medical History and Concurrent Diseases:

* History of thrombo-embolic disease within the last six months requiring therapeutic anticoagulation
* Subjects with history of poor wound healing or non healing ulcers
* Uncontrolled or significant cardiovascular disease

Allergies and Adverse Drug Reactions:

* History of allergy to brivanib its drug class, or related compounds

Prohibited Treatments and/or Therapies:

* Exposure to any investigational drug within 4 weeks of enrollment
* Other concurrent chemotherapy, hormonal therapy, immunotherapy regimens or radiotherapy, standard or investigational. Subjects may continue to receive hormone replacement therapy
* Prior exposure to brivanib