cyrilzakka/clinical-trials huggingface dataset:
Effect of 'Cramp Bites' on Period Cramps in Women Aged 18-25

85 percent of women of reproductive age experience consistent period cramps/menstrual pain, and 60% indicate that they do not use painkillers to relieve menstrual symptoms; there is a need for natural and non-medicative supplements to dysmenorrhea. The purpose of this clinical trial is to examine the effect of 'Cramp Bites'--classified by a mixture of natural ingredients researched to help with period pain--on women suffering from primary dysmenorrhea: this will be done through providing participants with the snack and surveying them on how it changes their period symptoms.

Participants will be asked the following information at the interview: name, month and year of birth, ethnicity, email, and phone number. As well, they will be prompted for their lifestyle habits, allergies, prior pregnancies and deliveries, presence of pathological disorders, medication (specifically asking about oral contraception), use of over-the-counter painkillers for period cramps/menstrual pain, expected date of next period, and menstrual cycle history. They will also be asked to complete the Menstrual Symptom Questionnaire.

The baseline questionnaire will ask the participant about their prior experience with primary dysmenorrhea symptoms and with period cramps/menstrual pain on a sliding scale.

The daily questionnaire will ask the participant to rate the extent of their period cramps/menstrual pain, to describe their pain, and whether they have taken any drugs for their period pain on that day. This questionnaire will be completed by all participants starting 2 days before their next onset of menstruation. Participants were randomly assigned Cramp Bites or the Placebo Snack: all other protocols remain the same.

After their next menstrual cycle ends, participants will be asked to fill out a final questionnaire: this questionnaire will ask the participant if they have noticed any changes in their period pain, the efficacy of the snack, and if they have suggestions/comments about the snack. This study is divided into 4 parts. Some parts will take place at Cornell University, and other parts can be completed online.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18 and 25 who experience primary dysmenorrhea and have no pathological disorders.

Exclusion Criteria:

* Pregnancy or breast feeding within 6 months
* Primary or secondary amenorrhea
* Body mass index less than the 1st percentile or body weight above 300 lbs
* Undergoing menstrual suppression by medicative means
* Unwilling to avoid painkillers (ibuprofen or naproxen) for the duration of the study unless absolutely necessary
* Has allergies or aversions to ingredients used in either Cramp Bites or the Placebo Snack
* Not fluent in English
Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site

Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of unfavorable site under the currently standard surgical therapy.

Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of unfavorable site under the currently standard surgical therapy. Main end of study: 3-year disease free survival rate

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 75 years old
2. Primary gastric lesion confirmed pathologically GIST by endoscopic biopsy. Preoperative endoscopy, ultrasound endoscopy or computer tomography, Magnetic resonance suspected GIST, and then postoperative pathology confirmed as the original GIST
3. Written informed consent
4. Expected R0 resection by laparoscopy
5. Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale
6. ASA (American Society of Anesthesiology) class I to III
7. Maximum tumor diameter ≤10cm

Exclusion Criteria:

1. Pregnant and lactating women
2. Suffering from a severe mental disorder
3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
4. History of previous gastric surgery (including ESD/EMR for gastric cancer)
5. Rejection of laparoscopic resection
6. History of other malignant disease within the past five years
7. History of unstable angina or myocardial infarction within the past six months
8. History of a cerebrovascular accident within the past six months
9. History of continuous systematic administration of corticosteroids within one month
10. Requirement of simultaneous surgery for another disease
11. Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
12. FEV1\<50% of the predicted values
13. Maximum tumor diameter \>10cm
The Effects of Game-Based Exercises on Balance, Kinesiophobia, Fatigue Levels, and Pain in Sedentary Individuals

Physical activity is a significant factor that greatly affects human health. However, with the development of technology, there has been a significant decrease in the physical activity levels of individuals in their daily lives, leading to the emergence of a sedentary society.

Technological advancements, such as electronic devices and machines that replace human labor, push individuals toward laziness, encouraging them to adopt a more inactive lifestyle.

Eligibility Criteria:
Inclusion Criteria

* Accepting to participate in the study
* Between the ages of 18 and 45
* Physical activity level according to the International Physical Activity Questionnaire (short form) between 600 MET- 1500 MET min/week
* Having an appropriate cognitive level (not having a cognitive level that would make it difficult to understand the study or to perform the exercise) Exclusion Criteria
* Physical activity level \>1500 MET-min/week according to the International Physical Activity Questionnaire (short form)
* Having cancer and malignant tumours
* Presence of cognitive problems
* Severe vision problems (colour blindness, blindness, etc.)
Motor Learning-based Clinical Pilates Rehabilitation Protocol for Patients with Parkinson's Disease

Individuals with Parkinson's disease demonstrate impaired motor learning, including a slower acquisition rate and poor retention, which may result from deficits in cognitive function, especially executive function. Considering the reduced motor learning ability in this patient group, exercises should be designed with a focus on strengthening sensory inputs and basic functional training. Therefore, the investigators established this program according to previous experience published study \[NCT04063605\]. Therefore, the feasibility of this rehabilitation protocol, which combines motor learning and clinical pilates principles and is adapted to the needs of individuals with Parkinson's disease, will be examined.

The patients with Parkinson's Disease will be randomly assigned into two groups: Motor Learning based Clinical Pilates (MLCP) Group and Conventional Physiotherapy (CP) Group. Both groups will be treated for 12 weeks. The evaluation of the patients will be done before the beginning of exercise program, midterm evaluation in the 6th week and will be repeated at the end. Also there will be followed up evaluation with the same assessments at the 3rd month. Physical function/motor function of patients will be evaluated with The Unified Parkinson's Disease Rating Scale (UPDRS) III subscale, dynamic balance with Functional Reach Test (FRT), postural control and dynamic balance will also be evaluated with Berg Balance Scale and functional mobility by Timed Up and Go Test. Gait, balance and functional domains of the patients will be evaluated with Gait and Balance Scale (GABS), Nelson foot reaction test will be used for the reaction time.

Eligibility Criteria:
Inclusion Criteria:

* Having modified Hoehn \& Yahr Scale grade 2-3 symptoms
* Be over 45 years old
* Having a score of 24 or 24\< on the Mini Mental test
* To be able to read and write in Turkish
* Having at least 2 years Parkinson's Disease

Exclusion Criteria:

* Serious mental and psychological disorder
* Significant musculoskeletal disorders
* Lower extremity deformation
* Having another neurological disease
* Drug or dose change during treatment
Characterization of Transcriptional Regulators of Ghrelin Hormone Which Causes Genetic Obesity

The problem point of the Prader-Willi Syndrome (PWS) patient is the obesity which is intense and the plasma ghrelin level which increases unusual from the recently PWS patients was discovered. The Ghrelin is endogeneous ligand of growth hormone secretagogue receptor with peptide hormone and the location is 3p26-p25. Becomes the secretion even from nervous system but from dignity X/A cell it is secreted mainly and growth is important even in the vagal control against food and intake and a dignity function even on the action outside which promotes the secretion which drives it operates. It increases food intake specially and in order to accomplish the action which diminishes fat utilization the obesity with the week cause which it does the mortar it is thought. Active the ghrelin of the form is essential in hormonal activity of the ghrelin and appetite and growth hormone it participates to the secretion promotion which drives. Action of the Ghrelin measuring the quantitative change in middle acylated of the PWS patient ghrelin in order to happen after the acylation initially by one interest ghrelin which is attempted the appetite of the PWS patient is is controlled the method it will be able to prove the thing directly, it used the RIA kit and the ELISA it will be able to measure kit it will be able to measure the whole ghrelin to pick the PWS patient and the blood of the normal army and active ghrelin it measured a change.

It will reach to respect, in 5 ' -flanking region of the ghrelin 2000 bp focus it let and it got luciferase assay it led and and it searched for the binding it sorted it put out and and to sleep the transcription factor which and and is the possibility of doing the essential region in the transcription and and it did an order deletion clone and and. is important in result and ghrelin activity the region role, -300\~-200 region Basic helix-loop-helix (bHLH) are containing -USF (-236 to -231) binding site specially to be compressed in -500\~-400 and -300\~-200 two portions.

Eligibility Criteria:
Inclusion Criteria:

* PWS patients were genetically confirmed using the standard methylation test. GHD was diagnosed using a GH stimulation test. The lean and obese normal subjects (comparison group) enrolled were the children or siblings of hospital staff who understood the purpose of and the procedures used.

Exclusion Criteria:

* GHD patients had no history of GH treatment, and were not being treated with GH at study commencement
The Effect of the Glycemic Variability on Macular Retinal Microcirculation and Cognitive Functions in Patient With Type 1 Diabetes

Revadiab is case-control study aimed to demonstrate that retinal capillary density is altered in patients with type 1 diabetes with glycemic variability compared to those with comparable glycemic control without glycemic variability. An OCT angiography will be used to precisely evaluate retinal capillary density.

A secondary objective will be to evaluate if glycemic variability is associated with cognitive dysfunction, using a neuro psychologic evaluation.

HbA1c doesn't explain all the microvascular complications of diabetes, especially microvascular complications. Glycemic variability is associated with increased oxidative stress, free radicals and endothelial dysfunction; it contributes to the pathogenesis of diabetic complications.

The relationship between glycemic variability and microangiopathic complications especially retinal but also neurological, needs to be studied.

The principal objective of Revadiab study is to demonstrate a correlation between glycemic variability and macular retinal microcirculation in patient with type 1 diabetes.

The secondary objective is to search a correlation between glycemic variability and :

* Alteration of cognitive functions.
* Severity of peripheral diabetic retinopathy and retinal neuronal damage.
* Other micro and macro angiopathic complications.
* Oxidative stress and inflammation.

Two groups of type 1 diabetic patients will be compared:

* Case: Patient with significant glycemic variability.
* Control: Patients without glycemic variability.

The severity of diabetic retinopathy will be evaluated by the degree of occlusion of small vessels in the central retinal region as measured by OCT angiography.

Acts or Product necessary to research :

* Non-invasive retinal imaging (OCT and OCT- Angiography, retinophotography)
* Neuropsychological tests.
* Blood test.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years
* Type 1 diabetes (T1D)
* Using Free FreeStyle
* Diabete evolving for 10 years or more
* Case: Patients with glycemic variability, defined by a coefficient of variation (CV) \> 36%, calculated from continuous glucose measurements data by Free Style Libre® (Abbott)
* Controls: Patients without glycemic variability, defined by a coefficient of variation (CV) ≤ 36%, calculated from Free Style Libre® data and matched to patients in the Case group for HbA1c (+/- 0.5%)

Exclusion Criteria:

* Type 2 diabetic patient
* Corticotherapy
* Comorbidity like cancer
* Antecedent of vitreoretinal pathology
* Antecedent of vitreoretinal surgery
* Important cataract, with an important opacity that prevents a reliable evaluation of capillary density in OCT angio
* Pregnant or lactating woman
Steroid Aromatase Inhibitors Versus Progestogens for nSAID-resistanced Late Stage Breast Cancer

Steroid Aromatase Inhibitors and Non-Steroid Aromatase Inhibitors in Late Stage Breast Cancer is the recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. In the past controlled clinical trials with small sample.

A Randomized Study of Steroid Aromatase Inhibitors Versus Progestogens for Non-Steroid Aromatase Inhibitor-resistanced Late Stage Breast Cancer.The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be the postmenopausal women
2. Patients must be diagnosed with advanced breast cancer by imageology，cytology or histopathology
3. Immunohistochemistry shows ER and/or PR positive
4. Patients ECOG score must be 0-2
5. Drug resistant about Non-Steroid Aromatase Inhibitors

Exclusion Criteria:

1. Not suitable for endocrine therapy
2. Have receive the standard Steroid Aromatase Inhibitors treatment
3. Severe hepatic dysfunction
Prevention Of Morbidity In Sickle Cell Disease Pilot Phase

The hypothesis is that in sickle cell anaemia, nocturnal oxyhaemoglobin desaturation, is associated with low processing speed index, and this morbidity can be reduced with overnight auto Continuous Positive Airways Pressure and/or oxygen supplementation.

Intervention: Overnight auto Continuous Positive Airways Pressure (CPAP) with oxygen supplementation if mean overnight oxyhaemoglobin saturation is not \>94% after 2 weeks of autoCPAP

Eligibility Criteria:
Inclusion Criteria:

1. Age \>4 years.
2. Informed consent with assent in accordance with UK ethical committee(COREC) system must be signed by the patient's parent or legally authorized guardian acknowledging written consent to join the study. When suitable, patients will be requested to give their assent to join the study.
3. Haemoglobin SS (homozygous sickle cell anaemia) diagnosed by standard techniques. Participating institutions must submit documentation of the diagnostic haemoglobin analysis.
Muscle Energy Technique and Static Stretching on Pain Intensity and Functional Disability in Patients With Mechanical Neck Pain

Neck pain is becoming increasingly common throughout the world with a considerable impact on individuals, communities, health-care systems and businesses (Hoy et al, 2011).Neck pain is a common problem within our society affecting individual's physical and social functioning considerably and interfering with the patient's daily activities. There is lack of evidence to allow conclusions to be drawn about the effectiveness of MET when compared with stretching exercises for relieving mechanical neck pain. Therefore, this study is designed to examine the effect of MET, static stretching and to compare their effects on pain intensity and functional disability in patient with mechanical neck pain.

This experimental study purposively recruited 24 subjects (male: n=10, female: n = 14) with mechanical neck pain from the Outpatient Physiotherapy Department of the Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife. Subjects were randomly allocated into the MET and SS groups. Subjects in MET group received 6 treatment sessions of Muscle Energy Technique in addition to conventional physiotherapy treatments. Patients in SS group received 6 treatment sessions of Static Stretching in addition to conventional physiotherapy treatments. All subjects were treated twice a week for six weeks. Visual Analogue Scale (VAS) and Neck Disability Index (NDI) were used to assess the pain intensity and functional disability at baseline, 3rd week and 6th week of treatment sessions respectively. Descriptive and Inferential statistics were used to analyse the data. Alpha level was set at \< 0.05.

Eligibility Criteria:
Inclusion Criteria:i. Male and female patients with history of mechanical neck pain of more than 3 months

Exclusion Criteria:

* Patients with acute neck pain
* Subjects were excluded if they have neck pain associated with an underlying pathology such as fracture of the cervical spine, neck pain radiating into the arms or upper extremity or associated with headaches or facial pain, malignancy, infections, inflammatory disorders, osteoporosis or cases of disc prolapse.
* Patients with history of surgery of the cervical spine during the previous 12months
18 Month Prospective Efficacy and Safety Study of Bimatoprost Intracameral Implant (DURYSTA)

Study to collect effectiveness and safety data after administration of a bimatoprost intracameral implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).


Eligibility Criteria:
Inclusion Criteria:

- Patient diagnosed with OAG or OHT who is scheduled to receive a bimatoprost intracameral implant in at least one eye.

Exclusion Criteria:

- A history of any of the following ocular surgeries in the eye due to receive a bimatoprost intracameral implant:Ahmed Glaucoma Valve, Baerveldt shunt, Ex-Press glaucoma shunt implantation, Molteno shunt, Trabeculectomy, Vitrectomy, retinal surgery, CyPass Micro-Stent or Anterior Chamber Intraocular Lens (AC IOL) placement.

* Concurrent or anticipated enrollment in an interventional clinical trial involving either an investigational medicinal product or medical device.
* Previous enrollment in another Allergan bimatoprost intracameral implant study.
Promoting Early Detection of Breast Cancer in Rural Rwanda: Impact of Community Health Worker and Nurse Training

This project proposes a pilot intervention in Burera District to train rural Rwandan community health workers (CHWs) in breast awareness, and to train primary care nurses at rural health centers in the assessment and management of breast complaints, with a focus on when patients must be urgently referred for more advanced evaluation. The project will randomize health centers to receive the intervention and will evaluate the impact of these trainings on nurse and CHW knowledge and skills. In order to help Rwanda prepare for national early detection efforts, the investigators will also assess the impact of these trainings on patient volume at the health center level, and visits and further diagnostic testing at the district hospital level. The investigators will also examine the impact on the length of diagnostic delays experienced by patients with a breast problem. Among those patients diagnosed with breast cancer, the investigators will also assess their stage at diagnosis.


Eligibility Criteria:
Inclusion Criteria

* Community health workers or health center nurses affiliated with a designated intervention health center
* Interested in participating

Exclusion Criteria

* Not interested in participating
* Not available for training
Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention

The objective of the study is to assess the safety and efficacy of Angiomax® (bivalirudin) versus unfractionated heparin (UFH) in patients presenting with stable angina or silent ischemia (positive stress test without chest pain) that undergo percutaneous coronary intervention (PCI).

The primary endpoint of the study will be major and minor bleeding events, defined by the REPLACE-2 trial definition, during the index hospitalization and up to 30 days post discharge.

The purpose of this study is to compare in a randomized, controlled, single-blinded, 1:1 fashion UFH versus bivalirudin in patients with stable angina pectoris or silent ischemia undergoing PCI.

Secondary study endpoints will include:

* Major adverse cardiac events (MACE) comprising of all cause mortality, myocardial infarction (MI), ischemia driven target vessel revascularization (TVR), and cerebral vascular accident (CVA).
* Net adverse clinical events (NACE) will be consistent of MACE plus major bleeding as defined by the REPLCE-2 criteria.
* Cardiac death in-hospital and up to 30 days post discharge.
* MI in-hospital and up to 30 days post discharge.
* CVA in-hospital and up to 30 days post discharge.
* Incidence of all-cause mortality at 6 months and 1 year.
* MACE at 6 months and 1 year.
* Incidence of acute (0-24 hours post procedure) stent thrombosis rates.
* Incidence of sub-acute (24 hours - 30 days) stent thrombosis rates.
* Length of hospital stay (LOS)
* Economic analysis (total cost during hospitalization) and up to 30 days post discharge.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is male or female ≥ 18 years of age.
2. The patient presents with stable angina pectoris, or silent ischemia (positive stress test without chest pain).
3. The patient is scheduled for coronary angiography, with possible angioplasty.
4. The patient is able to tolerate dual anti-platelet therapy with aspirin and clopidogrel for a minimum of 30 days and is on those medications at the time of the PCI (clopidogrel may be administered during PCI or within 30 minutes post PCI).
5. The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent.
6. The patient does not present with any form of illness or condition that in the investigator's opinion would impair the results of the study.
7. Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment.

Exclusion Criteria:

1. Patients in cardiogenic shock.
2. Patients with acute coronary syndrome, which includes unstable angina, non-ST-elevation MI or STEMI.
3. Known history of heparin-induced thrombocytopenia.
4. Contraindication to unfractionated heparin, bivalirudin, or any anticoagulant or antithrombotic pharmacological agent.
5. Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study.
6. Pregnant women or nursing mothers.