cyrilzakka/clinical-trials huggingface dataset:
Oral Gabapentin in Management of Chronic Pelvic Pain in Females: A Randomised Placebo-controlled Study.

Aim :The aim of this study is to evaluate the efficacy of oral Gabapentin in the treatment of chronic pelvic pain in females.

The study is designed as a randomised, placebo-controlled, clinical trial.32 patients will be enrolled each arm.

Group A (cases):

This group will include (32) women according to inclusion and exclusion criteria and will receive a card of Gabapentin which will be taken orally by the patient at home three times daily and maximum dose 2700mg per day by 300 mg increments each week until sufficient pain relief, or the occurrence of side effects such as dizziness, somnolence, edema and ataxia. Group B (controls):This group will include (32) women .

Assessment of the patient's pain during the physical examination will be done using the Visual Analogue Scale (VAS). The patient will be asked to place a mark on a drawn 10 cm line at a point which is corresponding to the intensity of her pain. One end of the line denotes no pain and the other end of the line indicates that pain is as bad as it can be (the worst pain).the distance in cm from the low end of VAS to the patient's mark will be used (it gives a number.Questionnaire: will be given to all participants at randomization (0 months) , at 3 months and at 6 months to assess the degree of pain improvement via VAS.

Patients' overall satisfaction with their pain treatment \&Side effect recording (e.g., dizziness, somnolence, mood changes, appetite and poor concentration).


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe chronic pelvic pain for at least 6 months.
* Pain was unrelated exclusively to menstruation.
* Pain incompletely relieved by Non-steroidal Ant-inflammatory drugs.
* Patients had regular menstrual cycles for 3 months.
* Patient receiving regular, effective contraceptive method.

Exclusion Criteria:

* Pregnancy or planning of pregnancy in next 6 months.
* Breast feeding.
* Acute pelvic infection.
* Known history of hypersensitivity to Gabapentin.
* Patients with severe renal or hepatic failure.
* Women with previous diagnosis of endometriosis confirmed by laparoscopy.
* Women with previous diagnosis of Malignancy.
* Plans for surgery in next 6 months.
* Women with chronic or recurrent gastrointestinal disease, including irritable bowel syndrome.
* Women with histories of alcohol use or other chronic tranquilizers. Patients refuse to sign an informed consent form.
Volatile Organic Compounds in Cystic Fibrosis

This experiment is designed to test the effectiveness of a new electronic nose device, which allows a non-invasive breath test for markers of lower respiratory tract infection, which may predict the probability of bacterial organisms in the lower respiratory tract. It consists of:

* A breath collection apparatus for collection of volatile organic compounds in breath onto a sorbent trap and Tedlar bag, as well as for the collection of a separate sample of room air.
* Analysis of the volatile organic compounds in breath and room air by short acoustic wave/gas chromatography.
* Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of lower respiratory tract colonization and infection.

This study will test the hypothesis that the investigators can identify the presence of Pseudomonas aeruginosa by sampling the "head space" above culture media of sputum provided by patients with cystic fibrosis. This study will test the additional hypothesis that the investigators can identify the presence of Pseudomonas aeruginosa by sampling exhaled breath from the patient providing the sputum.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Cystic Fibrosis
* Must be able to give breath and sputum samples

Exclusion Criteria:

* Heavy smoker
* Inability to regularly give breath and sputum samples
* History of additional pulmonary disease
Comparison Between TOMOFIX and BodyCAD Fine Osteotomy

This is a single centre, randomised, patient blinded pilot study that will assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge high tibial osteotomy (MOWHTO) to either current standard of care with TOMOFIX plating system, or utilise patient specific instrumentation and custom-made plate development, with BodyCAD Fine Osteotomy. If the definitive study is deemed feasible, an additional 110 participants will be randomized, for a total of 150 participants.

The proposed study is a single centre, pilot randomised controlled, patient blinded study that will randomly assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge proximal tibial osteotomy (MOWHTO) to either current standard of care, with TOMOFIX plating system, or utilise patient specific instrumentation and custom-made plate development, with BodyCAD Fine Osteotomy. Participants will follow a standardized rehabilitation protocol. Outcomes will be assessed over two years postoperatively utilising CT assessment for accuracy of correction, bony union and construct stability as well as PROMs including KOOS and EQ5D.

Complications, adverse events, returns to theatre and costs will also be recorded. End of study is defined when the last enrolled subject reaches the 24-month follow-up time point and close-out activities are complete.

If the pilot study demonstrates the feasibility of the definitive trial, an additional 110 participants will be ennrolled, for a total of 150 participants.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-70 years old
* have medial compartment osteoarthritis, with varus alignment, deemed suitable for a MOWHTO
* able to speak, read and understand English

Exclusion Criteria:

* found to have a cruciate ligament deficiency
* require multiplanar or rotational alignment correction
* have greater than 5 degrees fixed flexion deformity
* unable to have CT scans for follow up
* evidence of tricompartmental osteoarthritis
* evidence of lateral compartment osteoarthritis on arthroscopy
* received injection therapy within 3 months of surgery on the operative knee
* have a medical history of inflammatory arthropathy, diabetes
* actively smoke
A Bioequivalence Study of Levetiracetam Versus Keppra

The purpose of this study is to assess the bioequivalence of Levetiracetam versus Keppra administered under fasting conditions to healthy adult subjects.

This study is a randomized, single, two-way crossover pivotal study. The pharmacokinetic blood samples and vital signs were obtained before and after administration at scheduled intervals as indicated in the study protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
2. Healthy adult male, aged between 20 and 40 years old.
3. Body Mass Index between 18.5 and 25 (inclusive).
4. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
5. No significant deviation from normal biochemistry examination.
6. No significant deviation from normal hematology examination.
7. No significant deviation from normal urinalysis examination.

Exclusion Criteria:

1. History of drug or alcohol abuse within the past year.
2. Medical history of severe drug allergy or sensitivity to analogous drug.
3. Evidence of acute or chronic disease or having undergone surgery from 4 weeks prior to Period I dosing.
4. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
5. Ongoing peptic ulcer and constipation.
6. Planned vaccination during the time course of the study.
7. Taking any clinical investigation drug from 2 months prior to Period I dosing.
8. Use of any medication, including herb medicine or vitamins from 4 weeks before the study.
9. Blood donation of more than 500 mL within the past 3 months.
10. A positive Hepatitis B surface antigen or positive Hepatitis C antibody result.
11. A positive test for HIV antibody.
Functional Near-infrared Spectroscopy for Anxiety Monitoring and Neurofeedback.

The objective of this subproject is to validate the efficacy of the fNIRS real-time anxiety monitoring and neurofeedback system. In the first year, the cerebral hemodynamics measured by commercial fNIRS during resting state and cognitive tasks from 60 generalized anxiety disorder (GAD) patients and 30 healthy subjects will be processed and analyzed using AI algorithms. The novel anxiety fNIRS biomarker will be identified and correlated to clinical anxiety scales (such as HARS and STAI). In the second year, the validity and responsiveness of the AI-fNIRS biomarker will be validated. The accuracy of using AI-fNIRS biomarker to predict the diagnosis of GAD (according to DSM-5) and anxiety rating scales will be calculated from 60 GAD patients and 30 healthy subjects. In the third year, a neurofeedback method using AI-fNIRS biomarkers to guide digital cognitive behavior therapy (dCBT) through visual/audio cues will be developed. A pilot study with 12 GAD patients will be performed to test the feasibility of mindfulness training during AI-fNIRS neurofeedback. In the fourth year, a large scale RCT will be performed to validate the therapeutic efficacy of AI-fNIRS neurofeedback dCBT in 40 patients with GAD. The protocol of using real-time AI-fNIRS biomarkers as a neurofeedback to augment mindfulness training will be optimized according to previous year.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with generalized anxiety disorder (GAD) by psychiatrists based on DSM-V.
* Native Chinese speakers.
* Right-handers.
* Normal vision without or after correction.
* Normal hearing and verbal expression.
* Regular returns of medical or psychological intervention during participation.

Exclusion Criteria:

* Being diagnosed with other major neurological or mental disorders.
A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary Embolism

This study to collect the real-world clinical outcome data of EkoSonicTM Endovascular System in Chinese patients with acute pulmonary embolism during practical clinical care.

This is a multi-center, single arm, prospective, observational, real-world study.To collect the real-world clinical outcome data of EkoSonicTM Endovascular System in Chinese patients with acute pulmonary embolism during practical clinical care.

Up to 30 patients will be enrolled in this study and up to 30 patients will be enrolled in this study to observation safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. The patients with acute symptomatic pulmonary embolism (Symptomatic duration \< 14 days).
2. The right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio ≥1 measured by echocardiographic image
3. Investigator has selected the EkoSonicTM Endovascular System with r-tPA to treat patient.

Exclusion Criteria:

1. The patients with acute symptomatic pulmonary embolism (Symptomatic duration \< 14 days).
2. The right ventricle diameter to left ventricle diameter of end-diastolic dimension ratio ≥1 measured by echocardiographic image
3. Investigator has selected the EkoSonicTM Endovascular System with r-tPA to treat patient.
Development and Exploration of the Effectiveness and Feasbility of a Digital Intervention for Type 2 Diabetes Mellitus

The study is conducted to assess potential effectiveness and feasibility of a comprehensive digital intervention for people with poorly-controlled Type 2 Diabetes Mellitus (T2DM), to explore the intervention effects of a combined online and offline management for people with T2DM and ultimately to improve the accessibility of lifestyle intervention among participants with T2DM.

The study is a single-arm, non-randomized clinical trial conducted to assess potential effectiveness and feasibility of a comprehensive digital intervention for people with poorly-controlled T2DM, to explore the 16 weeks intervention effects of a combined online and offline management for people with T2DM and ultimately to improve the accessibility of lifestyle intervention among participants with T2DM.

Primary objective is to study the proportion of participants with decrease in Hba1c by 0.6% by providing digital based lifestyle modifications. Secondary objectives include to 1) estimate the change in Hba1c, body mass index (BMI) and improvement in lipid profile components at week 16 compared with baseline readings; 2) to evaluate of the use of the Ramadan Risk Score (IDF-DAR Risk Stratification Scoring Tool); 3) to evaluate the rate of fasting and diabetes complications (hyperglycaemia / hypoglycaemia) amongst Muslims with T2DM during Ramadan.

Eligibility Criteria:
Inclusion Criteria:

* participants diagnosed with T2DM;
* HbA1c 7% and above in the latest blood test valid up to 12months prior to recruitment;
* age range between 20-70 years old;
* BMI between 23-50kg/m2

Exclusion Criteria:

* Pregnant / Breast feeding participants
* Participants on insulin therapy or non-insulin injectable medication
* History of diabetes crisis (hyper or hypoglycaemia) in the past 6 months
* Blood pressure ≥ 160/100 mmHg
* Recurrent history of acute pancreatitis
* Decompensated liver cirrhosis
* eGFR \<60ml/min/1.73m2
* History of acute myocardial infarction/acute coronary syndrome(within the past 1 year), arrhythmias, heart failure (NY Class II -IV)
* Proliferative diabetic retinopathy-Foot ulcer, gangrene
* Deep vein thrombosis of lower limbs(within the past 12 months)
* Intermittent claudication -History of cerebral haemorrhage or acute cerebral infarction (within the past 12 months)
* History of active cancer
* Post-transplant/perioperative participants(defined as planned for operation for the next 6 months)
* History of hypo or hyperthyroidism, including subclinical states
* Musculoskeletal injuries resulting in difficulty to perform physical activities
* Failure to provide consent
* Unable to perform activities of daily livings (ADLs)
* Unable to use WhatsApp and YouTube via mobile devices, e.g. phone or tablet.
Improving Community Health Worker Performance With a Supervision Dashboard

Countries across sub-Saharan Africa are scaling up Community Health Worker (CHW) programmes, yet there remains little high-quality research assessing strategies for CHW supervision and performance improvement. This randomised controlled trial aims to determine the effect of a personalised performance dashboard used as a supervision tool on the quantity, speed, and quality of CHW care. This study is a randomised controlled trial in a large health catchment area in peri-urban Mali. One hundred forty-eight CHWs conducting proactive case-finding home visits were randomly allocated to receive individual monthly supervision with or without the CHW Performance Dashboard from January to June 2016. Randomisation was stratified by CHW supervisor, level of CHW experience, and CHW baseline performance for monthly quantity of care (number of household visits). With regression analysis, we used a difference-in-difference model to estimate the effect of the intervention on monthly quantity, timeliness (percentage of children under five treated within 24 hours of symptom onset), and quality (percentage of children under five treated without protocol error) of care over a six-month post-intervention period relative to a three-month pre-intervention period.


Eligibility Criteria:
Inclusion Criteria:

* To be a CHW in the study site at the time of enrolment (n=148)

Exclusion Criteria:

* CHW who pretested the Dashboard tool (n=2)
Testing the Effect of Whole-wheat Sourdough Bread Compared to White Bread on Healthy Individuals

Bread is the most common grain product in the world, with consumption surpassing 3 billion individuals per year. Sourdough whole-grain bread is considered a healthy alternative to white, refined-wheat bread.

This cross-over study will test the effect of consumption of sourdough bread compared to white bread following a short dietary intervention period (one week) on multiple clinical parameters and gut microbiota.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide and signed informed consent form
* Over 18 years
* Not in active military service
* Ability to technically operate a glucometer

Exclusion Criteria:

* Prediagnosed type I / type II diabetes mellitus
* Pregnancy
* Usage of antibiotics within three months prior to participation
* Chronically active inflammatory or neoplastic disease in the three years prior to enrollment
* Skin disease, including contact dermatitis, precluding proper attachment of the continuous glucose monitor
A Clinical Study of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery

The study is being conducted to evaluate the efficacy and safety of remimazolam tosilate compared to propofol for general anesthesia during elective surgery.


Eligibility Criteria:
Inclution Criteria:

1. 18\~60 years, female or male
2. Patients scheduled for an elective surgical procedure(mechanical ventilation via endotracheal tube)
3. BMI: 18\~30 kg/m2
4. Patients understand clearly and participate in the study voluntarily, and sign the informed consent

Exclusion criteria:

1. Patients scheduled for emergency surgery
2. Patients with a history of drug abuse and / or alcohol abuse 2 years prior to the screening period
3. One or more of the laboratory findings fall out of the limitations for this study(platelet,hemoglobin,aspartate aminotransferase,etc.)
4. Pregnant women or those in lactation period
5. Allergic to drugs used in the study
6. Patients with respiratory management difficulties (Modified Mallampati grade IV)
7. Patients have participated in other clinical trial within the 3 months prior to randomization
8. Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be inappropriate for the subject for any other reason
Research on the Characteristics and Application of Lactobacillus Rhamnosus X253 as Oral Probiotics

The aim of the study is to study the application of Lactobacillus rhamnosus X253 as oral probiotics by the way of a randomised, double blinded, parallel, placebo-controlled clinical trial, and to eto detect the changes in oral flora of volunteers, and judge the improvement effect of X253 lozenges on the human oral flora.

population experiments were carried out, and Quantitative Real-time PCR was used to detect the expression level of the target strains in volunteers' oral, High-throughput sequencing technology to detect the changes in oral flora of volunteers, and judge the improvement effect of X253 lozenges on the human oral flora. The effects of X253 lozenges on the volunteers' oral odor, defecation frequency and gum bleeding was surveyed and conuted by questionnaire.

Eligibility Criteria:
1. Age: 18 years old and above;
2. Gender: There is no restriction on men or women (women are not pregnant);
3. Keep more than 20 original teeth in the oral cavity;
4. Have not had periodontal treatment, tooth whitening (ceramic veneer, cold light whitening), orthodontics, etc. in the past 6 months;
5. No oral topical medication (such as mouthwash, watermelon frost) within 1 month;
6. No dental filling plan in the next 2-6 weeks;
7. Have not taken antibiotics (such as amoxicillin, cephalosporin, roxithromycin, ofloxacin, etc.), hormones (such as glucocorticoids, thyroid hormones, insulin, etc.) and immunosuppressive agents(such as dexamethasone, methylprednisolone, sirolimus, azathioprine) in the past half month; no taking plan for antibiotics (such as amoxicillin, cephalosporin, roxithromycin, ofloxacin, etc.), hormones (such as glucocorticoids, thyroid hormones, insulin, etc.) and immunosuppressive agents (such as dexamethasone, methylprednisolone, sirolimus, azathioprine) within the next 2-6 weeks;
8. No obvious abnormal occlusal relationship (the corresponding relationship between the upper jaw and the lower jaw is not normal, and the chewing efficiency is low).
Phase 2b Study of GSK4532990 in Adults With NASH

The purpose of this study is to measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo in participants with NASH and advanced fibrosis on biopsy (F3 or F4). The study duration will be up to 76 weeks including the screening period. The treatment duration will be up to 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≥25 kilogram per meter square (kg/m\^2) (all ethnic origins) except for Asian participants who qualify for the study with BMI ≥23 kg/m2 at Screening.
* In the opinion of the investigator, there are features of metabolic syndrome and NAFLD is the most likely cause of liver disease. Metabolic syndrome may include type 2 diabetes mellitus (T2DM), obesity, dyslipidemia and hypertension.
* A liver biopsy at baseline showing NAFLD Activity Score (NAS) \>=4 with at least 1 point each in steatosis, inflammation and ballooning and either Fibrosis 3 or Fibrosis 4 using NASH CRN Scoring System.
* Able and willing to comply with all study assessments, including a liver biopsy at Week 52.

Exclusion Criteria:

* Current alcohol consumption ≥14 standard drinks (24 units, 196 g ethanol) per week for females or ≥21 standard drinks (37 units, 294g ethanol) per week for males.
* Weight reduction surgery or procedures (including gastric banding and intragastric balloon insertion) within 2 years of Screening 1 and/or planned during the study.
* History of cancer within previous 2 years from Screening 1, except basal or squamous cell carcinoma of the skin or in situ cervical carcinoma or any other type of cancer which has been treated medically or surgically with curative outcome.