cyrilzakka/clinical-trials huggingface dataset:
Clinical Trail of Transtek Glass Body Fat Analyzer

The clinical protocol of the clinical testing of this device:

1. Objective of the test: To verify the functions and efficiency of devices.
2. Test methods and procedures: Comparison Test.
3. DUT(Device Under Test): Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D.
4. Comparison device: Transtek Glass Body Analyzer, GBF-950 (Predicate Device).
5. Study endpoints: Transtek devices and the predicate device are substantial equivalence.
6. Statistical methodology used: Description of statistical methods.
7. Result: Efficiencies of Transtek devices and predicate device are in the same level.

Hospital Information The data was collected by Zhongshan City People's Hospital Clinical Investigator Team at Zhongshan City People's Hospital, No.2 Sunwen Dong Road, Zhongshan, Guangdong 528403, P. R. China.

Investigator: Dr. Stephen Feng, Leader; Fan Futao, Nurse A; Wu Yanting, Nurse B.

Contact Dr. James Zhu Tel: +86 760 88823818 Used Equipments DUT (Device Under Test): Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D.

Reference Device: Transtek Glass Body Analyzer, GBF-950 (Predicate Device). Test Protocol

1. Test Purpose:

   The aim of clinical test is to collect weight, body fat, total body water, bone mass, and muscle mass reading value which measured by DUT and reference device.

   Note: GBF-733-W1 and BF-1039 have not bone mass functions. So it just collects weight, body fat, total body water, and muscle mass data.
2. Target Subject:

   The subject database shall contain at least 25 male and 25 female subjects and all above 18 years old. Patient's population analysis is bellow.
3. Test procedures 1) Record the name, age, and gender values of each subject. 2) Let subject seated calmly for two minutes before test, dry the feet. 3) Use device to measure weight, body fat, total body water, bone mass, and muscle mass; record reading value.

4) For each subject, repeat 3) to get 3 pairs measurements. 5) Repeat step 1) to 4) for every device (DUT: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D; and reference device: GBF-950).

6) Repeat step 1) to 5) for each subject. 5. Note:

1. No motion and speaking are allowed during the measurement.
2. All DUT use the same algorithms, have the same number of electrodes and contact the patient at the same body locations (feet), and operate on the same frequency.
3. Test environment: Temperature: 22±1℃; Relative humidity: 40\~50%.

Eligibility Criteria:
Inclusion Criteria:

* male,female

Exclusion Criteria:

* below 18 years old
Effectiveness of a Cognitive Training Program (UMAM Method) in Elderly People Without Dementia

The study is oriented to analyze the effectiveness of a cognitive training method (UMAM) on cognitive functions, subjective memory and mood state in elderly people without dementia. On the other hand, the study aims to examine whether variables such as cognitive reserve (e.g. educational level), APOE genotype and intracranial volume are related to increased benefit after the intervention. The researchers hope to find that greater cognitive reserve, not having the APOE allele ε4, and a greater volume of memory-related brain areas, are associated with better outcomes after the cognitive intervention.


Eligibility Criteria:
Inclusion Criteria:

* Being over 60 years old.
* Having a global cognitive performance \> 23 in the Mini Mental State Examination Test.
* Having no history of neurological or serious psychiatric disorders (severe psycho-affective disorders and psychosis or other psychiatric disorders like alcoholism).

Exclusion Criteria:

* Chronic use of anxiolytics.
* Chronic use of neuroleptics.
* Chronic use of anticonvulsants.
* Having hearing or vision impairments that would preclude testing.
* Magnetic Resonance Imaging (MRI) contraindications.
A Study to Evaluate the Efficacy and Safety of SHR-2004 Injection in Preventing Postoperative Venous Thromboembolism in Patients Undergoing Ovarian Cancer Surgery

This study is designed to evaluate the efficacy and safety of SHR-2004 injection in preventing postoperative venous thromboembolism in patients undergoing ovarian cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 18 years old on the day of signing the informed consent form;
2. Diagnosed as stage III-IV or recurrent ovarian cancer;
3. Have surgical indications and no contraindications to surgery, and voluntarily undergo laparotomy or laparoscopic surgery to treat ovarian cancer;
4. Understand the research procedures and methods, voluntarily participate in this trial, and sign the written informed consent form.

Exclusion Criteria:

1. The primary site of the tumor is not the ovary or there is brain metastasis;
2. A history that may increase the risk of bleeding;
3. A history of VTE in the past or during screening, or a disease that increases thrombosis tendency such as protein C deficiency;
4. Patients with atrial fibrillation requiring anticoagulant treatment or the use of artificial heart valves during screening;
5. Acute coronary syndrome within 3 months;
6. Poorly controlled hypertension before screening, and uncontrolled hypertension within 6 months severe cardiac arrhythmia;
7. Any laboratory test indicator during screening or baseline does not meet the standards in the exclusion criteria;
8. Have had a history of adverse reactions or allergies related to rivaroxaban or enoxaparin, such as heparin-induced thrombocytopenia;
9. Have used any drugs prohibitedother than investigational drugs within 7 days before screening or plan to use during the study;
10. Those who have participated in any drug intervention clinical trial within 1 month before screening, or those who are within 5 half-lives of the investigational drug at the time of screening, Whichever is longer;
11. Those who are expected to use postoperative neuraxial analgesia;
12. Those who are expected to use plantar vein pumps, intermittent pneumatic compression devices, electronic or mechanical muscle stimulators after surgery;
13. Other circumstances in which the researcher believes that the subject is not suitable to participate in this trial.
Multiple Ascending Dose Trial of MSB0010841 (Anti-IL17A/F Nanobody) in Psoriasis Subjects

This is a multicenter, Phase 1, randomized, double-blind, placebo-controlled trial in subjects with moderate to severe psoriasis to assess the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of multiple subcutaneous ascending doses of MSB0010841 (Anti-interleukin-17A/F \[Anti-IL-17A/F\] Nanobody).


Eligibility Criteria:
Inclusion Criteria:

* Chronic plaque psoriasis for at least 6 months before screening
* Greater than or equal to (\>=) 10% of BSA with plaques
* Psoriasis Area and Severity Index (PASI) \>=12
* Static Physician's Global Assessment (sPGA) \>=3 (where scores range from 0 \[clear of disease\] to 5 \[severe disease\]) at the screening and baseline visits
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Any condition, including protocol-specified laboratory findings and findings in the medical history or in the pre-trial assessments which in the Investigator's opinion constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation
* Currently having a form of non-plaque psoriasis as specified in the protocol
* Drug induced psoriasis
* Biological treatments as specified in the protocol, within 3 months prior to Day 1
* Systemic immunosuppressants or phototherapy as specified in the protocol, within 1 month prior to Day 1
* Use of anti-coagulant medications and/or antiplatelet medications as defined in the protocol
* Use of aspirin as defined in the protocol
* Topical corticosteroid treatments other than low-strength or lower-mid strength corticosteroids on the face, scalp, axillae, and/or groin within 1 month prior to Day 1
* Any previous treatment with an agent targeting interleukin (IL)-17, IL-12 and/or IL-23 as specified in the protocol
* Other protocol defined exclusion criteria could apply
Nomogram for Predicting Difficult Laparoscopic Appendectomy

No prior studies have stratified the difficulty of laparoscopic appendectomy (LA). The investigators aimed to investigate preoperative factors as indicators of difficult LAs based on the experience of surgical trainees and to develop a predictive model accordingly.

Acute appendicitis is the most common cause of surgical emergencies and laparoscopic appendectomy (LA) is usually attempted by surgical trainees. This study aim to explore the preoperative and intraoperative factors affecting the degree of surgical difficulty and to establish a model for validation, so that it can be subsequently replicated in training programs.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute appendicitis
* Participants who underwent laparoscopic appendectomy

Exclusion Criteria:

* Participants refused or could not tolerate laparoscopic appendectomy
* Incomplete preoperative examination or missed information
A Naturalistic Study of Ketamine for Treatment Resistant Mood Disorders

This study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of IV, nasal spray and oral ketamine for treatment-resistant mood disorders.

Current pharmacological treatments for depression prove unsatisfactory efficacy with a proportion of subjects demonstrating treatment-resistant depression (TRD). The observation applies both to major depressive disorder (MDD) as well as bipolar I depression. There is growing evidence that the glutamatergic system plays a role in the pathophysiology and treatment of depression. Discovery of rapid, although transient antidepressant effect of ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist used in a single sub-anaesthetic intravenous dose in unipolar, bipolar and treatment-resistant patients provides evidence for a glutamatergic antidepressant. Subsequent studies confirmed this effect in repeated doses. Further research demonstrated that repeated ketamine infusions result in sustainable antidepressant effect with both, twice-weekly and thrice-weekly administration schedules. However, the worsening of depression may occur after infusions are completed. Given the risk of relapses, there is a definite need for the development of new strategies to maintain the beneficial effects of ketamine treatment. In the present study, the investigators aim to openly assess the safety, tolerability, and effectiveness of repeated, individually tailored IV, nasal spray and oral ketamine for treatment-resistant mood disorders. The investigators intend to explore questions regarding optimal dose, treatment frequency and duration.

Eligibility Criteria:
Inclusion Criteria:

1. Major depressive disorder (MDD) or bipolar disorder (BD) diagnosis as provided by DSM-5 criteria
2. TRD defined as the patient does not reach remission within the 8 week trial of an antidepressant or combination at a therapeutic dose of at least two trials of first-line evidence-based treatments and/or electroconvulsive therapy (ECT)

Exclusion Criteria:

1. Pregnancy and lactation
2. Hypersensitivity to ketamine
3. Uncontrolled hypertension
4. Other uncontrolled somatic diseases that may impact safety per investigators judgement
Frailty in Older HIV-infected Individuals

Frailty has been proposed as a measure of biological (as opposed to chronological) aging. In this study the investigators plan to: (1) measure frailty in a cohort of older HIV-infected individuals in Hong Kong, and its association with mortality and quality of life; (2) identify risk factors predictive of development of frailty in HIV-infected individuals in Hong Kong; and (3) determine the outcomes of HIV-infected individuals in Hong Kong with and without frailty.

The following assessment will be done:

1. Physical examination including measuring height, weight, hip and waist circumference.
2. Grip strength, chair stand test, gait speed test, balance tests, and neurocognitive tests
3. Geriatric syndromes, screening for depression, disability and quality of life.
4. Blood tests during fasting state to measure metabolic parameters.

This is a prospective longitudinal observational study that lasts for 10 years.


Eligibility Criteria:
Inclusion Criteria:

* HIV infection with positive anti-HIV antibody
* Age ≥50 years

Exclusion Criteria:

* Refuses to consent
Fesoterodine Flexible Dose Study

This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (OAB) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well tolerated.


Eligibility Criteria:
Inclusion Criteria:

* Overactive bladder symptoms for greater than or equal to 3 months.
* Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary.
* Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary.

Exclusion Criteria:

* Contraindication to fesoterodine (antimuscarinics).
* Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).
* Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
* Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.
The Gut Brain Axis, Effect of Dietary Changes and Probiotics Supplement on Depression Symptoms .

To investigate the effects of a high-fiber diet and probiotic supplementation on depression symptoms in adult individuals.

Depression is prevalent mental health disorder that significantly impacts individuals' quality of life. Despite the availability of effective treatments such as pharmacotherapy and psychotherapy, there are still significant limitations to these approaches. Medications can have unwanted side effects and may not be effective for all patients, while psychotherapy can be time-consuming and expensive. Furthermore, many individuals may not have access to these treatments due to financial, geographical, or cultural barriers.

A more recent study published in the Journal of Pediatric Gastroenterology and Nutrition in 2020 investigated the effects of a probiotic supplement on gastrointestinal symptoms and quality of life in children with functional abdominal pain. The study found that the probiotic supplement improved gastrointestinal symptoms and quality of life in the children.

Overall, while there is limited research on probiotics in Egypt, the available studies suggest that probiotics may have potential health benefits for various populations. However, further research is needed to better understand the optimal types, doses and duration of probiotic supplementation for specific health outcomes in Egyptian populations.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals aged 18 to 65 years.
* Both sexes.

Exclusion Criteria:

* Pregnancy or lactation
* Recent use of antibiotics or corticosteroids (within the past 3 months)
* Chronic medical conditions that may interfere with study participation or interpretation of results (e.g., hypo or hyperthyroidism , cancer, diabetes, cardiovascular disease)
* Current or past diagnosis of major depressive disorder or anxiety disorder
* Current use of antidepressant or anxiolytic medications
* History of gastrointestinal disorders or diseases (e.g., inflammatory bowel disease, celiac disease , malabsorbtion )
* History of substance abuse or dependence
Treatment of Chidamide and Venetoclax for Retinoic Acid and Arsenic Resistant Acute Promyelocytic Leukemia

Based on the current treatment with retinoic acid (ATRA) and arsenic (As), most patients with APL achieved long-term survival. There are few patients relapsed and became refractory to the RA and As treatment. In our pre-clinical study, we found that targeting histone deacetylase inhibitor 3 (HDAC3)degraded PML-RARa oncoprotein and induced differentiation and apoptosis of RA and As resistant APL in vitro and in vivo. In this study, we evaluate the efficacy and feasibility of combination therapy for HDAC3 inhibitor and venetoclax in patients with refractory APL.

For patients with newly-diagnosed acute promyelocytic leukemia (APL), the combination therapy retinoic acid (ATRA) combined with arsenic (As) is the mainstay upfront treatment. Most patients enjoy long-term survival with or without chemotherapy. Even though with such good prognosis, there are still some patients relapsed and eventually became refractory to RA and As treatment. In our pre-clinical study, we demonstrate that targeting histone deacetylase inhibitor 3 (HDAC3) could degrade PML-RARa oncoprotein and induce differentiation and apoptosis of RA and As resistant APL in vitro and in vivo. In this multi-center prospective study, we evaluate the efficacy and feasibility of combination therapy for HDAC3 inhibitor (chidamide) and venetoclax in patients with refractory APL.

Eligibility Criteria:
Inclusion Criteria:

* Patients with PML-RARα+ APL
* Patients in non-remission status after treatment of RA combined with As
* Patients with life expectance \>=3 months
* Inform consent provided

Exclusion Criteria:

* Patients with incontrollable infection
* Patients with life-expectancy less than 2 months
* Patients with abnormal liver (\>3XN) and renal function (\>3XN）
Spinal Anaesthesia for Knee Arthroscopy: Does Lignocaine Shorten the Effect of Bupivacaine

The purpose of the study is to investigate if a small amount of lignocaine added to bupivacaine for spinal anesthesia to patients planned for arthroscopic knee surgery, can shorten the duration of the sensoric and the motoric blockade.


Eligibility Criteria:
Inclusion Criteria:

* The patient want spinal anaesthesia
* No contradictions against spinal anaesthesia
* Healthy people (ASA-score 1 or 2)
* Body mass index \< 35 and between 155 and 190 cm

Exclusion Criteria:

* Known allergic reactions to planned drugs
* Neurologic disturbances
* Diabetes
The Impact of Preoperative Fasting Period on Cardiac Index Variability After Anesthesia Induction in Pediatric Patients

The minimum period of fasting recommended by the 'American Society of Anesthesiologists' for the preoperative period is 6 hours for solid foods and 2 hours for clear liquids. Knowing the effect of preoperative fasting time on intravascular volume status may lead us to determine the amount of fluid to be administered intraoperatively. Cardiac preload static indicators are often insufficient to predict the need for fluid and are often measured by invasive methods. Knowing the adequacy of the preload is important in anesthesia practice; there is no hemodynamic benefit of fluid replacement in non-responsive patients. In this study, the investigators aimed to determine the effect of preoperative fasting period on cardiac index change after anesthesia induction in pediatric patients aged 5-12 years. The primary implication of this study is to determine the fasting period of fluid evacuation by assessing patients' intravascular volume status.


Eligibility Criteria:
Inclusion Criteria: pediatric patients, aged between 5 to 12, undergoing surgery -

Exclusion Criteria: any comorbidity

-
An RCT in Treatment of Adhesive Capsulitis Arthrographic Joint Distention With Local Anesthetic Alone

Frozen shoulder or adhesive capsulitis is a common cause of shoulder pain, estimated to affect 25% of the general population. Many forms of treatment have been advocated for frozen shoulder including physiotherapy, injection with steroid, distension arthrogram with steroid, manipulation under anesthetic and arthroscopic releases. There is no general agreement in favour of one form of treatment, and the response to a particular treatment varies in different series. A few randomized controlled trials appear in the literature. Most of these showed improvements with steroid use, but the results were not always statistically significant. One randomized control trial reported superior results in favor of arthrographic joint distension with steroid compared to a saline placebo. To our knowledge there have been no other similar randomized trials to support these results. The objective of this study is to determine if arthrographic distension of the shoulder joint with steriods is an effective treatment modality for adhesive capsulitis as compared to injection with local anesthetic and contrast alone. The study design is a placebo-controlled, double blind clinical trial where participants will undergo distension arthrogram of the shoulder and be randomized to receive either Triamcinalone (steroid), lidocaine and contrast or injection with lidocaine and contrast alone.


Eligibility Criteria:
Inclusion Criteria:

* Age range 19-70
* Female and male
* Ability to understand and give consent
* Diagnosis of adhesive capsulitis (frozen shoulder) pain and stiffness for at least 3 months.

Exclusion Criteria:

* • Frozen shoulder secondary to trauma

  * Previous surgery on the affected shoulder
  * Age less than 19 or greater than 70
  * Systemic inflammatory joint disease such as Rheumatoid Arthritis
  * Radiographic evidence of osteoarthritis of the shoulder
  * Allergy to contrast material
  * Pregnant or breastfeeding women
Targeted Extinction of Drug Cues During Sleep - Olfactory Cue Reactivity Task

The study aims to utilise olfactory stimulation in addition to the visual stimulation in cue reactivity tasks to enhance precision in measuring alcohol based cues in individuals diagnosed with heavy drinking. The study consists of one cue reactivity task with visual stimuli, another cue reactivity task with matching odour/visual stimuli and lastly a monetary incentive delay task.

The intention of the study is to enhance the measurement precision in image-based cue reactivity task by introducing a new level of stimuli in the form of odours. During the course of the functional Magnetic Resonance Imaging (fMRI) screening, participants are required to finish three tasks, namely; odour-based cue reactivity task (OCRT), image-based cue reactivity task(ICRT) and monetary incentive delay task (MID).

Participants will be randomly divided into two groups, one group will receive tasks in the following order: OCRT-MID-ICRT and the other group will receive them in the following order: ICRT-MID-OCRT. With this, the habituation effect from receiving odours during OCRT is expected to be balanced.

Eligibility Criteria:
Inclusion Criteria:

* An Heavy Drinking diagnosis, confirmed by Alcohol Use Disorders Identification Test
* Ability to provide fully informed consent and to use self-rating scales in fMRI
* Understanding of the German language

Exclusion Criteria:

* Severe mental or physical illnesses
* Insomnia
* Any metal parts and pieces in the body
* Claustrophobia; fear of confined spaces
High Flow Nasal Cannula and Aerobic Capacity Training

The aim of this study is to compare exercise capacity in Chronic Obstructive Pulmonary Disease (COPD) patients before and after an 8 week pulmonary rehabilitation program.

Patients will be randomised in two groups, one arm will received oxygen through High Flow Nasal Cannula (HFNC) and the other group by The Venturi Mask (VM)

Design: randomized, single blind, controlled trial.

The main goal of this study is to compare the exercise tolerance in COPD patients after an 8 week pulmonary rehabilitation program using High Flow Nasal Cannula or The Venturi Mask. The exercise tolerance will be measured in seconds in a Constant Load Treadmill Test (CTLT).

Eligibility Criteria:
Inclusion Criteria:

1. Long term oxygen therapy (LTOT) or oxygen needs during exercise.
2. Clinically stable defined as four weeks without exacerbation

Exclusion Criteria:

1. Refusal to participate
2. Any neuromuscular, cardiovascular or any other condition that limits test performance.
3. Contraindication for exercise