cyrilzakka/clinical-trials huggingface dataset:
Alendronate in Juvenile Osteoporosis

The investigators earlier have shown that treatment of patients with juvenile osteoporosis with alendronate (Fosamax) for 12 months increased the bone density without side effects. In an open label study (10 patients) and double blind, crossover study (11 patients alendronate and 11 patients placebo), the investigators have further observed that alendronate increased the bone density significantly where as placebo (calcium and vitamin D) increased only minimally. These trials were completed. Thus, a post study is designed to evaluate the current status of the bone density and fractures after the patients discontinued the alendronate treatment. No treatment is involved.

With the availability of Dual Energy X-ray Absorptiometry (DXA), juvenile osteoporosis has been recognized and diagnosed in recent years. The disease results from either diminished bone formation or increased bone removal (resorption) resulting in low bone density and fractures. No specific drug therapy has been recommended for juvenile osteoporosis. In an open label study, we earlier have shown that alendronate treatment (10 patients) for 12 months increased bone density without side effects. Subsequently, in a double blind, crossover study, we have further confirmed that alendronate treatment (11 patients) increased bone density significantly whereas, placebo (11 patients with calcium and vitamin D), increased the bone density only minimally. There were no side effects. These patients were treated with alendronate only for 12 months and the clinical trials have been completed. We therefore, have designed a post study to evaluate the current status of the bone density and fracture history in the above participants after the discontinuation (1-6 years) of alendronate treatment. Available participants, who have completed the earlier study, will be scheduled for a one time clinic visit. Measurements include DXA bone density measurement of spine and hip, urinalysis and blood work. No treatment is involved.

Eligibility Criteria:
Inclusion Criteria:

* Participated in our earlier clinical study;
* Completed the earlier open label or double blind study;
* Availability to participate in the post study;
* Male and female children who have earlier participated in our clinical trial; AND
* Parental consent (and patient assent after age 12 years) to participate in the study. Participant's consent for those who have completed 18 years of age and above at the time of clinic visit.

Exclusion Criteria:

* Not participated in our earlier clinical study;
* Not completed our earlier trials; OR
* Pregnancy.
Anal Sphincter Prosthesis in Treating Patients Who Are Undergoing Surgery for Anal or Rectal Cancer

RATIONALE: An anal sphincter prosthesis may replace the need for a permanent colostomy and may improve the quality of life of patients who are undergoing surgery for anal or rectal cancer.

PURPOSE: Clinical trial to study the effectiveness of an anal sphincter prosthesis in treating patients who have anal or rectal cancer and are undergoing surgery to remove the anus and rectum.

OBJECTIVES:

* Determine the risk of complications and feasibility of total anorectal reconstruction using the Acticon Neosphincter prosthesis after abdominoperineal resection in patients with anal or rectal cancer.
* Determine continence, bowel function, and quality of life of patients treated with this surgery.

OUTLINE: Patients undergo abdominoperineal resection (APR) with perineal colostomy and diverting loop ileostomy. At least 3 months after APR, patients undergo placement of the Acticon Neosphincter prosthesis. At least 6 weeks after prosthesis placement, the prosthesis is activated. When the patient demonstrates the ability to operate the prosthesis, the ileostomy is reversed.

Quality of life is assessed at 6 and 12 months and then annually thereafter.

Patients are followed at 6 and 12 months and then annually thereafter.

Eligibility Criteria:
Subject Inclusion Criteria:

* Histologically proven cancer of distal rectum or anus
* Not candidates for sphincter preservation
* \> or = 18 years of age
* an acceptable risk for surgery and general anesthesia
* sufficient dexterity and mental capacity to operate the device
* willing and able to give valid Informed Consent

Subject Exclusion Criteria:

* Patients with recurrent anorectal cancer
* Patients with metastatic anorectal cancer
* Patients at high risk for local recurrence
* Patients with active pelvic sepsis
* Patients currently enrolled in another study involving an investigational product
Open Label, Healthy Volunteers, ADME Study With Single Oral Administration of [14C] AZD5069

This is a phase I, open label, healthy volunteers, ADME study with single oral administration of \[14C\] AZD5069.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg.
* Regular daily bowel movements (ie, production of at least 1 stool per day).
* Non-smoker or ex-smoker who has not used tobacco or nicotine products for ≥6 months prior to Visit 1
* Healthy Male volunteers aged 50 and over

Exclusion Criteria:

* Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of \>5 mSv in the last year, \>10 mSv in the last 5 years, or a cumulative total of \>1 mSv per year of life
* Participation in any prior radiolabelled study within last 5 years
* History of alcohol abuse or excessive intake of alcohol as judged by the investigator.
Cortical Neuromodulation in Post Stroke Dysphagia

The investigators aim is to try to rehabilitate post stroke dysphagia using electrical stimulation of the mylohyoid muscles.

Aspiration could have fatal complication especially in post stroke dysphagia. The aim of this study is to improve post stroke dysphagia using electrical stimulation of mylohyoid muscles.

The investigators measure swallowing time before and after electrical stimulation, performed one hour per day, 5 consecutive days during paste consistency swallowing

Eligibility Criteria:
Inclusion Criteria:

* post stroke dysphagia

Exclusion Criteria:

* contraindication to magnetic stimulation, unability to accept the study
RCT to Investigate Whether an Exercise Programme Improves the Physical Performance and QOL After BMT

The hypothesis is that exercise will improve the physical performance and quality of life of bone marrow/ haemopoietic stem cell transplants.The aim of the trial is to provide definite clinical evidence as to which( if any) type of exercise is most beneficial for this patient population. It is also aimed at improving the provision of physiotherapy services to this group of patients.

A three group, single blinded, randomised trial was designed to compare the effects of

1. aerobic plus active exercise and
2. aerobic plus resistance exercise to
3. control group of bone marrow/haemopoietic recipients not recieving exercise.

The hypotheses being tested is that

1. Exercise improves the physical performance of transplants recipients.
2. Exercise improves the quality of life of these patients;
3. resisted exercise added to aerobic exercise increases muscle strength or lean muscle mass and
4. There are no adverse events during either form of exercise

Eligibility Criteria:
Inclusion Criteria:

Recipient bone marrow transplant Alfred Hospital, Platelets \>= 20 x 10E9 / l Provide written consent, 30 days after a bone marrow transplant have an absolute neutrophil count of 1x10E9/l be in a stable medical condition

Exclusion Criteria:

febrile neutropenia Have active graft versus host disease Have cardiomyopathy (ejection fraction \< 20%) require \> 28% oxygen
Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients.

Mirror Therapy (TM) has been shown to be effective in motor rehabilitation of the hemiplegic upper limb, but its implementation in current clinical practice has several difficulties, both from the patient and physiotherapist point of view.

A new computerized Mirror Therapy (TM) device (Intensive Visual Simulation 3 (IVS3), Dessintey) which aims to solve the TM compliance problems and make it more efficient have been developed.

The aim of this study is to compare the observance and efficiency of the Intensive Visual Simulation 3 (IVS3) therapy as compared to traditional Mirror Therapy (TM) in a population of hemiplegic stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* First ischemic or hemorrhagic stroke for less than one year
* Not having reoffend
* Responsible for an initially complete hemiplegia,
* Upper-limb deficiency with the modified Frenchay Score below 70,
* Not neurological history other than stroke,
* Having signed the written consent
* Affiliated or entitled to a social security scheme

Exclusion Criteria:

* Patient who have not Magnetic Resonance Images (MRI) of the brain during stroke
* Having complete lesion of the primary motor cortex
* With an addiction to alcohol or drugs
* With psychiatric illness, cognitive impairment, uncontrolled disease / epilepsy, malignancy, severe renal or pulmonary impairment
* History of associated disabling general disease
* With associated cerebellar syndrome
* With clinical involvement of the brainstem
* Pregnancy in progress
* Patients under the protection of justice.
Nutritional Intervention in Malnourished Elderly Patients

The purpose of this study is to investigate whether nutritional supplementation will improve functional outcome parameters and nutritional status in elderly patients.

Malnutrition is still a problem in elderly patients and this may be associated with reduced muscle strength and ADL function (activities of daily living). Malnourished Medical Inpatients/Outpatients and District Nurse patients with a Body Mass Index \< 20 kg/m2 are asked to participate.

Comparison(s): The patients are randomized to either ordinary dietary advice with a recommendation of four meals per day or similar dietary advice and two daily sip feeding supplements. The study supplementation is Fresubin Protein Energy Drink and this will give additional 600 kcal and 40 gram protein a day. The study period is 12 weeks with a visit at inclusion, week 6 and week 12.

Primary and secondary outcome parameters are measured at inclusion and week 12

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index \< 20 kg/m2
* Medical In/Outpatient or District Nurse-patient
* Able to take nutritional supplement (sip feeding)
* Able to walk
* Written patient informed consent

Exclusion Criteria:

* Actual malignancy
* Dementia with a Mini Mental Status score \< 24
* Severe depression
* Need for Total Parenteral Nutrition or Tube Feeding
* Prescribed nutritional supplements during more than the last week
* Life expectancy of less than 6 months
Colonoscopy Check-up in People With Lynch Syndrome

Lynch Syndrome, an inherited condition, increases bowel cancer risk. People with Lynch Syndrome are recommended to have regular colonoscopies where a camera in a tube is used to look inside the bowel for cancer and for polyps (growths that sometimes can become cancerous). UK guidelines recommend that people with Lynch Syndrome have colonoscopy check-up every 2 years after reaching a certain age; however, they face many challenges which make it difficult to have the recommended check-up.

Among a subset of people with Lynch Syndrome in England, this study will investigate the:

* percentage who are having colonoscopy check-up as recommended by UK guidelines
* factors influencing whether a person is more/less likely to have the recommended colonoscopy check-up
* views, experiences, and challenges of living with Lynch Syndrome and colonoscopy check-up

This study will collect information from people in the 'Lynch Syndrome registry pilot' using a questionnaire. The Cancer Screening and Prevention Research Group (CSPRG) at Imperial College London are conducting the Lynch Syndrome registry pilot, which is recruiting people with Lynch Syndrome who are aged \>18 years and in the Cancer Prevention Programme 3 (CaPP3) trial, from Nov 2022-Nov 2023.

This study will include people in the Lynch Syndrome registry pilot who provided consent on the registry pilot consent form to be contacted about future research and are aged ≥25 years. People who have had previous surgery to remove their rectum will be excluded.

The investigators will use the 'Views, experiences, and challenges of colonoscopy check-up' questionnaire, together with a few pieces of additional information previously collected as part of the Lynch Syndrome registry pilot.

Participation involves completing the questionnaire only. The study will take approximately one year from administering the questionnaire to sharing results with participants.


Eligibility Criteria:
Inclusion Criteria:

* People in the Lynch Syndrome registry pilot who have provided consent to be contacted about future research and are aged ≥25 years

Exclusion Criteria:

* People who have had surgery involving removal of their rectum
Bioequivalence Study of an Amoxicillin-Clavulanic

The objective of this study was to confirm if two formulations of amoxicillin and clavulanic acid (suspension) are bioequivalent.

Test product was AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic acid/ 5 ml; Glaxo Wellcome France) and reference product AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic acid/ 5 ml; GlaxoSmithKline Mexico). The single dosage was 10 ml of suspension.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 35 healthy volunteers, both genders, adults between 18-50 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility Criteria:
Inclusion Criteria:

Both genders. Ages between 18 and 45 years old. BMI (Body Mass Index) between 20 to 26 kg/m2. Anti-doping tests negative results. Females with negative pregnancy tests Clinical biochemical test values: Hematic Biometry, Urine Analysis, Biochemical Profile: (Glucose, Ureic Nitrogen, Urea, Creatinine, Uric Acid, Cholesterol, Triglycerides, Total Proteins, Albumin, Globulin, Bilirubin (total, indirect and direct), Alkaline Phosphatase, Lactic Dehydrogenase, AST, ALT, Calcium, Phosphorus, Sodium, Potassium, Chlorine and Iron), Ac VIH, AgsHB and RPR (luetic test), must fall within an interval between minimum and maximum values in connection to said tests accepted values.

Normal Electrocardiogram and Chest X-rays. In exception cases, accepted may be a candidate for which any previously mentioned test is exceeded regarding considered valid maximum and minimum accepted normal values, as long as it involves an isolated value and there are no other manifestations which could allow assuming that a given value is related to a disease or is remnant of another. These cases must be approved by clinical area and declared as "Non-clinically significant".

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Exclusion Criteria:

Biochemistry, Electrocardiographic Radiological Anomalies; Anti-doping tests positive results, Positive results regarding RPR; VIH and AgsHB tests. Personal or family history of allergy to medication in question. Having any kind of allergy, since these persons are in higher risk of suffering from medicamentous allergy.

Tobacco use. Recreational drug use. Persons undergoing any medical treatment. Existence of concurrent or intercurrent disease. Existence of justified doubt regarding questionnaire answers truthfulness. Having participated in bioequivalence or bioavailability studies or having donated blood 2 months before the study.

Presence of clinically important gastrointestinal diseases or malabsorption history during the last year.

Presence of a medical condition requiring regular medication (with prescription or over-the- counter medication) with systemic absorption.

Narcotics or alcohol addiction history requiring treatment. Finally, excluded will be all those volunteers not meeting that established in Mexican Official Standard NOM-177-SSA1-1998.

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Individualized Analgesia After Adenotonsillectomy

A high incidence of respiratory morbidity after adenotonsillectomy is reported in children with obstructive sleep apnea syndrome (OSAS). So we designed a prospective, double-blind, randomized controlled study to determine the effects of individualized opioid analgesia compared with conventional opioid analgesia on respiratory morbidity after adenotonsillectomy in Children with OSAS.

All children were randomized 2 groups based on a computer-generated random number. The main interventions were occurred in post anesthetic care unit (PACU). In the operating room, all patients received a standardized anesthetic regimen by one anesthetist. Sevoflurane was used for maintenance without any opioids. Before the end of the procedure, spontaneous respiratory was recovered. All the patients were given 1 mcg/kg fentanyl intravenous injection after the end of the procedure. The positive result was defined as spontaneous respiratory rate decreased more than 50%, the others were defined as negative result. The result of fentanyl test submitted to assistant, and prepared the rescue analgesic drugs according to this result. One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine. Another group: all received 25μg/kg morphine .The trachea was extubated when patients were awake, and then transported to the PACU. Patients with a Children's Hospital of Eastern Ontario Pain Scale score\>6 received rescue analgesic drugs and observe respiratory morbidity in each group.

Eligibility Criteria:
Inclusion Criteria:

* children with obstructive sleep apnea syndrome undergoing elective T\&A, ASA physical status I-II

Exclusion Criteria:

* developmental delay cardiac and craniofacial abnormalities ASA classification III or more body mass index more than the 95th percentile for age
Development and Validation of an Automated Self-administered Visual Acuity System

Visual acuity tests, commonly conducted in clinics and used for health screenings, are becoming more in demand due to an aging population. Current online self-eye check apps are limited as they don\&#39;t accurately reflect true distance vision assessed in clinical settings. These tests, performed by trained personnel, are time-consuming and can cause delays in clinics. This project aims to develop an automated Visual Acuity (VA) station using AI technologies like speech-to-text and computer vision, hypothesizing that it can match the accuracy of manual assessments by clinic staff, thus potentially reducing waiting times and improving efficiency.

Visual acuity is done as a routine eye check for the majority of eye patients in the clinic. It is also done as a screening test for pre-employment health checks and health screening. Patients can be checked for refractive errors, on a community level or screened for eye diseases, for those with chronic medical conditions. With the increasing burden of aging population and eye conditions, the number of patients in eye clinics will increase.

There are a few existing online applications that allow self-eye checks, however there are limitations. They are usually done at an intermediate distance, i.e. distance from phone to eye and does not accurately represent true distance vision. Distance vision is typically set at 4- 6m in a clinical setting.

A visual acuity test is administered by specially trained healthcare personnel, such as optometrists and patient service assistants, which is often time-consuming and labour intensive, where one-on-one attention is required. In addition, vision is subjective and re-testing may be required at times to ensure accurate vision assessment.

As the visual acuity test is the first clinical station patient goes to after registration, this leads to a bottleneck in workflow causes delays in the subsequent services and eventually increases patient waiting times in the clinics.

This project aims to develop and validate an automated Visual Acuity (VA) station through speech-to-text and computer vision technology in comparison to existing manual VA assessments.

We hypothesize that we are able to use artificial intelligence to understand patient\&#39;s speech and posture to automate the visual acuity test. We also hypothesize that the automated visual acuity test is comparable to having VA checked manually by a clinic staff.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age \&gt;21 and able to give consent
2. Patients who have at least counting finger vision
3. Patients who is able to speak in an audible and clear voice
4. Patients who is able to use a digital device independently (e.g. handphone)

Exclusion Criteria:

1. Patients on wheelchair/ walking aids
2. Patients with hearing difficulties
3. Patients with speech difficulties
4. Patients who have cognitive impairment
5. Patients who are hemiplegic/ motor dysfunction
6. Patients who have vision worse than counting fingers
7. Patients who are pregnant
Mechanism of Ketogenic Diet-Induced Hypercholesterolemia

Very-low carbohydrate ketogenic diets can dramatically increase blood cholesterol levels, particularly in normal-weight people, for reasons that are not well understood. This study will enroll normal-weight adults, will identify "responders" who develop high cholesterol on a ketogenic diet, and will measure rates of production and removal of certain types of cholesterol-carrying particles called lipoproteins in responders. The results will clarify the mechanism by which a ketogenic diet can cause high cholesterol in certain susceptible people.

This study will evaluate the mechanism of ketogenic diet-induced hypercholesterolemia in susceptible normal-weight adults. The first stage of screening will identify eligible young adults who are normal-weight and at low cardiovascular risk. The second stage of screening will identify "responders" who demonstrate susceptibility to ketogenic diet-induced hypercholesterolemia by displaying an increase in LDL-cholesterol concentration after a 3-week screening ketogenic diet. Responders will be eligible to complete a randomized crossover clinical study at Washington University School of Medicine in St. Louis, MO. The randomized crossover study will involve isotope tracer studies of lipoprotein and cholesterol kinetics after two separate 4-week dietary interventions \[ketogenic diet and control diet\], conducted in random order with a 4-week washout period between interventions. All food will be provided to the participants as packed-out meals. Certain outcomes will use data from the screening process, comparing screen successes and screen failures to evaluate factors that could influence susceptibility to ketogenic diet-induced hypercholesterolemia.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 and \< 40 years
2. BMI ≥ 18.5 and \< 25.0 kg/m2
3. baseline serum LDL-c \< 150 mg/dL (\< 3.9 mmol/L)
4. baseline serum TG \< 100 mg/dL (\< 1.1 mmol/L)
5. HbA1c ≤ 5.6%.

Exclusion Criteria:

1. personal or family history of familial hypercholesterolemia
2. current use of lipid-lowering drugs
3. currently on a ketogenic diet and unwilling to change diet
4. current tobacco use
5. hypertension
6. prediabetes or diabetes
7. elevated Lp(a) \> 6.5% of ApoB-containing lipoproteins at baseline
8. oral contraceptive use
9. contraindication to heparin
10. known atherosclerotic cardiovascular disease
11. unwilling to abstain from alcohol