cyrilzakka/clinical-trials huggingface dataset:
The Effect of Caffeine in Elderly Citizens

The study investigated the effect of caffeine on physical performance in healthy citizens aged over 70 years. The main hypothesis was that 6 mg/kg caffeine would improve cycling endurance at 65% of expected maximal heart rate.

Caffeine ingestion increases the endurance of young people exercising at 60%-85% of their maximal oxygen uptake, and it also seems to improve endurance as measured by repeated sub-maximal isometric contraction and decreases the rate of perceived exertion during exercise. Although caffeine increases endurance in young people, an increase in endurance may be of greater interest in the elderly as the population of older adults with a physically active lifestyle is growing rapidly or for increasing endurance fitness through an exercise or rehabilitation program. Therefore the main hypothesis was that caffeine would improve cycling endurance at 65% of expected maximal heart rate, and the secondary hypotheses were that caffeine would improve postural stability, reaction and movement times, isometric arm flexion endurance, and walking speed, and would reduce the rate of perceived exertion after 5 minutes of cycling in healthy elderly citizens.

Eligibility Criteria:
Inclusion Criteria:

* Healthy elderly individuals aged over 70 years

Exclusion Criteria:

* Dementia or invalidating psychiatric disease
* General debility, angina, or other diseases that would render participation in the test program impossible
* Treatment with beta receptor blocking drugs, calcium-channel blocking drugs, digitalis, or nitroglycerine
* Acute disease and injury
* Diabetes
* Conditions that would contraindicate caffeine ingestion or participation in the test program
* Treatment with medication that interacts with caffeine
* Ingestion of caffeine containing drinks and foods 48 hours before each session
Effect of Repeated Exposures to Compressed Air on Patients With AIDS

The exposure of human beings to markedly altered environments (ambient pressure and inhaled gas mixtures) has profound effects on their innate immune capacity to effectively combat viral illnesses. This Phase IIA clinical trial examines the effects of an exposure to a 4 atmospheric environment has on HIV-infected humans whose clinical condition has progressed to formal AIDS status.


Eligibility Criteria:
Inclusion Criteria:

* CD4 count \<200
* Viral load \> 5000

Exclusion Criteria:

* Opportunistic infection
* Concurrent neoplasm (see protocol)
* Immunomodulators
* HIV vaccination
* Investigational HIV drugs (see protocol)
* Pregnant women
* Major organ transplant
The Zambia Ivermectin Trial for the Treatment and Prevention of COVID-19

The study aims to test whether Ivermectin would decrease mortality and reduces chances of getting infected with corona virus, improve management of clinical symptoms and reduce length of stay in ICU and transition probabilities to ICU (ventilator).

With the onset of global pandemic of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and the sharp rise in infection and mortality rates, efficient management of the current medical emergency has become an absolute priority. A lot of resources have been directed to developing a comprehensive therapeutic approach to preventing and curing this disease, and this has mostly been in western countries. However, lack of definite treatment, high number of infected people, limited capacity and the impact of COVID-19 on existing health infrastructure has left biomedical researchers and clinicians faced with the mammoth task of providing appropriate clinical care solutions and strategies with favorable cost-benefit outcomes, which can help in both curbing the disease and treating patients. To meet this challenge, repurposing of available drugs has become vital. Evidence from several recent clinical trials on the effects of available therapeutic clinical drugs and vitamin supplements on mortality rate and other clinical outcomes associated with COVID-19 are promising, however, the efficacy, safety, and appropriate dosing of therapeutic clinical drugs such as ivermectin, remain largely unevaluated in Sub-Saharan Africa. The investigators propose to evaluate and compare the efficacy of ivermectin in the management of Covid-19.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed positive for SARS-CoV-2 by real-time reverse transcription PCR (rRT-PCR with presence of a fever, cough, and/or sore throat.

Exclusion Criteria:

* Patients will be excluded if they report to be allergic to ivermectin or if there is potential for a drug-drug interaction with ivermectin;
* Have chronic illnesses (e.g., ischemic heart disease, heart failure, documented cardiomyopathy, chronic kidney disease, chronic liver disease);
* Have received ivermectin in the last 7 days; are pregnant or lactating;
* Or have participated in any other clinical trial within the last month.
The Effect of Liraglutide on Bone Turnover, Bone Mass and Bone Cell Function

The purpose of this study is to test whether liraglutide, a drug approved and widely used in the treatment of type 2 diabetes, has an effect on bone mass and bone cell function. Type 2 diabetes may cause multiple complications, and it is well known that patients with type 2 diabetes have a higher risk of fractures. If Liraglutide can be demonstrated to have a positive effect on bone, this may be one among other factors to consider before the decision about specific treatment of type 2 diabetes is made for the individual patient.

Background: Type 2 diabetes may cause complications such as ischemic heart disease, nephropathy, neuropathy, and retinopathy. Several epidemiologic and animal studies also suggest that fracture risk is increased in diabetes.

Bone is remodelled throughout life through bone resorption by the bone resorbing cells, the osteoclasts, and by bone formation by the bone forming cells, the osteoblasts. Bone remodelling can be monitored by biochemical markers of bone turnover and the effect of bone remodelling can be measured by changes in bone mineral density (BMD) by Dual X-ray absorptiometry (DXA) or bone structure by quantitative CT (QCT) or high resolution peripheral QCT (HRpQCT). The remodelling activity and the balance between resorption and formation are influenced by many factors including food consumption. The gut hormone glucagon-like polypeptide 1 (GLP-1) is released in relation to food intake and reduces serum levels of glucagon, increases serum levels of insulin, and reduces blood glucose in diabetes. Liraglutide is a GLP-1 analogue and has been approved for the treatment of type 2 diabetes.

Aim: To investigate the effect of the GLP-1 analogue Liraglutide on bone turnover, bone mass, and bone structure in patients with type 2 diabetes.

Methods: The clinical study will be conducted as a randomised, double-blinded, placebo-controlled, prospective, clinical trial with comparative treatment regimes with either subcutaneous Liraglutide or subcutaneous placebo injections.

Perspectives: The project will bring new knowledge about the possible effects of GLP-1 analogues on bone turnover and structure. This is important given that type 2 diabetes deteriorates bone health and increases risk of fractures. If Liraglutide can be demonstrated to have a positive effect on bone, this may be one among other factors to consider before the decision about specific treatment of type 2 diabetes is made for the individual patient.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Diagnosis of type 2 diabetes (HbA1c \> 48 mmol/mol)
* Age older than 30 years

Exclusion Criteria:

* Type 1 diabetes
* Treatment with insulin
* Body weight \> 140 kg
* HbA1c \> 75 mmol/mol
* Treatment with GLP-1 analogues, Dipeptidyl peptidase-4 inhibitors, or glitazones
* Chronic kidney disease
* Hepatic disease
* Pancreatitis
* Inflammatory bowel disease
* Osteoporosis
* Family or personal history of medullary thyroid carcinoma
* Treatment with glucocorticoids
* Hormone replacement therapy
* Diabetic gastroparesis
* Pregnancy or lactation
Evaluation of Body Composition Improvement With Visceral Adiposity-Focused Anti-Obesity Telehealth Program

A retrospective review of body composition changes in patients who participate in a 9-week non-invasive intensive health care provider supervised weight loss program as an overall cohort and in sub-cohorts of interest.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years of age and older, who enroll in the weight loss program are eligible for inclusion of the data review.

Exclusion Criteria:

* Pregnancy or breastfeeding
* Current treatment of cancer
* Major organ transplant with immunosuppressant medication,
* Adult with a strict vegetarian diet,
* Certain psychiatric conditions (schizophrenia, bipolar disorder, manic depression)
* Adults with a BMI \< 25.0 and no cardiovascular or metabolic comorbidities
the Impact of Ketamine Gargling on the Incidence of Post Intubation Sore Throat

Tracheal intubation often causes trauma to the airway mucosa, leading to postoperative sore throat (POST), which has been reported to occur in 21-65% of cases. While considered a minor complication, POST can contribute to postoperative discomfort and patient dissatisfaction.

Patients have ranked POST as the eighth most adverse effect during the postoperative period. Various methods, both non-pharmacological and pharmacological, have been explored to mitigate POST with varying degrees of success. Non-pharmacological approaches include using smaller-sized endotracheal tubes, lubricating the tube with water-soluble jelly, employing careful airway instrumentation, ensuring intubation after full relaxation, employing gentle oropharyngeal suctioning, minimizing intracuff pressure, and deflating the tracheal tube cuff completely before extubation, all of which have been reported to reduce the incidence of POST.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients from both sex and aged between 18 and 45 years.
* All participants were scheduled for elective laparoscopic appendectomy or cholecystectomy under general anesthesia.
* Classified as ASA (American Society of Anesthesiologists) I or II.
* Intubation duration is less than 90 minutes.

Exclusion Criteria:

* Patients classified as ASA III or higher.
* Patients exhibiting symptoms of sore throat prior to entering the operating room, or presenting with any respiratory illness or signs of respiratory infection.
* Patients who smoke.
* Patients with a history of allergy to drugs used in this study.
* Patients who are addicted to steroid drugs (inhaled or oral).
* Patients with predicted difficult airway and intubation, indicated by a Mallampati score of II or higher.
* Obese patients with a BMI exceeding 35.
* Patients with neurological diseases.
ABCB1/P-glycoprotein Expression Influence on Non-metastatic Osteosarcoma of the Extremities

Post-authorization, observational, multicenter and prospective study in patients between 2 and 30 years old diagnosed with non-metastatic high-grade osteosarcoma of the extremities.

All patients included in the study will receive the initial neoadjuvant treatment prescribed by the doctor of each center, according to standard practice (involving methotrexate, cisplatin, and adriamycin). This initial treatment precedes surgical treatment.

After surgical treatment, the histological response to neoadjuvant chemotherapy will be evaluated. The histological response to primary chemotherapy will be expressed as a percentage of tumor necrosis. In the case of tumor necrosis above 90% the patient is defined as a "good responder" in case of a lower percentage as a "poor responder".

As an adjuvant treatment, the following options may be given according to standard practice in each center:

1. - If there is overexpression of ABCB1 / P-glycoprotein and poor response to induction treatment, in many sites ifosfamide at high doses and MTP-PE, is incorporated in addition to adriamycin.
2. - If there is overexpression of ABCB1 / P-glycoprotein and a good response to induction treatment, in many centers the option of additional administration of methotrexate, CDDP and adriamycin will be chosen.
3. - If there is no overexpression of ABCB1 / P-glycoprotein, the administration of methotrexate, adriamycin and cisplatin will be chosen in many sites.

In some sites they will consider the non-administration of MTP-PE or the non-administration of high doses of ifosfamide. And, in some hospitals, they will consider administering MTP-PE to all patients.

The Primary objective is:

- Disease-free survival measured as a 5-year rate in patients with localized osteosarcoma treated, according to standard practice, with all the drugs currently registered for the treatment of non-metastatic osteosarcoma (methotrexate, cisplatin, adriamycin, ifosfamide, MTP-PE), according to ABCB1 / P-glycoprotein expression.

The Secondary objectives are:

* Evaluate overall survival in a homogeneous population of patients with non-metastatic osteosarcoma.
* Disease-free survival at 2 and 3 years.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed histological diagnosis of high-grade osteosarcoma of the extremities.
2. Age: from 2 to 30 years old.
3. Localized disease (metastasis skip accepted).
4. Normal liver, kidney and spinal function.
5. Ventricular ejection fraction of 50%.
6. Absence of previous surgical treatments or chemotherapy for osteosarcoma.
7. Interval between histological diagnosis and initiation of chemotherapy not exceeding 4 weeks.
8. Signing of the consent form to participate in the study.

Exclusion Criteria:

1. Presence of lung metastases on chest CT or in other locations.
2. Parosteal, periosteal, or secondary osteosarcoma.
3. Contraindications of the medications prescribed in the protocol.
4. Pregnant or lactating.
5. Mental or social conditions that do not guarantee adequate adherence to the protocol.
6. Not having an adequate understanding of study participation.
CIK in Treating Patients With Bladder Cancer

Chemotherapy is the main treatment method for patients with Bladder Cancer. However, Relapse remains the major cause of treatment failure.Biological therapies such as CIK stimulate the immune system and stop tumor cells from growing. A series of studies reported that cytokine-induced killer cells (CIK) have a broad anti-tumor spectrum. The investigators suppose that CIK will improve the prognosis. Combining chemotherapy with biological therapy may kill more tumor cells. In this study, the patients will be treated with CIK cells after chemotherapy. The purpose of this study is to evaluate the efficacy of CIK for Bladder Cancer.

About 1500 patients with staging I-III of Bladder Cancer, after accepting chemotherapy, will be randomly divided into group A (receive CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK cells treatment (every 12 weeks). Patients in group B will have no anti-tumor therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients histologically confirmed carcinoma in of the bladder with urinary cytology;
* Patients with staging I-III of Bladder Cancer;
* Patients who had completed chemotherapy;
* Patients who have a life expectancy of at least 12 weeks;
* Eastern Cooperative Oncology Group (ECOG) performance status was 0-1;
* The bone marrow functioned normally (WBC\>4.0×10\^9/L, Hb\>120 g/L, Platelet(PLT)\>100×10\^9/L);
* The ECG results were normal, and the liver and kidney were functional.

Exclusion Criteria:

* Patients who had upper urinary tract disease (e.g., vesico-ureteral reflux or massive stones) that would make multiple transurethral procedures risk;
* Patients who had urethral strictures that would prevent endoscopic procedures and repeated catheterization;
* Patients who had prior or concurrent upper urinary tract tumors;
* Patients who had distant metastases by imaging studies;
* Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
* Patients who were lactating;
* ECOG perform status ≥ 2;
* Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment;
* Patients who are pregnant or nursing;
* Patients with active tuberculosis (highly positive skin tests allowed if no active disease);
* Patients with disease that would preclude general anesthesia;
* Patients with active intractable or uncontrollable infection.
To Investigate the Safety and Tolerability of TC-5214 Following Oral Administration of Multiple Doses for up to 8 Days

To investigate the safety and tolerability of TC-5214 following oral administration of single and multiple ascending doses compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male and nonpregnant, nonlactating female, with suitable veins for cannulation or repeated venipuncture
* Contraceptive use from the first dose of investigational product until12 weeks after their last dose
* Body mass index (BMI) between 19 and 32 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

* History of any clinically significant medical, neurologic or psychiatric disease or disorder which, in the opinion of the Investigator and Sponsor, may either put the volunteer at risk because of participation in the study, or influence the results of
* History of gastrointestinal surgery (except for cholecystectomy and appendectomy) or unintentional rapid weight loss
* Volunteers with a history of suicide attempts in the past year and/or seen by the Investigator as having a significant history of risk of suicide or homicide, or considered at risk for suicide or homicide during the study
Early Neurovascular Adaptations in Aging Women

Our goal is to enhance our understanding of early vascular adaptations in aging women with an emphasis on the sympathetic nervous system.


Eligibility Criteria:
Inclusion Criteria:

* Assigned female at birth (AFAB)
* 18-55 years of age

Exclusion Criteria:

* Assigned male at birth (AMAB)
* Pregnancy, breastfeeding
* Body mass index ≥30 kg/m2
* Taking medications known to affect metabolic, autonomic, and/or respiratory function
* Oral hormonal contraception in last 6 month
* History of hormone replacement therapy
* History of hyster- or oophor-ectomy
* Current smoking/Nicotine use
* Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy
* Chronic disease
* Blood pressure ≥140/90 mmHg
* Communication barriers
Fracture-Related Outcome Study for Operatively Treated Tibia Shaft Fractures

Approximately 1000 patients presenting with tibial shaft fractures (AO type 42) will be enrolled prospectively in this registry. All patients are treated and followed at 6 weeks, 6 months and 1 year postoperative always following the local standard of care (routine) visit schedule up to 36 months if required.

Data collection includes patient and fracture details, treatment details, functional, clinical and patient-reported outcomes and anticipated or procedure- and implant-related adverse events (i.e. complications) and their corresponding treatment


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older at the time of the injury
* Diagnosis of a primary tibial shaft fracture (fracture type 42 according to the AO/OTA Fracture and Dislocation Classification) that will be treated operatively as part of standard of care

Exclusion Criteria:

* Pathological fracture caused by malignancy
* Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study
Potential Benefits of Black Seed Oil Supplementation on Asthma Inflammation and Outcomes

Traditionally, Black Seed (Nigella sativa) is a well-known food supplement and herbal product that has a wide range of medical claims (including asthma) that originate from different historical backgrounds. Today in the era of Evidence-based medicine, it is hard to accept those traditional medical claims of medicinal plants without valid scientific experiments. Thus, randomized clinical trials is important to rational the uses of herbal products.

Asthma is a common chronic disorder of the airways, characterized by variable reversible and recurring symptoms related to airflow obstruction, bronchial hyper-responsiveness, and underlying inflammation. In Saudi Arabia, Asthma is considered one of the leading chronic diseases affecting more than 2 million Saudi citizens. The global Asthma Report 2014 considered Asthma as an epidemic disease probably affecting about 334 million people worldwide and becoming a global health priority.

This project investigates the use of herbal products to enhance asthma control in Saudi Arabia. In this context, Black Seed is one of the common herbal products used traditionally for asthma in the Saudi region. Black seed is a common unconventional therapy used among 10% of Asthmatic patients in King Abdulaziz Medical city, Riyadh. In fact, there are some pre-clinical evidence and preliminary clinical studies support the usefulness of Black seed in Asthma and its underlying causes


Eligibility Criteria:
Inclusion Criteria:

* Adult male/female (age 18-65 years),
* asthmatic patient with Asthma Control Test (ACT) score \<25
* No severe asthma exacerbation in the last 4 weeks
* Able to obtain consent

Exclusion Criteria:

* Patients with serious co-morbid conditions such as; cancer, renal, hepatic, cardio-vascular, gastrointestinal diseases, mental health conditions and respiratory disorder such as TB and COPD.
* Smoking history
* Pregnant women
* Currently taking any form of Black seed.
* Known history of hypersensitivity to Black seed.
* Taking medications that may interact with black seed supplement: Anticoagulant/Antiplatelet, CNS depressants, and Immunosuppressant drugs
Reduction of Risk for Cardiovascular Diseases

To establish and evaluate a new prediction model for assessing cardiovascular disease risk in community-dwelling adults.

This is an ambispective, observational cohort study. In the retrospective part, we will enroll residents from Guangzhou or Foshan who participated in the annual health checks provided by the Chinese National Basic Public Health Service project between January 2015 and December 2019. The demographic characteristics, anthropometric measurements, laboratory assays, medical history, living habits, and medications will be collected through personal electronic health records obtained from the regional chronic disease management platform. In the prospective part, residents who participated in the annual health checks provided by the Chinese National Basic Public Health Service project after January 2020 will be enrolled. In addition to the data collected in the retrospective part, blood, urine and fecal samples and lifestyle questionnaires will be collected for further analysis. All participants will be followed-up till December 2025. A new prediction model for assessing cardiovascular disease risk will be established and evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Meet at least one of the following conditions: 1. Age ≥ 65 years; 2. Diabetes mellitus; 3. Hypertension;

Exclusion Criteria:

* Refuse to provide informed consent;