cyrilzakka/clinical-trials huggingface dataset:
Effects of Herbal Products on Metabolism and Hunger

to test safety and efficacy on metabolism, heart rate, blood pressure, TSH (and other blood)and hunger/caloric compensation on ephedra versus placebo


Eligibility Criteria:
Inclusion Criteria:

age 18-50, non-smoking, not pregnant (serum), Beck \<15, physician permission

Exclusion Criteria:

pregnant, lactating, smoker, use of appetite-affecting medications
A Short-Term Study to Examine the Effects of ATHX-105 Phosphate on Weight Loss and Safety

This primary purpose of this study is to determine if ATHX-105 phosphate causes weight loss over a 12-week period.

The rate of obesity in adults continues to increase. Obesity affects overall health and is associated with an increased risk for diabetes, high blood pressure, coronary artery disease, osteoarthritis, and sleep apnea. To date, the medication options to treat obesity have been limited.

This study will examine if a new investigational drug, ATHX-105 phosphate, may cause weight loss in humans over a 12-week period.

Eligibility Criteria:
Inclusion Criteria:

* Obese adults with a body mass index of 30-45 kg/m2

Exclusion Criteria:

* Pregnancy
* Diabetes
* Adults with serious or unstable current or past medical conditions
Platelet Count Trends in Pre-eclamptic Parturients

Thrombocytopenia (platelet count \< 100,000/mL) occurs in approximately 15% of women with preeclampsia. Neuraxial analgesia is contraindicated in parturients with a coagulopathy; therefore, the platelet count(PC) is routinely checked prior to the initiation of neuraxial analgesia in women with preeclampsia/eclampsia. Catheter removal is also contraindicated in the presence of a coagulopathy. Some women have an acceptable PC at the initiation of neuraxial analgesia, but may become significantly more thrombocytopenic during labor and delivery. In a study of severely preeclamptic parturients, some with HELLP (H=hemolysis of red blood cells, EL=elevated liver enzymes, LP=low platelet count) syndrome, the admission PC correlated with the PC nadir. However, the natural progression of the PC has not been studied in women with mild preeclampsia. We hypothesize that women with mild preeclampsia or severe preeclampsia without HELLP syndrome, and whose admission PC is greater than 150,000/mL, will have a stable PC during the course of labor and delivery and do not require another PC check prior to initiation of neuraxial analgesia or removal of the epidural catheter. The purpose of this study is to determine the positive predictive value of an initial PC greater than 150,000/mL for maintaining a PC greater than 80,000/mL during labor and delivery.

All women who delivered from 1/2000 through 12/2002, with the discharge diagnosis of mild preeclampsia, severe preeclampsia (including HELLP and eclampsia), and preeclampsia superimposed on chronic hypertension were identified through the Perinatal Database. Platelet counts (PC) for each patient, from one month prior to the delivery admission, until hospital discharge, were analyzed. The number of PC determinations per parturient was determined. For each diagnosis, the positive predictive value (PPV) of an initial PC \> 150,000/mL for maintaining subsequent PC \> 80,000/mL, as well as the PPV of the PC prior to initiation of neuraxial analgesia was calculated. The median time interval from the closest PC determination to initiation of neuraxial analgesia was calculated.

Eligibility Criteria:
Inclusion Criteria:

* All participants who delivered between January 1, 2000 and December 31, 2002, identified as having preeclampsia (without HELLP syndrome) in the Perinatal Database.

Exclusion Criteria:

* Participants not diagnosed with preeclampsia and/or outside the given criteria dates.
Feasibility and Acceptability Trial of a Video Based CBT Guided Self Help Intervention for People With Low Literacy

This study aimed to assess the feasibility, acceptability, and preliminary efficacy of a video-based CBT guided self-help intervention 'Khushi or Khatoon' to treat anxiety and depression.

Cognitive Behaviour Therapy (CBT) is now included in the National Treatment Guidelines in the UK. However, little progress has been made in its delivery in developing countries. Limited resources for the delivery of services and their concentration in big cities have implications for the choice of mode of delivery of treatment. A range of methods are needed to deliver treatment starting from self-help to more specialist interventions. Various CBT based self-help materials have been assessed and shown to be effective in the West . The effectiveness of a Culturally adapted CBT (CaCBT) based guided self-help has been reported, supervised by carers, against care as usual in patients with depression, who attend secondary care in Pakistan .

However, CBT requires a person to be literate, especially for guided self-help or self-help. Pakistan has a literacy rate (ability to read or write) of 58%. An estimated 67% of children study up to primary level (years 1-5) and an estimated 43% have achieved secondary education (up to year 12). These are mostly people from low socio-economic backgrounds who are less likely to suffer from mental health problems such as depression and anxiety. In order to overcome this barrier a video intervention based on self-help intervention is developed. This study aims at testing the feasibility, acceptability and preliminary effectiveness of this intervention.

This will be a rater-blind RCT to evaluate the feasibility and acceptability of video-based guided self-help in addition to treatment as usual (TAU) compared with the waitlist and TAU in Pakistan. This study will employ a pre-post measure and parallel design. It will be conducted from March 2023 to August 2023. Participants who met the inclusion criteria will be randomly allocated to one of the groups, i.e. CBT video plus TAU (intervention group) or waitlist plus TAU (control group) in a 1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged 18 to 65 years
2. without schooling
3. able to use a smartphone
4. Owning a smartphone or a personal computer with a reliable internet connection
5. Score of 8 or higher on Hospital Anxiety and Depression Scale-Depression or Anxiety Scales

Exclusion Criteria:

1. Substance use disorder according to DSM-5 criteria as determined by primary care clinician
2. Significant cognitive impairment (for example, profound learning disability or dementia) as determined by primary care clinician
3. Active psychosis as determined by their primary care clinician
Digital Monitoring for Patients Post Coronary Interventions to Reduce Risk for Recurrent Adverse Cardiovascular Events

The study aims to support patients immediately after percutaneous coronary intervention (PCI) by implementing a telemonitoring program. Eligible patients have coronary heart disease and undergo PCI. The intervention group receives remote monitoring and text-based follow-up, with established health goals and education on using the telemonitoring application, along with necessary devices. The control group gets standard care. Outcomes measured include blood pressure, LDL levels, patient satisfaction, revascularization, and mortality. The study findings will enhance patient care after PCI and contribute evidence for widespread telemonitoring implementation in healthcare systems, aiding medical therapy and lifestyle modifications.

The study involves 200 participants divided into intervention and control groups, all diagnosed with coronary heart disease and treated with PCI. Upon discharge, the intervention group receives remote monitoring, text messages, and devices for self-management. Control group receives standard care. Recruitment is from cardiology and primary care clinics, with interpreters available. Study coordinator guides device setup during enrollment. Intervention group receives daily messages for a week, then weekly reminders and counseling. Messages are in English or Spanish as per preference. Patient data is collected, including demographics, medications, and outcomes such as blood pressure and readmission rates. Satisfaction is evaluated through surveys and interviews.

Eligibility Criteria:
Inclusion Criteria:

* Includes patients with coronary heart disease diagnosis and treatment with PCI who follow up at University of California Davis Health.
Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries

The purpose of the study is to determine whether the introduction of early ultrasonography screening will change the diagnostic spectrum of soft tissue shoulder injuries in patients aged forty years or more. We also want to study whether certain physical tests will be able to predict or rule out full-thickness tears of the rotator cuff (shoulder tendons) in the acute phase. Another purpose is to explore the course of soft tissue shoulder injuries over a year, as well as to compare the results to studies on the prevalence of rotator cuff full-thickness tears.


Eligibility Criteria:
Inclusion Criteria, all of the following:

* patient at Section for Orthopaedic Emergency, Oslo University Hospital
* living in the municipality of Oslo
* acute injury
* sudden onset of symptoms
* International Classification of Diseases (ICD) -10 S4-diagnosis (except injuries of middle and distal third of humerus and related soft tissue)
* no sign of acute injury on radiographs in two views, or successfully reduced dislocation without fracture
* turns up for follow-up appointment within 21 days of injury

Exclusion Criteria:

* patients that are incapable of giving and or receiving adequate information, or that cannot undergo a normal clinical investigation, due to for example language problems, level of consciousness, drugs, mental or emotional status or other
* patients that have undergone shoulder surgery during the last 6 months
* injury of both shoulders
* patients with neck-/shoulder problems or generalised muscle pain during the last three months before the injury
* other serious disease such as cancer, rheumatic disorders, haematological, neurological, endocrinological or gastrointestinal disease that according to the doctor's best clinical judgement makes participation or follow-up difficult
* does not want to participate
Proton Pump Inhibitors in Cirrhotic Patients

Proton pump inhibitors (PPIs) inappropriate use, in patients with cirrhosis, presents a significant clinical challenge. This study evaluates overprescription and misuse of PPIs in cirrhotic patients. The patterns of use of PPIs will be classified into two groups based on adherence to the proven indications: Group A: Inappropriate use of PPI, Group B: Appropriate use of PPI. We will estimate the prevalence of PPI misuse in cirrhotics and correlate it with different factors.

The inappropriate use of PPIs in cirrhosis patients is a growing concern. Evidence supporting the use of PPIs in cirrhosis-related conditions is limited. Several adverse outcomes have been linked to PPI use in cirrhosis, including an increased risk of spontaneous bacterial peritonitis and hepatic encephalopathy.

The study aimed to assess the appropriateness of prescribing PPIs to patients with cirrhosis, examining its impact on prescribing practices and identifying associated factors.

in this observational, descriptive, cross-sectional study, cirrhotic patients receiving proton pump inhibitors will be included in the study. Enrolled patients will classified according to the indication for PPI administration: Group A: Inappropriate use of PPI, Group B: Appropriate use of PPI. Use of PPI will be considered inappropriate when prescribed without approved indication or used for a prolonged period beyond the recommended duration. The prevalence of PPI misuse in cirrhotics will be estimated and multivariate analyses will be conducted in order to identify independent predictors of inappropriate use of PPI.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving proton pump inhibitors at the time of enrollment.

Exclusion Criteria:

* Refusal to sign the informed consent form or failure to provide the required information
Comparative Effects of Group Based Exercises with and Without Cognitive Functional Therapy on Clinical Outcomes in Patients with Chronic Low Back Pain

1.1Research objective The objective of the study is to find the comparative effects of group based exercises with and without cognitive functional therapy on clinical outcomes in patients with chronic low back? 1.2 Hypothesis Null Hypothesis H0= There is no significant difference of clinical outcomes between the cognitive functional therapy with group exercises and group based exercises only in patients with chronic low back pain.

Alternative Hypothesis H1= There is a significant difference of clinical outcomes between the cognitive functional therapy with group exercises and group based exercises only in patients with chronic low back pain.

Background: Low back pain is the problem gradually increasing in both young and older adults. It can be specific and non-specific, the specific low back pain is the pain which arises due to any structural or functional disease like due to any mechanical factors, poor posture, improper way of lifting and bending while non-specific low back pain is the pain which have no any known causes. Cognitive functional therapy and group based exercises both have beneficial effects to reduce LBP. Aims and objectives: The aim of the study will be to find the comparative effects of group based exercises with and without cognitive functional therapy on clinical outcome in patients with chronic low back pain. Methodology: This study will be Randomized controlled trial. The subjects will be selected through Probability Purposive Sampling.Sample will be 40 calculated by the rao-soft with 20 percent chances of drop out. The participants will be taken from Mujahid hospital, Faisal Hospital and Madina teaching hospital. Participants will be assessed by using Oswestry Disability index and Numerical Pain Rating Scale NPRS for low back pain. Participants will be randomly allocated into two groups.One group will be treated with CFT and group based exercises and one with only group exercises. And at the end, data will be analyzed by using Statistical Package for the Social Sciences (SPSS).

Eligibility Criteria:
Inclusion Criteria:

* Pain level equal or more than 3 on NPRS A score of fourteen percent 14% or more on the Oswestry Disability Index (ODI) Low back pain for at least 6months duration

Exclusion Criteria:

* Red flags (neoplastic diseases or cancer in the spine, inflammatory diseases, infections, and fractures) Neurological symptoms and psychiatric, rheumatologic, and cardiac diseases Radiculopathy with symptoms Lumbar stenosis Spondylolisthesis History of spinal surgeries Pregnancy
Feasibility Study of a Novel Subcutaneous Continuous Glucose Monitoring System in Diabetics

Mono-centre, open label (unblinded). 8 patients + 2 potential replacements. Duration up to 9 weeks: up to 6 weeks screening (42 days), 2 weeks of treatment (14 days, depending on sensor functionality) and 1 week of follow up (7 days)

This study is an investigational study, which will be conducted only at one site in Germany. The investigators, the patient and the sponsor will be unblinded.

As soon as the eligibility of the patient is confirmed the patient is enrolled. The screening results are valid up to 42 days. Within that time the first measurement visit including the insertion of the device should be performed. If the first measurement visit is delayed a re-screening has to be performed. Should the patient not pass the re-screening, the patient is considered as a screening failure and must be excluded.

The trial is structured into three phases, the screening/enrolment phase, the insertion/measurement phase and the follow-up phase.

Screening/Enrolment Phase: 6 weeks (42 days), 1 visit

Insertion/Measurement phase: Up to 2 weeks (14days), up to 6 measurement visits

Follow-up Phase: 1 week (7 days), 1 visit

Eligibility Criteria:
Inclusion Criteria:

* Body mass index within the range of 19-40 kg/m2, inclusive
* Diabetes type 1 and 2
* Females (if of childbearing potential) must agree to abstain from sexual intercourse or use reliable forms of contraception e.g. condom or diaphragm with spermicide or oral contraceptives to prevent pregnancy during the study
* Signed written Informed Consent

Exclusion Criteria:

* Inability to follow the protocol schedule
* Participating in another clinical trial, if it is not a "non-investigational clinical study (NICS)
* Pregnant or lactating females,
* Any known hypersensitivity to any of the products used in the study, including preservatives etc.
* Malignancies requiring therapy during the study
* Severe chronic diseases e.g. renal failure, liver cirrhosis etc. which may interfere with the conduct or completion of the study
* Acute severe infection disease at the time of enrolment
* Alcohol and/or drug abuses
* Vulnerable patients (e.g. persons kept in detention)
* Poorly controlled diabetes mellitus with hemoglobin A1C higher than 10%
Effect of Muscle Damage After Downhill Running on Postprandial Lipids

All participants underwent three experimental trials, namely downhill running (DR), level running (LR), and the control (CON) in a cross-over design. Each trial lasted for 2 days. The participants were fed the same breakfast and lunch on day 1 in each trial. The participants arrived at the laboratory at 18:00 on day 1 and ran on the treadmill at 60% VO2max (downhill and level surface trials) or rested (CON trial) for 30 min. Subsequently, they were fed a standardized dinner (A meal box containing chicken, vegetables, and rice, 692 kcal, with 50% energy from carbohydrate, 32% from fat, and 18% from protein) within 20 min.

The participants returned to the laboratory at 07:30 on day 2 after an overnight fast. After baseline blood and gas samples were collected, the participants were fed a high-fat meal that included cereal, white bread, whipping cream, cheese, and butter. The high-fat meal provided fat 1.2 g/kg (65% energy), carbohydrate 1.1 g/kg (27% energy), protein 0.33 g/kg (8% energy), and 16.5 kcal/kg.

A 10-mL blood sample was collected from a forearm vein into nonheparinized tubes before and immediately after exercise or rest on day 1. On day 2, postprandial blood samples were collected from forearm veins into nonheparinized tubes by using an indwelling venous needle and a three-way stopcock. A 10-mL blood sample was collected before (0 h) and 0.5, 1, 2, 3, 4, 5, and 6 h after the high-fat meal.


Eligibility Criteria:
Inclusion Criteria:

* generally healthy, had not engaged in regular exercise or received any medication in the past 6 months

Exclusion Criteria:

* history of cardiovascular disease, hypertension, hyperlipidemia, diabetes, atherosclerosis, or osteoporosis, free of any musculoskeletal injury during the study
Study to Evaluate Safety and Effects of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs in People Treated for Rheumatoid Arthritis

This is a secondary structured database observational study conducted in Rheumatoid Arthritis (RA) patients treated with biologic and nonbiologic DMARDs, including tofacitinib, collected as part of the CorEvitas Japan RA Registry.

The data as of September 2022 will be used for this study. The study will include data from March 2016 to the latest data cut available in 2022 for both effectiveness and safety outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Rheumatoid Arthritis (RA) according to the 1987 American College of Rheumatology (ACR) or the ACR/European Lead Against Rheumatism (EULAR) 2010 RA Classification Criteria;
* At least 18 years of age or older;
* Was / Must be prescribed or switching to the following eligible medication for the first time ever at the enrollment visit:
* csDMARD: methotrexate (closed in February 2018);
* Anti-TNF bDMARD: adalimumab (originator or biosimilar), certolizumab pegol, etanercept (originator or biosimilar), golimumab, infliximab (originator or biosimilar), or any other anti-TNF biosimilar approved during the study;
* Non-TNF bDMARD: abatacept, tocilizumab, sarilumab (closed in June 2020);
* JAK inhibitor: tofacitinib, baricitinib, peficitinib, filgotinib, upadacitinib.

Exclusion Criteria:

* Data that are prior to March 2016 and after June 2022
Characterization of Tissular T Follicular Helper Cells in IgG4-RD

IgG4-related disease (IgG4-RD) is a recently identified rare disease characterized by inflammatory lesions with polyclonal lymphoplasmocytic infiltrate, with IgG4+ plasma cells predominance, and fibrosis in involved tissues. Despite a preferential involvement of exocrine organs, virtually all tissues can be affected by the disease. Corticosteroids are usually effective in this indication, but with poor tolerance and a high risk of relapse after decrease or withdrawal of this treatment. In this context, identification of new therapeutic targets is a major concern for these patients. Physiopathology of IgG4-RD remains actually unknown. In previous studies, it has been shown that T follicular Helper (Tfh) cells are expanded in the blood of these patients. Tfh cells have an important role in the formation of germinal centers (GCs), and ectopic GCs have been found in tissues of patients with IgG4-RD. Tfh cells have a major role in proliferation and differentiation of B cell compartment. In this context, this population could have an important contribution in the pathophysiology of IgG4-RD and could represent a therapeutic target in this disease.

TIFOLH4 study intend to analyze tissue Tfh cells in patients with IgG4-RD at diagnosis. This study is an exploratory prospective multicentric study. Thirty patients with a suspected diagnosis of IgG4-RD, because of 1 or more suggestive organ involved, will be included in the study. A 50 mL blood sample and a biopsy, obtained in the same time of the diagnostic biopsy sample, will be obtained in this study. The results obtained in patients with a confirmed diagnosis of IgG4-RD (" IgG4-RD group ") will be compared to results of patients with another diagnosis (" control group "). Main objective of the study is to show by confocal microscopy an expansion of the number of Tfh cells (CD3+CD4+PD1+ cells) in tissue of IgG4-RD patients compared to controls. Secondary objectives include : tissue analysis of Tfh subsets (Tfh1, Tfh2 and Tfh17) ; tissue analysis of B regulatory cells, T regulatory cells, and T helper cells (Th1, Th2, Th17); correlation between tissue and circulating biomarkers; tissue proteomic analysis; and functional analysis of circulating Tfh cells after sorting of these cells and co-culture tests with autologous naive B cells. All these results will be compared between the " IgG4-RD group " and the " control group ". This study should clarify the role of these Tfh populations in IgG4-RD, identify diagnostic tissue and blood biomarkers, and identify therapeutic targets in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of disease associated with IgG4
* Patient signed a consent
* Patient affiliated to the social security scheme

Exclusion Criteria:

* Patients with a corticosteroid therapy current or less than 3 months.
* Patients with an immunosuppressive treatment or being less than 3 months
* Patients with a biotherapy treatment by ongoing or less 6 months