cyrilzakka/clinical-trials huggingface dataset:
The Impact of Hyaluronic Acid Injections on Osteoarthritic Knee Mechanics

The purpose of this study is to determine the impact of a regular course of treatment with Hyaluronic acid (HA) injections on gait in knee osteoarthritis (OA) patients. Three consecutive HA injections will be compared to three consecutive placebo injections to determine whether HA's analgesic effect is greater than that of a placebo injection, and to observe whether HA's viscoelastic properties are manifested in a human knee OA population. We hypothesize that HA injections will relieve pain to a greater extent than placebo injections in knee OA patients, and will afford them with improved walking characteristics, such as increased walking speed, and step length.

Knee osteoarthritis (OA) is a severely debilitating disease associated with stiffness and pain in the knee joint, and with a loss of function. Hyaluronic acid (HA) injections are incorporated into non-surgical standard of care for knee OA patients and have been proven to relieve pain in patients who have not received symptomatic relief with other knee OA interventions. HA allows synovial fluid to act as a lubricant and shock absorber for joints, and although this is encouraging ground to advocate for the use of HA treatment in knee OA patients, these properties have yet to be proven in a controlled clinical trial setting. Therefore, we are undertaking this study to observe whether the physiological adaptation in the OA knee joint, initiated by HA injection, will result in biomechanical improvements in human knee OA patients, specifically walking mechanics.

Eligibility Criteria:
Inclusion Criteria:

* 60 - 80 years old.
* Mild to moderate knee osteoarthritis:
* Clinical diagnosis (symptoms).
* Radiographic diagnosis (Kellgren-Lawrence grade I - III).
* Must provide provide informed consent and knowledge of all possible benefits and possible adverse events.
* Available for duration of the study.
* Not taking any other knee osteoarthritis medications during the study.

Exclusion Criteria:

* Non - OA arthritides.
* Hip, ankle, or foot OA.
* End stage OA.
* Lower back/extremity pathology.
* Previous surgery on knee affected by OA (except arthroscopy within the past 12 - 18 months).
* Neurological/Cardiovascular gait impairment.
* Pregnant.
* Cognitively impaired.
* Not available for duration of study.
* Taking other knee OA medications at time of study.
* Gastro-intestinal disturbance.
* Avian allergy or any other contraindication to intra-articular injections with Hyaluronic acid.
Universal BCMA-targeted LUCAR-B68 Cells in Patients With Relapsed/Refractory Multiple Myeloma

A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of Universal BCMA-targeted LUCAR-B68 Cells Product in Patients With Relapsed/Refractory Multiple Myeloma

This is a prospective, single-arm, open-label, dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LUCAR-B68 cell preparations in relapsed/refractory multiple myeloma subjects who received adequate standard therapy

Eligibility Criteria:
Inclusion Criteria:

1. The subject voluntarily participates in the clinical study; Fully understand and be Informed of the study and sign the Informed consent (Informed Consent Form, ICF); Willing to follow and able to complete all test procedures; Informed consent must be obtained before initiating any tests or procedures related to the study that are not part of the standard treatment of the subject's disease;
2. Subjects ≥ 18 years of age.
3. Eastern Cooperative Oncology Group performance status score of 0, 1, or 2;
4. Documented initial diagnosis of MM according to IMWG diagnostic criteria.
5. Presence of measurable disease at screening.
6. Received a PI and an IMiD (except thalidomide).
7. Received at least 3 prior lines of therapy for multiple myeloma, undergone at least 1 complete cycle of treatment for each line, unless progressive disease (PD) was documented by IMWG criteria as the best response to the regimen. Also, subjects refractory or intolerant to any PI and any IMiD in their previous treatment afterwards are eligible.
8. Expected survival ≥ 3 months.
9. Clinical laboratory values meet screening visit criteria
10. Fertile women must be negative using a highly sensitive serum pregnancy test (β human chorionic gonadotropin \[β -HCG\]) at screening time and before initial treatment with cyclophosphamide and fludarabine;

Exclusion Criteria:

1. No response to prior BCMA-targeted CAR-T therapy (except in subjects who relapsed after CR to prior CAR-T treatment);
2. Prior treatment with any antibody targeting BCMA;
3. Known active, or prior history of central nervous system (CNS) involvement, or clinical signs of membrane/spinal membrane involvement of multiple myeloma;
4. Serious underlying medical conditions
5. Positive of any hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), human immunodeficiency virus antibody (HIV-Ab) at the time of screening;
6. Male subjects who have a birth plan during the study period or within 1 year after the study treatment
7. Female subjects who are pregnant, breast-feeding, or plan to become pregnant during the study period or within 1 year after the study treatment
8. The investigator considered that the subjects were not suitable for any conditions of participation in the study
Proadrenomedullin and Copeptin in Patients With Septic Shock

This study evaluates the usefulness of pro-adrenomedullin (precursor of a vasodilatory peptide involved in septic shock pathogenesis) and copeptin (a stable peptide of the arginine vasopressin precursor) to predict, at the moment of septic shock diagnosis or their changes at 6 hours, the vasopressor requirements (measured by inotropic index and vasopressor dependency ratio) and volume requirement for resuscitation.

Physiologically, adrenomedullin has a potent and prolonged vasodilatory effect. In both experimental animals and humans, the intravenous administration of ADM induces a marked and prolonged hypotension. Serum ADM levels are elevated in patients with septic shock. In fact, ADM seems to be one of the main mediators involved in hypotension that these patients present.

ADM is not stable in plasma due to its short half-life and rapid binding to receptors. ADM levels can be measured indirectly by determining proadrenomedullin (proADM) which is a more stable molecule and whose levels are reflected in the plasma of ADM.

Copeptin is released primarily in response to changes in serum osmolarity or blood volume by increasing peripheral vascular resistance and blood pressure.

Copeptin is elevated in patients with shock of different etiologies such as hemorrhagic shock or septic shock.

It is not defined in what situations and at what moment an invasive monitoring of the cardiac output and the different hemodynamic variables that reflect the preload and afterload in patients with septic shock should be performed. In fact, there is great variability in the management and treatment of patients with sepsis and septic shock, which includes the selection of patients who require invasive monitoring and the time of onset.

Having a biomarker or the combination of biomarkers that allow early determination of which patients will evolve poorly with the development of a shock that requires volume in large quantities and high doses of vasopressors will allow identifying a subgroup of patients that should be performed early hemodynamic monitoring and intensify medical treatment to try to reverse these severe hemodynamic changes.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years
* Diagnosis of septic shock
* Obtaining written informed consent.

Exclusion Criteria:

* Initial dose of norepinephrine at ICU admission ≥ 0.6 mg / kg / min.
* Acute myocardial infarction in the previous month.
* History of pituitary surgery.
* Pregnancy.
Efficacy of Dexamethasone in Attenuation of Postinduction Hypotension in Geriatric Patients Undergoing General Anesthesia

* Geriatric patients who undergo general anesthesia experience post induction hypotension which is treated with intravenous fluids and ephedrine. The main cause of post-induction hypotension is the decrease in the sympathetic outflow causing arterial vasodilatation, a decrease in venous return and consequently the activation of the Bezold Jarish reflex (BJR) that elicits a triad of bradycardia, vasodilatation and further hypotension. BJR is elicited by activation of 5-HT3 receptors within the intracardiac vagal nerve endings.
* Glucocorticoids in general inhibit 5-HT3 expression and dexamethasone was found to decrease the level of 5-HT3 in the cerebral cortex and hippocampus in developing rats. So, the research team hypothesizes that dexamethasone can attenuate the postinduction hypotension in geriatric patients undergoing general anesthesia if administered preoperatively.


Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) Physical Status Class-I and II.
2. Elective surgery under general anesthesia.

Exclusion Criteria:

1. Emergency surgeries.
2. Ischemic heart disease.
3. Peptic ulcer \& active infection.
4. Psychiatric disorder.
5. Patients on steroids or serotonin related medications (e.g., selective serotonin reuptake inhibitor).
Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women

The purpose of this study is to study longitudinal changes in maternal metabolism and pregnancy outcomes in obese pregnant women.

We will study how normal metabolic changes of pregnancy are modified in obesity and investigate the consequences of altered fat and carbohydrate metabolism for pregnancy outcome. The results will aid our understanding of why pregnant obese women and their babies are at higher risk of complications and may highlight potential therapies to reduce these risks.

Overall aim and hypothesis:

The overall aim is to increase knowledge about the relation between obesity, metabolic profile/risk factors and pregnancy outcome in order to improve antenatal care and the health of the next generation.

We hypothesize that obese pregnant women can be differentiated into subgroups according to their metabolic risk profile and their risk of adverse pregnancy outcomes.

Specific aims:

Establish an outpatient clinic for obese pregnant women at Department of Obstetrics, Drammen, Vestre Viken HF in order to:

* Provide improved antenatal care for obese pregnant women who have increased risk of pregnancy complications by offering:

  * antenatal care according to national guidelines (Veileder i fødselshjelp 2014)
  * fetal surveillance (ultrasound)
  * planned delivery according to national and local guidelines
* Conduct an observational study in which clinical and biochemical data will be collected in order to increase knowledge on longitudinal metabolic changes in pregnancies complicated by obesity and how these relate to pregnancy outcomes

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with pregestational BMI \> 35

Exclusion Criteria:

* diabetes mellitus type 1
Post-market Clinical Follow-up on the balanSys UNI Knee Prosthesis Implanted With a Spacer Block Surgical Technique

The purpose of the study is the evaluation of the clinical and radiological long-term performance of the balanSys UNI fix in a multicenter routine clinical setting.

Prospective multicenter follow-up study which examines the short- to long-term post-market clinical data on the safety and performance of the balanSys UNI fix knee prosthesis.

In total at least 100 participants in 3 clinics are included in this multicenter study.

The primary endpoint of the study is the Knee Society Score (KSS) 2 years after surgery.

The following parameters will be collected during the regular clinical and radiological follow-up: Knee Society Score, Knee and Osteoarthritis Outcome Score (KOOS), radiographic evaluation and detection of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent form (signed by participant and investigator)
* Primary implantation
* Age at inclusion: Between 18 and 90 years old
* Willing to participate in the follow-up

Exclusion Criteria:

* Missing Informed consent form
* Known or suspected non-compliance (e.g. drug or alcohol abuse)
* Enrollment of the investigator, his/her family, employees and other dependent persons
* Patient younger than 18 years old
* Revision surgery
* Does have a known allergy to metal in medical devices
* Suffers from ACL rupture
* Pregnancy or in the breast feeding period
FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study

Purpose The purpose of this study is to compare the economical impact and clinical parameters of short daily hemodialysis using the NxStage® System One hemodialysis device with thrice-weekly conventional in-center dialysis using a matched cohort from the US Renal Data System (USRDS) database.

In the 21st century, nephrologists in the United States face many challenges including a forecast of decline in physician manpower. Challenges that are specific to hemodialysis (HD) include reimbursement constraints, a growing shortage of nurses and major technological advances in dialysis equipment. There is a growing interest in alternative dialysis regimen and frequency, but a lack of patient incentive for self-care dialysis either in the center or in the home setting. The proposed phase 4 post-marketing study plans to explore whether daily HD is economically attractive compared with thrice weekly HD, while improving health-related quality of life and other dialysis adequacy measures. This project is unique as it provides a large prospective cohort of patients converted to daily HD, with a longitudinal follow up and an ability to compare to a matched cohort from the United States Renal Data Services. This study will help develop whether daily dialysis is economically attractive through the use of new technologies that reduce treatment costs and decrease hospitalization rates, with the long-term hope of increasing life expectancy. All patients will have the option to participate in the Quotidian Dialysis Registry, coordinated by the Lawson Health Research Institute (LHRI) in London, Ontario.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ESRD and require dialysis
* Medicare as primary payor (NOTE: Does not include Medicare HMO as primary payer)
* Candidate for daily hemodialysis (defined as 6 or more times per week)
* Ability to understand and willingness to sign an informed consent statement and a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement

Exclusion Criteria:

* Current use of the NxStage System One hemodialysis device
* Previous enrollment in this study
* Current enrollment in another investigational drug or device trial which might impact the outcome measures planned in this study
* Likelihood of not surviving the training period
The Prevalence of Sub Clinical Hypothyroidism During Early Pregnancy in Pakistan

The Precious study is likely to help determine the frequency (percentage) of subclinical hypothyroidism among pregnant women in Pakistan It will also help to determine the risk factors for developing subclinical hypothyroidism during pregnancy


Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet all of the following criteria to be enrolled into the study
* Patient between 18-45 years of age; is pregnant and in First Trimester
* Patient willing to give blood sample for laboratory testing
* Patient willing to provide written authorization to obtain data for the study
* Exclusion Criteria:
* Patients suffering from any

  * Chronic Cardiac Disease - Chronic Cardiac Failure, Cardiac Arrhythmia
  * Hepatic Disorder : Cirrhosis
  * Renal Disease : Patients on dialysis and Transplant Therapy
  * Respiratory Disorder
* Subjects with history of non-thyroid malignancy
* Patient currently taking medication for hyperthyroidism
* Active systemic infection
* Patient with physical or mental impairment
* Patients on systemic steroid therapy or lithium therapy
* Patients in second or third trimester of pregnancy
* Patient not willing to give blood sample for laboratory testing
* Patient not willing to provide written authorization to obtain data for the study
Inositol Treatment in Different Type of PCOS Phenotype

Evaluation of the efficacy of inositol treatment in women with PCOS in relation to the phenotype (according to the Rotterdam Criteria)


Eligibility Criteria:
Inclusion Criteria:

* women with PCOS of any phenotype

Exclusion Criteria:

* hormonal treatment (such as contraceptive pill)
* use of supplements containing myo-inositol
* severe co-morbidities
Sustainable Eating for a Healthy Tomorrow - Effectiveness of Digital Nutrition Workshops to Implement the Planetary Health Diet for Hospital Employees

The investigators will explore the effect of digital media on communicating a planetary diet and invite participants to change dietary habits. Standardized questionnaires, physical examinations, and qualitative interviews will be used to obtain data on the effectiveness of the intervention. Once initial assessments are complete, a blinded researcher will randomly assign participants to one of two groups, without influence from either participants or study coordinators.

Both groups will participate in a nutrition course over a 13-week period, followed by a booster session five months after randomization, and will be encouraged to practice the methods at home. One group will receive intensive support, including a digital training program (around 2 hours per week), while the other group will receive digital information and sustainable recipes with limited support (about 30 minutes per week).


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 years
* Employee at the University Hospital Essen
* A functioning smartphone
* Moderate willingness (at least 5 points on NRS) to want to change diet
* Access to digital media and social media

Exclusion Criteria:

* Insufficient knowledge of the German language
* Simultaneous participation in other clinical intervention studies
Antiangiogenic Factors in Gastric Cancer

Endogenous antiangiogenic factors are related with gastric cancer progression.

Gastric cancers have been known to secrete the proangiogenic cytokine VEGF in vitro and in vivo. Tumor VEGF expression is correlated with the severity of disease in patients with gastric cancer and some authors have suggested using circulating VEGF as a prognostic factor or tumor marker.In addition to producing proangiogenic cytokines, recent data demonstrate that tumors can produce antiangiogenic cytokine as well. It has been suggested that, in humans, the generation of antiangiogenic compounds in the presence of a primary tumor suppresses the growth of distant metastases. This phenomenon has been demonstrated in mice and in patients with clear cell renal cancer, breast cancer, and colorectal cancer. However, the presence of endogenous antiangiogenic cytokines in patients with gastric cancer has not been reported.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of gastric adenocarcinoma
* No other forms of cancer therapy, such as chemotherapy or radiotherapy for at least 3 weeks before the enrollment in study
* Performance status of 0, 1, 2 on the ECOG criteria
* ASA class I, II
* Patient compliance that allow adequate follow up
* Informed consent from patient or patient's relative.

Exclusion Criteria:

* Second primary malignancy
* EMR (Endoscopic mucosal resection) indication
* Laparoscopic gastrectomy
* Radiologic or clinical evidence of metastasis
Comparison of Tramadol, Pethidine and Morphine in the Treatment of Pain After Thoracic Surgery

Comparison of analgesic effects of tramadol, aldolan and morphine under thoracic surgery

Thoracotomy is one of the most painful surgical procedures known, and severe pain is encountered in 21-67% of patients after thoracotomy. The most important causes of this pain arise from the bone structures of the thoracic wall, damage to the costal joint junctions, stretching of the ligaments, rib fractures, and damage to the intercostal nerve and major muscles. Another factor that causes pain after thoracotomy is the chest tubes placed in the thorax to provide drainage (1).

As a result of this pain caused by loss of tissue and pulmonary reserve, effective coughing and decreased chest expansion can lead to serious complications such as atelectasis, ventilation/perfusion mismatch, hypoxemia, immobilization, thromboembolism and infection. These complications are associated with increased morbidity and mortality in thoracic surgery (2).

Ensuring pain management in patients undergoing thoracotomy is important in terms of reducing postoperative complications, ensuring early mobilization and increasing patient comfort. Since there is no single source that causes pain after thoracotomy, pain must be controlled at all levels. For this reason, a multimodal approach using pharmacological and non-pharmacological techniques is preferred in analgesia after thoracotomy. This approach reduces drug side effects along with the consumption of analgesics. Opioids and nonsteroidal anti-inflammatory drugs are used in pharmacological analgesia.

In our study, the investigators aim to compare the effects of tramadol, pethidine and morphine using intravenous patient-controlled analgesia in the treatment of postoperative pain in elective thoracic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Having non-urgent thoracic surgery
* over 18 years old
* Being in group I-III according to the American Society of Anesthesiologists (ASA) classification
* Not have allergies to the drugs to be used (volunteers with diseases that prevent the use of drugs will not be included in the study
* regardless of gender

Exclusion Criteria:

. Have allergies to the drugs to be used
To Explore the Effects of Different Training Periods and Dietary Pattern on the Gut Microbiota, Metabolites and Protein Expression Levels of Strength and Endurance Athletes and to Find Relevant Biological Indicators.

The gastrointestinal tract contains hundreds of millions of microorganisms, collectively called the intestinal flora, which plays an important role in the health of the host. Many studies have also confirmed that the composition and function of the intestinal flora can be changed through the training chain. Changes in the composition of intestinal microbes can affect exercise performance, energy metabolism, oxidative stress, immune function, inflammation, and tissue repair. Therefore, maintaining a healthy gut microbial balance is essential for athletes' health, training, nutritional status, and athletic performance. This project intends to use metagenomics, proteomics, and metabolomics and other technologies to systematically explore the effects of different training periods and dietary interventions on the intestinal flora of muscle strength and endurance athletes. , Protein expression and the influence of metabolites. In the plan, explore the differences in the intestinal flora between muscle strength and endurance sports athletes during the preparation period, competition period, and transition period, and collect blood and feces to perform protein and metabolite molecular changes. It is hoped that through the smooth implementation of this research project, the research results can be applied to personalized diet planning, improve intestinal adaptability and the effectiveness of sports nutrition intervention, and then adjust athletes' status and improve sports performance to win the highest honor for the country in the arena.


Eligibility Criteria:
Inclusion Criteria:

* 20-30 years old healthy muscle strength and endurance sports athletes

Exclusion Criteria:

1. Exclude cardiovascular disease, hypertension, metabolic disease, asthma, or neuromuscular sports injuries within six months, etc.
2. Exclude those who regularly take lactic acid bacteria-related foods for a long time
3. Exclude students and related stakeholders under the guidance of the project host