cyrilzakka/clinical-trials huggingface dataset:
The Effects of Resistance Training and Protein Supplementation in Healthy Elderly Men and Women.

The main objective of this study is to examine the effects of resistance type exercise training combined with nutritional support on body composition and muscle characteristics in healthy elderly men and women. For a comprehensive insight into the potential underlying mechanisms of the intervention effects on whole body-, muscle- and myocellular level, a broad range of tests will be performed before, during, and after the intervention period.


Eligibility Criteria:
Inclusion Criteria:

* over 65 years
* healthy men and women

Exclusion Criteria:

* cardiovascular disease
* COPD
* Parkinson
* rheumatoid arthritis
* musculoskeletal/orthopaedic disorders
* cognitive impairment
* subjects with metal implants
Preoperative Octreotide Treatment of Acromegaly

The purpose of this study is to investigate whether 6 months preoperative treatment with the somatostatin analogue octreotide improves the surgical outcome in patients with acromegaly.

After a baseline evaluation, patients are randomized separately for each study center in blocks of four directly to transsphenoidal surgery or to 6-month preoperative treatment with octreotide.

To reduce the risk of gastrointestinal adverse effects in the pretreatment group, octreotide is initiated at a dose of 50 µg sc three times a day for the 1st week and 100 µg sc three times a day for the 2nd week. From the 3rd week on, the patients receive octreotide LAR (Novartis International AG, Basel, Switzerland) 20 mg im every 28th day for 6 months. Patients receive transsphenoidal surgery within 28 d of the last injection. If surgery are delayed, an extra octreotide LAR injection is given before surgery.

Eligibility Criteria:
Inclusion Criteria:

* GH nadir during a standard 75 g OGTT \>= 5.0 mmol/L.
* Pituitary tumor by MRI-scan.

Exclusion Criteria:

* Immediate surgery indicated by usual clinical criteria.
* Pregnant.
* Known adverse effects of octreotide.
* Unfit for participation by any other reason.
Post-Surgical Non-Small Cell Lung Cancer (NSCLC) Follow-up

The follow-up of patients operated on for lung cancer is heterogeneous. An intensive follow-up including routine clinic visits, chest X-rays, chest computed tomography (CT) scans and fiberoptic bronchoscopies might detect more small, potentially curable, recurrences and second cancers. However, as it appears in the American Society of Clinical Oncology (ASCO) recommendations, a large randomized study is necessary to evaluate the survival impact of such a follow-up strategy. This is the main objective of this IFCT-0302 study, which is a large randomized controlled study conducted in France comparing this intensive follow-up to a follow-up with only routine clinic visits and chest X-rays.


Eligibility Criteria:
Inclusion Criteria:

* completely resected stage I, II, IIIa, and T4 due to satellite tumor nodule(s) N0-2 NSCLC

Exclusion Criteria:

* stage IIIb to IV NSCLC
Comparison of High-flow Oxygen vs. BiPAP in Type II (Hypercapnic) Respiratory Failure

A retrospective cohort study of all patients treated for type II (hypercapnic) respiratory failure with either High-Flow Oxygen Therapy or Non-Invasive Ventilation in a general adult hospital.

We will compare various clinically relevant outcomes in patients treated for type II (hypercapnic) acute respiratory failure (ARF) with either High-Flow Nasal Cannula (HFNC) or Non-Invasive Ventilation (NIV) in a general adult hospital.

All patients treated with HFNC were treated with an Optiflow device (Fisher\&Paykel). Various Bilevel positive airway pressure (BiPAP) devices were used during the study period.

All ventilatory parameters were set according to the treating physicians' preferences.

Eligibility Criteria:
Inclusion Criteria:

* All patients treated with respiratory failure not responding to conventional supplemental oxygen therapy
* Blood venous gas showing partial pressure of carbon dioxide\>50 mmHg before beginning therapy with either NIV or HFNC

Exclusion Criteria:

* Lack of records of the primary outcome
* End-of-life care
* Lack of gas before the beginning of NIV or HFNC
Stivarga Regulatory Post-Marketing Surveillance Study in Korea

To investigate and collect post-marketing data on the safety of Stivarga in real world practice in its registered indication(s) as required by Health Authority.


Eligibility Criteria:
* Inclusion Criteria:
* Signed and dated informed consent
* Patients diagnosed with histologically confirmed metastatic colorectal cancer and/or metastatic or unresectable locally advanced gastrointestinal stromal tumors and/or HCC who have been previously treated with sorafenib by physician
* Patients who are prescribed with Stivarga tablet 40mg(Regorafenib) for the first time
* Exclusion Criteria:
* Patients participating in an investigational program with interventions outside of routine clinical practice
* All contra-indications according to the local marketing authorization have to be considered.
A Study of HS248 in Patients With Advanced Solid Tumors

This study is a non-random, open multi-center study This study is a non-random, open multi-center phase I study, aimed at evaluation period research, aimed at In the evaluation phase study, it aims to evaluate the safety, tolerance PK characteristics and preliminary anti-tumor activity of HS248 in patients with advanced solid tumors. The study was divided into 2 phases, including dose escalation and dose expansion。

Main purpose:

Assess the safety and tolerability of HS248 in patients with advanced solid tumors, and determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of HS248.

Secondary purpose: Secondary purpose:

Assess the pharmacokinetic (PK) profile of HS248 in patients with advanced solid tumors; To evaluate the preliminary antitumor activity of HS248 in patients with advanced solid tumors. Preliminary antitumor activity in patients with advanced solid tumors.

Other purposes:

Population-based PK (PopPK) analysis method, exploratory description) analysis method, exploratory description) analysis method, exploratory description) analysis method, exploratory description of HS248 in patients with advanced solid tumors PK features in; Evaluate the relationship between exposure and efficacy and adverse events (AEs) of HS248 in patients with advanced solid tumors, as data permit; To explore the changes of HS248 in myeloid-derived suppressor cells (MDSC) and CD8+ T cells in patients with advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily participate in this clinical trial, understand and follow the research procedures and voluntarily sign the ICF;
2. Male or female, age ≥18 when signing the ICF;
3. Expected survival period ≥ 12 weeks;
4. Patients with advanced solid tumors confirmed by histology/cytology, who have progressed through standard treatment, have toxicity intolerance, or have no standard treatment plan (patients with multiple solid tumors are included in the dose-escalation phase, and the population included in the dose-expansion phase will be based on dose escalation phase study data and the potential advantageous population of similar drugs);
5. Eastern Cooperative Oncology Group (ECOG) physical status score 0-1

Exclusion Criteria:

1. Symptomatic or untreated central nervous system metastasis or primary central nervous system malignancy;
2. Other known malignant tumors in the past 5 years, except cured localized tumors, including carcinoma in situ of the cervix, basal cell carcinoma of the skin, and carcinoma in situ of the prostate;
3. Previous history of autoimmune diseases, stem cell transplantation or organ transplantation;
4. Known drug-induced liver injury, chronic active hepatitis, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, persistent extrahepatic obstruction caused by gallstones, cirrhosis or portal hypertension;
5. Peptic ulcer and/or gastrointestinal bleeding at present or in the past;
6. Gastrointestinal dysfunction that may limit the absorption of the test drug, including motility disorders, malabsorption syndrome or inflammatory bowel disease;
Safety and Efficacy of Deferasirox in Patients With Transfusion Dependent Iron Overload - a Non-comparative Extension Study

The purpose of this study is to assess the safety and the effects on liver iron of Deferasirox when given for a long treatment period in patients with transfusion dependent iron overload.


Eligibility Criteria:
Inclusion Criteria:

* Patients Currently participating in the 9-month comparative prolongation of extension phase of the original study.
* Patients currently participating in the food-effect sub-study, according to amendment 3.
* Ability to provide written informed consent prior to participation in this non-comparative extension study.
* Female patients sexually active must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation.
* Body weight of at least 35 kg.

Exclusion Criteria:

* Pregnant or breastfeeding patients.
* History of non-compliance to medical regimens and patients who are considered potentially unreliable.
* Proteinuria \> 300 mg/L second void morning urine.
* Patients with serum creatinine above the upper limit normal.

Other protocol-defined inclusion/exclusion criteria may apply.
Feasibility of a Yoga- and Mindfulness-Based Intervention for Resident Physicians

The investigators aim to initiate and complete the first investigation of the effect of a yoga-based program on resident physicians' psychological health using a randomized controlled trial to assess feasibility of the program in this population and measure outcomes across several domains. To meet the goals of the proposed project the investigators have identified 3 specific aims:

Specific Aim 1: Assess the acceptability and feasibility of the yoga program through measuring participation and conducting standardized interviews with a subset of yoga participants.

Specific Aim 2: Evaluate the effect of the yoga program on resident physicians' stress, burnout, resilience, mindfulness, mood, depression, anxiety, and sleep quality using quantitative self-report measures.

Specific Aim 3. Examine whether outcome measures were perceived as relevant to the participants' work environment and were not burdensome as to the length and content of the program.

The project will implement a single group mixed-methods randomized controlled trial to investigate the impact of the 6-week RISE program on psychological health in Longwood medical area residents. The RISE program is an existing standardized yoga program at Kripalu that will be adapted for residents in a 60-90-minute, once-weekly class for six weeks. Participants will be randomized to either the RISE yoga program or a no-treatment control group. Participants randomized to the RISE program will also be instructed to maintain a short 10-15-minute daily home yoga practice. Sessions will be lead by experienced instructors from Kripalu and will be held in the Longwood medical area. Self-report outcomes will be assessed at baseline, at program completion (post-program), at 2-month follow-up, and at 6-month follow-up.

Participants will include resident physicians at Longwood medical area hospitals. The only exclusion criterion is having practiced yoga, meditation, tai chi, qigong, or another mind-body practice at least 25 hours or more in the past 6 months. Participants must be willing not to practice mind-body programs other than the treatment protocol during the intervention. We plan to enroll up to 200 participants with a goal of at least 60 participants with a 2:1 ratio of participants randomized to yoga to participants randomized to control. The control group will receive one session of RISE after their participation in the trial is complete.

Eligibility Criteria:
Inclusion Criteria:

* Individuals enrolled in residency programs at Brigham and Women's Hospital, Beth Israel Deaconess, Boston Children's Hospital, or a Harvard Combined Residency Program
* Individuals must be willing to not practice mind-body programs other than the intervention during the treatment protocol
* Must be proficient in English

Exclusion Criteria:

* Individuals who currently practice yoga, meditation, tai chi, qigong, and other mind-body practices more than 25 hours in the past 6 months
Effect of LIK066 on Reduction of Fatty Content in Livers of Obese Patients

The purpose of this study was to assess the effects of LIK066 on a variety of metabolic and inflammation biomarkers in patients with non-alcoholic steatohepatitis (NASH)

This was a a non-confirmatory, multicenter, patient and investigator blinded, randomized, placebo-controlled, parallel group study in patients with non-alcoholic steatohepatitis (NASH).

The study consisted of a 28 day screening period (Day -44 to Day -16), a baseline period of 14 days (Day -15 to Day -1), a treatment period of 12 weeks (Day 1 to Day 84), and a study completion evaluation approximately 28 days after the last drug administration. The patients were advised to maintain their recommended diet during the study.

Patients who met the inclusion/exclusion criteria at screening went to the study site for baseline assessments. All baseline safety evaluation results were available prior to the first dosing.

The study started by enrolling patients into the 150 mg and placebo arms with a randomization ratio of 2:1. After the enrollment of the first 33 patients, the 30 mg arm was added to the study and the randomization ratio changed to a 2:4:1 ratio (150 mg: 30 mg: placebo) to maintain the 2:2:1 ratio across the three groups (150 mg: 30 mg: placebo) at study completion.

Eligibility Criteria:
Inclusion Criteria:

EITHER

-Histologic confirmed NASH based on liver biopsy obtained 2 years or less before randomization with a fibrosis level of F1, F2 or F3 in the absence of a histological diagnosis of alternative chronic liver disease AND ALT greater than or equal to 50 IU/L (males) or greater than or equal to 35 IU/L (females) at screening.

OR

Phenotypic diagnosis of NASH based on presence of ALL three of the following at screening:

* ALT greater than or equal to 50IU/L (males) or greater than or equal to 35 IU/L (females) AND
* BMI greater than or equal to 27 kg/m\^2 (in patients with a self-identified race other than Asian) or greater than or equal to 23 kg/m\^2 (in patients with a self identified Asian race) AND
* Diagnosis of Type 2 diabetes mellitus by HbA1c: greater than or equal to 6.5 % and less than or equal to 10%
* Patients must weigh no more than 150 kg (330 lbs) to participate in the study.
* Male and female patients 18 years or older at the time of screening visit.

Exclusion Criteria:

* History or presence of other concomitant liver diseases
* History or current diagnosis of ECG abnormalities
* Use of GLP-1 agonists, SGLT2 inhibitors, TZDs, FXR agonists and any pharmacologically active weight loss drugs within 6 weeks of screening and until end of study
* Patients with contraindications to MRI imaging
* Current or history of significant alcohol consumption
* Clinical evidence of hepatic decompensation or severe liver impairment
* Women of child bearing potential (unless on basic contraception methods)
* Presence of liver cirrhosis
Exercising With a Surgical Mask in Both Athletic and Non-athletic Individuals

This study aimed to examine the impact of surgical masks on maximal and submaximal exercise in both athlete and non-athlete individuals.

All participants will be informed about the procedure and, will sign an informed consent form. They will undergone a detailed physical examination before enrollment in the study. The study is conducted in 2-phases, in non-randomized, controlled design. Cardiopulmonary exercise tests (CPET) are going to be performed with and without a surgical mask with 48 hours in between.

Eligibility Criteria:
Inclusion Criteria:

* healthy athletes
* healthy non-athletes

Exclusion Criteria:

* any musculoskeletal, cardiac or respiratory problem
Prediction of Complications After Major Gastrointestinal Surgery With Machine Learning and Point of Care Ultrasound

This is an observational study in patients undergoing major surgery. In which we attempt to predict complications (e.g. low blood pressure, ICU-admittance after major surgery using continuous blood pressure measurements. We will also attempt to predict their response to fluid therapy using point of care ultrasound. Eventually we aim to combine these methods to detect complications earlier and to give advice about whether or not administration of fluid is appropriate

The primary aim of this study is to develop a machine learning framework to predict major complications after major gastro-intestinal surgery. Secondary aims include combining this framework with point of care ultrasound to determine the best initial resuscitative strategy; and to determine which ultrasound parameters are best predictive of fluid intolerance. Furthermore if the renin angiotensin aldosterone system is more active after liver resection.

Study design:

Single centre observational cohort study

Study population:

Adult patients undergoing elective major gastrointestinal surgery

Primary study parameters/outcome of the study:

The main study endpoint is a machine learning framework based on the hemodynamic profile to predict major complications,especially cardiovascular/pulmonary instability, including, sepsis and septic shock. Data from the ClearSight will be used to collect non-invasive arterial pressure waveforms. point of care ultrasound of heart, lungs and abdominal veins, and clinical data from the electronic medical record will be collected

Secondary study parameters/outcome of the study (if applicable):

point of care ultrasound of heart, lungs and abdominal veins, and clinical data from the electronic medical record will be collected. Ina subgroup of 40 patients RAAS levels and portal blood samples will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age.
* elective major gastrointestinal surgery: esophagectomy, gastrectomy, pancreatomy or major liver resection (3 segments or more).

Exclusion Criteria:

* no informed consent
* Patients with major cardiac shunts
* Patients with dialysis shunts or peritoneal dialysis
* Patients in whom POCUS is not possible or assessment of fluid status is unreliable e.g. BMI\> 40, pulmonary fibrosis.
8-stage Model and Its Implications in National Pakistani Tennis Players

The aim of this study is to determine the effectiveness of structured exercises for tennis serve performance by using 8-stage model.

Tennis serve stroke is the most crucial component of tennis. 8-stage model like other training programs has proven to be effective in improving performance. This exercise program has yet not been implemented in Pakistani tennis players and remain to be tested in local population.

This randomized controlled trial has been designed to assess the effectiveness of 8-stage model based exercise program in Pakistani national tennis players. The present study has hypothesized that there will be a significant difference between the effects of 8-stage model and conventional training program. There are two arms of intervention in this study: experimental and control group. Experimental group would follow the 8-stage model based exercise training program while control group would follow their conventional exercise training program. Outcome measurements (speed, flexibility, strength) has been carried out at baseline and after 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* National level tennis players
* Players who are playing tennis from last one year continuously

Exclusion Criteria:

* Players with any MSK injury
* Any systemic disease affecting players performance
* Any inflammatory conditions.
Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique

This study intends to perform an all-inside and complete tibial tunnel ACL reconstruction technique in 80 patients, and compare the clinical and radiological outcomes of the two surgical procedures through follow-up.

This is a prospective randomized, controlled, single-center clinical trial study on ACL reconstruction surgery technique. In this study, 80 patients with ACL rupture were recruited according to the enrollment criteria. The recruited patients were randomly divided into groups. The ratio of the control group is 1:1. In this study, 40 patients with ACL rupture in the experimental group will be treated with all-inside reconstruction technique, and 40 patients with ACL rupture in the control group will be treated with complete tibial tunnel technique. All operations will be performed with 4-strand autologous semitendinosus tendon. All fixations will be performed using an adjustable cortical suspensory system. After reconstruction, all subjects will participate in the collection of clinical function scores including Marx Activity score, IKDC score, and clinical evaluation including physical examination, joint laxity, CT and MRI imaging analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided informed written written consent;
* Patients aged between 18 and 45;
* Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL)
* Patients undergoing ACL reconstruction with a 8 mm four-strand semitendinosus autograft

Exclusion Criteria:

* Patients who have not signed informed consent;
* Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery
* Revision procedures
* Patients unable to lay still in an MRI or CT scanner
* Patients with a torn ACL or previous ACL reconstruction in the contralateral knee.
* Patients who had an excessive tibial slope \>12 degrees
The Preventive Effect of Different Doses of Intranasal Insulin on Postoperative Delirium

Postoperative delirium is one of the common complications in the older aldults after surgery, which can lead to longer hospita stay，memory loss and reduced quality of life. There is currently no specific treatment. Therefore, it is important to prevent the occurrence of postoperative delirium. This study investigated the effect of intranasal insulin administration on the prevention of postoperative delirium and compared different doses of insulin to find a safe and acceptable method for preventing delirium.

Hip fractures are a common trauma in older adults and occur mainly in older people with osteoporosis. Surgery is the preferred choice for the vast majority of patients with severe pain and limited mobility in older aldults with hip fractures, resulting in higher mortality and disability rates with conservative treatment. But postoperative delirium becomes a challenge. At present, the treatment of delirium includes pharmacological and non-pharmacological methods, but the effect is limited, and now the focus is on preventing delirium, so this study investigated the effect of intranasal insulin administration on the prevention of postoperative delirium.

Eligibility Criteria:
Inclusion Criteria:

Patients with hip fracture scheduled for unilateral hip arthroplasty or intramedullary nailing under subarachnoid block.

Both genders. Age ≥65 years old. Body mass index (BMI) ≤24kg/m2. American Society of Anesthesiologists (ASA) grade I-III.

Exclusion Criteria:

Contraindications to nasal administration (nasal defects or lesions). History of insulin allergy. Inability to communicate preoperatively (coma, severe visual or hearing impairment).

History of severe heart,Liver and kidney disease. History of psychiatric disorders. Preoperative delirium. Multiple traumas or fractures. Contraindications to subarachnoid block.