cyrilzakka/clinical-trials huggingface dataset:
The PENG Block in Elective Hip Surgery and Its Effect on Postoperative Pain and Length of Stay.

Effective postoperative pain management in elective hip surgery is crucial for the patients well-being, rapid mobilisation and potential reduction of length of stay. In addition to standard intravenous pain medication, anaesthetic blocks are reportedly effective. Recently, the PENG block, a pericapsular pain block without impairment of the motor function has been introduced in literature and performed at the investigator's hospital (HFR Fribourg, Switzerland) for total hip arthroplasty and surgical hip dislocation - the two most commonly performed elective hip surgeries.

As high-quality evidence on the effectiveness of this novel block is lacking, the investigator's objective is to evaluate the effectiveness of (1) patient-reported pain reduction, (2) total consumption of postoperative morphine, and the length of stay at the hospital.

Forty patients undergoing total hip arthroplasty and 40 patients undergoing surgical hip dislocation will be enrolled in a prospective, double-blind, controlled trial performed at the investigator's hospital.

This study will be the first prospective study evaluating the potential of this pain block in elective hip surgery potentially affecting both patients' postoperative well-being and optimizing costs of the hospital by reducing length of stay.

Eligibility Criteria:
Inclusion Criteria:

* Anterior total hip arthroplasty for hip osteoarthritis
* Surgical hip dislocation for femoro-acetabular impingement (type cam-/pincer)
* Age 16-85 years
* American Society of Anesthesiologists (ASA) physical status 1 to 3

Exclusion Criteria:

* Patient refusal/no informed consent
* Inability to give informed consent
* Lateral approach for total hip arthroplasty
* Bilateral procedure
* Additional osteotomies of the femur and/or acetabulum
* Previous hip \& pelvis surgery
* Chronic opioid users
* Known allergy or intolerance to medications used in the trial (local anesthetic, opioid)
* Infection at the injection site
* Body mass index \> 40kg/m2
* Spinal anesthesia
Screening in Myocardial Perfusion Patients

To expand the understanding of the uptake and distribution of Tc-99m sestamibi in the breast in a normal female population undergoing myocardial perfusion imaging using Molecular Breast Imaging (MBI).

You are being asked to take part in this research study because you have been scheduled to have a scan of your heart. The radioactive dye used to image your heart is also taken up by many types of breast cancer. The investigators have developed a new method for detecting breast cancer, called Molecular Breast Imaging that uses this dye.

The purpose of this study is to see how well this new method works in normal subjects with no known breast cancer and to see if we can detect breast cancer at an earlier stage than mammography. As you read this form describing the study, ask any questions you have. Take your time to decide. Feel free to discuss the study with your family, friends, and healthcare provider before you decide. You may stop participating at any time during the study. You may decide not to participate. If so, none of your current benefits or normal health care will be affected in any way. When you feel comfortable that all your questions have been answered, and you wish to take part in this study, sign this form in order to begin your participation. Your signature means you have been told about the study and what the risks are. Your signature on this form also means that you want to take part in this study.

Eligibility Criteria:
Inclusion Criteria:

* They have had a mammogram at Mayo Clinic Rochester within the last 12 months
* Undergoing myocardial perfusion imaging

Exclusion Criteria:

* They are unable to understand and sign the consent form
* They are physically unable to sit upright and still for 20 minutes
* They have undergone breast surgery or breast biopsy within the last 12 months.
* They have had trauma to the breast tissue or undergone radiation treatment to the breast within the last 12 months.
Joint Infection Following ACL Reconstruction

This study was conducted to analyze the effect of joint infection on the bone tunnel, graft and articular cartilage following arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with autologous hamstring, to summarize the features of MR findings after joint infection, and to correlate these findings with their possible factors.

A retrospective matched cohort study was performed in 26 patients who underwent arthroscopic single-bundle ACL reconstruction with hamstring graft and developed postoperative joint infection in our institute from January 2002 to December 2017. They were matched 1:3 to patients who did not sustain joint infection after ACL reconstruction. MR scan was collected at the time of follow-up. Bone tunnel enlargement at tunnel aperture, midsection and exit of tibial and femoral tunnel was carefully assessed. Graft signal-to-noise quotient (SNQ) on MRI was calculated to evaluate graft maturity. Cartilage morphology was graded using Whole Organ Magnetic Resonance Imaging Score. A generalized linear mixed model was applied to analyze the effect of joint infection on the bone tunnel, graft and articular cartilage.

Eligibility Criteria:
Inclusion Criteria:

* Age between 16 to 50 years;
* Underwent single-bundle ACL reconstruction with autologous hamstring;
* Had valid follow-up magnetic resonance imaging (MRI) at least 1 year after surgery

Exclusion Criteria:

* Concomitant ligament injury which need surgical repair;
* Delayed onset of postoperative joint infection (\>3 months after surgery).
Paclitaxel or S1 Plus Cisplatin in Concurrent Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus

The purpose of this study is to determine which regimen is better for esophageal squamous carcinoma in concurrent chemoradiation(CCRT),paclitaxel or S1 plus cisplatin.

Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.

Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PT regimen (cisplatin of 20 mg/m2/d, d1-3; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles or PS regimen (cisplatin of 20 mg/m2/d, d1-3; S1(Tegafur Gimeracil Oteracil Potassium Capsule)of 50mg/m2/d, d1-14) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically proven squamous cell carcinoma of esophagus .
2. Locally advanced esophageal cancer , with no operation indication
3. M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer
4. Subjects haven't been given neither radiotherapy nor chemotherapy before
5. Age of 18-70
6. PS ≦2
7. Hemogram : WBC≧ 4000/mm3 or ANC ≧ 2000 /mm3 and Platelet ≧ 100,000/mm3 . Biochemistry : GOT/GPT ≦ 3.5 times , Cr ≦ 1.5 mg/dl and Bilirubin ≦ 2.0 mg/dl
8. With no difficulty in eating
9. Expected lifetime ≧3 months

Exclusion Criteria:

1. Invasion to surrounding organ ( T4 disease ) .
2. Distant metastasis , except M1a disease .
3. Complete obstruction of the esophagus, or patients who have the potential to develop perforation
4. Women in status of pregnancy
5. Patients who have complications exist as following:

   * Uncontrolled angina and heart failure, have a history of hospitalization in 3 months
   * A history of myocardial infarction in the past 6 months
   * There is a need for antibiotic treatment of acute bacterial or fungal infection
   * Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization
   * Drug addiction, alcoholism and AIDS disease or long-term virus carriers
   * Uncontrollable seizures, or loss of insight because of mental illness
Load Control in Eccentric Exercises in Volleyball Players

Introduction. Vertical jump is the main movement in volleyball, and the main etiological factor of patellar tendinopathy. The eccentric exercise has been proved as the most effective intervention in improving this factor.

Aim. Annalise the effectiveness of the load control during the eccentric exercise to increase the cross-sectional area as well as the increase of the pain threshold of the patellar tendon, and the gain of the quadriceps maximum strength, in volleyball older players.

Study design. Randomized clinical study, simple blind, multicentric and with a follow-up period.

Methods. 40 volleyball players will be recruited, who will be randomized to the two groups: experimental (control of the load based on the RM during the eccentric exercise of quadriceps) and control (without load control). There will be an intervention of 4 weeks with 2 weekly seasons of 10 minutes each. The dependent variables will be: cross-sectional area (ultrasound evaluation), pain threshold in the patellar tendon (analog or digital algometer) and the maximum strength of the quadriceps (linear encoder or estimating the RM). In case of normality of the distribution of the sample, parametric tests will be used: student t-test of related samples (difference between evaluations in each rump) and repeated measures ANOVA (intra- and intergroup effect).

Expected results. To observe an increase in the cross-sectional area, pain-threshold of patellar tendon and quadriceps maximum strength.


Eligibility Criteria:
Inclusion Criteria:

* Volleyball players
* Federated that at the time of the study compete in clubs of the Community of Madrid
* Over 18 years old.

Exclusion Criteria:

* Present a medical diagnosis of injury or illness
* Have suffered a knee injury in the 6 months prior to the study
* Doing some pharmacological or physiotherapy treatment external to the study
* Not signed the informed consent document.
Evaluation of the Multidimensional Dyspnea Profile (MDP)

Aim of this multicenter prospective cohort study is the evaluation of the multidimensional qualities of dyspnea in a number of diseases using the Multidimensional Dyspnea Profile (Banzett et al, ERJ 2015).

The study sites will examine patients with COPD (Chronic obstructive pulmonary disease) in state of acute exacerbation and in stable state, patients with congestive heart failure (CHF) in state of acute decompensated cardiac insufficiency, and patients newly diagnosed with obstructive sleep apnea (OSA) as a control group.

In the acute setting of COPD and CHF, the questionnaire will be given at the day of hospital admission and at the day of discharge. The patients will additionally fill the Severe Respiratory Insufficiency (SRI) Questionnaire (in COPD) or the Physical Activity Questionnaire 50+ (in CHF).

In stable state of COPD, the questionnaires will be given once during a routine control visit at the hospital or the medical practice.

In OSA, the questionnaire will be given once during the first visit in the sleep laboratory.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients with acute exacerbation (Group I)
* CHF patients with acute decompensation (group II)
* stable COPD patients (group III)
* OSA patients with AHI\>15 (group IV)

Exclusion Criteria:

* Other severe acute diseases that contradict the participation in a clinical trial
* Simultaneous participation in another clinical trial
* Not capable of giving consent
* Language abilities and other disabilities that contradicts the understanding or completing of a clinical questionnaire
A Geriatric Mobile Team for Nursing Home Residents: a Feasibility Pilot Study

Nursing home (NH) residents have complex healthcare needs. Barriers to collaboration hinder the delivery of high-quality care in nursing homes. To bridge the gap between hospital-based and NH-based care, various innovative approaches have been proposed, including geriatric mobile teams. In Belgium, geriatric expertise has long been confined to hospital settings. Until recently, no specific organization existed for outpatient geriatric assessment, particularly for NH residents. In April 2024, the National Institute for Health and Disability Insurance (INAMI) introduced a new reimbursement code for geriatric consultations in NHs, promoting the development of extramural geriatric activities. However, evidence on the effectiveness of mobile geriatric teams remains limited, particularly regarding hospitalization prevention.

The geriatrics department of CHU UCL Namur is implementing a one-year pilot project involving a mobile team composed of a geriatrician and a nurse to conduct geriatric assessments in the three nursing homes. This non-randomized pilot project aims to establish a new standard of care for residents selected by their general practitioner, leveraging the new reimbursement code. The project is accompanied by a clinical study assessing the feasibility, effectiveness, and acceptability of this intervention. Prospectively collected data will also help define key indicators for a future large-scale study focused on cost-effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 70 years
* Presenting with one or more of the following conditions:

  * Difficulties in establishing an advance care planning
  * Medical complexity (multiple specialists, repeated hospitalizations)
  * Polypharmacy
  * Recurrent falls
  * Unmanageable behavioral disorders
  * Weight loss
  * Memory impairment

Exclusion Criteria:

* Patients with an unstable medical condition requiring urgent care
* Patients under 70 years old
* Patients whose condition requires examinations or treatments available only in a hospital setting
PEAnut Anaphylaxis Predictors

Peanut allergy can be life-threatening. Current diagnostic techniques for peanut allergy have high sensitivity, but not high specificity. This clinical trial will test the validity of a novel blood biomarker (compared with current testing) as a diagnostic predictor of anaphylaxis to peanut.

Children aged 2-17 years with suspected peanut allergy will be invited to participate in the study.

They will have a questionnaire, a skin prick test to peanut, 2 breathing tests (spirometry and fraction of exhaled nitric oxide (FeNO)), and a blood test (specific peanut antibodies, allergic immune responses - including the novel blood biomarker - and genetic testing to identify novel potential molecular and genetic markers of food allergy in the future. The genetic testing component will be optional). The breathing test is not required for those under 6 years.

The final step is an open label peanut food challenge with incremental doses of peanut, (routine practise) as per the Australasian Society of Clinical Immunology and Allergy (ASCIA) food challenge protocol.The endpoints in the food challenge will be signs of allergy or anaphylaxis as per PRACTicing ALLergology (PRACTALL) consensus report for oral food challenges OR completion of the ASCIA food challenge protocol.

Outcome: The primary outcome of the project is to confirm that a novel blood biomarker has a higher diagnostic accuracy as compared to current best testing in predicting anaphylaxis at open label peanut challenge.

Secondary outcome: Will be to determine the value of the biomarker, FeNO and Ara h2 specific Immunoglobulin E (sIgE) (individually and in combination) at predicting anaphylaxis or clinical allergy at open label peanut challenge.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 2 - 17 years with an allergy to peanut and require peanut challenge to confirm peanut allergy.

Exclusion Criteria:

* Children with Peanut Skin Prick Test (SPT) wheal size greater than 10mm as these children are likely to have clinical peanut allergy (no clinical indication for food challenge).
Safety of Inhaled Hydrogen Gas Mixtures in Healthy Volunteers

Hydrogen gas may decrease the degree or incidence of brain injury following ischemia. The purpose of this study is to determine the safety and tolerability of inhaled hydrogen gas at the dose exposures required for a clinical efficacy study in healthy adult participants. Participants will breathe a gas mixture that contains a low concentration of hydrogen gas in air through a high flow nasal cannula. Investigators will test for any changes in breathing and neurologic status, as well as lab tests during and following the exposure period.

Inhaled hydrogen gas (H2) has been shown to have significant protective effects on ischemic organs. Clinical trials abroad have shown promise that treatment of patients suffering from stroke, cardiac arrest, or heart attacks may benefit from inhaling hydrogen gas during the early recovery period.

The purpose of this study is to determine the safety and tolerability of inhaled hydrogen gas at the dose exposures required for a clinical efficacy study in healthy adult volunteers.

Study design. Eight (8) healthy adult participants will be recruited from the greater Boston area for this study. Consenting participants will be admitted to the hospital and will undergo a series of screens (questionnaires, examination, tests) to ensure suitability to participate. Eligible and consenting participants will then undergo exposure to 2.4% H2 in medical air via high flow nasal cannula for either 24 (n=2), 48 (n=2) or 72 (n=4) hours. Participants will be screened for adverse effects as follows: vital signs every 8 hours, nursing assessment of symptoms (codified based on the National Cancer Institute's Common Terminology Criteria for Adverse Events, CTCAE) every 8 hours, bedside spirometry daily, mini-mental state exam daily, physician physical exam daily, and serum testing (blood count, chemistry, liver and coagulation profile, venous blood gas) following exposure period.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 35
2. Able to remain inpatient for duration of admission (24-72 hours)

Exclusion Criteria:

1. History of any chronic illness, including respiratory disorders such as asthma, chronic obstructive pulmonary disease, prior acute lung injury or acute respiratory distress syndrome;
2. Inflammatory disorders, such as lupus erythematosus, inflammatory bowel disease;
3. Heritable disorders, such as trisomy 21, cystic fibrosis;
4. Mitochondrial disorders;
5. Currently smoking cigarettes or have a history of smoking cigarettes;
6. The regular use of prescription medications (except for contraceptive medications) within 30 days of enrollment;
7. Any lifetime inpatient hospitalization for respiratory illness;
8. Pregnancy.
Early Child Care and Risk of Obesity

The purpose of this study is to examine risk factors associated with infant growth and the development of obesity in the first year of life. The investigators plan to establish a racially and ethnically diverse southern cohort of 800 mother/infant dyads, followed regularly from birth to 12 months of age. The cohort will be residents of Durham, North Carolina (NC) and the immediate surrounding area. The proposed longitudinal study will examine factors contributing to the development of obesity, including dietary behaviors, physical activity and inactivity, stress, and sleep duration and quality. Frequent in-home assessments throughout infancy and contact with other care providers will help pinpoint exactly when children begin to gain weight excessively and will identify risk factors related to energy intake, energy expenditure, stress, and sleep associated with obesity.


Eligibility Criteria:
Inclusion Criteria:

* mother over 18
* in 2nd or 3rd trimester of pregnancy with singleton
* speak and read English
* planning to stay in area for the first year of baby's life

Exclusion Criteria:

* baby born with conditions that may affect weight, feeding or motor activity
Malt-derived Ingredients and Their Prolactinotrophic Effects

This proof-of-concept study aims to investigate whether malt-derived ingredients have acute prolactinotrophic effects in healthy women of child-bearing age.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have/are

  1. Willing and able to provide written informed consent
  2. Healthy women aged 18 to 40.
  3. BMI in the range of 18 to 30.
  4. Willing to undergo an experiment in the follicular phase of the menstrual cycle i.e. day 0 to 14 of the menstrual cycle starting from the first day of the period.

Exclusion Criteria:

* Subjects who have/are
* Allergic to tested products
* Under regular medication including oral contraceptive pills or other form of hormonal replacement therapy.
* Under medications which affects prolactin levels.
* Pregnant or lactating or planning to conceive during the study period.
* Smokers, or excessive alcohol consumption (alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer) or other substance abuse.
* Not willing and/or not able to comply with the study procedures and requirements.
* Suffering from pre-existing medical conditions and chronic illnesses that in the opinion of the investigator may interfere with the study.
* Family or hierarchical relationships with research team members
Peroral Endoscopic Remyotomy for Failed Heller Myotomy

Achalasia is a rare esophageal motility disorder, which is characterized clinically by symptoms of dysphagia, regurgitation, weight loss and chest pain. With respect to long-term efficacy, Heller myotomy (HM) using an open or a laparoscopic approach has gained wide acceptance as the procedure of choice for the management of patients with primary achalasia in recent years. Although good or excellent long-term symptomatic response rates can be achieved in more than 90% of patients undergoing HM, recurrence or persistence of symptoms occurs in approximately 20%. Controversy exists regarding the therapy of patients with failed success after HM. Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia. Our purpose was to evaluate the efficacy and the feasibility of POEM for patients with failed HM.

1. Patients were eligible for enrollment in the study if they were age greater than 18 years and had recurrence/persistence of symptoms after primary HM with an Eckardt symptom score ≥ 4. The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy (EGD)). Exclusion criteria were severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk, pseudoachalasia, and megaesophagus (diameter of \> 7 cm).
2. All patients were scheduled for a follow-up visit at 1 month after POEM for EGD and manometry. Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires.
3. The primary outcome of the study was therapeutic success (a reduction in the Eckardt score to ≤3) at the follow-up assessment. The secondary outcomes included procedure-related adverse events, LES pressure on manometry pre- and post POEM, reflux symptoms and medication use before and after POEM, and procedure-related parameters such as procedure time, hospital stay, and myotomy length.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Recurrence/persistence of symptoms after primary HM with an Eckardt symptom score ≥ 4
* The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy)

Exclusion Criteria:

* Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk
* Pseudoachalasia
* megaesophagus (diameter of \> 7 cm)