cyrilzakka/clinical-trials huggingface dataset:
Effect of Osteopathy Medicine on Post-surgical Management of Lumbosacral Arthrodesis

Introduction : Low back pain represents a major public health issue. In some cases, surgery may be necessary, but it is not without consequences. Among these, we find pain that may require management in specialized centers as well as functional disability, particularly in cases of arthrodesis, thereby affecting the quality of life of patients. Objectives : To study the effectiveness of osteopathy in the post-surgical management of lumbo-sacral arthrodesis. Methods : A pilot study including 35 patients who underwent lumbo-sacral arthrodesis divided into 2 groups: standardized osteopathic treatment and sham. The protocol consists of 2 post-operative sessions (D2 3 and D90). The evaluated criteria were pain intensity using the VAS, functional disability with the Oswestry questionnaire, anxiety and depression with the HAD questionnaire, and analgesic consumption. Result : Compared to the sham group, the osteopathic treatment group exhibited a lack of significance in the VAS (p= NS), Oswestry (p= NS) and HAD (p= NS) scores. Analgesic consumption also demonstrated a lack of statistical significance (p= NS). Discussion : In this study, osteopathy did not show an impact on HAD, Oswestry, VAS scores, or analgesic consumption. Based on other articles, there seems to be a link between the effectiveness of osteopathy and the frequency of sessions. Thus, it might be interesting to repeat the study with a larger sample size, the use of other measurement tools, and an increase in session frequency to validate these results.


Eligibility Criteria:
Inclusion Criteria:

* having surgery in Institut de la Colonne Vertébrale
* surgery of lumbosacral arthrodesis

Exclusion Criteria:

* spine deformation
* inflammatory rhumatim
* neurodegenerative pathology
* cognitive trouble
* neoplasic pathology
* surgery complication
* second surgery
* out of the study
Proton Pump Inhibitor Use is Associated With High Risk of Pneumonia in Chronic Kidney Disease Patients

Chronic kidney disease is a severe medical problem in Taiwan public health issue, which the highest incidence and prevalence rate in the world.Proton pump inhibitors may increase the risk of pneumonia appearance, which were caused by profound irreversible gastric acid suppression. The study purpose was to characterize difference of developing pneumonia in chronic kidney disease of prior use proton pump inhibitors.

The study used data from Taiwan Health Insurance Research Database; the investigators conducted a population-based cohort study in Taiwan. Case consisted of all patients who had a first diagnosis of chronic kidney disease for the period between 1997 and 2008. The investigators utilized the use of Proton pump inhibitor from chronic kidney disease patients.

Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease

Exclusion Criteria:

* excluded those patients who had ever been diagnosed with CKD before 1997
Understanding Mechanisms of Health Behavior

This research seeks to examine psychological factors that may impact relationship between incentives and health behavior engagement, specifically fruit and vegetable consumption. Additionally, it will compare the impact of two different incentive schedules on behavior engagement, one providing immediate rewards (i.e. rewards received on a daily basis) and another providing delayed rewards (i.e. rewards received at the end of the study period), with a control condition in which no rewards are offered. Study participants will provide reports of their fruit and vegetable consumption each day for three weeks, and in the two incentive conditions, they will receive small monetary rewards for their fruit and vegetable consumption. Following the three week reporting and reward period, participants will complete two additional assessments, measuring psychological constructs and behavior engagement following the cessation of rewards.


Eligibility Criteria:
Inclusion Criteria:

* Consume fewer than 5 servings/day of fruits and vegetables
* Daily access to internet for 3 weeks following baseline session
* Have or are willing to create an account on PayPal

Exclusion Criteria:

-
Assessment of Quality of Life After Low Anterior Resection During Cytoreductive Surgery for Advanced Ovarian Cancer

This study aims to evaluate the incidence of low anterior resection syndrome and quality of life after cytoreductive surgery for advanced ovarian cancer patients.

In advanced ovarian cancer, 24-64% of patients require removal of tumors located in the rectum and sigmoid colon. In order to remove the tumor located in the rectum and sigmoid colon, low anterior resection (LAR) is performed to excise the rectum and sigmoid colon. All patients who underwent low anterior resection are at risk of developing low anterior resection syndrome, which presents symptoms such as frequent bowel movements, frequent defecation, and impaired stool control. Therefore, this study aims to evaluate the incidence of low anterior resection syndrome and quality of life after cytoreductive surgery for advanced ovarian cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Those with newly diagnosed ovarian cancer, fallopian tube cancer and primary peritoneal carcinomatosis who plan to undergo cytoreductive surgery and secondary cytoreductive surgery after neoadjuvant chemotherapy.
* Patients with PCDS or rectal and sigmoid coloni tumor invasion suspected on the preoperative image and need resection of the tumor and clinical FIGO stage IIIB or higher
* ECOG performance status : 0-2
* Age over 18

Exclusion Criteria:

* Patient who underwent low anterior resection in the past
* Past history of gastrointestinal malignant tumor except to ovarian cancer
* Patient who have colostomy
* Patient who underwent radiation therapy to abdominal or pelvic cavity
* ECOG performance status over 3
* Patient taking opioid analgesics
* Patient who have intellectual disability or dementia
Allergy and Asthma Following Children Who Were Fed Supplemented Infant Formula

Long-term cognitive outcome study of children who participated in randomized trials of LCP-supplemented formula during infancy.


Eligibility Criteria:
Inclusion Criteria:

* children previously randomized in a clinical study consuming LCP-supplemented infant formula

Exclusion Criteria:

* children who did not previously participate in a randomized clinical study consuming LCP-supplemented infant formula
Tendyne European Experience Registry

TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.

Mitral regurgitation (MR) is a common disease and is associated with high morbidity and mortality if left untreated. Due to age and comorbidities, patients are often ineligible for surgical repair or replacement. Over the last years, transcatheter systems have been introduced as an alternative therapeutic approach. The Tendyne Mitral Valve System (Abbott Vascular, Roseville, Minnesota) is a transcatheter transapical, self-expanding valve prosthesis for mitral valve replacement. A recent study has proven safety and feasibilty of the system, leading to commercial approvement (CE mark). However, data on real world experience with the system are not available.

TENDER is a multicenter, single-device, retrospective and prospective, observational study. Objectives of the study are 1) to assess early outcomes, including safety and efficacy, in patients treated with the Tendyne Mitral Valve System for severe MR at 30 days, 2) to assess clinical outcomes in patients treated with the Tendyne Mitral Valve System for severe MR at 1 year and 3 year follow-up, and 3) to identify echocardiographic and CT-based anatomic predictors associated with outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with the Tendyne Mitral Valve System for mitral valve disease in a commercial setting
* Patients providing written informed consent in compliance with the protocol, the ICH-GCP and all national legal and regulatory requirements

Exclusion Criteria:

* Patients not providing written informed consent
Treatment With UX007 for a Single Patient With GLUT1 Deficiency Syndrome

This treatment plan is intended for the use of UX007 (triheptanoin) in the treatment of a single patient with Glucose Transporter 1 (GLUT1) Deficiency Syndrome.

This treatment plan is intended for the use of UX007 (triheptanoin) in the treatment of a single patient with Glucose Transporter 1 (GLUT1) Deficiency Syndrome. Patient has already tried the other acceptable treatments for GLUT1 with either side effects that caused treatment to be discontinued (Ketogenic Diet) or a current treatment that is not showing any efficacy and is difficult to sustain for a long duration given this patient's age (modified Atkins diet). Due to the patient's ongoing neuroregression and lack of other viable treatments, the use of UX007 (triheptanoin) is warranted. There is no comparable or satisfactory alternative therapy to treat this patient's severely debilitating condition and the potential benefits to the patient justify the potential risks of the treatment. The potential risks from UX007 (triheptanoin) are not unreasonable given the context of this patient's condition.

Eligibility Criteria:
Inclusion Criteria:

* This treatment plan is intended for the use of UX007 (triheptanoin) in the treatment of a single patient with Glucose Transporter 1 (GLUT1) Deficiency Syndrome.

Exclusion Criteria:

* Not applicable as study only includes one patient.
Tunneled Pleural Catheter in Partially Entrapped Lung

An open randomized, prospective, single center; parallel group trial to compare efficiency and safety of PleurX-Pleural Catheter versus standard surgical treatment in patients with malignant pleural effusion and partial entrapment of the lung.

Patients with malignant pleural effusions undergo VATS-procedure. In the intraoperative finding of a partially entrapped lung, patients are randomized in 2 groups.

Arm 1: Insufflation of talc and insertion of a (standard) drainage which will be removed 4-7 days after surgery.

Arm 2: Insufflation of talc and insertion of a (standard) drainage which will be removed 4-7 days after surgery. Additionally, a subcutaneous tunneled catheter will be inserted and will remain in situ

Follow up period is 3 Months

Primary objective is the comparison of quality of life between the 2 arms.

Secondary objective is the reliability of the subcutaneous tunnelled catheter in practice as well as function and dysfunction of the drainage system. Clinical parameters (respiratory function measured as FEV1 and vital capacity, recurrent pleural effusion, infection, need for relief of effusion or pleuracentesis) are observed.

Eligibility Criteria:
Inclusion Criteria:

* One-sided malignant pleural effusion, first occurrence, or following repeated pleuracentesis
* History of dyspnea relieved after pleuracentesis
* Patient is suitable for VATS
* Surgery is indicated by diagnostic necessity
* Ability of subject to understand character and individual consequences of clinical trial
* Written informed consent must be available before enrolment in the trial
* For women with childbearing potential, adequate contraception.
* Histological proven pleural carcinosis by immediate sectioning
* Intraoperative: partial entrapment of the lung

Exclusion Criteria:

* Prior lobectomy or pneumonectomy on the affected side
* The patient is not operable for general reasons or Karnofsky performance score \< 50
* Intraoperative suspicion of a pleural empyema
* Chylothorax
* Prior attempts at pleurodesis
* Intended or prior intrapleural chemotherapy or radiotherapy
* Pregnancy and lactation
* Participation in other competing clinical trials and observation period of competing trials
Efficacy of Doxycycline Prophylaxis to Reduce Syphilis in High-Risk, HIV-Positive MSM

This pilot study will investigate the feasibility of conducting a large, randomized trial comparing a structural intervention to contingency management to reduce incident syphilis infections in an especially high risk group: HIV+ men who have sex with men (MSM) who have had syphilis twice or more since their HIV diagnosis. Subjects will be randomized to receive either QD doxycycline as syphilis prophylaxis or a financial incentive to remain STI free. The investigators will : 1) measure adherence to study visits in both arms; 2) measure adherence to the prophylaxis regimen; 3) measure any changes in risk behaviors among study participants and 4) to the extent possible in a small pilot study of short duration, compare effectiveness of doxycycline with that of a monetary incentive for remaining STI free.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected MSM or transgender women who have sex with men
* At least two documented and adequately treated episodes of syphilis since HIV diagnosis

Exclusion Criteria:

* Had a known allergy or intolerance to doxycycline
* Abused alcohol or other substances which in the opinion of the investigators would jeopardize adherence to study procedures
Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries

Permanent dependency of breathing apparatus due to spinal cord injury is traditionally treated with different types of mechanical ventilation. However, the electric ventilation became a possibility through their most current versions, such as diaphragmatic pacemakers.

Diaphragmatic pacemakers rhythmically stimulates the diaphragm to replace the functions of the respiratory center that doesn't works well or is inaccessible. However, this modality has the prerequisite that the phrenic nerve and diaphragm muscle are normal. The reason for the development of diaphragmatic pacemaker freeing the patient from the ventilator.

By using the mechanical energy of the diaphragm of the patient, the patient may come not need the ventilator tubing, tracheostomy, and with the help of their caregivers, the inconvenient mechanical ventilators.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or more
* Cervical spinal cord injuries patients under mechanical ventilation
* Clinically stable after spinal cord injury
* Clinical acceptable bilateral phrenic nerve function demonstrated with electromyography and neural conduction time
* Fluoroscopic visible diaphragmatic movements under stimulation
* Hemodynamically stable
* No co-morbidities that can interfere with pacemaker implantation or function
* Pregnancy negative test for women
* Patient or legal representative informed consent

Exclusion Criteria:

* Active pulmonary disease
* Active cardiovascular disease
* Active cerebral disease
* Hemodynamic instability or low oxygen levels in ambient air
* Hospitalization for infection in the last 3 months
* Significant scoliosis or chest disease
* Obesity
* Poor compliance to the protocol from the patient or the caregiver
Genetically-informed Behavioral and Cognitive Interventions for the Management of Tinnitus

Psychological and behavioral interventions, such as Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT), are commonly applied either alone or in combination for the management of tinnitus but selection of the intervention model remains arbitrary. Our purpose is to evaluate the hypothesis that genetic markers may guide the choice of tinnitus treatment towards improved therapeutic outcomes. Patients with subjective idiopathic tinnitus are assigned to either a genetically-informed CBT or TRT intervention protocol based on the status of four single nucleotide polymorphisms (SNPs) of the dopamine and serotonin pathways, namely COMT rs4680, HTR2A rs7997012, HTR2A rs6311, and TPH2 rs4570625, that have been associated with behavioral or cognitive responses (Group A), or to a conventional approach (Group B) in which the choice of treatment was not directed by genotypic data. Tinnitus Handicap Index (THI) scores of perceived tinnitus severity are recorded at the initial and at the fourth session of treatment using appropriate questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* adult patients with bothersome bilateral non-pulsative tinnitus and hearing loss

Exclusion Criteria:

* no major comorbidities
* no psychiatric history
Effectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis

The purpose of this study was compare the efficacy of two exercise programs - the first consisting of balance training and muscle strength and the second consisting of balance training and muscle stretching exercises - to improve postural control in elderly women with osteoporosis.

The decrease in postural control and muscle strength in lower limbs have been identified as major risk factors for falls in older people. Exercises have proven effective in decreasing risk factors in healthy elderly, but little is known about the effects of interventions with exercise in the elderly with osteoporosis.

Objective: To compare the efficacy of two exercise programs - the first consisting of balance training and muscle strength and the second consisting of balance training and muscle stretching exercises - to improve postural control in elderly women with osteoporosis.

Methods: Fifty elderly aged 65 or older, with a diagnosis of osteoporosis, were randomized into 3 groups: Strength Group (n = 17) performed balance training with muscle strengthening; Stretching Group (n = 17) performed balance training with stretching; and Control Group (n =16) did not do activity. The groups trained for 8 weeks, with sessions of about 60 minutes, twice a week. Postural control was evaluated by Modified Clinical Test of Sensory Interaction for Balance (CTSIBm) and Limits of Stability test (LOS) in Balance Master force plate, the functional balance by Berg Balance Scale (BBS), muscle strength by dynamometry, the shortening of the hamstrings by goniometry and posture by PAS/SAPO (Postural Assessment Software).

Eligibility Criteria:
Inclusion Criteria:

* women from 65 to 80 yrs of age
* diagnosis of osteoporosis classified according to the criteria of the World Health Organization, with bone mineral densitometry reduced by at least 2.5 SD when compared with young adults (region of lumbar spine)

Exclusion Criteria:

* severe visual deficiency
* physically incapable of participating in the tests
* neurological disorders, amputations, or prostheses
* individuals with regular physical activity (twice or more per week) or who had recently participated in exercise programs for muscular strength or balance
Elastographic Imaging of Renal Transplants

The study was developed to acquire images of normal, then abnormal, then unknown diagnosis for transplanted kidneys in order to determine whether the elastography imaging modality, a type of ultrasound imaging, can provide data useful for diagnosis of renal transplant abnormalities.

The specific aims of this study are:

1. To define normal elastography imaging by correlation with clinical findings.
2. To define specific abnormal elastography images by correlation with clinical findings.
3. To determine whether elastography could be useful in early diagnosis of abnormalities of renal transplants, especially in early rejection.

The study is collecting standard ultrasound and elastographic images of transplanted kidneys in order to perfect the imaging technique to get the best pictures, and to evaluate these images for characteristics that may be of diagnostic value.

Eligibility Criteria:
Inclusion Criteria:

* Adult (over 18) male or female renal transplant patient
* normally functioning
* or being evaluated for a possible problem

Exclusion Criteria:

* unwilling or unable to give informed consent
Assessment of the Glycemic Responses to Nutritional Products (v2.0)

This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or the test product. Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Several nutritional products will be tested over time.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 65 years
* Body mass index (BMI) between 18.5 and 27 kg/m²

Exclusion Criteria:

* Known history of gastrointestinal disease, bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2)affect the results.
* Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
* Major trauma or surgical event within 3 months of screening.
* Known intolerance, sensitivity or allergy to test products.
* Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
* History of cancer in the prior two years, except for non-melanoma skin cancer.
Asthma L-Citrulline Pilot Study

This study will evaluate whether treatment with L-citrulline, which is an amino acid found in some foods, can increase levels of L-arginine and thereby restore the concentration of nitric oxide (NO) in the airways.

Research has shown that some obese asthmatics have a metabolic imbalance in which L-arginine levels are reduced. L-arginine is an amino acid that is used to make NO, a gas that is normally made in the bronchi and ensures that the lungs function properly. In this pilot study subjects with asthma that have an increased body mass index compatible with being obese, will be invited to participate in a short open-label treatment with 15g/day of L-citrulline for two weeks. Study participants will be asked to do lung function testing and donate blood before and after taking the supplement. L-citrulline is safe and well tolerated and has been used at much higher doses without significant side effects.

Eligibility Criteria:
Inclusion Criteria:

* Adequate completion of informed consent process with written documentation
* Male and female patients, 18 - 70 years old, inclusive
* Physician diagnosis of asthma (for medical records, ICD 10 coding for physician's diagnosis)
* All racial/ethnic backgrounds may participate
* BMI ≥ 30
* Treatment of controller asthma medication(s) ≥ 4 weeks
* Smoking history ≤10 pack years and no smoking in the last year
* V1 eNO ≤ 30ppb (may be repeated 3x during visit; lowest ppb will be kept)

Exclusion Criteria:

* Respiratory tract infection within the 4 weeks prior to the study (may re-enroll after 4 weeks).
* Oral or systemic corticosteroid burst (for any indication) within the 4 weeks
* One-time doses, such as intra-articular injections into a shoulder or knee joint, require a 2-week washout.
* Asthma-related ER visit within the previous 4 weeks of Visit 1
* Significant concomitant medical illness, including (but not limited to)

  * Heart disease
  * Cancer
  * Uncontrolled diabetes,
* Chronic renal failure (creatinine \> 2.0) at Visit 1 (Associated with higher ADMA levels)
* Untreated sleep apnea
* Other chronic lung/respiratory diseases (COPD, IPF, etc.)
* High dose inhaled steroids (\> 1000 mcg/day of Fluticasone or equivalent)
* Current statin use (statins lower ADMA levels); patients may stop statins with approval from their primary physician and enroll after a 6-week washout
* Positive urine pregnancy test at Visit 1 or at any time during the study
* Intolerance or allergy to L-arginine or L-citrulline
* Concomitant use of PDE5 drugs or oral mononitrates
* Participation in an intervention study, use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study
* Unable or unlikely to complete study assessments in the opinion of the Investigator
* Study intervention poses undue risk to patient in the opinion of the Investigator
* Breastfeeding