cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment

This prospective cohort study investigates the surgical outcomes of laparoscopic pectopexy and laparoscopic colporraphy performed at the Wellbeing Services County of South Ostrobothnia. The primary outcome measure is to assess changes in sensation of bulge and pressure. Secondary outcome measures include evaluating other prolapse symptoms and pain, quality of life, anatomical correction of prolapse, surgical safety parameters, and postoperative complications. Approximately 40-50 laparoscopic pectopexies will be performed over two years by a single experienced surgeon. The study requires preoperative and postoperative assessments, including standardized patient questionnaires and anatomical measurements.

The study aims to evaluate the effects of laparoscopic pectopexy and colporraphy on pelvic organ prolapse (POP) symptoms, anatomical prolapse repair, and surgical outcomes. The primary outcome measure is the presence of a bulging sensation 12 months after surgery. Secondary outcome measure includes additional prolapse-related symptoms, residual urine volume, pelvic pain, urinary incontinence, and safety parameters such as intraoperative blood loss and complications. Anatomical correction will be assessed using the Pelvic Organ Prolapse Quantification (POP-Q) system.

All surgical procedures will be performed by a single experienced surgeon with over five years of experience and more than 100 laparoscopic pectopexies performed. Patients will undergo laparoscopic pectopexy, with or without concomitant anterior and posterior vaginal wall repair using sutures. The pectopexy procedure utilizes a 3x15 cm Dynamesh PRP PVDF mesh, secured with absorbable monofilament thread to the vaginal cuff or with non-absorbable multifilament sutures to the uterine cervical stump.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic pelvic organ prolapse
* Uterine or vaginal vault prolapse reaching the hymenal ring (POP-Q classification: ≥0 cm)
* If uterus in situ, consent for supracervical hysterectomy
* Suitable for laparoscopic mesh surgery
* Age: 18-79 years
* Non-pregnant, no pregnancy desire.
* Sufficient Finnish language skills
* Concurrent anterior and/or posterior prolapse repair if POP-Q criteria met: tvl \>8 cm and Aa, Ba, Ap, Bp ≥0

Exclusion Criteria:

* Unwillingness to undergo surgery or mesh implantation
* High anesthetic or surgical risk due to comorbidities
* Indication for laparoscopic sacrocolporectopexy due to rectal intussusception
* Desire to preserve the uterus
* Pregnancy or planning future pregnancy
* Inability to understand Finnish or study-related forms due to cognitive impairments
* Need for concomitant urinary incontinence surgery
Study on the Effects of an EMG-controlled Functional Electrical Stimulator for Upper Limb for Post-stroke Patients

Upper limb disabilities are among the most debilitating issues after a cerebral stroke. One promising approach in motor rehabilitation is the use of functional electrical stimulation (FES). This technique can be integrated into daily therapy to follow an adaptive approach, exploiting the residual capacities of patients. FES can help to stimulate the affected muscles, improve coordination and strengthen the weakened muscles, thus supporting the rehabilitation process.

FitFES is a wearable and non-invasive device that provides continuous stimulation set according to the residual myoelectric activity of hemiparetic muscles. Its bioinspired functioning has been implemented to restore the neurophysiological feedback from the muscles to the central nervous system while performing voluntary movements. This study aims to assess the effects of FitFES device on upper limb motor rehabilitation of post-stroke subjects, compared to traditional rehabilitation treatment. 50 post-stroke subjects will be recruited and randomized into an experimental group and a control group.

All participants will follow a 15-session rehabilitation program, and in each session they will execute task-oriented exercises. The experimental group will be assisted by the FitFES device, while the control group will perform the tasks without the device support.

Each subject will be assessed before and at the end of the rehabilitation protocol. Collected data from both groups will then be compared.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosis of first ischemic or hemorrhagic unilateral stroke for at least two weeks
* Medical Research Council score for at least one upper limb muscle greater than 0 and less than 5 (excluding extremes).
* Signed informed consent

Exclusion Criteria:

* Score at the Mini Mental State Examination (adjusted for age and schooling) \< 24
* Clinical evidence in the case of visual disturbance, ideomotor apraxia, behavioral disorders, neglect, sensory, visual and auditory disturbances of severe degree or otherwise that prevent use of the device
* Major head trauma
* Cardio-respiratory or internal clinical instability
* State of pregnancy or lactation
* Severe spasticity (Ashworth \> 3)
* Skin integrity problems at the interface surface with the device
* Implanted electronic devices
* Epilepsy not medically controlled
* Severe peripheral neuropathy
* Recent interventions
* Thrombosis, thrombophlebitis
* Active stent carrier less than six months
* Severe forms of arteriosclerosis, arterial circulatory disorders
* Hypertension not treated
* Cardiac arrhythmias
* Hemorrhagic disorders (hemophilia)
* Severe forms of diabetes mellitus
* Known allergy to materials making up the device or its applied parts
* Cancer or tumour disease
* Acute arthritis
* Other neurological diseases other than stroke
* Progressive muscular dystrophy
* Abdominal or inguinal hernias
* Undiagnosed back pain
* Diseases of internal organs
The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis

A majority of patients with end-stage renal disease (ESRD) on in-center hemodialysis (HD) require several hours to recover from fatigue after an HD session. Evidence for practical interventions to improve this recovery time from conventional in-center HD is lacking. This study investigates the effects of reducing HD blood flow rates on patients' self-reported post-dialysis fatigue.

Post-dialysis fatigue reduces patients' quality of life and is also associated with cardiovascular events and mortality. Dialysis recovery time (DRT) is a measure of post-dialysis fatigue. Internationally, it has been found that more than a quarter of maintenance HD patients report \>6 hours of DRT. The interventions showing the most improvement in DRT involve increases in treatment time, suggesting that post-dialysis fatigue may be in part related to the rate of solute clearance. Solute clearance rate is just one part of extending dialysis time, and its effect on DRT in patients undergoing typical-length dialysis sessions is not known. There is scant evidence to guide blood flow rate prescriptions aside from meeting clearance targets. Blood flow rate reductions are easily-implementable interventions that would slow solute clearance rates and may have an effect on post-dialysis fatigue.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of end-stage renal disease undergoing hemodialysis in the San Francisco Bay Area at approved Satellite Healthcare dialysis centers.
* Dialysis recovery time of 6 or more hours.
* Not hospitalized in the 7 days prior to study

Exclusion Criteria:

* Currently or possibly pregnant, currently trying to become pregnant
* Inability to provide informed consent
* Inability to provide responses to survey questions
* Planned move away from the current hemodialysis center within the study period
* Undergoing nocturnal hemodialysis, planned changed to nocturnal or peritoneal dialysis, planned kidney transplant within the study period, or other major planned change in hemodialysis prescription
* Primary nephrologist objection to enrollment
The Effectiveness of Graston Tecnique Compared to Traditional Physiotherapy to Improve Range of Motion After Arthroscopic Cuff Repair.

In shoulder rehabilitation after arthroscopic cuff repair, one of first objectives coincides with improving the range of passive movement: this process often requires considerable time of both patients and physiotherapists. This study aims to verify whether it is useful to add instruments assisted soft-tissue mobilization according to Graston Tecnique to the classic rehabilitation protocol in order to accelerate recovery times of passive range of motion.

There is conflicting evidence about early versus delayed postoperative rehabilitation after arthroscopic cuff repair: early protocol seems to reduce the risk of stiffness but could increase the risk of rupture of the tendon in long time, especially for large tears; delayed protocol impose a period of shoulder immobilization (from 2 weeks to 40-day) that can promote tendons healing but could determine shoulder stiffness. Our research question is if after the delayed protocol used in our institute (40 -day immobilization period) it migh be useful to add soft-tissue mobilization assisted by instruments according to Graston Tecnique to the classic rehabilitation protocol of the shoulder in order to speed up recovery times of the passive movement range.

Eligibility Criteria:
Inclusion Criteria:

* arthroscopic rotator cuff repair
* partial lesion due to tendon degeneration (1 or 2 anchors reparation)

Exclusion Criteria:

* traumatic tendon lesions
* associated conditions as arthritis, loss of superficial sensitivity, loss of muscle tone, mental impairment, oncological conditions
* shoulder stiffness before surgery due to calcific tendonitis, adhesive capsulitis
ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis

Phase 1B randomized, double-blind, placebo-controlled, two-cohort clinical trial of ABI-M201 in adult subjects with mildly-to-moderately active Ulcerative Colitis(UC) and ongoing treatment with mesalamine.

This multi-center randomized, double-blind, placebo-controlled study will evaluate the safety of ABI-M201 and its effects on disease activity measures in men and women with mildly-to-moderately active UC and ongoing treatment with mesalamine. The study will consist of 2 sequential, non-overlapping participant cohorts, separated by intervening interim analysis (IA). Both cohorts will involve 8-weeks of study drug treatment. Interim data from the initial treatment cohort (Cohort A) will inform decision to advance to the subsequent second cohort (Cohort B) and its dose selection. 20 subjects will be randomized to cohort A (1:1 allocation) and receive treatment with 1 capsule per day of ABI-M201 versus Placebo. 24 subjects will be randomized to cohort B (3:1 allocation) and receive treatment with up to 5 capsules one time a day of ABI-M201 versus Placebo.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of UC for at least 3 months prior to screening, with minimum disease extent of 15 cm from the anal verge
* Mildly to moderately active UC
* Inadequate response to ongoing treatment with oral mesalamine ≥2.4 g/day for ≥4 weeks from screening visit

Exclusion Criteria:

* Possible or confirmed diagnosis of Crohn's Disease or other forms of inflammatory bowel disorders
* Ongoing or failed prior treatment for UC with methotrexate, azathioprine, 6-mercaptopurine, cyclosporine, tofacitinib, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (FK-506), or biologics (e.g., TNF-alpha-antagonists, anti-integrin therapies, or agents targeting IL-12 or IL-23, etc.)
* Any immunosuppressive condition or treatment with immunosuppressive medications
* History of prior surgical intervention in any region of the gastrointestinal tract (excluding minor surgery)
* Prior diagnosis of any cardiovascular, renal, hepatic, endocrine, infectious, hematological, oncologic, neuro-psychiatric or immune-mediated disorder, which in the opinion of the Principal Investigator might impact the subject's safety or compliance, or the interpretation of results
* Treatment with any other investigational drugs ≤12 weeks prior to baseline visit
* The participant has a condition or is in a situation which, in the Principal Investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise

This non-interventional observational study is designed to gain data for Neupro® in restless legs syndrome (RLS) under real life conditions in line with the summary of product characteristics (SmPC) related to effectiveness, tolerability and switching practice from other dopaminergic drugs as well as titration schemes.

There is a total of 64 subjects recorded as having discontinued due to Adverse Events. Documentation of Visit 2 and Visit 3, where the reason for discontinuation was documented, was not available for all subjects. From the documentation on the Adverse Events page in the Case Report Form, it is known that 100 subjects discontinued due to Adverse Events.

The Last Observation Carried Forward (LOCF) method was utilized for all outcomes.

Eligibility Criteria:
Inclusion Criteria:

* It was recommended that the patient's treatment was in accordance with the local marketing authorization (MA) for Neupro®
* The patient must have a diagnosis of moderate to severe idiopathic RLS
* The patient is considered reliable and capable of adhering to the visit schedule or medication administration according to the judgment of the investigator
* The decision to prescribe the drug has been made by the physician independently of his/her decision to include the patient in the study
* Subject is informed and given ample time and opportunity to think about his/her participation in the study and has given written informed data consent

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients
* Magnetic resonance imaging or cardioversion (see SmPC)
Effect of Preoperative Information About Pain on Postoperative Pain Experience and Patient Satisfaction

Patients are randomized into 2 groups. The intervention group which receives preoperative counseling about pain and a control group which does not receive this counseling.

The patients are followed up looking at pain scores and pain experience and satisfaction with pain management for 2 days post operative.

* All patients admitted for elective upper and lower limb surgery, will be expected to have a preoperative visit by the anesthetic provider on the day before surgery.
* Those who will have consented to participate in the study will be randomized to either the intervention or control group.
* The intervention group will receive specific preoperative information about pain in private by the principal investigator in addition to the preoperative assessment.
* The following variables will be recorded preoperatively: socio-demographics (age, gender, tribe, education level) and vital signs (pulse rate, blood pressure and oxygen saturation).
* A Numerical pain score will be explained to patient before it is recorded preoperatively.
* The patient will also be informed that the pain scores will be repeated after surgery at (someone will take the pain scores again after surgery at) 0, 6, 12, 24, 48hours or till discharge if less than 48hours. In addition the pulse rate, number of analgesic intravenous/ intramuscular injections or tablets needed/or given will be recorded.
* Assessed pain will be classified as no pain (1-3), pain (4-10) but also as no pain (0), mild (1-3), moderate (4-6) and severe pain (7-10).
* Intra operatively, the anaesthetic technique (general or regional), medications given, duration of surgery will be recorded in) the questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years and above
* Elective orthopedic surgery patients admitted to orthopedic/trauma ward Mulago hospital
* Patient who gives consent

Exclusion Criteria:

* Patients with chronic pain not related to the surgery they are to undergo
* Patients with bone cancer
* Inability to speak or hear (deaf or dumb)
* Previously recruited but comes for re-surgery for same condition
HARMONY Study (Hypertension Analysis of Stress Reduction Using Mindfulness Meditation and Yoga)

The purpose of this study is to determine if Mindfulness Based Stress Reduction (MBSR) is an effective intervention for lowering blood pressure in early unmedicated hypertensives.


Eligibility Criteria:
Inclusion Criteria:

1. Age 20 to 75 years
2. Hypertension by ABPM at baseline (daytime \> 135/85 mmHg or 24-hour ABPM \> 130/80 mmHg)

Exclusion Criteria:

1. Use of antihypertensive within 6 months of the screening ABPM.
2. Screening office BP \> 180/100 and ABPM \> 160/100 mmHg.
3. Diabetes
4. Secondary hypertension
5. Renal disease (GFR \< 60 ml/min or overt nephropathy)
6. History of heart attack
7. Stroke or TIA or
8. Re-vascularization procedure.
9. Active malignant disease (except non-melanoma skin cancer)
10. Epileptic seizure 6 months before the screening visit.
11. Congestive heart failure
12. Severe liver disease
13. Pregnancy or lactation period
14. Participation in a clinical trial or receipt of investigational compound or treatment in the 3 months prior to the initial screening visit.
15. Planned elective surgery during the study period except for cataract surgery
Effect of Mindfulness-Based Relapse Prevention Program on Readiness for Change and Self-efficacy Among Clients With Substance Use Disorders

The treatment process of substance addiction is applied principally by psychiatrists, psychologists, and psychiatric mental health nurses. In this respect, psychiatric mental health nurses have a crucial role to play. As they are the one who is in touch with the patients for 24 hours, psychiatric nurses can enhance the treatment process a lot through the application of a mindfulness-based relapse prevention program.

As drug abuse is such a devastating affliction, further knowledge about specific traits that may increase the chances of a successful recovery would be greatly beneficial to enhance treatment and decrease relapse rate. Accordingly, this study will be conducted to determine the effect of mindfulness-based relapse prevention program on readiness for change, and efficacy among clients with substance use disorder.

AIMS OF THE STUDY

The aim of this study is to:

Examine the effect of the Mindfulness-Based Relapse Prevention Program on readiness for change and self-efficacy among clients with substance use disorder during the rehabilitation phase.

RESEARCH HYPOTHESIS Clients with substance use disorder who attend Mindfulness-Based Relapse Prevention program sessions exhibit higher levels of readiness for change and self-efficacy compared to those who receive conventional hospital treatment.


Eligibility Criteria:
Inclusion Criteria:

* Able to read and write.
* Able to communicate and willing to participate in the study.
* Male patients only Exclusion Criteria
* Patients who are only alcoholics will be excluded.
* Diagnosed with SUDs with mental illness comorbidity.
Statewide (Rhode Island and Neighboring States) Partnerships for Worksite Weight Management

The project is designed to test the effectiveness of a multilevel worksite wellness program, based in Rhode Island and nearby neighboring states to impact employee weight, dietary intake and physical activity, compared to an attention placebo condition.

Accomplishment of the specific aim will be determined by a two group randomized effectiveness study (Treatment vs. Comparison) utilizing 24 RI worksites with randomization by site. The specific impact and outcome evaluation measures (BMI, DHQ-FFQ, and 7-day PAR) will be collected at Baseline, 12, and 24 months on a longitudinal cohort selected at random from the employee lists of each participating worksite. Extensive process evaluation and a mediating variable framework are also included to identify the mechanisms in successful change at both the worksite and individual level, which will maximize the potential for dissemination and generalization of the intervention as well as advance theory and improve intervention practice and policy.

Primary outcome measure will be weight (BMI).

Eligibility Criteria:
Inclusion Criteria:

Worksite

* worksite located in Rhode Island or neighboring state
* has food service on site
* approximately 200 - 500 employees
* low rate of employee turnover

Exclusion Criteria:

* worksites outside New England

Cohort participants:

* permanent employee, who works 20 or more hours on site
* speaks/reads some English at level to complete survey eval items
* able to walk at a brisk pace
Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics of three different single doses activated recombinant human factor VII in Caucasian and Japanese healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian or Japanese
* Healthy as defined by medical history, physical and biological examinations

Exclusion Criteria:

* History of allergy or hypersensitivity reaction to any medication
* History or presence of any organic disorder likely to modify absorption, distribution or elimination of the medication
* Alcohol or substance abuse disorder
* Subject in his exclusion period in the Healthy Volunteers National Register of the French Ministry of Health
The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets in Patients With Proliferative Lupus Nephritis

This study investigated the effect of mycophenolate mofetil and cyclosphosphamide on lymphocyte subsets in patients with proliferative lupus nephritis. Patients with biopsy-proven Class III/IV+/-V LN were randomized to received: 1) prednisolone (0.8mg/kg/day) plus CTX (1.5-2mg/kg/d) for 6 months) followed by Azathioprine (AZA) (1-1.5mg/kg/d) maintenance; OR 2) prednisolone (0.8mg/kg/d) plus MMF (1g bd) for 6 months, followed by MMF (tapered according to clinical status) as maintenance. The lymphocyte subsets and serum cytokine profiles will be measured at 4-, 12-, and 24-, 36- and 48 weeks after induction treatment. The lymphocyte subsets and serum cytokine profiles will be compared between the two treatment regimens, and also correlated with subsequent risk of relapse.

This study investigated the effect of mycophenolate mofetil and cyclosphosphamide on lymphocyte subsets in patients with proliferative lupus nephritis. Patients with biopsy-proven Class III/IV+/-V LN were randomized to received: 1) prednisolone (0.8mg/kg/day) plus CTX (1.5-2mg/kg/d) for 6 months) followed by Azathioprine (AZA) (1-1.5mg/kg/d) maintenance; OR 2) prednisolone (0.8mg/kg/d) plus MMF (1g bd) for 6 months, followed by MMF (tapered according to clinical status) as maintenance. The lymphocyte subsets and serum cytokine profiles will be measured at 4-, 12-, and 24-, 36- and 48 weeks after induction treatment. The lymphocyte subsets and serum cytokine profiles will be compared between the two treatment regimens, and also correlated with subsequent risk of relapse.

Eligibility Criteria:
Inclusion Criteria:

- 1. Patients with biopsy proven Class III/IV+/-V LN (ISN/RPS classification) and active nephritis as indicated by an increase of proteinuria \>1g/day and/or rise in serum creatinine by \>15% compared with baseline, with or without serological reactivation.

2. Willing to give informed consent

Exclusion Criteria:

1. Patients who have received calcineurin inhibitors or proliferation signal inhibitors as maintenance immunosuppression in the preceding 3 months
2. Patients have received biologics therapy (e.g. rituximab, abatacept) in the preceding 12 months
3. Patients who are pregnant or lactating