cyrilzakka/clinical-trials huggingface dataset:
Effect of Different Acupuncture Schemes for Postoperative Urinary Retention in Cervical Cancer Patients

This is a retrospective cohort study using a paired control design. We will review the patients of PUR after cervical cancer surgery who went to the acupuncture department and the urinary retention department in Zhejiang Cancer Hospital from October 2020 to August 2024, and 73 patients met the screening criteria. All patients provided written informed consent. The purpose of the study is to compare the effect of acupuncture at different combinations of acupoints for postoperative urinary retention (PUR) after radical hysterectomy of cervical cancer. All outcome-measures data were obtained from past medical records. It is an observational study rather than an intervention study. 73 patients met the screening criteria. They will be assigned into two groups according to the treatment scheme of acupoints combination for acupuncture: Group A (37 cases) and Group B (36 cases).


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old
* Karnofsky Performance Scale (KPS) score \> 70
* met the diagnostic criteria of PUR
* no history of serious urinary system diseases or urinary retention before the operation
* had clear cognition and no severe mental diseases
* had complete medical records and records of residual urine volume data.

Exclusion Criteria:

* presence of other serious systemic diseases or advanced cachexia
* obstructive urinary retention caused by urethral stricture, stones, or other diseases
* receiving other treatments or self-change treatment
* poor compliance or failure to complete the acupuncture treatments
* incomplete clinical data.
Interest of a Tongue Strength Measurement in the Screening for Sarcopenia in Hospitalized Elderly Patients

Sarcopenia is a syndrome characterized by a progressive and generalized loss of skeletal muscle mass, strength and function that increases the risk of physical dependence, impaired quality of life and mortality. This is a major public health problem. Indeed, its prevalence has been estimated at 63.8% for elderly patients hospitalized in acute geriatric unit.

Several methods of sarcopenia screening exist at present. The European Working Group on Sarcopenia in Older People (EWGSOP) proposes to carry out three examinations for the diagnosis of sarcopenia: the Dual-Energy X-ray Absorptiometry (DEXA) test and two motor tests (walking speed and hand test). These measurements have already been evaluated and validated. They are reliable, inexpensive and easily achievable in clinical routine.

Recent studies have shown that decreased muscle mass and / or strength could be associated with dysphagia. Indeed, many muscles of the head and neck are simultaneously solicited for swallowing coordination. This suggests that a reduction in the mass or strength of these muscles could impact the swallowing function. The investigator's hypothesize that loss of lingual muscle strength may be associated with sarcopenia. The study will measure the tongue strength using the Iowa Oral Performance Instrument (IOPI) in a geriatric population with or without sarcopenia.

* Determine the incidence of lingual hypotonia in hospitalized elderly sarcopenia patients.
* To compare the sensitivity, the specificity of the measurement of the force of the tongue with the usual measures proposed by the EWGSOP in the context of screening for sarcopenia.


Eligibility Criteria:
Inclusion Criteria:

Patients hospitalized in an acute geriatric unit within the CHU Brugmann.

Exclusion Criteria:

None
Correlation Between Femoral Head and Cup Size and Postoperative Pain in Total Hip Arthroplasty

We want to investigate the correlation between the native femoral head and the implanted cup in Total hip arthroplasty. As second parameter to investigate we believe an oversized cup will cause groin pain. We want to find a cutoff value to predict groin pain after cup implementation in THA.


Eligibility Criteria:
Inclusion Criteria:

* all primary THA

Exclusion Criteria:

* DDH-LCP
* Acetabulum/femoral neck fracture
The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study

An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI).

An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI). Primary Objective: Improvement in continence measured by 24 hour pad weight test with at least a 50% reduction in weight from baseline at 6 months. Secondary Objectives: Cough stress test results at 6 months; Subject QoL as measured by validated questionnaires: PGI-I, improvements in UDI-6 and IIQ-7 scores from baseline at 6 months, 3 day voiding diary improvement from baseline at 6 months; Device and procedure related adverse events. Brief Entrance Criteria: Adult female with confirmed SUI through cough stress test or urodynamics; Failed two non-invasive incontinence therapies; No prior surgical SUI treatment; No prolapse POP-Q Stage 2 or higher; No concurrent pelvic floor procedure; No urge predominant incontinence; No incontinence due to neurological disorder/disease; No PVR \> 100cc; and, No contraindication to the surgical procedure. Study visits will take place at baseline, implant/hospitalization, 3 months, 6 months, 1 year, and 2 years post operatively. This study will enroll up to 113 subjects at up to 17 investigative sites in the US and Internationally.

Eligibility Criteria:
Inclusion Criteria:

* Subject is female at least 18 years of age
* Subject is able and willing to complete all procedures and follow-up visits indicated in this protocol
* Subject has confirmed stress urinary incontinence (SUI) through cough stress test or urodynamics
* The subject has failed two non-invasive incontinence therapies (such as Kegel exercise, behavior modification, pad use, biofeedback, etc) for \>6 months

Exclusion Criteria:

* Subject has an active urogenital infection or active skin infection in region of surgery
* Subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading
* Subject is having a concomitant pelvic floor procedure
* Subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions)
* Subject had a prior surgical SUI treatment
* Subject has undergone radiation or brachy therapy to treat pelvic cancer
* Subject has urge predominant incontinence
* Subject has an atonic bladder or a post void residual (PVR) consistently about 100cc
* Subject is pregnant and/or is planning to get pregnant in the future
* Subject has a contraindication to the surgical procedure or the Altis Instructions For Use (IFU)
* Subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function without the sponsor's approval
Imatinib Response in Patients With Chronic Myeloid Leukemia (CML) in Function of Abl Polymorphisms

The main objective of this study is to evaluate the existence of a relationship between the presence of certain abl polymorphisms (or haplotypes) upon CML diagnosis and the occurrence of primary resistance to the treatment of CML by imatinib.

The first secondary objective of this study is to identify, in patients not responding to treatment, possible changes in the polymorphisms of interest during the course of the disease, reclassifying such polymorphisms as mutations.

The second secondary objective is to compare the control patients in terms of polymorphism frequency on the nonpathological abl fraction.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan

Inclusion Criteria for all CML patients

* Patients diagnosed with CML
* Treatment with Imatinib in first-line monotherapy and this for at least 12 months
* RNA and / or cDNA used for diagnosis correctly stored in the biobank

Inclusion Criteria for CML patients already having undergone a follow-up visit at 12 months

* RNA and / or cDNA used for diagnosis/follow-up correctly stored in the biobank
* Cytogenetic results are available
* Absence of ITK mutation for the primary resistance subgroup
* Validated compliance

Inclusion Criteria for the optimal response group:

* bcr-abl typing is less than 0.1% at 12 months

Inclusion criteria for the primary resistance group

* bcr-abl typings is \>1% and/or Philadelphia+ is greater than 0

Inclusion Criteria for the control population

* Absence of hematologic malignancy

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient has a contraindication for a treatment used in this study

Exclusion Criteria for CML patients already having undergone a follow-up visit at 12 months

* Known or suspected cause for resistance (dose reduced due to intolerance, digestive disease responsible for malabsorption ...)

Exclusion Criteria for the control population

* History or suspicion of hemopathy
Study of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients

The purpose of this study is to Evaluate and compare safety and efficacy of Gemcitabine Maintenance Treatment in Patients With Extensive SCLC Patients Receiving Etoposide Combined With Platinum Based First-line Chemotherapy

from the first cycle of treatment (day one) to two month after the last cycle

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years
2. PS=0,1,2
3. Patients who were diagnosed by the histologic, cytologic diagnosis of extensive small cell lung cancer
4. Patients received Etoposide combined with platinum based first-line chemotherapy 6 cycles and there is evidence show the patent is PR/CR/SD
5. Expected lifetime\>12 weeks
6. Signed written informed consent

Exclusion Criteria:

Small cell lung cancer non small cell hybrid Women during pregnancy or lactation previously treated with two or more than two kinds of treatment Any non remission of \>CTCAE caused tumor treatment past grade 2 toxicity Ccr\<30 ml/min (calculated by Cockcroft-Gault formula) hepatic insufficiency：

1. Tbil\> 1.5×ULN
2. ALT and AST \> 2.5×ULN (Patients with liver metastasis\>5×ULN) Alkaline phosphatase\>2.5 ×ULN(Patients with liver metastasis\>5×ULN)
3. Severe symptomatic heart disease
4. Symptomatic brain metastases
5. In the last 5 years have been or are suffering from other histological types of malignant tumor
6. There are serious or uncontrolled systemic diseases
7. During the study period planned radiotherapy on target lesion
8. During the study period, plans to use other antineoplastic therapy
9. Clinical study on treatment of 30 days beginning period prior to participate in any study drug
Laser Therapy for Venous Leg Ulcers

This randomized controlled trial will evaluate the effects of high-intensity laser therapy on wound healing in patients with venous leg ulcers. Participants will be randomly assigned to receive either laser therapy plus standard care or standard care alone. The laser therapy will be administered 3 times per week for 8 weeks or until ulcer closure. The primary outcome is proportion of participants with complete ulcer closure.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged 18 years up to 65 years.
2. Presence of a venous leg ulcer, confirmed by clinical examination and Doppler ultrasound (venous reflux \> 0.5 seconds).
3. Ulcer size between 1 cm² and 20 cm² at screening.
4. Ulcer duration of at least 4 weeks but not more than 12 months.
5. Ankle-brachial index (ABI) ≥ 0.8, assessed by Doppler ultrasound.
6. Willing and able to provide informed consent and comply with study procedures.

Exclusion Criteria:

1. Presence of an active infection in the ulcer, confirmed by clinical signs and positive culture results.
2. Osteomyelitis, diagnosed by radiographs or magnetic resonance imaging (MRI).
3. Patients with a history of uncontrolled diabetes, defined as HbA1c level \> 10%.
4. Current or planned use of systemic immunosuppressive drugs or corticosteroids during the study period.
5. Pregnant or breastfeeding women.
6. Patients with a history of malignancy or photosensitive skin disorders.
7. Prior history of skin grafting or flap surgery in the affected area within the past 3 months.
Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder

The study investigates whether add-on treatment with eyewear that blocks the short wavelengths of visible light (\<500nm) reduces manic symptoms and improves sleep in patients receiving outpatient treatment as usual for bipolar disorder.

When in a hypomanic or manic phase, participants will be randomized to receive add-on treatment with either blue blocking or low filtration eyewear from 18 PM to 8 AM daily for 7 days.

After this initial intervention phase, the eyewear is used daily for 3 months in either antimanic dose (14 hours) or maintenance dose (2 hours before bedtime).

The study is a 2-arm single-blind RCT to assess the effects of blue blocking (BB) or clear glasses as an acute 7-day antimanic intervention and as a 3-month mood stabilizing maintenance intervention. BB or clear glasses will be applied in addition to outpatient TAU for BD. Participants will be recruited among patients treated for BD in specialized outpatient clinics within the Mental Health Center Copenhagen.

The active intervention is BB-glasses that eliminate 99 % of light with a wavelength below 530 nm, whereas the clear glasses filter out only 15% of short wavelength light (low filtration (LF).

Participation includes 3 months use of the designated eyewear along with daily electronic self-monitoring of mood, sleep and activity as well as participation in a 2-day baseline assessment and a total of 3 follow-up visits including clinical assessment interview, questionnaires, and actigraphic (48 hours) and pupillometric assessments at day 9, week 5 and week 15.

Participants will be included during hypomanic or manic state and begin treatment with an antimanic dosage of 14 hours (6 PM - 8 AM) for 7 consecutive days. Subsequently, during the 3-month follow-up period, the dosage (hours using the glasses) can be adjusted according to the current state, with use for 14 hours during hypomanic/manic phases and 2 hours before bedtime during euthymic and depressive states.

Outcome assessors will be blinded to the treatment assignment and patients will be informed that they are randomized to eyewear with either high or low filtration of light. Patients will be randomized on a 1:1 basis with stratification according to sex and outpatient clinic.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bipolar disorder
* YMRS-score \>13
* Age 18-60 years
* Speaks and writes Danish at a level equal to mother tongue

Exclusion Criteria:

* Not willing or able to adhere to the protocol
* Severe eye disorder or eye trauma
* Treatment with betablockers
* Sleep disturbances not related to BD (e.g, sleep apnea, restless legs syndrome) • • Substance abuse
* Unwilling to use the electronic self-monitoring system, the Monsenso system
* Prior/current use of BB glasses
* Current/planned pregnancy
* Night shift work
* Suicidality
Breast Cancer Molecular Analysis Protocol

This is a molecular testing study for patients with metastatic breast cancer. The purpose of this study is to find defects in the DNA of the cancer that could potentially be treated with US Food and Drug Administration (FDA)approved or investigational drugs. For example, if your cancer has a mutation in the Epidermal Growth Factor Receptor (EGFR) gene (a mutation is a change int he DNA sequence of a gene) that makes this receptor "superactive" a drug that inhibits this receptor may also inhibit the growth of the cancer. If this genetic defect is not present in the cancer the same drug may not work. This EGFR gene mutation based patient selection for treatment has worked in lung cancer and we are testing its value in breast cancer. What drugs may be available against particular genetic abnormalities in the context of this clinical study will change over time.


Eligibility Criteria:
Inclusion Criteria:

1. All patients with metastatic breast cancer who are considered for further systemic therapy are eligible regardless of number of prior therapies.
2. Patient must have a metastatic lesion that could be safely biopsied with or without image-guidance. The final arbiter to decide what lesion can be biopsied is the physician who will perform the biopsy.
3. There is no age limit for this study. However, this study will not include children because metastatic breast cancer does not occur in children.
4. Patients may participate in the biopsy study multiple times to repeat molecular assessment of the cancer after progression.
5. Patients who undergo routine clinical biopsy of metastatic breast cancer are also eligible to participate in this study. When the routine biopsies are obtained for diagnostic or other purposes, additional biopsies will be taken during the same biopsy session for molecular analysis.

Exclusion Criteria:

1. Known medical contraindication for needle biopsy procedure such as bleeding disorder, low platelet count, inability to provide informed consent
Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes

Type 2 diabetic patients who fast during Ramadan experience swings in glycaemic control between hypoglycaemic troughs and hyperglycaemic spikes. Hence, the dual challenge in fasting diabetics is to identify which treatment modality leads to the most stable blood glucose levels during a fast and how to smooth out these excursions and reduce risks of fast to a minimum.

Study Objectives:

* To compare changes in clinical and metabolic parameters from baseline to the end of four weeks fasting in Ramadan between four treatment arms:

  * diet and lifestyle measures alone.
  * metformin monotherapy.
  * combination therapy with metformin + sulfonylurea.
  * combination therapy with metformin + sitagliptin.
* To compare the 24 hour CGMS profile during Ramadan fasting in type 2 diabetic patients before and after addition of acarbose to these pre-existing sub-maximal hypoglycaemic regimens.

Eligibility Criteria:
Inclusion Criteria:

* HbA1c 6.5-9.5%.
* Type 2 diabetics on two or less oral hypoglycaemic agents.

Exclusion Criteria:

* Any contraindications either to fasting or to any of the trial medication.
* Pregnancy.
* Serum creatinine \> 1.4 mg/dl.
* Serum ALT \> twice upper limit normal.
* History of pancreatitis, serum amylase \> twice upper limit normal.
* History of intolerance to acarbose.
Examination of a Treatment Program for Overweight Children, Adolescents, and Their Families

The current study examined the effectiveness of a behaviorally-based group intervention for overweight children and their families. The target intervention was compared to an enhanced standard of care treatment. The impact of both treatment programs on numerous outcomes was explored.

The primary objective of the present investigation was to determine the effectiveness of an empirically supported intervention for pediatric overweight in two outpatient clinical settings. A number of previous randomized clinical trials have demonstrated the efficacy of behaviorally-based group interventions for overweight children and their families. As called for by Kazdin and Weisz (1998) and Chambless and Hollon (1998) the proposed investigation was designed to demonstrate the effectiveness of such a treatment in a clinical setting, and to examine the effects of the intervention on children's quality of life (QOL). Because the clinical impact of empirically supported interventions is mitigated by economic and consumer variables, a secondary aim of the proposed investigation was to examine (1) the cost-effectiveness of an outpatient group intervention for pediatric obesity, and (2) the consumer satisfaction with the proposed intervention. Finally, an additional exploratory aim was to examine predictors of adherence to treatment for the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Child between ages 7 and 17 (inclusive)
* Child BMI at or above the 85th percentile based on norms provided for age and gender
* Child's parent/guardian provides informed consent for treatment of the child as well as consent for study participation
* Child's parent/caregiver is willing to participate with the child in the program

Exclusion Criteria:

* Presence of serious mental illnesses or significant developmental delay that would reasonably predict altered ability to adhere to the treatment protocol
* Current physical illness or hospitalization of the child that would interfere with group attendance or protocol adherence
A Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects

The purpose of this study is to assess the pharmacodynamic interaction between gabapentin and ethanol


Eligibility Criteria:
Inclusion Criteria:

* Volunteers in good health aged 21 to 50 (inclusive) years who weigh 50 to 100 kg (110-220 lbs.)
* Experience with alcohol, defined as mild to moderate use of alcohol, ie, maximum of 14 alcoholic drinks per week

Exclusion Criteria:

* Recent history (within 2 years) of, or current treatment for, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition
* Recent history (within 2 years) of, or clinical evidence of significant unstable or uncontrolled respiratory (including asthma and congestive obstructive pulmonary disease), cardiovascular, gastrointestinal, hepatic, renal, endocrine, neurologic (including seizures), psychiatric or other chronic disease
* History of alcoholism or drug abuse; recreational drug use within the past 30 days; use of benzodiazepines, Ambien®, Sonata®, antidepressants or psychoactive medication within 30 days prior to screening; use of any other sedative, hypnotic, antihistamine, anticholinergic, melatonin, DHEA or herbal sleep/relaxation remedy within 7 days prior to screening