cyrilzakka/clinical-trials huggingface dataset:
Village-based Intervention for Late-life Depression

Investigators aimed to examine the feasibility and effectiveness of a village-based multilevel intervention for late-life depression. Two small rural villages in rural South Korea were selected as the intervention group and active control. All older adults living in the two villages were included in the intervention program or received standard CMHS care, and the effectiveness of the program was examined using representative samples from both groups.

OBJECTIVES: To examine the feasibility and effectiveness of a village-based multilevel intervention for late-life depression, focusing on strengthening the autonomy of village-dwellers with help from the community mental health service (CMHS).

DESIGN: A community-based randomized trial with participants (all village-dwellers) assigned to two parallel programs: intervention program or the CMHS's usual care.

SETTING: Two small villages in a rural area of South Korea

PARTICIPANTS: All older adults (aged ≥65 years) living in the two villages were included in the intervention or the CMHS's usual care, and the effectiveness of the program was examined using representative samples who were age- and sex-stratified randomly selected from both groups.

INTERVENTION: A 12-week intervention was comprised of individual-based risk-stratified case management and group-based activities.

MEASUREMENTS: The Korean version of Geriatric Depression Scale-Short form (SGDS-K) was used as the primary outcome while depressive episodes, suicidal ideation/plans/attempts, social network, functional status, and global cognitive function were measured as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* All community-dwelling older adults, aged 65 years and over

Exclusion Criteria:

* Subjects who had significant sensory deficits or medical illnesses that would substantially restrict the delivery of the assessment were excluded
Loss of Resistance, w/wo Stimulation, For Epidural Placement

The purpose of this randomized, observer-blinded, investigative trial is to determine if the use of electrical stimulation, compared to the traditional loss of resistance technique alone, improves the success rate of epidural catheter placement at an academic teaching institution.

All subjects will receive a thoracic epidural catheter placement at the level appropriate for their surgery and will be randomized to either have the epidural placed with a loss of resistance technique alone or loss of resistance technique with confirmation by nerve stimulation. In the traditional loss of resistance technique group, the epidural catheter will be placed after achieving loss of resistance to air. In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall. Nerve stimulation will be started at a pulse width of 0.3 ms and a frequency of 1 Hz and a current of 0.2mA.

Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing intra-thoracic or intra-abdominal procedures that normally would receive thoracic epidurals for post-operative analgesia will be eligible.

Exclusion Criteria:

* Subjects with contraindications to regional anesthesia:
* history of allergy to amide local anesthetics
* presence of a progressive neurological deficit
* patients that are on anticoagulant medications that prohibit placement of an epidural
* Systemic infection
* Infection at the site of placement
Blood Flow Restriction Exercise Study

This pilot study will investigate the effects of blood flow restriction (BFR) exercise for up to 4-6 weeks prior to total knee arthroplasty (TKA) surgery in older patients to measure clinical outcomes such as strength, lower extremity function, and pain.

The purpose of this study is to test the feasibility and efficacy of a low-resistance exercise protocol with blood flow restriction (BFR) using a tourniquet in the preoperative period of patients awaiting TKA. BFR exercise is a new exercise method that has not been studied in the perioperative period. The investigators will compare our intervention to a no-exercise group up to 4 - 6 weeks prior to surgery to determine if this type of exercise is feasible in the preoperative period and if BFR exercise will improve functional, physiological, and molecular outcomes when compared to patients without exercise.

Eligibility Criteria:
Inclusion Criteria:

* are scheduled for elective TKA for osteoarthritis
* are scheduled for unilateral joint replacement surgery only
* are able to give consent and follow instructions
* are willing to complete up to 15 study visits

Exclusion Criteria:

* patients below the age of 55 years old
* patients over the age of 80 years old
* patients who live in a radius greater than 45 miles from the University of Florida (a feasible distance to allow for transportation to and from the clinical center for assessment visits)
* patients with impaired cognitive function and mental disease, (e.g. diagnosis of Alzheimer's disease)
* patients with paraplegia/extremity amputation
* patients with end stage renal disease requiring dialysis
* patients with uncontrolled diabetes and insulin-dependent diabetes
* patients with uncontrolled cardiovascular disease e.g. (Classes of Heart Failure (CHF) New York Heart Association (NYHA) class 3 or higher, BP \> 180/110 mmHg)
* patients with severe pulmonary disease requiring continuous oxygen therapy
* patients with active neoplasm
* patients with peripheral vascular disease or deep vein thrombosis (within the last 3 years)
* patients with structured exercise/Physical Therapy(PT)/Occupational Therapy (OT)/fitness program enrollment within 12 weeks prior to surgery and/or more than 2 hours per month on gym/fitness room exercises
* patients with BMI greater than 40 kg/m2
* patients with opioid use of more than 30 mg Morphine-equivalents per day
* patients with chronic oral steroid use
* patients with chronic anticoagulation (e.g. Plavix, Warfarin)
* patients with planned postoperative admission to a skilled nursing/inpatient rehab facility
* patients with ipsilateral joint disease involving hip, ankle or spine
* neurologic or other etiology of quadriceps wasting
* surgery within less than 4 weeks
* patients with comorbidities that the PI judges as not suitable for the study
* patients with a minimal mental status (MMSE) score below 24
Paclitaxel, Cisplatin,5-FU vs. Radiotherapy Plus Paclitaxel, Cisplatin as Preoperative Therapy for Locally Advanced ESC

This is a Phase III clinical trail which Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF) Versus Radiotherapy with Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for Locally Advanced Esophageal Squamous Cancer. The Preoperative chemoradiotherapy with radical surgery is the standard treatment in China. But, many patients do not receive this treatment for many other reasons. Most of them refused or abandon radiotherapy because of the Intolerable adverse effects of radiotherapy, so we have launched a randomized controlled trial to confirm the non-inferiority of TCF over chemoradiotherapy with TC (TC-RT) as preoperative therapy for locally advanced esophageal squamous cancer in overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven squamous cell carcinoma.
* All lesions are located in the thoracic esophagus.
* Clinical stages IIB and III (excluding T4) based on the 7th UICC-TNM classification.
* 20-75 years old.
* ECOG performance status of 0 or 1.
* Measurable lesions not required.
* No prior therapy against esophageal cancer except for complete resection by endoscopic mucosal resection/endoscopic submucosal dissection with either pM1/M2 disease or pM3 disease without vascular infiltration.
* No prior chemotherapy, radiotherapy or hormonal therapy against any cancers
* Adequate organ function.
* Written informed consent.

Exclusion Criteria:

* Synchronous or metachronous double cancers, except for intramucosal tumor curatively resected by local therapy.
* Active infection requiring systemic therapy
* Positive hepatitis B surface antigen and hepatitis B core antigen or human immunodeficiency virus antibody.(only positive hepatitis B surface antigen should receive anti-virus treatment during study)
* Pregnant or lactating women or women of childbearing potential.
* Patients requiring systemic steroid medication.
* Iodine hypersensitivity.
* Psychiatric disease.
* Hypersensitivity for CremophorEL.
* Poorly controlled diabetes.
* Severe emphysema or pulmonary fibrosis.
* Poorly controlled hypertension.
* Unstable angina within 3 weeks or with a history of myocardial infarction within 6 months.
Cognitive Function and EEG Brain Network Remodeling Among Users of Hearing Aids With ARHL

This study intends to retrospectively collect and analyze the case data of patients with age-related hearing loss who were admitted to the Otolaryngology Department of Sun Yat-sen Memorial Hospital from January 2020 to June 2024. Participants were divided into an Aided Group and a Control Group based on whether they had regularly used hearing aids in the past six months.

Audiological, cognitive, emotional, and sleep assessments, as well as resting state electroencephalogram (EEG) features, are supposed to be compared between the two groups.

This study intends to retrospectively collect and analyze the case data of patients with age-related hearing loss who were admitted to the Otolaryngology Department of Sun Yat-sen Memorial Hospital from January 2020 to June 2024. Participants were divided into an Aided Group and a Control Group based on whether they had regularly used hearing aids in the past six months.

The audiological assessment comprises pure tone audiometry, speech recognition audiometry, and sound field audiometry. The cognitive assessment includes the Mandarin version of the Montreal Cognitive Assessment (MoCA) and the Mini-Mental State Examination (MMSE). The emotional assessment consists of the 24-item Hamilton Depression Scale (HAMD) and the 15-item Geriatric Depression Scale (GDS). Sleep assessment is conducted using the Pittsburgh Sleep Quality Index (PSQI).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ARHL
* Aged between 50 and 90
* Complete measuring data; including pure tone audiometry, speech audiometry, cognitive screening scales and resting-state electroencephalography
* Right-handed
* Regular daily use of hearing aid(s) for six-month period prior to the test date, or no hearing aid experience

Exclusion Criteria:

* Outer/middle ear abnormalities or any other central nervous system disorders
Cerebral Blood Flow Regulation and Concussions

The purpose of this study is to understand how biochemical markers in blood, balance disturbances, and cognitive performance are related to brain blood flow changes after a concussion.

Comparisons will be made between control data and data following a concussion collected from athletes participating in contact-collision sports. For those suffering a concussion, comparisons will be made between day 3 (acute phase), day 21 (recovery phase), and 3 months post-concussion.

Eligibility Criteria:
Inclusion Criteria:

* Student athletes actively participating in collegiate sports. Subjects should be wiling to provide informed consent for participation in the study.

Exclusion Criteria:

* Participants who are unable to play as a result of injury. Presence of irregular heart beat.
Immediate Versus Delayed FET Following a Stimulated IVF Cycle

Information regarding the optimal timing for frozen-thawed embryo transfer (FET) following a stimulated in vitro fertilization (IVF) is lacking. One option is to perform FET in the first cycle following the stimulated IVF cycle, i.e. immediate transfer. Another option is to postpone FET for at least one menstrual cycle, i.e. delayed transfer. This randomized study aims to compare the ongoing pregnancy rate of immediate versus delayed FET following a stimulated IVF cycle.


Eligibility Criteria:
Inclusion Criteria:

* Women aged ≤43 years at the time of IVF/ICSI treatment Undergoing IVF with a standard stimulation At least one frozen embryo or blastocyst The first FET cycle following ovarian stimulation in IVF/ICSI

Exclusion Criteria:

* Use of mild stimulation or natural cycle for IVF/ICSI treatment Severe ovarian hyperstimulation syndrome during IVF/ICSI treatment Preimplantation genetic diagnosis treatment Use of donor oocytes Presence of hydrosalpinx which is not surgically treated or endometrial polyp on scanning during ovarian stimulation
C-Reactive Protein (CRP) in Obese Diabetic Women

The purpose of this study is to determine whether treatment with rosuvastatin for 6 months in obese type 2 diabetic women will improve their lipid profiles and thus prevent the progression to cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Menopausal
* Diagnosed diabetes mellitus type 2
* Obese (body mass index \[BMI\] \> 25 ≤ 30)

Exclusion Criteria:

* Fasting blood glucose ≥ 200 mg/dl
* CRP \< 2 mg/L and \> 10 mg/L
Exploratory Study of L.S.E.S.r. (LipidoSterolic Extract of Serenoa Repens)(PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in Urinary Symptoms Related to BPH (Benign Prostatic Hyperplasia)

Inflammation is reported as one of the most recent hypotheses to explain BPH. Recent published works pointed out that urine and serum markers could be used for detection of prostatic inflammation.

The aim of the study is to assess the activity on inflammation biomarkers (serum and urine inflammation markers) of Permixon® 160 mg hard capsule and Tamsulosine Arrow LP in the treatment of urinary symptoms related to BPH.

The potential links between serum and urinary markers of inflammation and BPH clinical symptoms at baseline and on treatment will be explored.


Eligibility Criteria:
Inclusion Criteria:

* Male patient
* Between 45 and 85 years old.
* Patient with bothersome lower urinary tract symptoms such as pollakiuria (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream, existing for over 12 months
* I-PSS ≥ 10 at selection visit and ≥ 12 at randomisation visit (visit 2)
* Stable patient's disease at randomisation defined as an absolute difference of 2 or less on I-PSS between selection and randomisation visits (visit 1 and visit 2)
* I-PSS QoL score ≥ 3 evaluated at selection and randomisation visits,
* 5 mL/s ≤ maximum urinary flow rate \< 15 mL/s for a voided volume ≥ 150 mL and ≤ 500 mL evaluated at randomisation visit (2 measurements if necessary)
* Prostatic volume ≥30 cm³ determined by transrectal ultrasound at randomisation visit (visit 2)
* Serum total PSA at randomisation visit (visit 2) :

  * 4 ng/mL
  * 10 ng/mL and Prostate Specific Antigen (free) / Prostate Specific Antigen (total) ≥ 25% or negative prostate biopsy within the past 6 months prior to selection visit.
* Patient able to understand and sign the informed consent and understand and fill in self-questionnaires

Exclusion Criteria:

* Post-void residual urine volume \> 200 mL (by suprapubic ultrasound) at randomisation visit (visit 2).
* Urological history :

  * Urethral stricture disease and/or bladder neck disease
  * Active (at selection and randomisation visits) or recent (\< 3 months) or recurrent urinary tract infection
  * Indication of BPH surgery
  * Stone in bladder or urethra
  * Acute or chronic (documented) prostatitis
  * Prostate and cancer cancer treated or untreated
  * Interstitial cystitis (documented by symptoms and/or biopsy)
  * Active upper tract stone disease causing symptoms
* Patient with history of surgery of the prostate, bladder neck or pelvic region
* Any local and/or systemic inflammation disorders at selection and randomisation visit
Efficacy and Safety of Probiotics in the Treatment of Acute Gastroenteritis in Children

* Primary Objective:

  o To assess the efficacy of the probiotics in reducing the duration of diarrhea in children suffering from acute gastroenteritis.
* Secondary Objectives:

  * To assess the efficacy of the probiotics in improving the frequency and consistency of stools.
  * To assess the efficacy of the probiotics in avoiding recurrence of diarrhea.
  * To assess the efficacy of the probiotics on the disease severity.
  * To assess the safety and tolerability of the studied probiotics.


Eligibility Criteria:
Inclusion Criteria:

* Children of both gender aged between 6 months and 5 years
* Presenting with acute diarrhea (3 or more loose or liquid stools in a 24-hour period) since at least the last 24h but less than 5 days
* Signed informed consent of the legal representatives obtained before any study procedure
* Parents able to fulfill in the stool diary according to the physician's opinion.

Exclusion Criteria:

* Unable to take medication and fluids by mouth
* More than 50% breastfeeding
* Severe malnutrition, defined by a ratio weight/height at/or below -3SD
* Severe dehydration, defined by a need of IV rehydration
* Chronic underlying disease, including but not limited to severe gastrointestinal disorder, immunocompromised condition or systemic infection
* Use of prohibited treatments
* Contra-indications to the studied probiotics
Safety and Effectiveness of the Alma System in Treating Primary Postpartum Hemorrhage

Postpartum Hemorrhage (PPH) is an obstetric emergency that can occur up to 24 hours after vaginal birth or cesarean section.

In most cases, the uncontrolled bleeding is due to a lack of sufficient contraction of the uterus (hypotonia) and appears immediately after birth.

The purpose of this prospective, non-randomized, feasibility pilot study is to obtain information on the safety and effectiveness of an investigational new medical device - Alma System, that is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.

A prospective, non-randomized, feasibility pilot study that is intended to obtain information on the safety and effectiveness of the Alma System.

Study population: Women with vaginal deliveries in a hospital setting who failed first-line therapies for postpartum hemorrhage.

The main questions are:

1. Rate of device related SAEs up to six weeks following device treatment.
2. Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure.
3. Rate of occurrence of uterine inversion of folding during or immediately after device procedure.

Main tasks for participants:

* sign the informed Consent form and enrolment
* In case of PPH, treatment with Alma
* Participate in 2 follow-up visits After the treatment- 1st upon discharge and 2nd after 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Adult Female, 18 years of age or older at time of consent.
2. Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation.
3. Subjects who present with an atonic uterus for at least 10 minutes after expulsion of placement with failure to obtain contraction and/or Subjects who have lost blood post-partum \> = 500 ml and according to the Investigator's judgment, require an intervention.
4. Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding.

Exclusion Criteria:

1. Subjects who do not provide informed consent to participate in the clinical investigation.
2. Subjects who deliver at a uterus size \< 34 weeks.
3. Subjects who have lost greater than 1000 ml of blood.
4. Subjects who have abnormal PT, PTT and INR
5. Subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage.
6. PPH that the investigator determines to require more aggressive treatment, including any of the following:

   * Hysterectomy;
   * B-lynch suture;
   * Uterine artery embolization or ligation;
   * Hypogastric ligation.
   * Known uterine anomaly.
   * Ongoing intrauterine pregnancy.
7. Placental abnormality including any of the following:

   * Known placenta accreta;
   * Retained placenta with known risk factors for placenta accreta (e.g., history of prior uterine surgery, including prior c-section and placenta previa);
   * Retained placenta without easy manual removal.
8. Known uterine rupture.
9. Unresolved uterine inversion.
Five Year Follow-up of Internet-based Cognitive Behaviour Therapy (CBT) for Social Anxiety Disorder (SAD)

Social anxiety disorder (SAD) is one of the most prevalent anxiety disorders in the western world. Cognitive behavioural therapy (CBT) is the psychological treatment that has the largest empirical support. However, the availability to CBT is very limited in Sweden due to lack of therapists with proper training. Therefore it is important to evaluate alternative forms of treatment that are more time efficient. One of these methods is Internet based self-help therapy, which has proven to be an effective treatment for social anxiety disorder.

In this study, the investigators aim to conduct a follow-up assessment five years after completed Internet-based CBT. Participants received treatment within the context of a randomised controlled trial conducted in 2005. Thus, in the present study there will be no treatment interventions, only assessment.


Eligibility Criteria:
Inclusion Criteria:

* Must have a primary diagnosis of social phobia

Exclusion Criteria:

* Substance abuse during the last 6 months
* Other dominating diagnosis (not phobic personality disorder)
* A history of bipolar disorder or psychosis
* Major depression according to DSM-IV and \>20 on madrs-s
* Risk of suicide
* Start of medication or change of dosis during the last 2 months
* Other parallel psychological treatment
* Previous CBT (last 3 years) for social phobia
Perception of Symptom Variability in COPD

The objective of the study is to assess patient's perception with stable state COPD on symptom variability and to describe how symptom variability impacts daily quality of life in Chinese COPD patient with moderate, severe or very severe airflow limitation from tier 3 hospitals in China where most of COPD patients are diagnosed and treated.


Eligibility Criteria:
Inclusion Criteria:

* Provision of subject informed consent
* Out-patient
* Clinical diagnosis of COPD at least 6 months
* Lung function based on data available within 3 months in medical records confirming FEV1\<80% normal predicted (post-bronchodilator) and FEV1/FVC\<0.7 (post-bronchodilator)

Exclusion Criteria:

* Participation in any interventional study involving investigational drugs; Patient inability to understand the study procedures or inability/reluctance to answer questionnaire
* Ongoing exacerbation of COPD or exacerbation within the previous 3 months. An exacerbation is defined as a worsening of COPD symptoms leading to a treatment with antibiotics and/or a short course of system steroids and/or hospitalisation or emergency
* History of asthma and/or allergic rhinitis, Lung cancer or any other significant respiratory disease such as bronchiectasis, lung fibrosis, interstitial lung disease, tuberculosis, sarcoidosis
Seizures Post Intracerebral Hemorrhage

This study examines early antiepileptic treatment with valproic acid for acute cerebral hemorrhage against a placebo group immediately post event to evaluate the outcome of these patients regarding seizures and neurological outcome.


Eligibility Criteria:
Inclusion Criteria:

* cerebral hemorrhage spontaneous

Exclusion Criteria:

* early seizures