cyrilzakka/clinical-trials huggingface dataset:
Development of King's College Hospital Breathlessness Service

Breathlessness is a common, distressing symptom in advanced malignant and non malignant disease, and impacts significantly on quality of life. Breathlessness in end stage disease is also responsible for significant healthcare resource usage. Escalante \[1\] reported hospital admission rates of 60% in patients presenting to a cancer treatment centre with breathlessness. Preliminary trials of breathlessness clinics with selected groups of patients have been promising, but lack data on their cost effectiveness.

The principal aim of the research is to develop and evaluate the effectiveness and cost effectiveness of a multidisciplinary outpatient breathlessness support service (BSS) for the palliation of breathlessness, in advanced malignant and non malignant disease. This is a phase II study that aims to test the hypothesis that a BSS will improve patient mastery over breathlessness and reduce the use of healthcare resources (including GP consultations,accident and emergency attendances, and length of hospital stay) compared with usual best medical care alone (UC),at an acceptable level of cost effectiveness.The outcomes of this study will also help to determine sample size,develop and test methods for a phase III trial that will follow on from this project.

This study will run over 2 years. Breathless patients with advanced malignant and non malignant disease who have already been optimally medically managed will be eligible.

The service will be run in the outpatient department of King's College Hospital, and patients will also be assessed in their own home and by telephone interviews. At baseline we will assess respiratory function and breathlessness mastery and severity using validated scales, and health service usage. Individuals will be randomised to the intervention group \[IG\] (n=55) or UC (n=55). The IG will attend the new outpatient clinical service with multiprofessional input. Assessments will be repeated at 4, 10 \& 24 weeks.

1.Escalante, C.P., Martin, C.G., Elting, L.S. et al., Dyspnea in cancer patients. Etiology, resource utilization, and survival implications in a managed care world. Cancer, 1996. 78(6): p. 13149.


Eligibility Criteria:
Inclusion Criteria:

* Patients with any established underlying medical diagnosis with breathlessness on exertion or at rest.
* Cancer patients who have risk factors for breathlessness( risk factors include a history of smoking, asthma or COPD, lung irradiation, exposure to asbestos, coal dust, cotton dust or grain dust, lung involvement by cancer)
* Respiratory muscle weakness
* Anxiety.
* Patients must have advanced disease that is refractory to maximal optimised medical management. - Patients must be able to engage with a short term physiotherapy and occupational therapy intervention.

Exclusion Criteria:

* Patients with breathlessness of unknown cause.
* Chronic hyperventilation syndrome.
Tolerability and Efficacy of Intravenous Infusion of Autologous MSC_Apceth for the Treatment of Critical Limb Ischemia

MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells for the treatment of Critical Limb Ischemia


Eligibility Criteria:
Inclusion Criteria:

1. Patients with peripheral arterial occlusive disease (symptomatic PAOD), diagnosis of CLI defined as persistent, recurring ischemic rest pain for at least 2 weeks, and/or ulceration or gangrene of the foot or toe, with an ABPI \</= 0.5,
2. Patients with staging of ≥III according to Fontaine and ≥4 according to Rutherford categories,
3. Patients fulfilling the criteria for an invasive re-vascularisation procedure (PTA) at the discretion of the investigator,
4. Patients without major amputation of the lower extremities within the period of 6 months after inclusion in the opinion of the investigator,

Exclusion Criteria:

1. Patients with wounds of a severity of greater than grade 2 on the Wagner Scale,
2. Patients with life-threatening ventricular arrhythmia,
3. Patients with unstable angina pectoris,
4. Patients with severe congestive heart failure (i.e. NYHA Stage IV),
5. Patients with uncontrolled hypertension (defined as diastolic blood pressure \>110 mmHg or systolic blood pressure \>180 mmHg during screening),
6. Patients with an uncontrolled diabetes mellitus (HbA1c \> 9%),
7. Patients having any history of malignant tumour in the anamnesis or are currently on tumour treatment,
8. Patients who are unsuitable for a MSC stem cell therapy in the opinion of the investigator,
The Effect of Transcatheter Ventricular Septal Defect Closure on Heart Rate Variability Parameters

In this study; we evaluated the heart rate variability parameters of pediatric patients whose VSDs were closed with the transcatheter method before and after, and compared with the control group.

Heart rate variability (HRV) is a sign of cardiac autonomic nervous system. Evaluation of HRV in pediatric ventricular septal defect (VSD) cases before and after transcatheter closure will enlighten us in terms of cardiac autonomic control.

Methods: 19 VSD cases treated with transcatheter closure method and 18 healthy children were enrolled in the study. 24 hours Holter rhythm monitorization was applied to all patients before closure of VSD and to the control group. In the patient group, Holter rhythm monitorization was repeated in the third months. HRV parameters were obtained from Cardio Scan Premier 12® program. Frequency domain (Total power, VLF, LF, HF, LF/HF ratio) and time domain analysis (SDNN, SDANN, SDNNi, pNN50, rMSSD) were applied.

Eligibility Criteria:
Inclusion Criteria:

* VSD diameter \<6mm
* Significant left-to-right shunt
* Left atrial and ventricular enlargement detected by echocardiography or calculation of Qp/Qs ratio above 1.5 in the catheterization laboratory (Qp/Qs\>1.5)

Exclusion Criteria:

* Patients with arrhythmia after the procedure
* Young patients who may be inconsistent during Holter records
The Effect of an Urban Sanitation Intervention on Child Health

The purpose of this study is to determine the health impact of a basic sanitation intervention in Maputo, Mozambique.

We have designed a controlled, before-and-after (CBA) effectiveness study to estimate the health impacts of an urban sanitation intervention in informal neighborhoods of Maputo, Mozambique, including an assessment of whether exposures and health outcomes vary by localized population density. The intervention consists of private pour-flush latrines (to septic tank) shared by multiple households in compounds or household clusters. We will measure objective health outcomes in approximately 1000 children (500 children with household access to interventions, 500 controls using existing shared private latrines in poor sanitary conditions), at two time points: immediately before the intervention and at follow-up after 12 months. The primary outcome is combined prevalence of enteric infections among children under 5 years of age. Secondary outcome measures include soil transmitted helminth (STH) re-infection in children following baseline de-worming and prevalence of reported gastrointestinal illness. We will use exposure assessment, fecal source tracking, and microbial transmission modeling to examine whether and how routes of exposure for diarrheagenic pathogens and STHs vary and transmission impacts of the pathogens following introduction of effective sanitation. Our analysis will focus specifically on the impact of localized population density as a potential modifier of sanitation-related exposures.

Eligibility Criteria:
Inclusion Criteria:

* Children normally resident in households with access to new shared sanitation (the intervention) as selected by implementing organisation (WSUP) or control children normally resident in households sharing existing shared sanitation within geographically delimited project bounds and meeting WSUP site selection criteria (including number of people served)

Exclusion Criteria:

* Refusal to participate
Obturator and Femoral Nerve Block in Patients With Hip Fracture

A higher number than expected of patients with hip fracture have only insufficient analgesic effect of a femoral nerve block, which is the nerve block commonly used for this group of patients. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve.

With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve.

The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.

A higher number than expected of all patients with hip fracture have only insufficient analgesic effect of a femoral nerve block. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve. Earlier it was believed that the so called '3-in-1-block' or the iliac fascia compartment block would anesthetize also the obturator nerve, and these two nerve blocks have been uses extensively in the emergency ward for preoperative analgesia. Today that is not believed to be true and consequently is the part of the obturator nerve in patients with hip fracture unknown.

With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve before it branches into an anterior and a posterior branch. A selective nerve block of the obturator nerve to access its effect in patients with hip fracture has to our knowledge never been done.

The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.

Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicion of hip fracture
* Age ≥ 55 years
* Mentally capable of comprehending and using verbal pain score
* Mentally capable of differentiating between pain from the fractured hip and pain from other locations
* Mentally capable of understanding the given information
* Arrival in the emergency room at times when one of the doctors who do the nerve blocks for this investigation are on call
* Verbal numeric pain scale score (NRS 0-10) \> 5 with a dynamic test OR NRS \> 3 at rest
* Patients informed consent

Exclusion Criteria:

* Hip fracture not confirmed by x-ray
* Weight \< 40 kg
* Patient has previously been included in this trial
* If the patient wishes to be excluded
* Allergy to local anesthetics or adrenocortical hormone
* Visible infection in the area of the point of needle injection
Pre-operative Withdrawal of Aspirin in Laparoscopic Inguinal Hernia Repair

This study aims to assess the need to stop Aspirin before elective laparoscopic inguinal hernia repair. It will consist of 2 arms: patients who continue to take Aspirin perioperatively and patients who stop Aspirin 5-7 days before the surgery.

This study aims to assess the need to stop Aspirin before elective laparoscopic inguinal hernia repair. It will consist of 2 arms: patients who continue to take Aspirin perioperatively and patients who stop Aspirin 5-7 days before the surgery. Simple randomization will be performed and allocation is via closed envelope method. The surgeon will be blinded regarding the usage of Aspirin. The primary outcome is the incidence of post-operative hematoma formation within the first 24 hours after surgery. The secondary outcomes are the incidence of post-operative seroma formation within 24 hours, the incidence of post-operative hematoma requiring intervention (including blood transfusion, percutaneous drainage and surgical hemostasis) within 30 days, pain at regular intervals and the incidence of other post-operative complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of inguinal hernia undergoing laparoscopic repair
* Age 21-80 years
* Patients taking Aspirin
* BMI 18-30

Exclusion Criteria:

* Age \<21 and \>80years
* Recurrent inguinal hernia
* Coagulopathy
* Patients who can't stop Aspirin
* BMI \<18 and \>30
EBUS-TTFB vs EBUS-TBNA for Diagnosing Inadequate Lymph Node Specimens Based on MOSE

The study aims to compare the efficacy and safety of endobronchial ultrasound-guided transtunnel forceps biopsy to transbronchial needle aspiration in diagnosing inadequate lymph node specimens based on macroscopic on-site evaluation.

Mediastinal and hilar lymphadenopathy are common clinical conditions. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is the standard method recommended by guidelines for obtaining tissue from these patients. Endobronchial ultrasound-guided transbronchial forceps biopsy (EBUS-TBFB) can overcome the limitations of inadequate tissue acquisition with EBUS-TBNA, and its efficacy and safety have been proved. However, EBUS-TBFB often requires the assistance of the electrocautery for mediastinal window creation, which increases technical difficulty and requires electrosurgical equipment, making it unsuitable for application in grassroots hospitals.

This study aims to use the endobronchial ultrasound-guided transtunnel forceps biopsy (EBUS-TTFB) method. A single-use bronchoscopic puncture dilation catheter will be employed to establish a tunnel between the airway and the lymph node, with both puncture and dilation completed in the same procedure. Currently, there is a lack of prospective randomized controlled trials to verify the efficacy and safety of EBUS-TTFB.

This study is designed as a prospective, multicenter, randomized controlled trial. A total of 162 patients will be randomly allocated in a 1:1 ratio to the EBUS-TBNA group or the EBUS-TTFB group. The primary endpoint is thediagnostic yield. The secondary endpoints include specimen adequacy, procedure duration, tunnel creation success rate, and safety.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Chest imaging shows mediastinal or hilar lymphadenopathy (short axis ≥10 mm), requiring EBUS-TBNA for definitive diagnosis;
3. EBUS-TBNA can be performed on these lymph nodes, and the specimens obtained from conventional EBUS-TBNA with three needle passes are inadequate (macroscopic visible core \< 30 mm);
4. Willing to participate in this clinical study and sign the informed consent form.

Exclusion Criteria:

1. Enlarged lymph nodes are identified as cystic or abscesses;
2. Severe coagulopathy, insufficient anticoagulants/antiplatelets withdraw time or bleeding diathesis (platelets\<50\*109/L, INR\>1.3) that do not meet bronchoscopy requirements;
3. Other contraindications to bronchoscopy or transbronchial biopsy, such as severe cardiopulmonary insufficiency, intolerance to anesthesia, or endoscopic procedures;
4. Patients who have participated in another clinical trial within the past three months;
5. Vulnerable groups, such as pregnant women
6. Any other condition that the investigator considers inappropriate for participation in this study.
A 6 Month Safety Extension Study of MBGS205

Phase IIb, multicentre, double-blind, randomised, placebo-controlled parallel-group 36-week study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism (HH)

This is a 6 months, active treatment, extension study, open to subjects who have completed full 24 weeks in Study MBGS205 (A Phase IIb multicentre, double-blind, dose-ranging, randomised, placebo-controlled study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic hypogonadism \[HH\]).The main purpose of Study MBGS206 is to evaluate long term safety and efficacy parameters in subjects after 12 months exposure with BGS649.

Eligibility Criteria:
Inclusion Criteria:

* Participating in Study MBGS205 and completion of the 24 week treatment period without meeting any discontinuation criteria of Study MBGS205
* In opinion of the investigator has been compliant with the requirements of the Study MBGS205 protocol.

Exclusion Criteria:

-Meeting any of the discontinuation criteria of initial Study MBGS205
Clinical and Structural Outcome After Early Repair of the Traumatic Rotator Cuff Tear

The optimal timing for surgical repair of traumatic rotator cuff tears is controversial. Today there are no prospective studies investigating the short to mid-term outcome after early arthroscopic repair of traumatic rotator cuff tears and the Swedish National Musculoskeletal Competence Centre requests more research to this subject. The investigators will follow 60 patients with acute rotator cuff tear undergoing early rotator cuff repair during the first year after surgery.

The investigators hypothesise that the outcome after rotator cuff repair is good.

There exists controversy in the current literature regarding timing for surgical repair of traumatic rotator cuff tears. We have seen no prospective studies describing the progression of shoulder function improvement the first year after arthroscopic rotator cuff repair.

We hypothesize that early arthroscopic repair of traumatic rotator cuff tears yields successful functional and structural outcomes but there will be a progression of shoulder function improvement during the hole first postoperative year.

Eligibility Criteria:
Inclusion Criteria:

* trauma to the shoulder with sudden onset of symptoms
* asymptomatic shoulder before trauma
* mr positive for full thickness rotator cuff tear

Exclusion Criteria:

* fracture
* severe comorbidity
* more than 6 weeks after trauma
* glenohumeral degeneration signs or osteoarthritis on x-ray
Efficacy Evaluation of Collagen Drink Products

To assess MAXI Collagen drink on skin condition improvement


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 35-65 years old

Exclusion Criteria:

* Subject with skin surface damage larger than $50 coin area.
* Subject who had skin allergies caused by diet or undrwent cosmetic or medical treatment within 6 months.
* Subject who is a vegetarian and allergic to seafood, alcohol or listed ingredients in the product.
* Students who are currently taking courses taught by the principal investigator of this trial.
Adherence to Aromatase Inhibitors: The Role of Partners

This is a qualitative study which explores the role that partners play in breast cancer survivors adherence to aromatase inhibitors and management of their side effects. Both patients and their partners will be interviewed (separately) in order to capture multiple perspectives. The target number of subjects is 64 (32 patients and 32 partners). The primary method of data collection will be face-to-face semi-structured interviews. These interviews will be audio-recorded.


Eligibility Criteria:
Inclusion Criteria:

* Women and partners of women with stage I-III breast cancer who

  1. have completed primary cancer treatments (surgery, chemotherapy, radiotherapy)
  2. have experienced AI side effects
  3. live with a romantic partner.

     Exclusion Criteria:
Computer-Aided Breast Cancer Detection in Women Undergoing Screening Mammography

RATIONALE: A computer-aided detection program may help doctors find breast cancer sooner, when it may be easier to treat, in women undergoing screening mammography.

PURPOSE: This randomized clinical trial is studying how well computer-aided breast cancer detection works in women undergoing screening mammography.

OBJECTIVES:

* Compare, prospectively, the breast cancer detection rate and recall rate of single reading using computer-aided detection vs standard double reading in women undergoing screening mammography.

OUTLINE: This is a prospective, randomized, multicenter study. Participants are randomized to 1 of 3 screening arms.

* Arm I (double reading): Screening mammograms are independently reviewed by two readers (i.e., radiologist or radiographer), each of whom reports on any abnormalities and decides whether a participant is recalled for further assessment or returned home to routine screening. In the event there is disagreement between the readers' findings, a third reader acts as an arbitrator by rendering an interpretation of the mammogram and making the final decision to recall the participant or return to routine screening.
* Arm II (single reading with computer-aided detection \[CAD\]): Screening mammograms are reviewed initially by a single reader who reports on any abnormalities. The reader then re-examines the mammogram with the aid of CAD, a system that uses computer prompts to recall suspicious features or abnormalities that may have been overlooked or previously dismissed as being normal. Based on these evaluations, a recommendation is made by the reader to either recall the participant for further assessment or return home to routine screening. If there is a discrepancy between the reader's interpretation and the CAD findings, another reader may be consulted to review the mammogram.
* Arm III (double reading followed by single reading with CAD): Screening mammograms are reviewed by double reading as in arm I followed by single reading with CAD as in arm II.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 30,000 participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Currently undergoing 2-view mammography for routine breast cancer screening at any of the following participating National Health Services Breast Cancer Screening Program centers:

  * Manchester
  * Coventry
  * Nottingham
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* Not specified