cyrilzakka/clinical-trials huggingface dataset:
a Clinical Trial to Evaluate the Efficacy and Safety of Agnucaston Tablets in the Treatment of Premenstrual Syndrome (PMS)

To compare the efficacy and safety of Agnucaston tablets with placebo for the treatment of Premenstrual Syndrome (PMS) and assess if Agnucaston tablets are superior to placebo on efficacy or not.

Premenstrual syndrome (PMS) is a common disorder in women and consists of somatic and/or behavioral/mood symptoms, which can impair a woman's social and work-related functioning. Some clinical studies with preparations containing Vitex agnus castus have demonstrated a positive effect on PMS with good tolerability. The aim of this clinical trial is to investigate the efficacy and safety of Agnucaston tablets for the therapy of PMS.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of PMS disease
* Age between 18 and 45 years
* Patients is in general good health

Exclusion Criteria:

* Any of the following endocrinological diseases: diabetes mellitus, hypo-/hyperthyreosis, pituitary tumor.
* Clearly kidney or liver disease, abnormal kidney or liver function.
* Any of the following gynecological diseases: endometriosis, mammary carcinoma, intraductal papilloma, galactorrhea, mammary fibroadenoma.
* Prior to the start of the study any planned surgical intervention of the breasts (including cyst puncture), of the uterus and/ or adnexa.
Real-Time Telehealth to Promote Self-care Management for Chronic Obstructive Pulmonary Disease

HYPOTHESIS:The study purpose is to evaluate the effectiveness of a structured pursed-lips breathing (PLB) protocol taught via real-time interactive telecommunication with a home computer using the lnternet and Skype software in veterans with chronic obstructive pulmonary disease (COPD. The primary hypothesis is veterans with COPD and dyspnea on exertion who receive a PLB educational intervention taught via weekly interactive telecommunication over a 4-week period will have greater reduction of exertional dyspnea compared to those who receive the PLB educational intervention with no weekly interactive sessions.

RESEARCH PLAN: An experimental two- group design is used. All subjects receive a brief 5 - 10 minute one-on-one PLB educational session. Subjects are then randomized to either the intervention group or the control group. The intervention group receives 4 weekly interactive group sessions with the health educator (principal investigator)via computer. A free software program known as Skype allows synchronous video and audio interaction. The comparison group receives only the brief PLB educational session with no weekly follow-up.

RESULTS: At end of 4 weeks, the intervention group had significantly lower dyspnea intensity scores (group X time interaction F = 6.69, p = 0.02) and significantly higher social support scores (group x time interaction F = 4.34, p = 0.058).

CLINICAL SIGNIFICANCE: Skype is a viable means for providing patient education. A structured PLB protocol provides significant differences in exertional dyspnea over time. A structured PLB protocol plus Skype showed significant reduction in patients' sense of dyspnea intensity and increased social support scores.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of COPD, expiratory airflow limitation evidenced by forced expiratory volume 1 second/forced vital capacity percent (FEV1/FVC %) less than 70 and FEV1 % predicted less than 80 with no reversibility by inhaled bronchodilator, and self report of shortness of breath when walking as assessed with the modified Medical Research Council (MRC) chronic dyspnea questionnaire.

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Exclusion Criteria:

Exacerbation of symptoms (dyspnea, increased sputum volume, and/or increased sputum purulence) within the past four weeks, hospital admission within the past four weeks, change in bronchodilator therapy within the past two weeks, unable to walk, unstable angina, unstable cardiac dysrhythmia, unstable congestive heart failure, and/or unstable neurosis or psychiatric disturbance.

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68Ga-NI-FAPI PET/CT: First-in-human Study

68Ga-NI-FAPI is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI PET/CT in patients with different types of cancer.

Carcinoma-associated fibroblasts (CAFs) are an integral part of the tumor microenvironment, and fibroblast activation protein (FAP), as a specific marker of CAFs, is overexpressed in more than 90% of epithelial malignant tumors' CAFs, with limited expression in normal tissues, making it an appropriate target for various tumors. Currently, several tracers targeting FAP for diagnostic purposes have been developed, such as 68Ga-FAPI-04, 68Ga-FAPI-02, and showed high efficacy in tumor staging and restaging. 68Ga-NI-FAPI is a novel agent incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. This pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI in patients with different types of cancer.

Eligibility Criteria:
Inclusion Criteria:

* Various solid tumors with available histopathological findings
* Signed informed consent

Exclusion Criteria:

* pregnant or lactational women
* who suffered from severe hepatic and renal insufficiency
Economic Assessment of STarting Endoscopic Robotic Groin Hernia Repair

The material cost for robotic groin hernia repair is higher than for conventional laparoscopic surgery. In this study, this amount will be quantified and possible differences in early postoperative course, hospital stay and readmission rate that could influence the cost/benefit ratio for robotic groin hernia surgery will be analyzed.

Robot-assisted groin hernia repair has been introduced in AZ Maria Middelares hospital since September 2016. In these procedures, the daVinci robot is being used to perform minimal invasive repair of these hernias. At the moment, this technique is frequently being used for groin hernia repair. Literature shows a clear benefit of robot-assisted versus open repair. Hospital stay decreases and complications are less frequently observed in patients who underwent minimal invasive repair (Henriksen NA et al., 2018).

On the other hand, the benefits of robot-assisted repair are less obvious compared to conventional laparoscopy. Many robot-trained surgeons are in favor of robot-assisted repair, but current literature is still inconclusive about the economic feasibility of robot-assisted groin hernia repair as standard of care.

This retrospective observational study is primarily designed to analyze the additional cost of robot-assisted groin hernia repair compared to conventional laparoscopic repair. A cost-benefit analysis will be carried out for groin hernia repairs performed by the same surgeon (Dr. Filip Muysoms) in the period 2016-2019.

As primary endpoint, direct costs related to the introduction of robot-assisted groin hernia repair will be analyzed. These are: material costs, costs related to hospital stay, honoraria and costs related to intrahospital complications. A comparison will be made between conventional laparoscopic and robot-assisted groin hernia repair.

As secondary endpoint, indirect costs will be compared between both groups. These include costs related to late complications and readmissions related to the index operation.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* underwent uni-or bilateral groin hernia repair in the period 2015- 2019
* surgery through minimal invasive repair

Exclusion Criteria:

* open surgery or conversion from minimal-invasive to open surgery
* combined procedures
* age below 18 years
CAPABLE Transplant

The purpose of this mixed methods study is to adapt CAPABLE as CAPABLE Transplant to accomplish two things: 1) To resolve barriers to being classified as active on the Kidney Transplant (KT) waitlist and 2) as a surgical prehabilitation intervention targeting the pre-frail/ frail KT waitlist population. It consists of two phases- an open label pilot and a randomized waitlist control trial.

CAPABLE is a multicomponent goal-directed program that reduces physical disability by working with the person and environment but has not been explored in prehabilitation research. The purpose of this study is to adapt CAPABLE, an existing evidence-based program for functionally and socio-economically vulnerable older adults, as a prehabilitation intervention for people with frailty awaiting KT.

As in CAPABLE, the delivery characteristics of CAPABLE Kidney Transplant consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (\~6 home visits for ≤ 1hour), a registered nurse (RN) (\~4 home visits for ≤ 1hour) and a handy worker (HW).

In earlier phases, research team members conducted preliminary activities to design the CAPABLE Kidney Transplant intervention using Human-Centered Design techniques.

This study will seek to accomplish two aims:

1. To iteratively refine the CAPABLE -Transplant prototype for those currently KT inactive. -
2. To pilot test the CAPABLE-Transplant intervention

The investigators will collect feedback during the open label pilot to further refine the intervention that will be tested as part of the randomized control trial.

Eligibility Criteria:
Inclusion Criteria:

* Deceased Donor Waitlist
* ≥50 years old
* Community dwelling
* Current Inactive status or active and had been inactive in the last 18 months for cardiovascular disease, frailty, obesity, social support, mental health, incomplete testing.

Exclusion Criteria:

* Living Donor Waitlist
* Severe cognitive impairment
* Inactivity expected to last \> 3 months (eg cancer treatment)
* \>4 hospitalizations in the last 12 months
* Current home nursing, physical or occupational therapy
Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 Diabetes

This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional Biphasic Human Insulin 30/70.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily) for at least 3 months
* HbA1c (glycosylated haemoglobin) equal to or below 12%
* Willing and able to perform self blood glucose monitoring (SMBG)

Exclusion Criteria:

* History of drug or alcohol dependence
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
* Previous participation in this trial
* Receipt of any investigational drug within the last month prior to this trial
* Known or suspected allergy to trial products or related products
Modified Second Haplo-transplantation for Graft Failure

Graft failure is a fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. We previously reported encouraging results with a novel Flu/Cy regimen. However, there are still around 20% patients developed delayed platelet recovery. We designed a modified regimen to further improve the hematopoietic reconstitution after second transplantation. This prospective, single-arm study aims to investigate the safety and efficacy of this modified regimen.


Eligibility Criteria:
Inclusion Criteria:

* 1.Primary disease: hematological malignancies(AML, CML, MDS, lymphoma, etc.); 2.Graft failure after first allogeneic stem cell transplantation; 3.Time from the first transplantation to the second transplantation is less than 180 days; 4. Age≥14 years.

Exclusion Criteria:

* 1. Active infections; 2. Active GVHD; 3. Organ dysfunction: hepatic injury (Tbil≥2ULN), renal injury (Cr≥1.5ULN), heart injury (EF%\<50% or symptomatic heart failure); 4. Eastern Cooperative Oncology Group (ECOG) score\>2; 5. Expected life time\<30 days; 5. Patients could not cooperate; 6. Other situations that are considered inappropriate for enrollment by the investigators,
Indications of Erector Spinae Plane Block in Pediatric Patients

Patients who were operated by Department of Pediatric Surgery between the 1 September 2017 and 28 February 2019 and who received erector spinae plane blocks as a part of postoperative analgesia management will be scanned.

There are a few randomized prospective studies of ESPB for its clinical effectiveness and all of them are in adults, except one. Also pediatric case reports are limited when compared to adults. We have been applying ESPB to our patients almost since from its first definition. But ESPB applications for pediatric patients, in our clinic, have started after a learning curve. Patients who were operated by Department of Pediatric Surgery between the 1 September 2017 and 28 February 2019 and who received erector spinae plane blocks as a part of postoperative analgesia management will be scanned.

Demographical data of the patient, patient position for the block, indication/surgery type, level of ESPB, unilateral or bilateral application, total volume applied, additional analgesic use, type of the analgesic if used will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were operated by Department of Pediatric Surgery

Exclusion Criteria:

* Incomplete patient forms
NRS 2002: Nutritional Screen in Cancer Patients

Diagnosing the nutritional status of cancer patients is extremely important. An appropriate nutritional status supports a better tolerance to the treatment. A working protocol is essential to start with Nutritional Screening. If it is detected Malnutrition Risk or Malnutrition, diet counseling, and the specific therapeutic for each patient must be provided.

This descriptive study will serve three aims:

* Register in the cancer patient's electronic medical record their nutritional status at the admission and when the patient is discharged.
* Determine the percentage of malnourished patients or in the risk of malnutrition who are admitted to hospitalization.
* Recognize the number of patients that required specialized nutritional care.

The purpose of this study is to determine if 30% of the patients admitted to the headquarters of SOLCA in Guayaquil from the Ecuadorian Cancer Society are at malnutrition risk or with any specific malnutrition level.

A prospective, descriptive, non-interventional study that will be performed from July 1st to October 4th of 2019 in all hospitalized patients of the Internal Medicine Service from SOLCA in Guayaquil from the Ecuadorian Cancer Society.

Statistical analysis: Central tendency measures. The results will be presented with tables and graphs.

Two weeks before the start of the study, the training of the personnel that will intervene in the screening of the participants will be carried out and will have a flow chart of actions to follow according to the status of patients.

Eligibility Criteria:
Inclusion Criteria:

* Participants older than 18-year old that go to the mentioned service

Exclusion Criteria:

* All patients with more than 48 hours of hospital admission
* Pediatric population.
* Patients with edema, non-malignant conditions (family of SOLCA workers) or with oncologic diagnosis not confirmed
* Participants who use a wheelchair or stretcher and those who cannot stand up

The NRS 2002 screening tool will be used to collect data and register the electronic medical record of each patient according to their nutritional status.

The variables to be recorded in an online Excel shared sheet (Google Drive) are weight, height, BMI, age, cancer diagnosis, associated comorbidities.

For weight determination, a scale (mechanical or electronic) in good condition will be used
Vanderbilt-Zambia Innovations in Global Health Technologies

Investigators will evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to process capillary blood in order to improve the sensitivity of already approved Rapid Diagnostic Tests (RDTs) for detection of human malaria infection. Results will be compared to those obtained using unenhanced capillary blood specimens directly applied to approved malaria RDTs. Participants seeking care for possible malaria in Zambia will be recruited to enroll in the study.


Eligibility Criteria:
Inclusion Criteria:

* Individuals giving written informed consent for themselves
* Children under the age of 18 for whom a parent or guardian can give consent
* Individuals seeking care or treatment of suspected or possible malaria
* Individuals being screened as a contact of someone with recent malaria
* Other individuals willing to have their blood tested for malaria

Exclusion Criteria:

* Anyone over 18 unwilling or unable to provide informed consent
* Anyone under 18 who does not have a parent or guardian to give consent
* Anyone between the age of 12 and 18 who does not give assent
Chronic Low Back Pain - Epiduroscopy Treatment

Retrospective analysis of patients with low back pain after epiduroscopic procedure

Retrospective analysis of patients with low back pain after epiduroscopic procedure Retrospective analysis of ambulatory data and next phone survey

Eligibility Criteria:
Inclusion Criteria:

* all patients after epiduroscopy

Exclusion Criteria:

* patients disagreement
Identification of Depressive and Anxiety Symptoms Among a Sample of Emergency Department Patients Using Artificial Intelligence (AI) Technology

Behavioral health problems, such as depression and anxiety, are common yet often are not identified by emergency department doctors and nurses. These mental health conditions can be due to medical issues or can worsen medical problems. One way investigators hope to do a better job of learning about mental health is by training Artificial Intelligence (AI) software to detect anxiety and depression by analyzing facial expression and tone of voice.

Participants are invited to participate in a study which may help improve emergency department care. An audio and video recording of the participant's responses to some simple, non-psychological questions will be analyzed by a computer to determine whether investigators can assess mood and anxiety by analyzing speech and visual patterns. The audio and video will not be listened to nor watched by study personnel, only analyzed by a computer. The investigator's hope is that it will help others in the future by aiding in the assessment of psychological state. This study is being conducted at CMC ED only.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age 18 and over) who presents to the UHCMC ED voluntarily with no obvious psychological disturbance by self-report or nurse/provider initial assessment
* English-speaking
* Patients with non-emergent concerns of Emergency Severity Index (ESI) level 3, 4, or 5

Exclusion Criteria:

* Prisoners
* Patients who are deemed to be critically ill (including life or limb threatening illness) or unable to consent
* Non-English Speaking
Physical Training in Patients With Relapsing Polychondritis

Physical training may improve physical capacity and health parameters in various systemic autoimmune diseases. Therefore, the present study will assess the role of an exercise training program in patients with relapsing polychondritis.

Impact of physical training in patients with relapsing polychondritis.

Eligibility Criteria:
Inclusion Criteria:

* Fullfill the classification criteria of McADAM et al. (1976)
* Using prednisone ≤ 0.5 mg/kg/day in the last three months
* Sedentary

Exclusion Criteria:

* Disease relapsing
* Overlapping disease
* Chronic and/or current infections (viral, bacterial or fungal)
* Patients undergoing major surgery within six months before the study
* With commitment to ambulation (joint affection in limbs)
* Smoking
* Diabetes mellitus
Treatment Adherence of Tuberculosis Medicines

It was hypothesized that tuberculosis patients receiving multiple interventions like educations, counseling and default tracing along with DOTS were more likely to adhere to tuberculosis treatment as compared to few interventions or DOTS only.


Eligibility Criteria:
Inclusion Criteria:

* adult patient
* \> 18years
* either sex
* diagnosed to have tuberculosis through chest x ray or sputum microscopy
* eligible to participate in the study

Exclusion Criteria:
Pranayama and Deep Breathing Exercises Sleep Quality After Laparoscopic Cholecystectomy

This study explores the impact of pranayama and deep breathing exercises on alleviating shoulder pain and improving sleep quality following laparoscopic cholecystectomy.

The data were collected by the researcher by face-to-face interview method at SBU Van Training and Research Hospital General Surgery Clinics. Necessary information was given to healthcare professionals in the clinics where the research would be conducted, and the lists of patients who would undergo surgery were followed. Data collection started in the preoperative period, and the data collection phase ended when the patient was discharged after the surgery.

To collect pranayama, deep breathing and control group data, the researcher identified patients who were scheduled to undergo laparoscopic cholecystectomy surgery in general surgery services on a daily basis and met the sampling criteria. In the hospital where the research was conducted, laparoscopic cholecystectomy surgeries were performed excluding emergency surgeries.

It is performed electively and patient education is provided on the day of surgery. Patients are taken into surgery according to the surgery list determined the day before.

It was determined by randomization whether the patients participating in the study would be in the control or experimental groups. Patients were included in the study according to randomization order. Patients coming for surgery were randomly assigned to a pranayama group, a deep breathing group, and a control group.

This randomization technique was continued until the sample number in the research groups was reached, and the study was terminated when 22 patients were included in the pranayama group, 22 in the deep breathing group and 22 in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Shoulder pain after elective laparoscopic cholecystectomy surgery patients,
* No hearing-speech problems that would hinder communication,
* No cognitive-mental problems,
* Not having any psychiatric disease,
* No sleep disorder
* Patients who have not previously attended courses on breathing exercises and yoga,
* All volunteers who agreed to participate in the study were included in the study.

Exclusion Criteria:

* Admitted to the intensive care unit in the early postoperative period,
* Extra surgical intervention (hernia repair, etc.),
* During laparoscopic cholecystectomy, patients undergoing open cholecystectomy patients were excluded from the study.