cyrilzakka/clinical-trials huggingface dataset:
Acupuncture for Postoperative Urinary Retention After Hemorrhoidectomy: a Randomized Controlled Trial

The goal of this study is to examine the efficacy of acupuncture in the management of acute postoperative urinary retention.

Clinical question:

Is acupuncture efficacious for postoperative urinary retention after hemorrhoidectomy compared with sham acupuncture and neostigmine.

Study design:

The participants who undergo hemorrhoidectomy and report postoperative urinary retention will receive one session of acupuncture or sham acupuncture or one injection of 1-mg neostigmine. The primary outcome was the time to first urination after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65 years
* Meets the diagnostic criteria of postoperative urinary retention
* Received milligan-morgan hemorrhoidectomy and general anesthesia

Exclusion Criteria:

* Received Diuretic drugs
* Organic diseases that cause urinary retention
* Severe infection in the urinary tract
* Has a history of adverse reaction to neostigmine
* Cognitive dysfunction that affects outcome assessment
* Being pregnant
Epigenetic and Microbiota Modifications

In order to investigate how gut microbiota interventions are able to change gut microbiota population and impact insulin resistance, 30 type2 diabetes volunteers with obesity will be randomized to one of the three treatment groups: 1) probiotics arm, who will take a Lactobacillus fermentum D3 in pills daily; 2) FMT arm, who will take a lyophilized fecal microbiota transplant in pills; and 3) control group, who will take placebo pills. After 3 months, insulin resistance, glucose metabolism parameters, and gut microbiota variation will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Type2 diabetes in treatment with metformin
* 30 kg/m2≤IMC≤40 kg/m2
* 30-70 years old
* HOMA-IR \>6
* Informed consent

Exclusion Criteria:

* psychopathologic alterations that do not permit the adherence to the trial.
* Diabetes medication different from metformin.
* History of cholecystectomy.
* Use of Probiotics, and/or antibiotics in the last 3 months
Dapagliflozin in the Prevention of Post-Coronary Angioplasty Acute Kidney Injury

To compare the incidence of acute kidney injury (AKI) post percutaneous coronary intervention (PCI) in a Dapagliflozin treated group versus a group managed with the usual standard of care.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or more.
2. Scheduled/non-emergent Percutaneous coronary intervention (PCI).
3. Post-index procedure Staged PCI with at least 14 days from contrast exposure.
4. Patient can fully understand the study information and sign informed consent.

Exclusion Criteria:

1. Cardiogenic shock /need for inotrope or mechanical pump support.
2. Acute kidney injury as defined by KDIGO criteria (\<4 weeks) prior to PCI.
3. End-Stage Renal Disease prior to PCI (On renal replacement therapy).
4. Diabetes Mellitus type 1.
5. Active diabetic ketoacidosis or uncontrolled hyperglycemia (blood glucose \>400 mg/dl).
6. ST-segment elevation Myocardial Infarction undergoing index PCI.
7. Active Genitourinary infection.
8. Diagnostic Left Heart Catheterization without PCI.
9. Patients undergoing zero contrast PCI.
10. Participation in a randomized controlled pharmaceutical or treatment-related cardiac or pulmonary clinical study within 1 month prior to randomization.
11. Coexistent hemodynamically significant valvulopathy (Symptomatic and/or severe).
12. Patients with Acute Heart Failure admission \< 30 days prior to PCI.
13. Intercurrent illness resulting in volume depletion and hypotension (MAP\<60 mmHg).
14. Patients with a kidney transplant.
15. Any contrast exposure within 14 days.
16. Patients with estimated glomerular filtration rate (eGFR) \< 25 cc/min (Recommended eGFR threshold by Food and Drug Administration labeling).
17. Patients with an active intrinsic inflammatory or autoimmune renal pathology.
18. Women of child bearing age (\<50 years old).
19. Prison Inmates
Circulating Tumour DNA as a Marker of Residual Disease & Response to Adjuvant Chemotherapy in Stage I-IV Ovarian Cancer

To demonstrate that detectable ctDNA in peripheral blood following debulking of the primary tumour or following completion of adjuvant treatment for is associated with subsequent disease recurrence in stage I-IV epithelial, fallopian tube and primary peritoneal cancer (Ovarian Cancer)

This is a prospective,multi-centre study involving serial blood collections from 100 stage I-IV debulked (or to be debulked in the case of neoadjuvant chemotherapy) high grade serous, endometrioid and clear cell ovarian, fallopian tube and primary peritoneal cancer patients (EOC) or ovarian carcinosarcoma planned to receive adjuvant chemotherapy. Tumour samples will be made available following patient enrollment for the primary debulking group, and following surgery for the neoadjuvant group for mutation analysis. Ascites will not be accepted. Up to four blood samples in the primary debulking group and up to five blood samples in the neoadjuvant group will be collected from each patient over a 6-8 month period for ctDNA and Ca125 analysis Choice of chemotherapy will be platinum based treatment at the treating clinician's discretion as per standard of care.

Eligibility Criteria:
Inclusion Criteria:

1. Patients that have had primary debulking surgery for curatively resected stage I-IV high grade serous, endometrioid or clear cell carcinoma, or carcinosarcoma of the ovary, fallopian tube or primary peritoneum. Stage IV patients can only be included in the study if they have had a complete resection of all macroscopic disease with no residual disease.

   OR Patients commencing neoadjuvant chemotherapy for stage I- III high grade serous, endometrioid or clear cell carcinoma, or carcinosarcoma of the ovary, fallopian tube or primary peritoneum. Women must be planned to undergo interim debulking surgery.
2. A representative tumour sample can be made available for molecular testing after surgery or a core biopsy pre neoadjuvant chemotherapy if available.
3. Fit and planned for adjuvant chemotherapy

Exclusion Criteria:

1. History of another primary cancer within the last 3 years
2. Patients with Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer (EOC) of mucinous subtype and sarcoma
3. Patients with Stage IV disease who have residual disease
4. Patients \<18 years
Comparison of Combined Serratus Anterior Plane Block and Thoracic Paravertebral Block

Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block, serratus anterior plane block (SAPB), and erector spinae plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB and SAPB are some of them. There are two techniques for SAPB application. In Deep SAPB (DSAPB) application, a local anesthetic agent is given under the serratus anterior muscle. In the Superficial SAPB (SSAPB) application, the local anesthetic agent is given above the serratus anterior muscle. Since it is done by entering from the same point in two applications, it is possible to perform these two applications at the same time with a single needle entry. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, it may be possible to obtain a more effective analgesic effect in patients by combining the mechanism of action of DSAPB and SSAPB, as in the multimodal analgesia method. This study seeks to evaluate the effect of TPVB and combined SAPB (CSAPB) after VATS.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old
* ASA physical status I-II-III
* BMI 18 to 30 kg/m2
* Elective video-assisted thoracoscopic surgery

Exclusion Criteria:

* Patient refusing the procedure
* Emergency surgery
* Chronic opioid or analgesic use
An Observational Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (ACTIVATE)

This observational study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with moderate to severe rheumatoid arthritis. Data will be collected for 12 months from patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) and methotrexate (weekly dose at the discretion of the physician).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis
* RoActemra/Actemra treatment initiated by rheumatologist in an Arthritis Center for (up to 2 months prior to study entry)

Exclusion Criteria:

* History of severe allergic or anaphylactic reactions or known hypersensitivity to any component of the drug
* Active, severe infection or history of recurrent clinically significant infection
* Pregnancy
* Treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before baseline visit
* Methotrexate intolerance
Traditional Chinese Medicine, Western Medicine and Low-level Light Therapy（LLLT） for Primary Dysmenorrhea（PD）

To observe the clinical efficacy and safety of three methods for the treatment of primary dysmenorrhea. Establish an integrated biomarker index system for the evaluation of the efficacy of traditional Chinese medicine, western medicine and Low-level Light Therapy for the treatment of primary dysmenorrhea, and further explore the mechanism and therapeutic material basis of the three treatment methods for the treatment of primary dysmenorrhea

480 women clinically diagnosed of primary dysmenorrhea will be enrolled from nationwide multi-centers. Blood samples were collected from 480 patients before and after treatment (1 experimental group, 3 control groups, treatment cycle of 3 menstrual cycles, follow-up cycle of 5 menstrual cycles), Metabonomics study, and integration of clinical sample information (Serum biochemical indicators, imaging indicators, etc.), through bioinformatics to establish a comprehensive biomarker index system for the evaluation of the efficacy of traditional Chinese medicine, Western medicine and Low-level Light Therapy instrument Methods for the treatment of primary dysmenorrhea and its therapeutic basis.

Eligibility Criteria:
Inclusion Criteria:

1. Female (16-35 years old);
2. regular Menstruation (cycle 21-35 days, menstrual period 3-7 days);
3. Be clinically diagnosed with primary dysmenorrhea;
4. Be willing to participate in the whole process of the research in 5 consecutive menstrual cycles.

Exclusion Criteria:

1. irregular menstruation affecting the treatment and efficacy judgment;
2. Patients with secondary dysmenorrhea;
3. Those who have used related drugs in the past 3 months;
4. Abuse or dependence on substances (alcohol or medicine) in the past 3 months; heavy smokers (smokers who smoke 20 or more cigarettes per day);
5. Those who have severe or unstable physical illnesses, related to liver, kidney, gastrointestinal tract, cardiovascular, respiratory, endocrine, nervous, immune or blood systems, neuropsychiatric systems and so on;
6. Lactating or pregnant women, or women within 1 year after delivery;
7. Those who are allergic to the test drug or light, have contraindications for Marvelon and Ding kun dan;
8. Have a history of thromboembolic disease or a tendency to thrombosis;
9. one month before joining in this study (first interview), Who participated in another clinical trial;
10. Those who meet the inclusion criteria, fail to follow the doctor's advice so that we cannot judge the curative effect ,the incomplete data cannot be evaluated.
Evaluation of Kinesophobia in Patients With Metabolic Syndrome

Metabolic syndrome (MS) is a public health problem characterized by central obesity, increased blood pressure and triglyceride levels, decreased blood HDL levels and the presence of insulin resistance (1).Kinesiophobia is a fear of irrational movement that develops because of its belief in susceptibility to injury and is associated with low levels of physical activity. Considering that exercise improves metabolic processes in people with MS, we aimed to evaluate the presence of kinesophobia in patients with MS.

Patients aged 45-65 years diagnosed with metabolic syndrome and healthy controls will be included in the study. Patients with rheumatic and neurological diseases,history of trauma, gonarthrosis, lumbar disc hernia, previous fractures, fibromyalgia and those who have experienced pain for the last week will be excluded. The participants will be filled in the Short Form-36 (SF-36), the Hospital Anxiety and Depression Scale, and the Tampa Kinesiophobia Scale. 48 patients with MS and 48 healthy participants will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with metabolic syndrome

Exclusion Criteria:

* Patients with rheumatic disease
* Patients with neurologic disease
* Patients with history of trauma
* Patients with gonartrosis
* Pateints with fibromialgia
A Study to Assess Beta-Lactam in the Treatment of Hospitalized Patients With Bacterial Pneumonia

This study will assess the efficacy and safety of intravenous beta-lactam, in comparison with ceftriaxone, in hospitalized patients with community-acquired pneumonia not caused by Legionella. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients at least 18 years of age;
* hospitalization with community-acquired pneumonia or development of pneumonia within 48 hours of being hospitalized for another reason;
* fever;
* new or increased productive cough;
* chest pain, shortness of breath, or rapid breathing.

Exclusion Criteria:

* requiring intubation or ventilation;
* nursing home or extended care within 60 days before study;
* concomitant bacterial infection requiring antibiotics;
* long-term immunosuppressive therapy.
Prolotherapy for the Treatment of Plantar Fasciitis

The purpose of this study is to demonstrate that prolotherapy in conjunction with a physiotherapy program looking at reinforcing calf muscle and muscle of the plantar fascia, relieves pain and improves function of people suffering of plantar fasciitis, an inflammation of the plantar fascia, after basic treatment failure.


Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of Plantar Fasciitis
* experience pain in the plantar fascia for more than 6 months
* be capable to understand and execute physiotherapy exercises

Exclusion Criteria:

* previous operation of the plantar fascia
* deformation of the foot (congenital or acquired)
* presence or suspicion of infection of the skin at the site where the injection will occur
* history of systemic diseases capable of inducing pain or sensitivity to the feet (seronegative arthritis, diabetes, fibromyalgia, etc.)
* abnormal coagulation
* allergy to lidocaine and/or marcaine
* pregnancy
* lumbar, hip or knee pain
Biomarker for Friedreich's Ataxia (BioFridA)

International, multicenter, observational, longitudinal monitoring study to identify biomarker/s for Friedreich's Ataxia and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s

An ataxia is neurological disorder of balance and coordination resulting from dysfunctions of the cerebellum. Friedreich's ataxia (FRDA) is most common ataxia in white population, with an estimated prevalence of 2-4 cases per 100,000 individuals. With an average age of onset of 10-15 years, the disease is characterized by dysarthria, deep sensory loss, hypertrophic cardiomyopathy, spinocerebellar ataxia, pyramidal weakness, diabetes mellitus, and skeletal abnormalities.

FRDA is an autosomal recessive disorder caused by pathogenic variant/s in the FXN gene, which encodes the mitochondrial protein frataxin. In 98% of cases these are homozygous guanine-adenine-adenine (GAA) triplet repeat expansions in the ﬁrst intron of the FXN gene. The remaining cases are compound heterozygotes for a GAA repeat expansion plus a FXN point mutation or deletion. GAA repeat expansions suppress transcription of the FXN gene, leading to frataxin deﬁciency.

Until now there is no FDA-approved therapy for FRDA, but potential agents for treatment are in developing phases. As such, especially antioxidants like idebenone are tested in clinical trials as FRTA medication, whereas another study identified p38 inhibitors as potential therapeutic agents. Various clinical rating scales including the Scale for the Assessment and Rating of Ataxia (SARA), Friedreich's Ataxia Rating Scale (FARS), and the International Cooperative Ataxia Rating Scale (ICARS) have been used as trial endpoints in FRDA, but these measurements have limited sensitivity to disease progression over 12 months. Furthermore, there are no validated, objective central or peripheral nervous system biomarkers of disease progression for use in clinical trials as intermediate endpoints.

It is the goal of the BioFridA study to identify, validate, and monitor FRDA biomarker/s.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent is obtained from the participant or parent/ legal guardian
* The participant is aged between 2 and 50 years of age
* The diagnosis of Friedreich's Ataxia (FRDA) is genetically confirmed by CENTOGENE

Exclusion Criteria:

* Informed consent is not obtained from the participant and parent/ legal guardian
* The participant is younger than 2 years or older than 50 years of age
* The diagnosis of FRDA is not genetically confirmed by CENTOGENE
Beige Fat, Energy, and the Natriuretic Peptide System

Obese individuals experience an increased risk of cardiovascular and metabolic diseases. Evidence from genetic studies indicate that the natriuretic peptide (NP) system may protect against these diseases. NP levels differ by obesity status and race has not been established in humans. Thus, the investigators propose a study in which will quantify adipose tissue gene expression and energy expenditure in states of NP deficiency in humans. The overarching postulate is that obese and black individuals have NP deficiencies that contribute to less beige adipose tissue and lower energy expenditure.

Obesity represents a serious public health burden. Obese individuals experience increased risk of cardiovascular and metabolic cardiometabolic disease, including insulin diabetes, resistance, hypertension, and dyslipidemia. Obesity and obesity-associated cardiometabolic dysfunction are significant contributors to morbidity and mortality in Veterans. This indicates that obesity and cardiometabolic dysfunction are complex and multifactorial, and suggests that there are additional factors that contribute to the pathogenesis of obesity and its associated cardiometabolic risk that have been discovered. Moreover, some of the pharmacologic therapies for obesity can have adverse cardiovascular effects. Thus, it is crucial to improve the understanding of the multiple pathways contributing to the pathogenesis of obesity and obesity-associated cardiometabolic risk, including the identification of novel relevant pathways, in order to develop more effective treatments for these diseases. The proposed work will form a foundation for future high-impact studies of mechanisms for adiposity and cardiometabolic disease.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18-55 years
* Body Mass Index (BMI) \>= 18.5 and \<25 kg/m2 (lean), or BMI 30 kg/m2 (obese)

Exclusion Criteria:

* Significant pulmonary, liver, or renal disease
* Heart failure (any type) or unstable coronary artery disease
* Diabetes Mellitus (Types 1 and 2)
* Thyroid dysfunction
* Active malignancy
* Chronic inflammatory diseases, such as inflammatory bowel disease, hepatitis, rheumatoid arthritis
* Current use of medications likely to affect energy homeostasis, including glucocorticoids, amphetamines, and beta blockers
* Currently pregnant or breastfeeding, or unwilling to avoid becoming pregnant or breastfeeding during study duration
* Significant claustrophobia that would prevent the use of the metabolic cart as part of the study protocol
* Hemoglobin A1c (HbA1c) \>= 6.5%
* Liver Function Tests (LFTs) elevated \>3x upper limit of normal
* Estimated Glomerular Filtration Rate (eGFR) \<40 ml/min
* Currently abnormal thyroid stimulating hormone (TSH)
Retrospective Study in the Use of the Alfapump and the Treatment of Malignant Ascites

Treatment of malignant ascites with the alfapump offers a new treatment option for this patient group. So far, there is no systematic analysis of patients with this indication available in the literature.

This retrospective analysis offers the possibility to assemble already existing data within a reasonably short time frame. Based on this analysis, a prospective analysis can be designed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with malignant ascites
* Patients with alfapump implanted for malignant ascites
* Patients 18 years or older at the time of death

Exclusion Criteria:

* Patient is alive at the time of inclusion assessment
Spine Pain INtervention to Enhance Care Quality And Reduce Expenditure

Low back and neck pain are among the leading causes of medical visits, lost productivity and disability. There is an urgent need to identify effective and efficient ways of helping subjects with acute spine pain while guiding practitioners towards high-value care. This trial will be a block and cluster-randomized open-label multi-centered pragmatic randomized clinical trial comparing healthcare spending and clinical outcomes for subjects with spine pain of less than three months' duration, in whom there are no red flag signs or symptoms. Subjects will be randomized to one of three treatment strategies: (1) usual primary care provider-led care; (2) usual PCP-led care with spine pain treatment directed by the Identify, Coordinate, and Enhanced decision making (ICE) care model, and (3) usual PCP-led care with spine pain treatment directed by the Individualized Postural Therapy (IPT) care model. Our outcomes of interest will be spine-related healthcare utilization at one year as well as pain and functionality of the study participants.


Eligibility Criteria:
Inclusion Criteria:

* Patients with back or neck pain of ≤ 3 months' duration. All patients must have spine pain with or without radiation to the extremities or the head
* Age ≥ 18 years
* Willing and able to provide informed consent

Exclusion Criteria:

* Patients with symptoms attributed to the spine but without actual pain in the spine (e.g. those with cervicogenic headache without neck pain)
* Currently pregnant
* Currently receiving disability benefits, worker's compensation, or involved in litigation for a workplace injury
* Currently enrolled in another intervention trial for the management of acute back or neck pain
* Cancer that is metastatic or being actively treated. (i.e chemotherapy, radiation, surgery)
* History of receiving active therapy for back or neck pain in the past 3 months (7+ consecutive days of narcotic use, 6+ sessions of PT, chiropractic care, acupuncture, postural therapy, or other spine therapy delivered by a trained provider)
* History of spine surgery or spine injections/ablation in the past 6 months
* Severe, active psychosis or major depression inhibiting ability to physically participate in intervention
* Red Flag Symptoms (fever, night sweats, unintentional weight loss, bowel or bladder dysfunction, neurologic weakness, history of intravenous drug use)