cyrilzakka/clinical-trials huggingface dataset:
Effects of Mindfulness Meditation and Stress Management After Breast Cancer

The primary aim of this study is to examine the effects of a mindfulness-based stress reduction training program, delivered in individual web-based sessions, among breast cancer patients. The objectives are to study and answer questions regarding effects of the such training in a randomized controlled trial including the following outcome measures: physical and mental health status, perceived stress, post-traumatic stress symptoms, psychological well-being, and sleep quality. In addition to the primary aim, the investigators plan to explore potential mechanisms through which mindfulness training lead to improvement in perceived stress, well-being and sleep-quality. This will be studied by mediational analyses.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patient ≥ 18 years of age who has received the cancer diagnosis ≤ 2 years previously
* Access and regular use of the internet

Exclusion Criteria:

* Non Swedish speaking
* Previous sever psychiatric illness
Feasibility of Cryobiopsy from the Bile Duct - CRYLEO

This is a multi-center, prospective, feasibility study using a 1.1 mm flexible cryoprobe SU via percutaneous access in the bile duct. The device has a CE-approval. First feasibility and safety for application assessed in the bile duct performed ex vivo and in a patient case report study. The study will take place at 5 different sites in Germany. Recruitment is competitive. In total, 15 patients will be enrolled. Patients are screened for study inclusion at the participating hospitals.

Primary objective:

• Feasibility of percutaneous cryobiopsy in the bile duct

Secondary objectives:

* Size of biopsy (mean area (in mm2) of each biopsy technique)
* Percentage of successful retrievals of biopsies by each biopsy technique
* Representativeness of each biopsy sample
* Quality of each biopsy sample
* Grade of crash artifacts occurrence defined as crush artifact area per biopsy
* Rate of safety-relevant aspects, like for example bleeding, post-bleeding, perforation, infection and abscess


Eligibility Criteria:
Inclusion Criteria:

* Suspicion of any neoplastic alterations in the bile duct system or other indication for biopsy sampling in the bile duct
* A percutaneous drainage or an access by means of percutaneous transhepatic cholangiodrainage (PTCD) has been previously established independent from study participation, without adverse events
* Patient is at least 18 years of age
* According to physicians' assessment, patient is able to follow study protocol or is able to understand the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigation, able to comply with study requirements and understand and independently sign the Informed Consent Form

Exclusion Criteria:

* • Presence of hereditary bleeding disorder, e.g. hemophilia A or hemophilia B

  * Severe impairment of partial thromboplastin time (PTT) of \>80s; International normalized ratio (INR) \>3; platelet count \<50,000 /nl
  * Dual antiplatelet therapy (change to aspirin monotherapy is no exclusion criterion)
  * Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is no exclusion criterion) Patient is participating in another clinical study pregnant or breast-feeding or intending to get pregnant during the study
Treatment of Women with PCOS of Phenotype D

In this study, female patients diagnosed with PCOS of phenotype D will be enrolled. They generally display the following characteristics: menstrual cycle alterations; polycystic ovary morphology at ultrasound; normal blood levels of androgen, particularly testosterone; no signs of clinical hyperandrogenism.

Current treatments for this condition include insulin sensitizers (such as metformin) and hormonal contraceptives. However, this specific phenotype of PCOS do not feature metabolic or hormonal alterations, and the efficacy of these treatments has lately been questioned.

In the present clinical trial, patients will be given a dietary supplement containing Dioscorea extract (source of Diosgenin, a natural analog of progesterone), vitamin D and alpha-lactalbumin for six month. Restoration of regular menstrual cycle and physiological ultrasound appearance of the ovaries will be the primary goal of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PCOS of phenotype D, according to the Rotterdam Criteria and the EGOI-PCOS Criteria

Exclusion Criteria:

* Diagnosis of PCOS of phenotype A, B or C, according to the Rotterdam Criteria and the EGOI-PCOS Criteria
* Hormonal treatments;
* Treatments with inositol or other insulin sensitizers (such as metformin);
* Insulin resistance or pre-diabetes condition
* BMI \> 30
* Endocrinological alterations
* Chronic pharmacological therapies
* Major pathological conditions (e.g. tumors or autoimmune diseases)
Hysteroscopic Assessment of Fallopian Tubal Patency

Disease of the fallopian tubes is one of the most common reasons for infertility. The most common test, a hysterosalpingogram, tends to be painful,inconvenient, and frequently misses concurrent uterine disease. We propose using a less painful technique (through modified office hysteroscopy) for tubal assessment that can be performed in the office rather than hospital radiology and that uses gold standard technology for identifying coexisting uterine conditions.


Eligibility Criteria:
Inclusion Criteria:

1. 18 - 50 years old
2. Able to give consent
3. Must have a uterus
4. Must have documented negative testing for gonorrhea and chlamydia within the past year or previously negative when tested with a current partner in a monogamous relationship
5. Negative test prior to procedure

Exclusion Criteria:

1. Pregnancy
2. Active lower and upper genital tract infection
3. Patients with allergies to hysterosalpingogram contrast will not be exposed to a contrast material to which they are allergic
4. Premenarchal or postmenopausal
5. Unable to read English at a 6th grade level or above
6. History of endometrial Ablation
7. Asherman's syndrome \> Stage 1
Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients

Bariatric patients usually require the use of either intravenous or oral opioid medications. The use of opioids, however, is often associated with side-effects such as nausea, sedation pruritus, urinary retention and respiratory depression with often delay patient discharge. This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to determine if this will decrease the use of opioids post-operatively for pain management in morbidly obese patients undergoing laparoscopic bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* Morbidly Obese and body mass index (BMI) of 35
* Between ages 20-17
* Candidates for Laparoscopic Bariatric Surgery

Exclusion Criteria:

* know hypersensitivity to acetaminophen or opioids
* impairment in liver function
* renal dysfunction
* mental retardation
Effect of Low Level Laser Therapy in Patients With Chronic Rhinosinusitis.

This study aimed to evaluate the efficacy of low-level laser therapy (LLLT) for Chronic sinusitis in a randomized, double-blind, placebo-controlled trial.

Chronic sinusitis, or chronic rhinosinusitis, is an inflammatory condition defined by symptomatic inflammation of the paranasal sinuses lasting longer than 3 months. Common presenting symptoms include nasal obstruction, facial pressure or fullness, nasal discharge (anterior or posterior), and olfactory loss. Furthermore, chronic sinusitis is associated with reductions in patient quality of life (QOL), sleep quality, and daily productivity.

It has been suggested that low-level laser can be used in treating chronic sinusitis but there are limited studies about its usage.

HYPOTHESES:

There is no statistically significant effect of laser therapy on headache, fatigue, or CT finding in patients with chronic sinusitis.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from mild to moderate symptoms.

Exclusion Criteria:

* Pregnant or breastfeeding women
* Patients with a definite deviated nasal septum, sinusitis, or history of operation within the last 6 months.
* Patients with hypertension, diabetes mellitus, malignancy, active pulmonary tuberculosis, infection, active respiratory disease like asthma, or other systemic diseases; • patients with long-term use of corticosteroids or immunosuppressive agents.
* Patients with hypersensitivity to the laser.
* Patients who were involved in another clinical study within 30 days.
* Patients who were unable to comply with the follow-up schedules.
* patients who had used antihistamines within 1 week, topical corticosteroids within2 weeks, systemic corticosteroids within 4 weeks, anti-cholinergic drugs within 3 days, antileukotriene drugs within 1 week, decongestants within 3 days, tricyclic antidepressants or phenothiazines within 2 weeks, non-steroidal analgesics within 2 weeks, and other drugs whi
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1021958 in Otherwise Healthy Controlled Asthmatic Subjects

To investigate safety, tolerability, pharmacokinetics including posology, and pharmacodynamics of multiple rising doses of BI 1021958 in otherwise healthy mild asthmatic subjects


Eligibility Criteria:
Inclusion criteria:

1. Healthy male and female subjects ofn non child-bearing potential

Exclusion criteria:

1. Any relevant deviation from healthy conditions except mild controlled asthma
Is Self-Reported Quality Assessment in Surgery Reliable?

Aim of the study is to evaluate the reliability of self-reported surgical outcome by residents

* prospective assessment of postoperative complications done by residents using a validated five-scale complication classification
* simultanously, complications will be prospectively assessed in the same manner by an external clinical nurse
* Trial with surgical intervention


Eligibility Criteria:
Inclusion criteria:

* All patients undergoing elective surgery

Exclusion criteria:

* Patients not undergoing surgery
* Patient in outpatient setting
Mesh-free Suture Urethropexy for Treating Stress Urinary Incontinence, Efficacy and Durability Trial

In this proposed study, the investigators aim to evaluate a modified suture urethropexy technique for the treatment of female stress urinary incontinence.

Participants will be followed with postoperative visits after 2 weeks, 2 months, and 12 months. Pelvic floor ultrasound imaging will be performed before surgery and after 2 months and 12 months, to evaluate urethral mobility.

This study is designed as a prospective observational study. The hypothesis is that suture urethropexy will improve stress urinary incontinence symptoms in participants with stress urinary incontinence and normal urethral closure pressure at 2 months and 12 months after surgery.

Specific Aims:

Aim 1: Investigate the efficacy of this mesh-free suture based surgical technique for improving SUI symptoms

Aim 2: Investigate the efficacy of this mesh-free suture based surgical technique on key urethral support defects observed with 3D ultrasound

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older with stress dominant urinary incontinence
* Stress urinary incontinence confirmed by testing (e.g. urodynamics)
* Able to provide informed consent and attend post-operative visits

Exclusion Criteria:

* Detrusor overactivity (\> 40cm H2O)
* Maximum Urethral Closure Pressure (\< 40 cm H2O)
* Post void residual \> 150 mL
* Prior surgery for stress urinary incontinence with retained material (e.g. bulking agent, sling)
Effects of Different Deflation Methods on Coughing Response and Hemodynamics During Extubation

Patients with endotracheal intubation and general anesthesia often have severe choking and hemodynamic fluctuations during the extubation period, which increases the risk of cerebrovascular accident, arrhythmia, incision bleeding and so on . This study aimed to observe the effects of different methods of deflating of endotracheal tube cuffs on cough response and hemodynamics during periextubation in patients undergoing general anesthesia surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Elective endotracheal intubation under general anesthesia.
2. Operation time \< 3 h.
3. ASA grade I or II.
4. Age 18\~65 years old.

Exclusion Criteria:

1. Throat and neck surgery.
2. Those assessed to have a high risk of reflux aspiration.
3. Difficulty intubation.
4. History of snoring before surgery.
5. Recent respiratory illness such as chronic cough.
6. Previous airway hyperresponsiveness, such as asthma.
7. recent use of cough suppressants.
8. Patients with severe heart, liver and kidney diseases.
Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort

Previous research has shown that semen deposition in the vagina after intercourse leads to dripping, discomfort, and vaginal odor. This study is evaluating a hygiene device designed to be inserted into the vagina after intercourse to absorb semen deposited into the vaginal canal to determine if there is a reduction in dripping and odor, and to determine the amount of fluids absorbed.

Despite the significant number of sexual dysfunctions in women, physicians often avoid discussing these concerns in the office setting. With recent research on the role of the pelvic floor, and recently approved medical therapies for hypoactive sexual desire disorder, physicians have begun to adapt to questioning patients about libido and pain-related sexual dysfunctions. However, pain-related sexual questionnaires often focus on insertional and penetrational dyspareunia, without asking about discomfort minutes, hours, or even the day following sexual intercourse. One common compliant in ambulatory sexual medicine clinics is the bothersome dripping, odor, and discomfort women experience after sexual activity when no condom is used, and when intravaginal ejaculation occurs.

Previous studies have shown the effects of semen on alterations in the vaginal flora. These changes contribute to a multitude of clinical complaints and diagnoses, including malodor, continuous discharge after intercourse, and bacterial vaginosis (BV). The exposure of semen changes the vaginal flora by increasing the pH levels, in turn altering the bacterial growth pattern. This implies the persistent presence of semen in the vagina may be one of the causes of malodor and development of BV. Chvapil utilized gas chromatography and demonstrated that the longer period of time semen was present in the vagina, the more likely it resulted in a strong and unattractive vaginal odor. Gallo showed that an incidental diagnosis of BV was correlated with detection of sperm on gram stain, and frequent coitus with or without condom use.

The investigator's goal in this study is to evaluate a novel postcoital consumer health product and its effects on the complaints of continuous seepage of semen and vaginal odor after intercourse.

Eligibility Criteria:
Inclusion Criteria:

* Heterosexual
* Age 25-50
* Has used tampons in the past 5 years
* Sexually active (vaginal intercourse, minimum once per week)
* Answered "moderate" to "severe" to being bothered by dripping/discomfort on Patient Global Impression of Severity (PGI-S) questionnaire "on minutes, hours, or following day"
* Willing and able to use product
* Understands, reads, writes, and speaks English

Exclusion Criteria:

* Pregnant
* Currently using condoms
* Unable to use device due to poor motor function
* Chronic disease which makes prone to infection (diabetes, autoimmune)
* Recurrent yeast infections
* Recurrent Urinary tract infection (UTI) (\>2 within the past year)
* Diagnosis of pelvic organ prolapse (Stage II or greater)
* Previous pelvic or vaginal surgery which, in the opinion of the investigator, may prevent proper use of product
* Unable to sign informed consent
A Study to Evaluate a Quality Improvement Intervention to Reduce Wound Separation Rates in Obese Gynecologic Oncology Service Patients Undergoing Abdominal Surgery

Approximately 500,000 surgical site infections occur annually in the US. These lead to worse patient quality of life, more outpatient and emergency room visits, readmissions and home services, with an estimated increase in costs of at least $3500 per complication. Surgical site infections are associated with increasing body mass index. There is limited and conflicting data of the utility of multiple surgical interventions to decrease the risk of surgical site complications. The investigators explored the effect of a prospective care pathway for closure of vertical abdominal wounds on patient's wound complications.


Eligibility Criteria:
Inclusion Criteria:

Women were eligible if they were between the ages of 18-89, with a BMI ≥ 30 kg/m2 undergoing a gynecologic procedure via a vertical abdominal incision. -

Exclusion Criteria:

Planned laparoscopic surgery, planned panniculectomy or other plastic surgery procedure at the time of laparotomy, prior history of hernia repair with mesh or planned mesh hernia repair at the current procedure, enterotomy or intestinal surgery, a history of prior radiation to the abdomen or pelvis, concurrent pregnancy, current incarceration, or inability to provide informed consent, including inability to understand spoken English.
Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy

Increasing drug resistance presents a significant challenge to the efficacies of common empiric eradication regimens for Helicobacter pylori treatment in the mainland of China. Tailored therapy may be the best choice to achieve good efficacy, especially in patients with penicillin allergy. Few studies had evaluated the patients with penicillin allergy.This study is designed to evaluate the efficacy and safety of antibiotic sensitivity-based tailored therapy for Helicobacter pylori treatment in the patients with penicillin allergy.


Eligibility Criteria:
Inclusion Criteria:

* Participants with penicillin allergy who have non-ulcer functional dyspepsia or scarred peptic ulcer disease
* Ability and willingness to participate in the study and to sign and give informed consent
* confirmed H. pylori infection

Exclusion Criteria:

* Patients without penicillin allergy
* Less than 18 years old
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs
* Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
Administration of CBG000592 (Riboflavin/Vitamin B2) in Patients With Acute Ischemic Stroke

Administration of CBG000592 (riboflavin/vitamin B2) in patients with acute ischemic stroke to know if it causes a reduction of glutamate-mediated excitotoxicity.

The investigators hypothesis focuses on the effect of riboflavin given for the first three hours of ischemic stroke, as a reducing agent of cerebral glutamate concentration. This administration would produce a reduction of excitotoxic damage and consequently generate clinical improvement, while a lower income and a better functional outcome of patients at three months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years, both men and women.
2. Patient or legal representative able to understand and sign the informed consent.
3. Patients with suspected stroke within 3 hours of onset.

Exclusion Criteria:

1. Women of childbearing age, with potential for pregnancy or breastfeeding.
2. Patients with a score ≥ 2 point 1a in the NIHSS scale.
3. Scale pre-stroke modified Rankin ≥ 2.
4. Inability to prior testing image needed for the study.
5. Previous disorders that may interfere with the interpretation of neurological scales.
6. Treatment with probenecid, tricyclic antidepressants, phenothiazines, streptomycin, erythromycin, tyrothricin, tetracyclines and carbomycin, at the time of inclusion.
Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk

Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. The objective of this study is to determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA.

Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. To determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA. In a randomized, controlled parallel group study, 39 participants were randomized (2:1) to receive either 8-hour nightly CPAP (n=26) or oral placebo (n=13). Sleep was polysomnographically recorded in the laboratory on each night. CPAP adherence was ensured by continuous supervision. Participants continued their daily daytime routine activities outside the laboratory. Glucose metabolism was assessed at baseline and after 2-weeks of assigned treatment using both the oral and intravenous glucose tolerance tests (OGTT and ivGTT, respectively). The primary outcome was the overall glucose response as quantified by the area under the curve for glucose during 2-hour oral glucose tolerance testing.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese adults (age ≥45 yrs and BMI ≥25 kg/m2)
* prediabetes and OSA (AHI ≥ 5)
* regular life styles and schedules (no shift work in the past 6 months, no travel across time zones during the past 4 weeks)
* habitual bedtimes of at least 6 hours but not exceeding 9 hours will be eligible.
* not to take any medications during the study period with the exception of antihypertensives and lipid lowering agents
* not on hormone replacement therapy.
* have sedentary activities and no competitive athletes or subjects with high exercise levels.

Exclusion Criteria:

* previous or current treatment with supplemental oxygen
* requirement of supplemental oxygen or bi-level positive airway pressure for OSA treatment during titration
* presence of active infection, psychiatric disease or history of other significant illness (e.g., myocardial infarction, congestive heart failure, stroke, arrhythmia, chronic kidney or liver disease0
* clinical depression as evidenced by a score \>16 in CES-D scale
* smoking, or routine alcohol use (more than 2 drinks per day), or excessive caffeine intake (\>300mg per day)
Comparative Study of Rituximab Versus Combination of Rituximab and Intravenous Cyclophosphamide in Severe Pemphigus

The purpose of this study is to compare the effectiveness of rituximab alone vs combination of rituximab and cyclophosphamide in the treatment of pemphigus not responding adequately to routine medications.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of pemphigus based on clinical, histopathological and immunological features the following:
* Refractory disease defined as continuing extension of old lesions, development of new lesion, or failure of established lesions to begin to heal despite 3 weeks of therapy on 1.5 mg/kg/day of prednisolone or its equivalent with or without the concurrent use of cyclophosphamide 2mg/kg/day for 12 weeks or azathioprine 2.5 mg/kg/day for 12 weeks. Patients who fail to respond to 6 DCP/DP are also considered as refractory disease.

Exclusion Criteria:

* Infections- Hepatitis B, Hepatitis C, HIV, active tuberculosis or sepsis.
* Abnormal liver function tests and renal function tests
* Known cardiac arrhythmia or conduction abnormality
* Systolic ejection fraction \<40%
* Pregnancy and breast feeding
* Severely decreased bone marrow functions.
* Known history of bladder cancer or hemorrhagic cystitis
* Known allergy to cyclophosphamide
* Patients of reproductive age group who haven't completed their family
* Known hypersensitivity to murine proteins.
* Patients who do not consent for the study.