cyrilzakka/clinical-trials huggingface dataset:
Acupuncture for Chronic Pelvic Pain

The aim of the study is to assess the effects and safety of acupuncture for moderate to severe chronic pelvic pain in women.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged between 18 and 50.
* Chronic pelvic pain (with or without dysmenorrhoea or dyspareunia) of at least 6 months duration.
* Having not used medications, other than rescue medicine, or therapies for chronic pelvic pain for at least 4 weeks before randomization, and consenting not to use throughout the process of the research.
* Completing Weekly Pain Diary for at least three week during the four-week run-in period, and at least two of the worst pain scoring ≥4 on the Numeric Rating Scale.
* Volunteering to participate the trial and signing written informed consent.

Exclusion Criteria:

* Cyclical chronic pelvic pain, such as only with dysmenorrhea.
* Endometriosis.
* Adenomyosis.
* Complex ovarian cyst.
* Accessory cyst \>5cm.
* Uterine fibroids \>5cm.
* Malignant disease.
* Anterior sacral neurectomy or uterine sacral nerve ablation before or scheduled in the next 6 month.
* Irritable bowel syndrome.
* Symptomatic urinary tract infection.
* Acute pelvic inflammation.
* Uncontrolled vaginitis.
* Lactation period, pregnancy, or fetation planned in the next 6 months.
* Sever disorders in heart, lung, brain, liver, kidney and hematopoietic system, or obvious psychiatric or cognitive dysfunction.
* Poor adherence.
Boost Study 21270 (Cognition)

This study is designed to to test the technical feasibility of encouraging interaction with a mobile smartphone software package (mHealth app) for training aspects of executive function and cognition.

The purpose of this human subjects study is to test the technical feasibility of interaction with a mobile smartphone software package (mHealth app) for training in aspects of executive function and cognition. The study participants are healthy subjects recruited online, with consent secured at the time of screening, and with enrollees assigned to High or Low groups on the basis of initial screening task scores. Subjects are requested to participate in directed interaction activities for up to 8 weeks, with measures primarily evaluating feasibility of MHealth app package task completion and secondarily evaluating the cognitive effect of activities.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and above
* Fluent in English
* Resides in the United States
* Score on prescreen task is in 25% quartile
* Familiar with smartphone device app installation and device usage
* Possesses a compatible smartphone

Exclusion Criteria:

None
Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis

Adult cystic fibrosis (CF) patients admitted with an acute infection complicated by acid-base disturbance and decreased ventilation will be studied.

They will receive salt replacement to correct the acid-base disturbance and possibly their ventilation.

Assessment of symptoms (questionnaire), acid-base and electrolyte status (blood and urine tests) ventilation (overnight oxygen and carbon dioxide monitoring non-invasively) and sleep-wake pattern (actigraphy) will be carried out.

Study hypothesis: Acute volume and electrolyte replacement corrects hypochloremic hypovolemic metabolic alkalosis and compensatory hypoventilation/ hypercapnia in acute exacerbations of cystic fibrosis.

Background: Hypochloremic hypovolemic metabolic alkalosis contributes to hypercapnia in acute exacerbations of cystic fibrosis. Treatment of the metabolic alkalosis with volume and sodium chloride (NaCl) replacement could reduce hypoventilation and hypercapnia, thereby improving symptoms, sleep patterns and daytime activity level. This would avoid unnecessary treatment with non-invasive ventilation.

Hypothesis: Volume and NaCl replacement corrects hypochloremic hypovolemic metabolic alkalosis and compensatory hypoventilation/ hypercapnia in acute exacerbations of cystic fibrosis and results in symptomatic improvement.

Entry criteria:

* Adult cystic fibrosis patient
* Admission with acute exacerbation
* PaCO2 \> 45 mmHg
* Primary metabolic alkalosis (acid-base diagram of Stinebaugh and Austin)
* Serum chloride (Cl) ≤ 98 mmol/L
* Serum albumin (alb) \> 25 mmol/L

Intervention:

* Normal saline intravenously day(D)1,2,3. (Replace greater of Cl deficiency or acute weight loss, with 2/3 on D1 and remainder D2, D3)
* NaCl tablets 3 tds D4 to 10 (calculated to replace 7 mmol NaCl loss in 60 kg subject)

Random allocation to either:

1. Intervention + standard care (including standard dietary advice) D1-10
2. Standard care alone (including standard dietary advice) D1-10

Primary outcome measures: (D1, D4, D10)

* PaCO2 (performed at same time of day as admission ABG's)
* Acid-base status (Stinebaugh and Austin, ABG's)
* Serum chloride
* Overnight oximetry (% night SpO2\<90%) and PtcCO2 (rise in CO2 overnight)

Secondary outcome measures: (D1, D4, D10)

* Serum albumin, sodium
* Body mass index (BMI)
* Spirometry (D1, D10)
* Headache scale
* Epworth sleepiness scale
* Wrist actigraphy (circadian rhythm and daytime activity level)(D1-10)
* Urinary chloride, potassium, sodium, pH, osmolality
* Baseline ABG's as stable outpatient (within 3 months, pre or post admission)

Eligibility Criteria:
Inclusion Criteria:

* Adult cystic fibrosis patient
* Admission with acute exacerbation (criteria- fall in FEV1 \> 10% from best in last 12/12, change in sputum volume and colour, new pulmonary infiltrate)
* PaCO2 \> 45 mmHg on admission
* Primary metabolic alkalosis (acid-base diagram of Stinebaugh and Austin)
* Serum chloride (Cl) ≤ 98 mmol/L
* Serum albumin (alb) ≤ 25 mmol/L

Exclusion Criteria:

Concurrent diuretic therapy Concurrent glucocorticoid therapy
Happy Mommy! Happy Baby! Study

The purpose of this study is to determine how difficult life-events that women experienced during their childhood might affect their babies.

Women who are asked to participate in this study will fill out forms about their physical and mental health, have 3D ultrasounds of their baby's adrenal gland, have their stress responses measured and have their baby's development and stress responses assessed.

The objectives of this study are to further our understanding of maternal prepubertal adversity on fetal and infant neuroendocrine development. This study utilizes 3-D ultrasound to measure fetal adrenal gland volume, a battery of psychosocial/behavioral assessments to determine the degree of maternal stress and prepubertal adversity, and an acoustic startle paradigm and Trier Social Stress Test (TSST) to assess maternal arousal. This study also utilizes an infant stress test to assess infant arousal.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 45 years;
* Able to give written informed consent;
* Between 8 to 17 weeks at time of recruitment;
* Attendance at 20 week ultrasound at a UPHS site;
* Healthy full term (35 6/7 weeks) infants;
* Fluency in written and spoken English.

Exclusion Criteria:

* Presence of a known abnormality in the present fetus, twin pregnancy or a multiple pregnancy;
* Presence of a serious medical or neurological illness, requiring treatment during pregnancy;
* Use of an antipsychotic or antidepressant medication anytime within 2 months prior to the last menstrual period;
* Drug or alcohol abuse history within previous 2 years;
* Life-time history of psychotic disorder including, schizophrenia, schizoaffective disorder; major depression with psychotic features and bipolar disorder
* Active psychiatric illness requiring treatment based upon the clinical judgement of the study psychiatrist;
* Hamilton Depression Rating Scale Score \> 14;
* Suicidal ideation within the previous 6 months;
* Use of steroids drugs of antihypertensives during pregnancy as they could alter physiologic arousal;
* A history of preterm birth or history of preterm labor in the active pregnancy.
A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Single-dose of Danicamtiv in Healthy Participants

The purpose of this study is to evaluate the effects of co-administration of itraconazole or diltiazem on the single-dose pharmacokinetics of danicamtiv in healthy participants.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Body mass index between 18 and 30 kg/m\^2, inclusive, at the Screening Visit
* Normal ECG at the Screening Visit
* Normal renal function at Screening

Exclusion Criteria:

* History of ventricular arrhythmias
* History of heart disease or conduction disorders
* History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study intervention administration)

Other protocol-defined inclusion/exclusion criteria apply
Motivational Interviewing Nutrition Exercise Obese Adolescents

This study is a randomized controlled study in a quasi-experimental design in the pre-test post-test design.The aim of this study is to examine the effect of motivational interview applied to obese adolescents on nutritional exercise behavior, anthropometric measurements and sedentary activity level.The data of this study were collected using a personal information form, Nutrition exercise behavior scale, Adolescent Sedentary Activity Questionnaire and anthropometric measurement form.In this study, nursing initiatives include a MG-based training program that will be given to obese adolescents in the experimental group in the form of 6 sessions after collecting preliminary test data. The final tests will be collected after 3 months of follow-up. Pre-test and post-test will be applied to the adolescents in the control group. Each training will take 30 minutes. Various training methods and techniques such as oral expression, question and answer, brainstorming, feedback and powerpoint presentations will be used within the scope of the training program

Obesity has been increasing in children and adolescents as well as adults in recent years. Many factors play a role in the formation of obesity. The most important of these are sedentary lifestyle, wrong diet and insufficient physical activity. Motivational interviewing technique seems to give promising results in order to change risky health behaviors that cause obesity in adolescents. This study is a randomized controlled study in a quasi-experimental design in the pre-test post-test design.The aim of this study is to examine the effect of motivational interview applied to obese adolescents on nutritional exercise behavior, anthropometric measurements and sedentary activity level.The data of this study were collected using a personal information form, Nutrition exercise behavior scale, Adolescent Sedentary Activity Questionnaire and anthropometric measurement form.In this study, nursing initiatives include a MG-based training program that will be given to obese adolescents in the experimental group in the form of 6 sessions after collecting preliminary test data. The final tests will be collected after 3 months of follow-up. Pre-test and post-test will be applied to the adolescents in the control group. Each training will take 30 minutes. Various training methods and techniques such as oral expression, question and answer, brainstorming, feedback and powerpoint presentations will be used within the scope of the training program.

Eligibility Criteria:
Inclusion Criteria:

* being above the 95th percentile
* not going to a dietitian

Exclusion Criteria:

* having mental health problems
Physical Activity in Children at Risk of Post-thrombotic Sequelae (PACT)

'The PACT trial' is randomized pilot trial to demonstrate the feasibility and potential effectiveness of a personal "fitness tracker" to improve adherence to an activity regimen following an initial acute DVT in children.

The feasibility of an innovative intervention of a validated fitness tracker, the Fitbit, to improve adherence to a 12-week activity regimen in a pilot randomized controlled trial (RCT) will be tested in 44 subjects with first, acute, proximal lower extremity deep vein thrombosis (DVT).

The primary outcomes will consist of a) feasibility indicators determined a priori (eligibility, consent, adherence, retention) and b) estimates of effect size associated with the prescribed activity regimen, by describing within-subject change in QoL and potential biomarkers of postthrombotic syndrome (PTS) pre and post intervention in each group.

Eligibility Criteria:
Inclusion Criteria:

* A radiologically confirmed, acute, proximal first lower extremity DVT
* 4 to 8 weeks after starting anticoagulation
* Out-patient ambulatory status

Exclusion Criteria:

* Contraindication to increasing activity such as patients with juvenile arthritis, poor balance, congestive heart failure, etc.
SC-002 in Small Cell Lung Cancer and Large Cell Neuroendocrine Carcinoma

This is a Phase 1a/1b study of SC-002 in patients with relapsed small cell lung cancer (SCLC) or large cell neuroendocrine carcinoma (LCNEC). SC-002 is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody linked to a potent chemotherapy.

The purpose of this study is to assess the safety and tolerability of SC-002 at different dose levels, to determine the highest dose of SC-002 that can be given to patients with SCLC or LCNEC, to evaluate the side effects of SC-002, and to assess the anti-cancer activity of SC-002.

Part 1A is a dose escalation study in patients with small cell lung cancer or large cell neuroendocrine carcinoma with cytologically confirmed, limited or extensive SCLC or LCNEC that have relapsed or refractory limited or extensive disease following no more than 2 prior chemotherapy regimens.

Part 1B is an expansion study where patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in patients with SCLC or LCNEC and further characterize PK, immunogenicity and target expression and possible relationship to clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed SCLC (either limited or extensive disease) or LCNEC, that has relapsed from the most current treatment or was refractory to treatment
* Evidence of progressive disease during or following no more than 2 prior chemotherapy regimens
* Measurable disease as defined by RECIST
* ECOG performance status of 0 or 1
* Adequate hematological and organ function as confirmed by laboratory values
* Treatment with anticancer/investigational drugs, therapy ≤ 4 weeks prior to first dose of SC-002

Exclusion Criteria:

* Active central nervous system metastases
* Uncontrolled cardiac disease
* Positive serology for hepatitis B or hepatitis C or known HIV infection
* Presence of any condition that may increase the risks associated with study participation and interfere with the interpretation of study results
Deep Neuromuscular Block With Low Pressure Pneumoperitoneum in Laparoscopic Abdominal Surgeries

The aim of this study is to evaluate the effect of deep neuromuscular block on postoperative pain, duration of surgery, quality of surgical field, length of recovery room stays, Total amount of rescue analgesic, postoperative nausea/vomiting, and length of hospital stay.

Acute-pain management in surgery patients is accompanied by an array of negative consequences, including increased morbidity, impaired physical function, and quality of life, slowed recovery, prolonged opioid use during and after hospitalization, and increased cost of care.

Reducing pneumo-peritoneum (PP) is one technique for reducing postoperative pain. The effect of low PP on postoperative pain remains a controversial topic with other studies reporting no difference in postoperative pain levels between the Two pressures.

Deep neuromuscular block (DNMB) in abdominal surgeries is associated with various advantages, such as lower abdominal pressure, lower pain and rescue opioid consumption, as well as less bleeding. DNMB may facilitate the use of reduced insufflation pressure without compromising the surgical field of vision. However, its usage is limited due to a lack of predictable and rapid recovery with conventional NMB antagonists (neostigmine) or spontaneous recovery

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years old.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I-III.
* Patients scheduled for laparoscopic abdominal surgery.

Exclusion Criteria:

* Known allergies to cis-atracurium or neostigmine.
* Contraindications to the use of neostigmine, such as bronchial asthma, glaucoma, myocardial ischemia, and epilepsy.
* History of neuromuscular, renal, or hepatic disease; previous abdominal surgery.
* Treatment with drugs known to affect neuromuscular function.
* Preoperative hyperalgesia.
* Peripheral neuropathy is caused by diabetes.
* History of chronic analgesics treatment, drug, or alcohol abuse.
* Body mass index (BMI) \> 35 kg/m2.
Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy

Alfentanil (Alf) is used in combination with Propofol (Pro) in fiber-bronchoscopy and in many other conscious sedation procedures. Alf and Pro have the characteristic of rapid anesthetic onset and quick recovery, synergic sedative effect and unwanted side effects too. However, the amount of Alf needed in combination with Pro for induction and the timing of administration was no standardized. The investigators designed this study to evaluate the optimal regimen, dose and timing of Alf in Target-Controlled infusion (TCI) of Pro for flexible bronchoscopy sedation, and also to evaluate the influence of variable regimen of Alf and Pro on hypoxemia, hypotension, cough severity, and Pro injection related pain.

Alfentanil (Alf) is used in combination with Propofol (Pro) in fiber-bronchoscopy and in many other conscious sedation procedures. Alf and Pro have the characteristic of rapid anesthetic onset and quick recovery, synergic sedative effect and unwanted side effects too. However, the amount of Alf needed in combination with Pro for induction and the timing of administration was no standardized. The investigators designed this study to evaluate the optimal regimen, dose and timing of Alf in Target-Controlled infusion (TCI) of Pro for flexible bronchoscopy sedation.

Method: patients will be enrolled and assigned randomly into five groups. In group 1, normal saline two minutes before and Alf 2.5μg/kg before Pro were given; In group 2, normal saline two minutes before and Alf 5μg/kg before Pro were given; In group 3, Alf 2.5μg/kg two minutes before and normal saline before Pro were given; In group 4: Alf 5μg/kg two minutes before and normal saline before Pro were given; in group 5, normal saline two minutes and before Pro were given.

Concentration of effect site to loss of consciousness (LOC), dose of Pro to LOC, and induction time of variable regimen, as well as hypoxemia, hypotension, cough severity, and Pro injection related pain will be recorded and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* patients who required elective sedative bronchoscopy

Exclusion Criteria:

* any physical, psychiatric, social problem that avoid from conscious level evaluation,
* hypersensitivity or allergy to Propofol, Alfentanil
* severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s ,50% of predicted value, or requirement for oxygen therapy)
* unstable haemodynamic status (defined as a heart rate \< 60 or ≧ 120 bpm and/or
* a systolic blood pressure (SBP) \< 100 or ≧ 180 mmHg)
* predictable difficult upper airways (Mallampati classification score of IV)
* severe obstructive sleep apnea with apnea hypopnea index (AHI) \> 45
* Body mass index (BMI) more than 42 in male and 35 in female
* renal insufficiency
* liver cirrhosis
Tegoprazan-containing Sequential for H. Pylori

As H. pylori eradication, the investigators prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy

Eradication treatment containing potassium-competitive acid blocker has shown acceptable eradication efficacy. In regions such as Korea, where the prevalence of antimicrobial resistance is high, alternative combinations of antibiotics such as sequential or concomitant therapy are needed. This study compared the outcome of sequential therapy containing tegoprazan, a new potassium-competitive acid blocker, with the conventional esomeprazole-containing sequential therapy.

Eligibility Criteria:
Inclusion Criteria:

Patients who had H. pylori infection proved by positive test result of urea breath test (UBT), rapid urase test or pathologic examination (warthin-giemsa staining)

Exclusion Criteria:

* congestive heart failure, NYHA III or IV
* end-stage renal disease
* alcoholics
* drug abusers
* pregnant or nursing women
Intravenous Continuous LMWH Seems to Be Safe Alternative to UFH in VV ECMO Patients

Unfractionated heparin (UFH) is worldwide anticoagulation used and recommended anticoagulation in patients with ECMO support. However, it is accompanied with incidence of bleeding or thrombotic compliaction at about 40-60% and high mortality. Because ECMO produce primary haemosthasis pathology, there is a theory that prophylaxis of thrombosis with low molecular weight heparin (LMWH) e.g. Enoxaparin might be sufficient to prevent ECMO throbosis and thrombosis development in patients.

We decided to performed retrospective observation study and analysis of data, from may 2019 until august 2023, in all patients who were put on VV ECMO and to analysis incidence of bleeding, thrombotic and neurologic complications.

Unfractionated heparin (UFH) is worldwide anticoagulation used and recommended anticoagulation in patients with ECMO support. However, it is accompanied with incidence of bleeding or thrombotic compliaction at about 40-60% and high mortality. Because ECMO produce primary haemosthasis pathology, there is a theory that prophylaxis of thrombosis with low molecular weight heparin (LMWH) e.g. Enoxaparin might be sufficient to prevent ECMO throbosis and thrombosis development in patients. This phenomenon of primary haemosthasis pathology may protect ECMO from thrombotic complication as primary haemosthasis plays major role in haemosthasis taking places in high shear stress condiditon such as ECMO. Because LMWH is connected with lower incidence of bleeding complication and HIT (heparin induced thrombocytopenia) in general, in case that patients on VV ECMO developed primary haemosthasis pathology detected by PFA 200, we started to use LMWH instead of UFH in VV ECMO patients.

We decided to performed retrospective observation study and analysis of data, from may 2019 until august 2023, in all patients who were put on VV ECMO and to analysis incidence of bleeding, thrombotic and neurologic complications. We want to compare this incidence of compliactions with data known from patients with other studies using UFH.

Eligibility Criteria:
Inclusion Criteria:

* VV ECMO - use of 2 separate cannulas (jugular and femoral)
* anticoagulation with only intravenous continuous LMWH (Enoxaparin)
* only a period of the first ECMO set running

Exclusion Criteria:

* pregnancy
* Avalon cannula (one double lumen cannula)
* patients after thoraco-abdominal surgery
* patients after lung transplantation in early postoperative period
* patients after trauma without any type of heparin ,,heparin free" ECMO