cyrilzakka/clinical-trials huggingface dataset:
Synergistic Effects of Traditional Chinese Medicine Practices and Pelvic Floor Muscle Training

This study was conducted within a randomized controlled trial framework using a double-blind design. Participants were assigned to one of three intervention groups: the Pelvic Floor Muscle Training group (PFMT), the Pelvic Floor Muscle Training combined with the Qigong group (PFMTQG), and the Qigong Practice group (QG). Randomization was performed using a random number table. Professional trainers implemented the intervention programs. Researchers conducted a 12-week intervention study, with training sessions held thrice weekly. During the trial, participants agreed not to engage in other forms of physical exercise.


Eligibility Criteria:
Inclusion Criteria:

* Aged 20-35 years.
* Within 12 months postpartum.
* Diagnosed with mild to moderate SUI.
* Physically capable of participating in mild to moderate exercise.
* Provided written informed consent.

Exclusion Criteria:

* Severe pelvic floor dysfunction.
* Systemic health conditions that contraindicate physical activity.
* Pregnant at the time of recruitment or planning pregnancy during the study
* Prior structured training in Qigong or PFMT.
* Ongoing physiotherapy for pelvic floor health.
* Participation in other urinary incontinence research.
* Inability to provide informed consent due to cognitive or language barriers.
Conversion Surgery in Stage IV or Unresectable Gastric Cancer

This study aims to identify the safety and the survival benefit of the conversion surgery in stage IV or unresectable gastric cancer. The study designed single-arm phase II trial. All the patients would undergo curative-intent radical gastrectomy after palliative chemotherapy if the tumor responded to the chemotherapy. Primary endpoint was three-year overall survival. Secondary endpoints included short-term postoperative outcomes within 30 days, three-year relapse free survival, and success rate of conversion surgery (rate of R0 resection).

The survival rate of patients with stage IV gastric cancer (GC) is very low. Recently, several retrospective studies about conversion surgery have been introduced. The results of the studies showed around 30\~40% of three-year survival rate in conversion surgery group. Eight institutions in Catholic University of Korea analyzed 419 stage IV GC patients, and they had divided into four groups: chemotherapy only, chemotherapy followed by gastrectomy, gastrectomy followed by chemotherapy, and best supportive care group. The group of gastrectomy followed by chemotherapy, which is similar with conversion surgery, showed 40% of three-year survival rate. However, the study included only small number of patients who were in conversion surgery group, and had several biases. Thus, we planned multi-national, multi-center phase II trial for conversion surgery in stage IV or unresectable GC.

Eligibility Criteria:
Inclusion Criteria:

* Gastric adenocarcinoma
* Stage IV or unresectable gastric cancer was diagnosed by pre-operative evaluation including endoscopy, endoscopic ultrasound, Computed tomography (CT), Positron emission tomography-computed tomography (PET CT), or staging laparoscopy
* Partial or complete response to chemotherapy
* Eastern Cooperative Oncology Group (ECOG) score \<3
* Who agreed to enroll the study

Exclusion Criteria:

* Synchronous or metachronous malignancy
* remnant gastric cancer
* BMI less than 18.5
* Pregnancy
A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea

This Phase I double blind, randomized clinical study to evaluate the safety of human milk oligosaccharides (HMO) is designed to assess the safety and dosage ranging of PBCLN-003 in adults with Clostridium difficile-associated diarrhea (CDAD). Within 3 dose cohort, subjects will be randomized in a 3:1 ratio to receive PBCLN-003 or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment episode of CDAD diagnosed based on \> 3 loose stools per day and detection of CD toxin by nucleic acid amplification tests (NAAT), EIA or GDH
* Mild to moderate CDAD during enrollment episode (per Society of Hospital Epidemiologists of America (SHEA)/lnfectious Disease Society of America(ISDA) criteria)
* Current therapy with standard of care antibiotics for recurrent CDAD(vancomycin, metronidazole, fidaxomicin)
* BMI \> 18.5 and \< 40
* Age 18 years or older
* Agreement to adhere to the study protocol
* Informed consent is obtained
* Women who are capable of bearing children must have a negative pregnancy test at the time of screening
* Female subjects of childbearing potential must use birth control (defined as oral or injectable contraceptives, intrauterine devices, surgical sterilization or a combination of a condom and spermicide) during the study period and for up to 8 weeks after the first drug of study.

Exclusion Criteria:

* Severe CDAD during enrollment episode (per SHEA/ISDA criteria) characterized as follows:

  * History of five (5) or more recurrences of CDAD within the past 12 months prior to potential study enrollment
  * History of fecal microbiome transplant or other microbiome directed experimental intervention for CDAD
  * History (ever) of CD complicating inflammatory bowel disease (Crohn's disease, ulcerative colitis), or history of bowel resection surgery (other than uncomplicated appendectomy) or history of other infectious diarrhea or diarrhea of unknown etiology since the initial episode of CDAD
* Clinically immunocompromised due to any primary immune or autoimmune deficiency, as a result of chronic disease, cancer or medication used to treat these diseases
* Initiating a new diet or weight loss amounting to 10% within two weeks prior to date of study entry
* Enrolled in another clinical study for the therapy of CDAD or affecting nutritional management during the study period
* Enrolled or has been enrolled in another experimental (IND) study within two weeks prior to date of study entry
* Is pregnant or lactating
* History of swallowing difficulties, including dysphagia or odynophagia for liquids or solids
* Use of any Probiotics (any formulation) within the two weeks prior to date of study entry
* New, or a change in the consumption of the following prescription medications or over-the-counter (OTC) medications within two weeks prior to date of study entry:

  * Proton pump inhibitors (for example: Prilosec®, Nexium®)
  * Histamine-2 receptor antagonists (for example: Zantac®, Pepcid®)
* Consumption of the following prescription medications during the current enrollment episode: • Bezlotuxamab/Zinplava®
Improving Substance Abuse Treatment Aftercare Adherence and Outcome

Although substance abuse treatment continuing care participation is strongly related to positive treatment outcomes, participation rates are low and few interventions have been developed that improve continuing care adherence and outcome.

Background:

Although substance abuse treatment continuing care participation is strongly related to positive treatment outcomes, participation rates are low and few interventions have been developed that improve continuing care adherence and outcome.

Objectives:

The objectives of the study were: 1) to compare the effectiveness of an aftercare intervention consisting of a participation contract, attendance prompts, and attendance reinforcers (CPR) to a standard treatment (STX) on adherence to therapy; and 2) to assess the effects of this intervention on treatment outcome

Methods:

We recruited 150 veterans from the Salem VAMC�s SARRTP who could participate in aftercare. Our population is similar to those in other VA�s (97% male, 54% Caucasian, 46% minority, 49 years mean age, 44% alcohol dependent only, 56% drug dependent, and 44% with a dual diagnosis). In this randomized clinical trial, treatment adherence and outcome were measured at baseline and 3-, 6- and 12-months after participants entered treatment using interviews, questionnaires, alcohol and drug screens, VA medical records, and therapist ratings. The study design is a repeated measures nested cohort design, with an intervention and a standard care group. The primary outcome, abstinence rate, will be analyzed using a logistic regression model in which the parameters of interest are estimated using Generalized Estimating Equations (GEE).

Status:

Participant recruitment and follow-up interviews were completed in June 2003 and August 2004, respectively. The HSR\&D final report was submitted in April 2005. The main results paper and additional papers will be submitted for publication in 2005.

Eligibility Criteria:
Inclusion Criteria:

All graduates of the Salem VA's SARRTP who: live within a 60 minute drive of the Salem VAMC, or 1 of our 5 SARRTP outreach clinics; have transportation and a job schedule that allows them to attend outpatient aftercare therapy.

Exclusion Criteria:
A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LFX453

The purpose of this first-in human study is to demonstrate systemic and local tolerability and investigate pharmacokinetics of LFX453 after multiple topical applications in healthy subjects.

The current study has been designed with three distinct parts. Part 1 focuses on safety and tolerability of once daily application on the back, prior to moving forward and assessing the safety and tolerability in more sensitive treatment areas in Part 2 or twice daily application in Part 3.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects of non-childbearing potential, 18 to 65 years of age inclusive (at the time of the screening visit), and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
* Male subjects must agree to total abstinence from male:female intercourse or agree to use a condom during drug dosing and for four weeks after dosing has stopped.

Exclusion Criteria:

* History of serious allergic reaction to any drug.
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
* History of any atopic dermatitis (only within the last 2 years), autoimmune disease, psoriasis or erythema multiforme.
* Presence of skin disease (e.g. warts) or skin features on treatment areas that may affect local tolerability or the ability of the investigator to evaluate local tolerability.
* History of heart failure, left ventricular dysfunction or known family history or known presence of long QT syndrome.
* A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening or baseline:

  * 2nd or 3rd degree AV-block
  * PR \> 200 msec
  * QRS complex \> 120 msec
  * QTcF \> 450 msec (males)
  * QTcF \> 460 msec (females)
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
Italian Registry of Arthritis on Biologic Therapy

The biologic drugs targeting TNFa, IL-6, IL-1, T cells, B cells have represented a fundamental discovery to treat rheumatic patients whose disease appears to be refractory to conventional therapy. These biologic drugs have been registered for human therapy from a few years, thereby the investigators miss long-term data for safety and efficacy. Aim of this study is to register all the clinical data of patients with rheumatoid arthritis and spondyloarthritis beginning a treatment with biologic drugs in order to assess the long-term safety and efficacy in the real life.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis
* Patients with active disease refractory to traditional disease modifying drugs (methotrexate, leflunomide, sulphasalazine, cyclosporine, hydrossiclorochine)
* Patients eligible to begin conventional biologic therapy

Exclusion Criteria:

* Any criteria excluding treatment with biologic drugs according to international guidelines
Virtual Reality Effect on Labor Pain and Satisfaction

The primiparous women wore virtual glasses during labor, playing games and exercising. pregnant women were divided into two groups. Experimental and control groups each consisted of 60 pregnant women.

Aim: The research was carried out to determine the effect of virtual reality application in labor on perceived labor pain and satisfaction levels in primiparous.

Material and Method: The study was conducted in a randomized controlled manner with a total of 120 primiparous women who applied to the delivery room of Elazig Fethi Sekin City Hospital between June 2020 and June 2021 (60 Experiments, 60 Controls). The pregnant women in the experimental group were played by the researcher during the active and transitional phases of labor with virtual reality glasses, which were designed for research and included methods used to cope with labor pain. Except for routine care, no application was made to the pregnant women in the control group. In order to determine the pain level of the pregnant women, SDS and SCS were applied four times, before and after the Virtual Reality applications. After delivery, DME-C was applied to both groups.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women who were able to communicate verbally
* Between 37-42 weeks of pregnancy
* Single, live fetus and head presentation
* Cervical opening \<4 cm based on the labor follow-up form at admission to the delivery room, were included in the sample

Exclusion Criteria:

* Women with a risky pregnancy diagnosis (such as preeclampsia, placenta previa, gestational diabetes)
* Obstetric complications in labor (such as fetal distress, bleeding)
* Visual and hearing problems
* Any pharmacological pain-reducing method applied, were excluded from the study
Pharmacokinetic and Pharmacodynamic Profiles of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients With Asthma

The primary objective of this study is to compare the pharmacokinetic (PK) profiles of Albuterol Spiromax® and ProAir HFA after administration of a single inhaled dose of 180 mcg albuterol base from each product.

This is a single center, open-label, 2-period crossover study. The study consists of a screening visit followed by a treatment period comprising 2 treatment visits. The treatment period visits will be separated by a 4 to 14-day washout period. Eligible patients will be kept overnight prior to each treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent/assent signed and dated by the patient and/or parent/caregiver/legal guardian (as appropriate) before conducting any study-related procedure.
2. Male or pre-menarchal female patient 4-11 years of age, inclusive, as of the Screening Visit (SV)
3. Has a documented physician diagnosis of persistent asthma of a minimum of 3 months duration that has been stable for at least 4 weeks prior to the SV. The asthma diagnosis must be in accordance with the National Asthma Education and Prevention Program Guidelines Expert Panel Report 3 (EPR3).
4. Forced expiratory volume in 1 second (FEV1) \>80% predicted for age, height and gender and race at the SV based on the pediatric population standards.
5. Any patient being treated with inhaled corticosteroids (ICS) must be on a lowdose regimen (200 mcg or less of fluticasone propionate per day or equivalent), which has been stable for at least 4 weeks prior to the SV and which is expected to be maintained for the duration of the study
6. Has required less than 4 inhalations per week of a rescue bronchodilator (on average) for the 4 weeks preceding the SV
7. Has the ability to withhold inhaled albuterol for at least 72 hours preceding each Treatment Visit (TV).

   * Other criteria apply, including must weigh at least 45 pounds

Exclusion Criteria:

1. A known hypersensitivity to albuterol or any of the excipients in the inhaler formulations (lactose, ethanol, etc.)
2. Participation (receiving study drug) in any investigational drug trial within the 30 days preceding the SV or planned participation in another investigational drug trial at any time during this trial
3. History of severe milk protein allergy
4. Proneness to orthostatic dysregulation, syncope, or blackouts
5. History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza) that has not resolved within 2 weeks preceding the SV.
6. History of life-threatening asthma or that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures
7. Any asthma exacerbation requiring systemic corticosteroids within 3 months of the SV. A patient must not have had any hospitalization for asthma within 6 months prior to the SV.

   * Other criteria apply.
Burden of Invasive Group B Streptococcal (GBS) Disease in Young Infants in China

Evaluate the burden of invasive group B streptococcal (GBS) disease in young infants (up to 90 days of age) in China, in terms of incidence, case fatality rate and serotype distribution


Eligibility Criteria:
Inclusion Criteria:

1. Positive culture for GBS from one or more of the following normally sterile sites: blood, cerebrospinal fluid (CSF), pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, joint fluid, suprapubic bladder aspiration or internal body site (e.g., lymph node, brain).
2. ≤90 days old at the time of GBS confirmation.
3. Voluntary written informed consent provided.

Exclusion Criteria:

* None.
Predictive Factors Affecting the Efficacy of Local Tetracycline Injection for Treatment of Post-mastectomy Seroma.

female patients with established diagnosis of post-mastectomy seroma following modified radical mastectomy, were treated by local injection of tetracycline after the seroma fluid was aspirated, then a crepe bandage was applied over the mastectomy area. Then after 5 days the patient were examined again for seroma re-collection or the presence of complications. The amount of seroma aspirated in each session.

In this study, 18 patients with established diagnosis of post-mastectomy seroma were included. All of them were females undergoing modified radical mastectomy where seroma appeared after drain removal.

The age, co-morbidities, total leukocytic count (as an indicator of infection), serum albumin and tumour size and pathology for all of them were recorded. Then we interfered with our tetracycline injection technique for the treatment of seroma.

All the patients were consented regarding this therapeutic technique explaining the expected possible occurrence of some pain during and after injection, other complications like wound infection or flap necrosis necessitating further intervention. Moreover, repetition of the technique may be needed

In our technique the following was adopted:

1. First, the seroma fluid was aspirated completely using a 20 cc syringe while the patient lying flat and the needle inserted in the most dependent area
2. Then, 10 cc of saline containing 2 gm of tetracycline mixed with 5 ml of 2% xylocaine (as a pain relieving agent) was injected at the seroma bed.
3. After completion of injection, a crepe bandage was applied over the mastectomy area (flaps covering the seroma bed)
4. Then after 5 days the patient were examined again for seroma re-collection or the presence of complications as infection or flap necrosis. If there were any re-collection, the tetracycline injection procedure would be repeated.

The amount of seroma aspirated in each session in addition to the complications if present were recorded.

Eligibility Criteria:
Inclusion Criteria:

* any patient with post-mastectomy seroma following modified radical mastectomy after removal of drain
* no signs of infection or flap necrosis

Exclusion Criteria:

* patients with post-mastectomy seroma following modified radical mastectomy with drain still in
* if signs of infection or flap necrosis present
Allopurinol and Endothelial Function in Diabetic CAD Patients

This is a randomized trial assessing the impact of allopurinol on endothelial function in optimally treated diabetic patients with coronary artery disease. After initial screening, subjects were randomized to receive either optimal medical therapy (OMT) + allopurinol or OMT alone for 8 weeks. The dose of allopurinol was 300 mg for 4 weeks and 600 mg for 4 weeks with a 4-weekly check on hematology and biochemistry


Eligibility Criteria:
Inclusion Criteria:

* Diabetes type 2
* Known coronary artery disease with previous percutaneous coronary intervention and optimal medical therapy for at least one month

Exclusion Criteria:

* Pregnant or breast- feeding women
* creatinine clearance \<60ml/min
* Known history of gout disease or ongoing treatment with allopurinol
* Allergy to allopurinol
* Inability to provide informed consent
Study of the Administration of a Food Supplement in Patients With Lithiasis Treated With Extracorporeal Shock Wave Lithotripsy.

The extracorporeal shock wave lithotripsy (ESWL) is the treatment of choice for most stones in any of their locations. It is about breaking the stone without surgically intervening on the patient and getting him to expel the fragments himself.

It is thought that additional treatments to the ESWL could improve the success rate of ESWL for less favorable stones.

The components of our authorized food supplement have shown an inhibitory effect in vitro on the growth of calcium oxalate monohydrate crystals, even in hightly supersaturared solutions. Also these components show an inhibitory effect on the growth of calcium phosphate crystals. To sum up, it reduces the formation, inhibits the growth and promotes the dissolution of calcium oxalate and calcium phosphate kidney stones.

This is the reason why this experimental study aims to modify the size limit of the stones in the ESWL with adjuvant food supplement.

The study treatment will be administered for 10 weeks. First, one dose will be administered every 12 hours for each patient during the 4 weeks prior to ESWL. After ESWL, and for 6 weeks, one dose will be administered every 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Renal lithiasis with high radiological and clinical suspicion of calcium oxalate or calcium phosphate, size of the largest diameter between 1.5x1cm and 2x1cm, which will be treated by ESWL, being symptomatic with little probability of spontaneous expulsion.
* Signed informed consent to participate in the clinical study.

Exclusion Criteria:

* Lithiasis of more than 20 mm and less than 15 mm for the largest diameter.
* Taking medications with influence on urinary lithogenesis (citrate, bicarbonate, thiazides, bisphosphonates, magnesium, calcium, vitamin B6, vitamin D, vitamin A, xanthine-oxidase inhibitors, uricosurics, probiotics, urease inhibitors, cystine binders, topiramate , antiretrovirals).
* Taking medications that influence urine pH (citrate, bicarbonate, carbonic anhydrase inhibitors, L-methionine, vitamin C, ammonium chloride).
* Taking selective serotonin reuptake inhibitor antidepressant medications.
* Taking anticoagulants and antiaggregants.
* ESWL contraindications: urine infection, active or recurrent; hemorrhagic diathesis; pregnant or lactating patients; others (extreme obesity, arterial aneurysm near the location of the stone, etc.).