cyrilzakka/clinical-trials huggingface dataset:
Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects

A randomized, prospective clinical trial analyzing whether the use of lightweight prostheses during laparoscopic inguinal hernia repair of male patients could have a beneficial effect on postoperative discomfort, chronic pain development, recurrence and male fertility aspects.


Eligibility Criteria:
Inclusion Criteria:

* Primary, unilateral or bilateral, inguinal hernia patients
* Informed consent

Exclusion Criteria:

* Sterilized patients
The Effect of Partner Massage in Labor on Pain, Anxiety and Birth Process

H1-1 = There will be a difference between the pain levels of the partner massage group, midwife massage group, and control group following the massage application.

H1-2 = There will be a difference between the state anxiety levels of the partner massage group, midwife massage group, and control group following the massage application.

H1-3 = There will be a difference between the active phase durations of the partner massage group, midwife massage group, and control group following the massage application.

Supporting the woman with massage during the labor process reduces the severity of pain, provides general relaxation and reduces anxiety. The application of spousal massage for supportive care to the woman during the labor process can provide important positive results in terms of providing both physical and emotional support. A positive perception of birth can be strengthened by meeting women's needs at a higher level. This may contribute to effective pain management, reduction of anxiety in women, improvement of birth outcomes and positive neonatal health outcomes. When the literature is examined, it has been determined that the scope and number of studies examining the effect of partner massage in labor on pain, anxiety and birth process is very limited, and there is no study on the subject in the national literature.

Eligibility Criteria:
Inclusion Criteria:

* Those aged 20-35
* Term pregnancies (those at 37-41 weeks of gestation)
* Those with a single fetus
* Primiparous
* Those who do not have any risk factors during pregnancy (Preeclampsia, premature rupture of membranes, placental anomalies, macrosomic baby, etc.)
* Those who do not have any chronic disease
* Pregnant women who do not have skin disease, infection or varicose affecting the massage application.
* Pregnant women with no deterioration in skin integrity
* Those with cervical dilatation less than 4 cm
* Those who are open to communication, mentally and mentally healthy
* Those who agreed to participate in the study
* Pregnant women with a spouse who agree to apply and apply massage for the spouse/partner massage group.

Exclusion Criteria:

* Those who are in the active and transitional phase of labor
* Abnormal changes in fetal heartbeats
* Unexpected complication in pregnancy and fetus
* Pregnant women who use pharmacological methods to reduce pain during labor
* Pregnant women with contraindications for massage application (deterioration of skin integrity, varicose veins, skin disease and infection)
* Pregnant women who are reluctant to continue participating in the research
Comparison Between Robotic, Endoscopic and Traditional Open Surgery in Thyroidectomy

Comparison of endoscopic thyroidectomy, robotic thyroidectomy and conventional open surgery, the safety of the operation, the timing of the operation and the complications.

With the further development of endoscopic technique, thyroid surgery of the robot has emerged, which may become a trend of endoscopic technology due to its convenience and accuracy.In this study, the advantages and disadvantages of endoscopic thyroidectomy and robotic thyroid surgery were compared, and the experience in the transition stage of thyroid surgery in robotic and endoscopic thyroidectomy was summarized.

Eligibility Criteria:
Inclusion Criteria:

* Thyroid papillary carcinoma.
* The tumor diameter is less than or equal to 1cm.
* The lymph nodes are limited to the VI level.
* Voluntary choice of endoscopy or robotic surgery.

Exclusion Criteria:

* Patients without beauty needs.
* There is lateral neck or mediastinal lymph node metastasis.
* The tumor invades the nerve and surrounding organs.
Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China

Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China (ChiTwiMC) is supported by National Key Research and Development Program of China - Reproductive Health and Women's and Children's Health Protection Project. This project is funded by the Ministry of Science and Technology of China under grant number 2023YFC2705900. The ChiTwiMC cohort is led by Professor Wei Yuan from the Department of Gynecology and Obstetrics at Peking University Third Hospital.

The ChiTwiMC Cohort focusing on the serious complications of twin pregnancy, establish a multicenter large prospective mother-child cohort of twin pregnancy covering pregnancy→neonatal period→early childhood, and a multi-variety, multi-stage biobank for the study of adverse outcomes of twin pregnancy. The ChiTwiMC Cohort is planning to recruit 2000 pregnant women aged 18-45 years from 9 large obstetrical center of major University-affiliated Hospitals across China, between December 2023 and May 2026. All women will be enrolled prior to 14 wks of gestation, pregnancy was followed up at 22-28 wks, 30-38 wks of gestation, delivery, postpartum 42 days, 6 months, 12 months. Data including demographics, medical history, reproductive history, clinical diagnosis, treatment information, and pregnancy and birth outcomes will be collected via electronic data capture system. Track the outcome of severe maternal-fetal complications and early neonatal outcomes of twins, and collect biological samples, including peripheral venous blood, hair and cervicovaginal secretions from pregnant women, placenta tissue, amniotic fluid and unbilical cord blood at delivery, meconium and hair from newborns, buccal mucosa from infants and peripheral venous blood from the husband.

Eligibility Criteria:
Inclusion Criteria:

* Twin pregnancies
* Female aged between 18-45 years
* Gestational age is less than 14 weeks
* Planning to receive prenatal healthcare and delivery service at the study hospital
* Signing informed concent and willing to participate

Exclusion Criteria:

* Women with mental disorders or serious maternal illness that is not eligible to participate
* Inability to provide informed consent
* Pregnant women not registered in our hospital
Neoadjuvant Nivolumab for Operable Esophageal Carcinoma

This is a single arm phase II study, in which maximum 3 cycles of nivolumab (240 mg fixed dose every 2 weeks) is administered for T2- or T3-node negative esophageal squamous cell carcinoma, before curative operation.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed esophageal squamous cell carcinoma
2. Clinical stage T2N0 (invasion to muscularis propria) or T3N0 (invasion to adventitia)
3. ECOG performance 0 or 1
4. Age 19 years or older

Exclusion Criteria:

1. Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer
2. Ineligibility or contraindication for esophagectomy
3. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
5. Has severe hypersensitivity and adverse events (≥Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors.
A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients

This study is designed to find out whether HIV-positive patients whose immune systems have improved after receiving anti-HIV treatment should take azithromycin to prevent Mycobacterium avium complex (MAC) disease. This study also examines the possibility of putting off MAC prevention treatment in patients who respond well to anti-HIV drug therapy.

Azithromycin is approved for the prevention of MAC disease in people with HIV and low CD4 cell counts. However, some people who have taken azithromycin have been found to carry antibiotic-resistant bacteria (germs that can grow despite the presence of drugs used to kill them). It is not known whether the risks associated with taking azithromycin outweigh the risk of getting MAC disease.

The need for MAC prophylaxis in advanced HIV disease is recognized. Prophylactic therapy is complicated, however, due to drug toxicity, potential drug interactions, patient noncompliance with multiagent regimens, microbial drug resistance, and high treatment costs. This study assesses the feasibility of deferring MAC prophylaxis in patients whose CD4+ cell counts rebound in response to antiretroviral therapy.

In this double-blind, placebo-controlled trial, patients are randomized to receive azithromycin weekly or matching placebo. Patients are switched to open-label azithromycin if they have an average CD4+ cell count less than 50 cells/mm3 on 2 consecutive counts obtained at least 48 hours apart (preferably no more than 60 days).

\[AS PER AMENDMENT 10/23/97: SUBSTUDY CPCRA 054: A subset of participants of CPCRA 048 have oropharyngeal swabs taken at baseline and 4 months after randomization. Antibiotic susceptibility tests are then performed on isolates of S. pneumoniae.\] \[AS PER AMENDMENT 9/3/99: Participants in protocol version 3.0 are followed for data collection purposes every 4 months for 18 months until January 31, 2001. Data collection includes CD4 cell counts, viral RNA measurements, macrolide susceptibility in MAC isolates, and antibiotic susceptibility of isolates from bacterial pneumonia episodes.\]

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Have 2 CD4 counts over 100 cells/mm3 at least 30 days apart.
* Have a history of CD4 counts under 50 cells/mm3.
* Are at least 13 years old (need consent if under 18).
* Are in reasonably good health.
* Are expected to live for at least 6 months.
* Are receiving anti-HIV medications at study entry.

Exclusion Criteria

You will not be eligible for this study if you:

* Have/had MAC disease.
* Have been unable to take azithromycin in the past.
* Are on any medications that act against MAC.
Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of selenium may keep bladder cancer from growing or coming back. It is not yet known whether selenium is more effective than a placebo in preventing cancer recurrence in patients with bladder cancer.

PURPOSE: This randomized phase III trial is studying selenium to see how well it works compared with a placebo in preventing cancer recurrence in patients with bladder cancer.

OBJECTIVES:

Primary

* To determine the effect of selenium, when administered with standard care, in preventing the recurrence of bladder cancer in patients with non-muscle-invasive transitional cell carcinoma of the bladder at risk for recurrence.

Secondary

* To determine the effect of selenium on the recurrence of bladder cancer, in terms of histological type, number, and size.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral placebo daily in addition to standard care.
* Arm II: Patients receive oral selenium daily in addition to standard care.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Histopathologically confirmed non-muscle-invasive transitional cell carcinoma (TCC) of the bladder (\< pT2 )

PATIENT CHARACTERISTICS:

* Able to swallow pills
* Not pregnant
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years
* No known hypersensitivity or adverse reactions to selenium
* No other serious medical or psychiatric illness that would preclude giving informed consent
* No condition that, in the opinion of the investigator, may interfere with the safety of the patient or the evaluation of the study objectives

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 30 days since prior daily dietary supplements containing selenium
* No other concurrent selenium (contained in individual supplements, antioxidant mix, or multivitamin) intake
* No concurrent participation in another study involving a medical, surgical, nutritional, or lifestyle intervention

  * Concurrent participation in the follow-up phase of another study allowed
Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease

OBJECTIVES:

Evaluate the safety and efficacy of collagenase in improving flexion deformity, range of motion, and grip strength in patients with residual Dupuytren's disease.

PROTOCOL OUTLINE: This is a randomized, investigator-blinded, placebo-controlled study.

Patients receive a single dose of either collagenase or placebo into the target finger on day 0. Patients who do not respond at the 1 month follow up visit may receive an injection of open label collagenase, if IgE antibody levels are no greater than 15 ng/mL.

Following treatment, patients use a nighttime extension splint for 4 months and perform finger flexion/extension exercises. Patients are followed at 1, 7, and 14 days, and at 1, 2, 3, 6, 9, and 12 months, for each joint treated.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Diagnosis of residual Dupuytren's disease with fixed flexion deformity of the fingers of at least 20-30 degrees caused by a palpable cord Positive table top test (inability to simultaneously place affected finger and palm flat against a table top) --Prior/Concurrent Therapy-- Surgery: At least 30 days since surgery for Dupuytren's disease Other: At least 30 days since prior investigational drug --Patient Characteristics-- Hematopoietic: No history of hematologic disease Hepatic: No history of hepatic disease Renal: No history of renal disease Cardiovascular: No congestive heart failure within 6 months No angina within 6 months No myocardial infarction within 6 months Pulmonary: No history of respiratory disease Other: HIV negative Not immunocompromised No history of significant illness, e.g., endocrine or neurologic disease No history of illicit drug abuse or alcoholism within 1 year No psychosis At least 2 weeks since infectious illness No chronic or debilitating disease No IgE antibodies to collagenase greater than 15 ng/mL No known allergy to collagenase or any of the inactive ingredients in the injection Not pregnant or nursing Fertile patients must use effective contraception
To Investigate Pharmacokinetics (Absorption, Distribution, Elimination), Safety and Tolerability of a Single Oral Dose of 75 mg Molidustat Tablet in Male and Female Subjects Requiring Hemo- or Peritoneal Dialysis Compared to Healthy Subjects

The study investigates the pharmacokinetics (absorption, distribution, elimination) of molidustat after intake of a single 75 mg tablet in subjects with renal impairment requiring hemo- or peritoneal dialysis compared to age-and gender-matched healthy subjects. In addition, the effect of molidustat on the hormone erythropoietin will be evaluated as well as the safety and tolerability of molidustat.


Eligibility Criteria:
Inclusion Criteria:

* Male and female (without childbearing potential)
* Age: ≥18 and ≤79 years of age
* Body mass index (BMI): ≥18 and ≤34 kg/m2
* Ethnicity: White
* Subjects with severe renal impairment on hemodialysis or peritoneal dialysis, and
* Healthy subjects

Exclusion Criteria:

* Women of childbearing potential, pregnant or lactating women
* Use of medication within the 2 weeks preceding the study which could interfere with the investigational product
* Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (HCV Ab), human immune deficiency virus 1 and 2 antibodies (HIV 1/2 Ab)
* Exclusion periods from other studies or simultaneous participation in other clinical studies
Evaluation of DermStream(tm) - an Irrigation Product for Chronic Wound Management

The primary purpose of this study is to evaluate the safety of DermaStream(tm) in the management of chronic wounds.

Other goals of this study are to gain feedback from patients and healthcare providers on the ease of use (the ergonomic aspect) of the device, and to make a preliminary evaluation of the efficacy of DermaStream(tm) in chronic wound management.

Until now no expected or unexpected adverse events were occurred

Eligibility Criteria:
Inclusion Criteria:

* Diabetic ulcer, OR Venous insufficiency ulcer
* Age range: 18-80 years
* Wound max. diameter range: 1.5 - 10 centimeters
* Wound San Antonio assessment system: grade 1 and 2, stage A and B
* Palpable pulses in the Posterior Tibial and the Dorsalis Pedis arteries
* Ankle-Brachial Index \> 0.7 by Doppler
* Wound present for at least 6 weeks
* Wound location: foot or calf, at a location where the device can be attached properly
* Lack of purulent discharge from the wound.

Exclusion Criteria:

* Hypoalbuminemia: Albumin \< 2gr/dl
* Right-side congestive heart failure with edema of legs: +2 or higher
* Renal insufficiency: Cr \> 2 mg/dl
* Abnormal liver function: ALT or AST\>300
* Skin disorders adjacent to the wound, unrelated to the pathology of the wound
* Non-cooperative patient
Yoga for Veterans With CLBP

Chronic low back pain (CLBP) is a prevalent condition among VA patients, but many current treatment options have limited effectiveness. In addition to chronic pain, people with chronic low back pain experience increased disability, psychological symptoms such as depression, and reduced health-related quality of life. This randomized controlled study will examine the impact of yoga therapy for improving function and decreasing pain in VA patients with chronic low back pain. Although not every VA patient with chronic low back pain will choose to do yoga, it is an inexpensive treatment modality that is increasingly appealing to many VA patients. If yoga is effective, it could become an additional low-cost option that the VA can offer to better serve Veterans with chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Has a VA primary care provider
* Diagnosis of chronic low back pain \> 6 months
* Willing to attend a yoga program or be assigned to delayed treatment with yoga
* Willing to complete 4 assessments
* English Literacy
* Has not begun new pain treatments or medications in the past month
* Willing to not change pain treatments (e.g., discontinue a treatment; increase medication dose) during the 12-week intervention period unless medically necessary

Exclusion Criteria:

* back surgery within the last 12 months
* back pain due to specific systemic problem (eg, lupus, scleroderma, fibromyalgia)
* morbid obesity (BMI \> 40)
* Significant sciatica or nerve compression \< 3 months or chronic lumbar radicular pain \> 3 months
* Unstable, serious coexisting medical illness (eg, CHF, cancer, COPD, morbid obesity; dementia)
* Unstable, serious psychiatric illness (e.g., unmanaged psychosis, active substance dependence)
* Insufficient data to rule out acute, metastatic disease, (unless primary care physician approves)
* Attended or practiced yoga \> 1x in the last 12 months
* Positive Romberg test (with or without sensory neuropathy)
Pediatric Epilepsy Study

This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on therapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.


Eligibility Criteria:
INCLUSION CRITERIA: To enter this study, patients must:

* Have a diagnosis of partial seizures
* Be willing to be hospitalized
* Weigh a minimum of 6.6 pounds
* Be taking a stable dose of one to two concomitant anti-epileptic medications
* Have had a previous CAT scan/MRI confirming the absence of space occupying lesions or progressive neurological disease
* Have normal laboratory results

EXCLUSION CRITERIA: To enter this study, a patient must not have or be:

* Seizures caused by metabolic disturbance, toxic exposure, or active infection
* A primary diagnosis of generalized epilepsy (exception - secondarily generalized seizures)
* A history of status epilepticus within 30 days
* Seizures not related to epilepsy
* Frequent use of additional anti-epileptic medications to treat increases in seizures (for example: rectal diazepam)
* Taking felbamate within 6 months
* Serum sodium levels \<135 mEq/L
* Significant heart, breathing, kidney, stomach, liver, blood, or cancer disorder requiring treatment/therapy
* A history of chronic infection (e.g., hepatitis or HIV)
* Significant electrocardiogram (ECG) abnormalities
* A nursing mother taking anti-convulsant drugs
* Previously demonstrated sensitivity/allergic reaction to Trileptal or related compounds
* Used experimental medication within 30 days of entering this study
Same Day Discharge After Laparoscopic Hysterectomy

Patients who are scheduled for laparoscopic hysterectomy will be included in the study.

After the operation, those who are well and without major distress will be discharged from the hospital before 24 hours. Those who have pain or have additional health problems will be observed further.

Our aim is to compare these two groups in terms of early complications and operation characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Patients Scheduled For Hysterectomy

Exclusion Criteria:

* Diagnosis of Malignancy
* Those with intraoperative complication
The Prediction Model of Hypoxemia for Safe Bronchoscopy

The purpose of this study is to develop the hypoxemia prediction model during fiberoptic bronchoscopy under MAC(monitored anesthesia care) anesthesia.

Currently, diverse sedatives and analgesic methods are used during fiberoptic bronchoscopy for reducing patients' discomfort and facilities of procedures as British Thoracic Society recommendation. MAC anesthesia, one of the widely used sedative method during bronchoscopy, have many advantages, occurrence of respiratory depression, hypoxemia are not uncommon during the procedures. The investigators try to find out risk factors and develop the prediction model for hypoxemia during bronchoscopy under MAC anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 15 yrs
* patients who are planned to get fiberoptic bronchoscopy under MAC anesthesia in Seoul National University Bundang Hospital

Exclusion Criteria:

* Patients who will get Endobronchial ultrasound guided transbronchial needle aspiration
* patients whose baseline oxygen saturation is below 90%
* Intubated patients
* Patients do not agree with the study enrollment