cyrilzakka/clinical-trials huggingface dataset:
Effects of Pilates on Respiratory Mechanics

The aim of this study was to evaluate the influence of a fitness program from the application of Pilates on lung function, thoracoabdominal mobility and respiratory muscle strength in women.

Study in the Cardiorespiratory Physiotherapy laboratory and clinics of Pilates in the region, in which the voluntary of the Pilates group would start the Pilates method.

The study included women with body mass index (BMI) ≤ 29 kg/m2 were not engaged in regular physical activity, or sedentary lifestyle with scores up to eight, according to Baecke et al., non-smoker, non-alcoholic, without any abnormalities of the cardiovascular, respiratory and neuromuscular.

The study excluded women with disabling diseases, pregnancy, postpartum less than a year, inability to understand the tests and exercises proposed or refuse to participate in the study.

The volunteers, aged between 25 and 55 years, were allocated in to two groups:

1. Pilates Group (n = 16): sedentary volunteers, but that would begin activities with the Pilates method and evaluated three months.
2. Control group (n = 13): sedentary volunteers and remain sedentary and evaluated in three months.

Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) ≤ 29 kg/m2
* not physically active on a regular basis, ie, sedentary lifestyle with scores up to eight, according to Baecke et al.
* nonsmokers
* non-alcoholic
* without any abnormalities in the cardiovascular, respiratory or neuromuscular

Exclusion Criteria:

* disabling diseases
* gestation
* puerperium there is less than a year
* inability to understand the tests and exercises proposed
The Effect of Dexmedetomidine on Brachial Plexus Block for Shoulder Surgery

The purpose of this study is to determine whether a small dose of Dexmedetomidine, when given either intravenously or as part of the interscalene nerve block solution, prolongs pain relief following shoulder surgery compared to local anesthetic solution alone.

Unilateral shoulder surgical procedures, including acromioplasty, rotator cuff repair and Bankart procedure generally allow the patient to go home the same day. However, post-surgical pain is often severe and it is common to encounter a delay in discharge from the hospital due to difficulty in pain control.

Single shot interscalene block is used in ambulatory shoulder surgery for its advantages that included a significant reduction in acute pain and analgesic requirements, prolonged time to first analgesic request, decreased incidence of nausea, as well as earlier hospital discharge. Previous studies have attempted to prolong the duration of the analgesia of interscalene block by administering additional drugs to the local anesthetics but these studies have had varying degrees of success. Dexmedetomidine has recently been considered as a potentially useful drug in prolonging nerve block analgesia. Various modes of administration of Dexmedetomidine have demonstrated a consistent effect on the duration of analgesia. So far, the systemic infusion of Dex has been shown to prolong both neuraxial and peripheral nerve blocks. When combined with local anesthetics in intravenous regional anesthesia 9IVRA), Dex enhanced the duration of analgesia. Furthermore, data from animal studies strongly support the use of Dex as a safe potent adjunct to local anesthetics capable of prolonging the duration of analgesia of peripheral nerve blocks.

The use of Dexmedetomidine as an adjunct in interscalene block has not been studied yet. This trial will study the effects of adding Dexmedetomidine as an adjunct to local anesthetics in interscalene brachial plexus block.

Eligibility Criteria:
Inclusion Criteria:

* unilateral surgical shoulder procedures under general anesthetic
* English speaking patients
* ASA I-III patients
* BMI \<38 kg/m2

Exclusion Criteria:

* proximal clavicular surgery
* preexisting neurological deficits or peripheral neuropathy
* known coronary heart disease, congestive heart failure, cardiomyopathies, or arrhythmias
* known cerebrovascular disease
* baseline heart rate \<60 beats per minute or baseline systolic blood pressure \<100 mm Hg
* medications that reduce heart rate (as beta-blockers, calcium blockers) known liver dysfunction or existing diseases known to cause hepatic or renal impairment
* severe bronchopulmonary disease
* local infection
* contra-indication to regional anesthesia (bleeding, coagulopathy)
* chronic pain disorders
* current use of over 30mg oxycodone or equivalent per day
* contraindication to a component of multimodal analgesia
* allergy to local anesthetics or dexmedetomidine
* history of significant psychiatric conditions that may affect patient assessment
* pregnancy
* inability to provide consent
A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study to evaluate the efficacy and safety of PM8002 in combination with etoposide and platinum in first-line treatment of extensive-stage small cell lung cancer

The study is divided into two parts.

The first part is single-arm study, 50 participants were enrolled as of 21 Nov 2023，and recruitment was completed.

The second part is randomized, double-blind study, active controlled design , which will be integrated to another global III study （NCT06712355）.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form before any trial-related processes;
2. Age ≥18 years;
3. Histologically or cytologically confirmed ES-SCLC;
4. No prior systemic therapy for ES-SCLC;
5. Have adequate organ function;
6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
7. Life expectancy of ≥12 weeks;
8. Had at least one measurable tumor lesion according to RECIST v1.1.

Exclusion Criteria:

1. Histologically or cytologically confirmed mixed SCLC;
2. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
3. The toxicity of previous anti-tumor therapy has not been alleviated；
4. Have received anti-platelet therapy within 10 days prior to the first dose of the study drugs;
5. Evidence and history of severe bleeding tendency;
6. History of severe cardiovascular diseases within 6 months;
7. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
8. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
9. History of alcohol abuse, psychotropic substance abuse or drug abuse;
10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
11. Pregnant or lactating women;
12. Other conditions considered unsuitable for this study by the investigator.
Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis

Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic hemodialysis patients against infection by Staphylococcus aureus.

Two part clinical trial designed to evaluate the efficacy of StaphVAX in adults on hemodialysis. Part A will evaluate the prevention of bacteremic infections in End Stage Renal Disease (ESRD) patients during the interval between 3 and 35 weeks after a single dose of StaphVAX. Part B of this study is designed to assess immunogenicity of a second \[booster\] dose of vaccine in patients completing Part A, and the cumulative (Part A + B) efficacy.

Eligibility Criteria:
Eligible subjects must already be receiving chronic hemodialysis treatment from the centers participating in this study. Interested subjects should discuss enrollment with their nephrologist.

Inclusion Criteria:

* Age 18 years or older.
* Diagnosis of chronic end-stage renal disease with maintenance on hemodialysis continuously for at least eight (8) weeks prior to enrollment.
* Hemodialysis access using native vessel fistula or synthetic/heterologous graft (not catheter).
* Expectation of compliance with protocol procedures, and visit schedule.
* Negative serum pregnancy test in females of child-bearing potential (serum -HCG within 7 days prior to each study drug injection).
* Written informed consent.

Exclusion Criteria:

* Known serious S. aureus infection within 3 months of study entry.
* Known recurrent S. aureus infection of the current graft.
* Known active viral or bacterial infection or symptoms/signs consistent with such an infection with the two weeks prior to injection of investigational product. Mild intercurrent viral illness with a temperature of 100.6F or less does not require exclusion, if in the judgement of the investigator this illness will not interfere with the evaluation of the vaccine.
* Known HIV infection (testing not required for protocol).
* Known hypersensitivity or previous anaphylaxis to polysaccharides or polysaccharide-conjugate vaccines or to components of such vaccines.
* Known or suspected abuse of any drugs, prescribed or illicit, in the past year.
* Current use of immunosuppressive or immunomodulatory drugs (including systemic glucocorticoids, chlorambucil, cyclophosphamide, azathioprine, methotrexate, cyclosporine, mycophenolate, human immune globulin in excess of 0.2 g/Kg per month, any monoclonal antibody specific for any human leukocyte subset or cytokine, or any interferon preparation), except low-dose physiologic replacement glucocorticoid therapy (Less than or equal to 10 mg of prednisone or equivalent per day).
* Known malignancy or treatment for malignancy within the past six months, other than basal cell or squamous cell carcinoma of the skin.
* Use of investigational drugs, products, or devices within 30 days prior to vaccine injection.
* Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardized the quality of the data to be generated.
* Previous administration of StaphVAX
Pre-exposure Prophylaxis (PrEP) Rapid Access

The goal of phase 1 is to determine the feasibility and acceptability of an intervention ('Rapid PrEP Access') providing people who use drugs (PWUD) one-time access to HIV self-testing at the Victory Program.

Aim 1: To offer HIV self-testing to PWUD in the community through a study called 'Rapid PrEP Access'. The study will be carried out at the Victory Program.

Aim 2: To determine the feasibility and acceptability of 'Rapid PrEP Access' at the Victory Program.

For phase 1 of the study, participants will be recruited for a one-time baseline interview and HIV self-testing. A questionnaire will also be administered to assess their interest in the HIV prevention pill (PrEP= pre-exposure prophylaxis), but PrEP will not be offered. Study duration for each participant is one day; participants will not be followed over time.

After the prescreener and consent forms are completed, the Research Assistant (RA) will offer the participant an opportunity to administer an HIV self-test. The participant will be provided the test for unboxing and retrieving the user instructions.

All testing will be performed and interpreted by participants. The RA can provide assistance with reading the instruction on how to obtain a proper sample. Alternatively, the RA will direct them to information in the package insert which includes support offered by the OraQuick® Support Center.

After completing the HIVST, the RA will complete the baseline questionnaire with each participant while waiting for the participants' HIVST results. After the baseline questionnaire is complete, the RA will conduct satisfaction surveys to assess acceptability of the intervention and interest of PrEP initiation using REDCap.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Opioid use that was not prescribed by a health professional in the past 6 months

Exclusion Criteria:

* Pregnant women
* Persons with previous HIV diagnosis
* Individuals currently taking PrEP
* Individuals who express desire to harm themselves or others
Accuracy of Different Technologies for Dental Cast Digitization; CBCT Versus Desktop Optical 3D Scanner

The objective of this study is to evaluate and compare the accuracy of digital dental models generated from plaster casts by two different scanning techniques including Cone Beam Computed Tomography (CBCT) and extraoral Scanner (EOS) .

The comparison between the two techniques is assessed by orthodontic arch space analysis using linear measurements for arch length and width .


Eligibility Criteria:
Inclusion Criteria:

* Patients with maxillary or mandibular complete permanent dentition
* Partially edentulous patients provided the dentition are complete from the first molar to the first molar.

Exclusion Criteria:

* Patients with fractured teeth, attrition and/or erosion affecting the anatomical points
* Patients having non-anatomic restorations that may alter cusp anatomy affecting the accuracy of measurements consequently.
Open Preperitoneal Mesh Versus Retromuscular Mesh Versus Suture Repair for Abdominal Wall Hernias

Randomized clinical trial comparing open preperitoneal mesh, retromuscular mesh and suture repair for ventral hernias less than 3 cm diameter

Many techniques of ventral hernias repair have been reported. It is shown that open mesh hernia repairs have low recurrence and low complication rates then suture repair. But for hernias less than 3 cm some surgeons defend the treatment by suture. The main variable of interest is the location of mesh placement compared to suture repair. The investigator will compare in a prospective randomized clinical trial three techniques of abdominal wall hernia repair: preperitoneal polyester mesh, retromuscular polyester mesh and suture for hernias less than 3 cm. All patients underwent general anesthesia. The investigators used Polyester-based mesh because it has shown minimal shrinkage and excellent tissue ingrowth in animal models. Operative notes were physician-abstracted and the presence, type, and location of mesh prosthesis was recorded. Independent variables of interest were patient-level demographics (age and sex), facility where hernia repair occurred, year of hernia repair, preoperative comorbid conditions, history of prior repair, and intraoperative variables. The results compared postoperative pain was evaluated using a visual analogue scale (range, 0-10) on the day of the first outpatient visit, operating time evaluated as skin-to-skin time, drain management and both of early and late complications including seroma and hematoma formation, wound infection, fistula formation and recurrence rates.

Eligibility Criteria:
Inclusion Criteria:

* Vebtral hernia or post incisional hernia diameter \< 3 cm
* Male or female aged between 18 and 90 year-old
* Elective surgery for ventral hernia

Exclusion Criteria:

* Any contraindication to the prosthetic treatment.
* Any hernia or incisional hernia with a collar strictly greater than 3 cm.
* Previous hernia mesh repaired
* contraindication for general anaesthesia
* Pregnancy
How Would the Creation of a Follow-up Methodology in Consultation Improve the Care of the Epileptic Patient?

The goal of this observationnal study is to identify the informative and educational needs of epilepsy patients to avoid interrupting the therapeutic pathway.

The main question it aims to answer are :

* Identify the patient's expectations of a nurse specializing in epilepsy in the areas of information, predictive elements of good care and adaptation to their state of health
* Identify under-addressed or misunderstood themes
* Identify patient resources and interventions already in place
* Ensuring better continuity of care
* Improve the knowledge of patients and their relatives about the management of their pathology

After a consultation with the neurologist (as part of their usual follow-up), the participants will be referred to a nurse for a semi-directive, individual interview, lasting 30 minutes and composed of open and closed questions. The announcement of the diagnosis, the quality of life or the factors contributing to the difficulties and their repercussions on a daily basis will be discussed during the interview.


Eligibility Criteria:
Inclusion Criteria:

* Adult epileptic patients, over 18 years old
* Patients with focal or generalized epilepsy
* Patients affiliated or entitled to a social security scheme
* Patients who have received informed information about the study and who have co- signed, with the investigator, a non-objection to participation in the study
* Patients whose diagnosis has been made for at least 6 months

Exclusion Criteria:

* Patients with intellectual disabilities
* Minors
* Untreated patients, in remission
* Patients without affiliation to a social security scheme
* Patients under guardianship or curatorship
Pain Relief During IUD Insertion in Women Delivered Only by Elective Cesarean Section

The aim of the work is to assess the effect of combined misoprostol 200 mcg and isosorbide mononitrate 40 mg versus misoprostol 200 mcg and placebo as local vaginal tablet on the successful IUD insertion.

Fear of pain during insertion of an IUD may deter women from choosing the IUD as a method of contraception. According to Hubacher et al. predictors of increased pain during IUD insertion include nulliparity, age greater than 30 years, lengthier time since last pregnancy or last menses, and not currently breastfeeding. Allen et al. predicted pain to be greater based on history of no previous vaginal delivery, and difficulty of the procedure. Pharmacological interventions for pain control during IUD insertion include analgesics, local anesthetics, and the use of prostaglandins to soften the cervix; however, there is wide variation in the use of these methods . Misoprostol has also been proposed as an agent to ease IUD insertion and decrease procedure-associated pain .

Nitrous oxide has been used for years for procedural analgesia in outpatient settings and has recently been investigated as an approach to pain management in the context of IUD insertion .

Sewell and Vincent have been offering nitrous oxide for reducing the pain of IUD insertion and have had a positive response.

Eligibility Criteria:
Inclusion Criteria:We will include

* Nonpregnant women,
* aged 18-45 years, .delivered before only by elective CS and did not receive any analgesics in the 24 h prior to IUD insertion.

Exclusion Criteria:We will exclude

* Women with any uterine abnormalities as congenital anomalies,
* Women with endometrial lesions,
* Women with adenomyosis,
* Women with fibroids,
* Women with intrauterine adhesions,
* Women with chronic pelvic pain,
* Women with spasmodic dysmenorrhea,
* Women with abnormal uterine bleeding,
* Women with history of cervical surgery, .Women with allergy to misoprostol or isosorbide mononitrate or any medical disease that contraindicates its use and those who refused to participate in the study.
Trial of Different Dosages' Ge Gen Qin Lian Decoction in the Treatment of Type 2 Diabetes

Ge Gen Qin Lian Decoction are one kind of Chinese prescription, and previous study showed they had antidiabetic effects on the clinical patients and no obvious toxicity was found. The purpose of this study was to evaluate the efficacy and safety of different dosage of Ge Gen Qin Lian Decoction in the treatment of type 2 diabetic patients and explore relationship of the dosage and effect and the safety of 3 dosages of Ge Gen Qin Lian Decoction.

two hundred and forty primary diabetic patients will be expected to be recruited, which were divided into different groups in a randomized, doubled blind, dose-paralleled-control multi-centre clinical design. The patients were randomly taken with high-dosage(5 times of low-dosage),mild-dosage(3 times of low-dosage), low-dosage,placebo(4.5% of low dosage) by 2 times every day for 12 weeks. Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG),postprandial 2 hours plasma glucose(2hPG),insulin(0h,1h,2h),syndrome,symptoms,body mass index (BMI),waist circumference (WC) of these groups were measured and analyzed. Some safety indexes such blood and urine and stool routine examination, electrocardiogram (ECG)and liver and kidney function tests were measured and analyzed during the experiment. The treatment period is 12 week.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes mellitus
* 30-65 years old
* HbA1c≥7.0%, and FPG\>7.0 mmol/L, but \<13.9 mmol/L or 2hPG\>11.1 mmol/L
* Informed consent has been signed
* Dampness and Heat in Spleen

Exclusion Criteria:

* The patients accepted diabetic treatment for more than a month continuously
* The patients were treated by drugs in 3 week before they were given test drugs
* Diabetic ketosis, diabetic ketoacidosis or serious inflammation in a month
* The contractive pressure \>160 mmHg or diastolic pressure \>100 mmHg
* Pregnant, preparing for pregnancy or breast-feeding women
* Mental patients
* The patients whose ALT or AST are \>100U/L,and BUN or Cr are abnormal.
* The patients who have serious heart, lung, liver, kidney and brain or other primary complications
* Allergic persons
* The patients who are attending other clinical trial
* The patients who have serious diabetic complications
* The patients who ever attended this clinical trial
* Alcohol and / or psychoactive substances, drug abuse and dependency
* The person maybe loss for some reason such as work or life condition according to the investigator's judgement
* The lipid-lowering or antihypertensive drug dosage and category which the patients are taking could not be kept stable
* The patients who are eating some drugs or health food which can affect the body weight
Magnetic Nanoparticle Sperm Separation for Teratozoospermia Male and Women Older Than 35 Years

Women over 35 years old are likely to suffer from impaired oocyte repair capacity. Teratozoospermia is a condition reflects morphological affection of sperm. These spermatozoa would add an extra burden on the oocyte after ICSI. Whether selecting mature sperm by magnetic nanoparticle protocol would provide a more competent sperm to a likely affected oocyte would improve ICSI outcomes is the question of this research.


Eligibility Criteria:
Inclusion Criteria:

* women indicated for ICSI but with teratozoospermia

Exclusion Criteria:

* Women not failing in this group
The Becoming of Children With Doose Syndrome

Doose syndrome is a rare epileptic syndrome that can lead to learning difficulties and a poor quality of life. The goal of this study is to evaluate the evolution of epilepsy and its consequences on cognitive development and learning issues in children with Doose syndrome.

Doose syndrome is a rare epileptic syndrome beginning between ages two and five, characterized by myoclonic-astatic seizures which can be associated with myoclonic seizures, astatic seizures, absences and generalized tonic-clonic seizures. These seizures can be difficult to treat effectively and may lead to learning difficulties. During this study, parents of children with Doose syndrome will receive a questionnaire regarding learning disabilities, quality of life and epilepsy of their children.

Eligibility Criteria:
Inclusion Criteria:

* children with doose syndrome diagnosed between ages 1 and 6
* normal development until onset of seizures

Exclusion Criteria:

* unconfirmed diagnoses
* abnormal diagnoses
* abnormal psychomotor development before onset of seizures
* cerebral MRI abnormalities
* other child epileptic syndromes