cyrilzakka/clinical-trials huggingface dataset:
The Use of Hyperbaric Oxygen to Increase the Blood Supply in the Injured, But Still Alive Tissue, Around an Old Stroke

To confirm or refute recently published data regarding the reduction in post-stroke ischemic penumbra, that used SPECT/CT, by using the more precise tools of PET/MRI.

Most patients who suffer an acute ischemic stroke improve over the immediately ensuing 30-90 days. However, many patients do not improve beyond this initial period in spite of continued intensive physical therapy and supportive care. A prospective, randomized trial of the use of hyperbaric oxygen treatments in 59 such patients was published in January 2012. That study which used 40 hyperbaric oxygen treatments, indicated significant clinical neurological improvement in residual motor deficit in patients who had sustained a stroke over a year previously. An increase in brain activity in the region immediately surrounding their stroke (penumbra) was reported on the basis of SPECT studies. Regions of live cells were determined by CT. Because SPECT is primarily a measure of perfusion and not metabolic activity and CT is a poor measure of cell life, the investigators plan to assess areas of physiologic/anatomic mismatch in similar patients following hyperbaric oxygen treatment by the use of the more appropriate and precise tools, PET and MRI.

Eligibility Criteria:
Inclusion Criteria:

* person must have sustained an acute ischemic stroke 6-12 months prior to enrollment, exhibited clinical improvement during the initial 30-90 days post stroke, exhibited no further improvement for at least 1 month in spite of continued supportive care and physical therapy, must have at least one residual measurable motor deficit.

Exclusion Criteria:

Smoking, Contraindications to an MRI e.g. pacemaker, Contraindications to hyperbaric oxygen treatment e.g. emphysema, claustrophobia. seizure disorder, Inability to tolerate pressurization e.g. Eustachian tube dysfunction, other uncontrolled co-morbidities e.g. diabetes, hypertension, thyroid disorders, renal or hepatic dysfunction.
Voluntary Termination of Pregnancy: Comparison of Women's Experiences Depending on the Method Used.

Voluntary termination of pregnancy (abortion) is a major current societal issue. This is a very common situation, around 225,000 abortions are carried out every year in France. The French law of March 2, 2022 (no. 2022-295) extended the legal deadline for voluntary termination of pregnancy from 14 to 16 weeks of amenorrhea (SA). The recommendations have not been updated following this legal extension, the centers performing abortions are therefore free regarding the protocol for carrying out these so-called late abortions (between 14 and 16 weeks). There are two pregnancy termination techniques practiced in France: medical or surgical. The drug method consists of drug-induced expulsion of the pregnancy. This method is carried out in the delivery room, and lasts several hours. The surgical method consists of an endouterine aspiration carried out in the operating room, which lasts approximately 30 minutes. At the Toulouse University Hospital, as in many centers in France, it is the patient who chooses the method, apart from a contraindication to one or other of these methods. Due to the recent nature of these late abortions, practitioners still have little experience of the consequences of these procedures and this compromises the quality of the information provided to patients. It is necessary to have quality studies to improve knowledge about late abortions, in order to be able to correctly inform patients and allow them to make an informed choice regarding the method used.


Eligibility Criteria:
Inclusion Criteria:

* Any adult patient
* Having given her non-opposition after clear and fair information (patient who understands and reads French)
* Patient treated at the Toulouse University Hospital for an abortion between 14 and 16 weeks (dating by ultrasound)
* Singleton pregnancy
* Progressive pregnancy

Exclusion Criteria:

* Protected adult patient (guardianship, curatorship, protection of justice)
* Developing psychiatric pathologies
* Fetal anomaly detected
Hyposalivation Response To Transcutaneous Electrical Nerve Stimulation In Diabetic Type 2 Patients

This study evaluates response of abnormal low salivary flow rate to transcutaneous electrical nerve stimulation (TENS) in diabetic type 2 patients. Response of saliva monitored for all participants receiving only one session of 5-minute extraoral TENS on bilateral parotid glands.

Diabetes mellitus is the most significant disorder associated with varied oral manifestation ranging from xerostomia (subjective sensation od dry mouth) to serious bacterial and fungal infections due to alterations in flow rate of saliva.

Systemic agents increase rate of stimulated salivary flow but often have unfavourable side effects such as profuse sweating, rhinitis, dyspepsia.

Use of TENS in stimulation of saliva has been studied in the past which showed moderate promising results. However, it never became a part of the mainstream therapy of hyposalivation.

It has been postulated that transcutaneous electric nerve stimulation (TENS) could directly stimulate the auriculotemporal nerve, which supplies the parotid gland, whereas it remains unclear whether there is also an indirect action (via afferent pathways) onto the salivary reflex arch.

Starting a prevention program as early as possible considering the most practical, cost effective and efficient treatments with the best risk-benefit ratio will help to diminish dry mouth symptoms and sequelae (intraoral and extraoral complications).

Eligibility Criteria:
Inclusion Criteria:

1. non-smoker diabetic patients type II
2. Patients with unstimulated resting saliva ≤ 0.16 ml/min considered to be abnormally low flow rate and included in the study (Navazesh et al., 1992)

Exclusion Criteria:

* Cancer patients (patients on chemotherapy/immunotherapy and history of head and neck radiotherapy).
* Cardiac patients (cardiac pacemakers and defibrillators).
* Patients wearing hearing aids.
* Chronic inflammatory autoimmune diseases
* Acute oral inflammatory disorders
* Patients with neurological disorders.
* Habits (mouth breathing, smoking, alcohol and drug abuse).
* Salivary gland diseases and disorders.
* Psychogenic diseases.
* Endocrine diseases.
* Patients undergoing pharmacological management for xerostomia.
Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women With Twin Pregnancy

twin pregnant women requesting cesarean section, the effectiveness and safety of temporary uterine packing coupled with topical tranexamic acid as an adjuvant for decreasing blood loss during delivery were compared to placebo.

The most common cause of postpartum hemorrhage (PPH) is uterine atony, which accounts for up to 80% of PPH occurrences. PPH is the main cause of maternal morbidity and mortality, accounting for up to 28% of all maternal deaths globally. As a result, generating a fast and efficient uterine contraction after birth is critical. Obesity, White or Hispanic race/ethnicity, polyhydramnios, preeclampsia, anemia, and chorioamnionitis, as well as a twin pregnancy, are all risk factors for uterine atony.

Eligibility Criteria:
Inclusion Criteria:

* Women With Twin Pregnancy Undergoing Cesarean Section

Exclusion Criteria:

* Patients with cardiac, hepatic, renal, or thromboembolic disease. ,
* patients with a high possibility of the morbid adherent placenta,
* known coagulopathy and
* those presented with severe antepartum hemorrhage
* refuse to participate
Correlation of Menstrual Cycle Phase at Time of Primary Surgery With 5-Year Disease-Free Survival in Women With Stage I or Stage II Breast Cancer

RATIONALE: Timing of breast cancer surgery may improve effectiveness of treatment and may help patients live longer.

PURPOSE: Clinical trial to determine whether timing of primary surgery in relation to menstrual cycle is associated with disease-free survival 5 years after surgery in women who have stage I or stage II breast cancer.

OBJECTIVES:

* Document menstrual phase (follicular vs luteal) by circulating hormones and menstrual history at the time of primary surgery in premenopausal women with stage I or II breast cancer.
* Correlate menstrual phase at primary surgery with 5-year disease-free survival in these patients.
* Compare the menstrual cycle data obtained by hormone levels and study-specific menstrual cycle history with information recorded in the general written record.
* Compare the menstrual cycle data (e.g., hormone levels and cycle history) for these women with the data for the general population.
* Estimate the disease-free survival of women who undergo a 2-stage surgical procedure with cancer found at both stages when the surgery is not confined to the same menstrual cycle phase.

Premenopausal women age 18 to 55 years, who were interviewed for menstrual history and who were surgically treated for stages I to II breast cancer, had serum drawn within 1 day of surgery for estradiol, progesterone, and luteinizing hormone levels. Menstrual history and hormone levels were used to determine menstrual phase: luteal, follicular, and other. Disease-free survival (DFS) and overall survival (OS) rates were determined by Kaplan-Meier method and were compared by using the log-rank test and Cox proportional hazard modeling.

Eligibility Criteria:
Inclusion Criteria:

1. Women age 18 to 55 years
2. Regular menstrual cycles of 21- to 35-days duration
3. Pathologic stages I to II breast cancer, in whom all gross disease-including ductal carcinoma in situ-was surgically removed either in a one-stage or two-stage procedure.
4. required serum be drawn within 1 calendar day of the lumpectomy/mastectomy for women who underwent a one-stage procedure and within 1 calendar day of each stage for women who underwent a two-stage procedure.

Exclusion Criteria:

1. Lactation within the past 3 months
2. galactorrhea
3. neoadjuvant therapy
4. previous breast cancer, and history of any cancer (except squamous or basal cell skin carcinoma) in which the patient was not disease-free for at least 10 years
SY-005 （Recombinant Human Annexin A5）in Patients With Sepsis

This Phase IIa Randomized, Double-blind, Parallel Group, Placebo-controlled, multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Multiple Intravenous Injection of SY-005（recombinant human annexin A5） in Sepsis Subjects. 96 patients will be entered into the study and randomised in a 1:1:1:1 ratio to receive SY-005 2.5mg or SY-005 5mg or SY-005 10mg or placebo.


Eligibility Criteria:
Key Inclusion Criteria:

* Patients are diagnosed with sepsis and receive study treatment within 48 hours
* Sepsis-related Organ Failure Assessment（SOFA）score range from 2 to 13
* The informed consent form signed by the patient or the patient's legally acceptable representative

Key Exclusion Criteria:

* Pregnant or breastfeeding women ; Women of childbearing potential (WOCBP) could not take effective method of contraception
* Moribund, and death is considered imminent within 24 hours or patient expected survival time is less than 6 months due to the underlying disease
* Absolute neutrophil count (ANC) \<0.5 x 10\^9/L
* New York Heart Association (NYHA) classification IV
* Patient with end-stage lung disease
* eGFR \<60ml/min
* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>3.0 times the upper limit of normal (ULN)
* Immunosuppressed patients with following situations:

  1. Human immunodeficiency virus (HIV) infection
  2. Patients undergoing active radiation or chemotherapy treatment within the past 3 months
  3. Any organ or bone marrow transplant and related immunosuppressive therapy
  4. High dose steroids (eg, \> 0.5 mg/kg prednisone or a steroid with equivalent activity, daily for a month) within 3 months before provision of written informed consent for the study
* Patients with high bleeding risk:

  1. Recent surgery \<72 hours, or a planned surgical procedure in the next 24h
  2. Severe thrombocytopenia (\< 30 x 10\^9/L, before platelet transfusion)
  3. Recent trauma \<72 hours
  4. History of gastrointestinal bleeding or intracranial hemorrhage in the past 6 weeks.
  5. Stroke or head injury in the past 3 months
  6. On-going therapeutic anticoagulants that could not be interrupted (except prophylactic heparin treatment that can be continued）
  7. Any history of Chronic liver disease with a Child score B or C
  8. Any condition at risk of bleeding, as appreciated by the physician in charge of the patient
* Severe anemia (hemoglobin \<5.9 g/dL)
Monitoring of Non-invasive Ventilation

The purpose of this study is to determine whether clinical examination, report from ventilator software, nocturnal Sp02 and daytime arterial blood gas are sufficient as screening tools to reveal clinical relevant problems with patients receiving long term treatment with non invasive ventilation.

Patient with chronic hypoventilation with stable on long term treatment (LTMV) with non-invasive ventilation for at least 3 month taking part of our LTMV program will be included.

In addition to clinical examination,report from ventilator software, nocturnal Sp02 and daytime arterial blood gas all patients will be investigated with sleep polygraphy and transcutaneous Co2.

Eligibility Criteria:
* Admitted to our unit for optimal treatment of long term non invasive ventilation
* Readmitted for control after 6-8 weeks
* Then treated for at least 3 month with long term non invasive ventilation outside of hospital.
* Informed written consent

Exclusion Criteria:

* Under 18 years old
* Lack of cooperation
* Pregnant
* Acute exacerbation last 3 month leading to hospital admission.
* Change of treatment last 3 month
Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty

The study attempts to quantify the relative risks for chronic postoperative inguinal pain (CPIP) after Lichtenstein repair of groin hernia, depending on mesh type and fixation suture material.

For this purpose the investigators will analyze data from the Swedish Hernia Registry (SHR).

This is an open cohort study design where the investigators will analyze existing data that have been prospectively collected in SHR, which covers \> 95% of all groin hernia repairs in Sweden. The large database enables assessment of the relative risks for CPIP depending on in particular mesh and mesh fixation, adjusted for other plausible risk factors.

Each participant was entered at the date of surgery, when demographic and intraoperative data were registered. One year postop, each patient was sent a questionnaire focusing on present pain.

Eligibility Criteria:
Inclusion Criteria:

All Lichtenstein and similar open mesh repairs that have been registered in the SHR from September 1, 2012, until December 31, 2018.

Exclusion Criteria:

* Laparoscopic repairs.
* Preperitoneal open repairs.
* Pure suture repairs
* Patients not having a 10-digit state-assigned Patient Identification Number.
Effectiveness of 12 Clips in Maternal and Neoanatal Health Through Applied Neuroscience Tools (Neuromarketing Strategy)

Objective: To evaluate the effectiveness of 12 knowledge transfer clips of maternal and neonatal health in order to generate knowledge appropriation. Methodology: Randomized cross-over clinical trial with a non-probabilistic sample of intentional feature of 150 subjects: pregnant women, non-pregnant women and men. Participants will be evaluated during the observation of 13 clips (one of them is the control clip) in which sequence will be assigned randomly. The level of attention will be assessed by means of eye tracking, to see the ocular gaze and fixation in relation to the content of clips, and emotional reaction through the psychophysiological record (galvanic skin response). In addition, recall of information will be assessed through the application of questionnaires at the end of each video. The analysis will focus on identifying differences in the three outcomes between intervention clips and the control clip, and between the three groups, and determine the clips and segments that generate greater emotional response, attention and recall.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women, Men, and Non-pregnant women that accept to participate in the study

Exclusion Criteria:

* Participant that don't sign informed consent or have clinically significant visual or auditory impairment
Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia

The goal of this non-randomized prospective study is to use 18F-EF5-PET/CT imaging to identify and locate intraabdominal hypoxic ovarian cancer lesions. With targeted surgical sampling, precisely obtain hypoxic and potentially chemoresistant cancer tissue for our analyses and identify key molecular differences between hypoxic and non-hypoxic tumors within the same patient.

A portion of advanced stage EOC are inoperable at diagnosis and can be treated with neoadjuvant chemotherapy (NACT) before surgery. This approach offers a unique opportunity to study how hypoxic tumor areas respond to treatment.

MORE SPECIFIC AIMS

1. To validate the feasibility of PET-tracer EF5 in EOC imaging.

   * Quantify the amount and exact locations of hypoxic tumors in EOC patients using herein developed protocol and tracers (18F-EF5 and 18F-FDG) in diagnostic and neoadjuvant settings.
   * Measure the non-cancer related EF5 accumulation spots and establish the potential pitfalls in abdominal EF5 imaging
   * Establish a method to verify hypoxic locations with 18F-EF5-PET/CT information during the operation.
   * Develop and validate a model that predicts chemotherapy response based on functional imaging information.
2. To reveal hypoxia related alterations in collected tissue samples (i.e. altered DNA damage repair, altered mitochondrial respiratory functioning, overexpression of hypoxia response elements etc)

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed advanced epithelial ovarian, primary peritoneal or fallopian tube cancer.
* age 18-79 years
* informed concent

Exclusion Criteria:

* previous cancer
* pregnancy or nursing
Hamstring Tightness

The purpose of this study is to find out if individuals with tight hamstring muscles who receive dry needling in addition to a standard stretching exercise program, show an improvement in hamstring tightness and function compared to individuals with tight hamstrings who receive either sham dry needling or no needling (blunt needle) in addition to a standard stretching program.

Tightness of the hamstring muscles is a risk factor for injury. Currently, there is no data on the effect of dry needling on hamstring extensibility or functional performance measures among asymptomatic individuals with hamstring muscle tightness. The investigator wants to assess if individuals with tight hamstring muscles who receive dry needling in addition to a standard stretching exercise program, exhibit reduced hamstring tightness and improved functional performance compared to individuals with tight hamstrings who receive either sham dry needling or no needling (blunt needle) in addition to a standard stretching program.

Eligibility Criteria:
Inclusion Criteria:

* Hamstring 90/90 extensibility goniometric measurement of more than 20 degrees of knee flexion bilaterally
* Ability to perform a squat to 90 degrees of knee flexion without assistance of the upper extremities
* Asymptomatic during walking

Exclusion Criteria:

* History of systemic neurological or arthritic condition
* History of bony or peripheral nerve trauma or surgery lower extremities
* History of treatment with dry needling
* No contraindications to dry needling
Comparative Trial in Hormone Withdrawal Associated Symptoms

This clinical research study will examine whether an oral contraceptive pill taken with a monthly hormone-free interval of 4 days reduces hormone withdrawal associated symptoms compared to an oral contraceptive pill taken with a monthly hormone-free interval of 7 days after 4 cycles of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 18 and 35 years (inclusive)
* Smokers with a maximum age of 30 years at time of informed consent
* Healthy female subjects requesting contraception and currently using a low-dose EE containing oral contraceptives (OC) in a 21-day regimen (for at least three months) and suffering from at least two of the hormone withdrawal associated symptoms headache, pelvic pain and bloating during all three months prior the planned baseline cycle and requiring further OC use
* To be valid for randomization, the total 7-day composite score of hormone-withdrawal symptoms during the baseline cycle must show an increase of at least 50% during Day 22 - 28 versus the 21-day composite score during Day 1 - 21 (21-day score divided by three \[for normalization\])
* History of regular cyclic menstrual periods

Exclusion Criteria:

* Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, or presence or history of prodrome of a thrombosis (e.g. transient ischemic attack, angina pectoris) and conditions that could increase the risk to suffer from any of the above mentioned disorders, e.g., a family history indicating a hereditary predisposition. Hereditary or acquired predisposition for venous or arterial thrombosis, such as APCresistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
* History of migraine with focal neurological symptoms.
* Diabetes mellitus with vascular involvement.
* Obesity (Body Mass Index \>32.0 kg/m2)
* Moderate to severe hypertension (repeated measurements of systolic blood pressure \>140 mmHg and/or diastolic blood pressure \>90 mmHg).
* Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.
* Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
* Jaundice and / or pruritus related to cholestasis (Gilbert´s syndrome excepted), or history of cholestatic jaundice associated with pregnancy or previous combined OC use
* Severe renal insufficiency or acute renal failure.
* Presence or history of liver tumors (benign or malignant), or known or suspected sex-steroid influenced malignancies or premalignant disease (e.g. of the genital organs or the breasts).