cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Thumb-tack Needle Treatment for Diminished Ovarian Reserve

Diminished Ovarian Reserve (DOR) is characterized as an important cause of infertility. Acupuncture has been extensively used to treat female infertility. This study was conducted to investigate the efficacy of thumb-tack needle，as a new special type of acupuncture and long-lasting treatment modality,in the treatment of DOR.

There will be a multi-center, randomized, sham-controlled trial. 106 patients will be randomly assigned into thumb-tack needle acupuncture or sham-acupuncture in 1:1 ratio. All the patents will achieve 12 sessions of verum or sham treatments in 20 weeks(12 weeks for treatment and 8 weeks for follow-up). Patients, outcome assessors and statisticians are masked from group assignment. The study is aim to evaluate the efficacy of thumb-tack needle for DOR.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old ≤ age \< 40 years old, female;
* Clinical diagnosis of Diminished Ovarian Reserve: meet both items in twice tests with an interval of at least 4 weeks(tested between 2rd to 4th day of menstrual cycle):

  1. 10 IU/L \< FSH \< 20 IU/L,
  2. Anti-Müllerian hormone(AMH) \< 1.1ng/mL.
* without any mind disease, willing to participate in the study and sign the informed consent.
* without any other treatment.

Exclusion Criteria:

* Low or no response to exogenous gonadotropins, or with congenital anomalies in the development of the reproductive tract；
* Pregnant or breastfeeding;
* Abnormal body temperatures at the moment;
* Psychopath, alcoholic, Patient with severe depression, history of substance abuse and severe primary diseases of cardiovascular, liver, kidney and hematopoietic system;
* Currently enrolled in other clinical trials or refuse to cooperate with the study protocol.
Research of Circulating Tumor Cells Released During Endometrial Cancer Surgery.

The purpose of this study is to investigate the spread of Circulating Tumor Cells (CTC) during surgery in endometrial cancer. Although this cancer is often discovered at early stage, the risk of recurrence is estimated at 6 to 21%, according to grade. Early stage tumor is accessible for curative surgical treatment by laparoscopy but this kind of surgery may induce CTCs spread, and could be an explanation of this recurrence. Through this study, concordance between two blood punction sites, peripheral vein and ovarian vein, will be evaluated to detect these cells during surgery.

The goal of this single-center clinical trial is to determine the best blood punction site to observe the spreading of CTC during surgery in endometrial cancer. CTCs are very rare events on blood and their detection require extremely sensitive technologies. This pilot study will investigate CTC spread during surgery on 10 patients with endometrial cancer.

The main objective is to compare venipuncture site for detection of CTCs in endometrial cancer during surgery. Blood samples are collected on a simple sampling (arm) compared to sampling as close as possible to the tumor (ovarian vein).

Eligibility Criteria:
Inclusion Criteria:

* Patients with endometrial cancer
* Being affiliated or benefiting from a French social security system

Exclusion Criteria:

* Patients with an other cancer
The Effect of Traxi Panniculus Retractor on Surgical Time at Non-emergent Cesarean Delivery in Obese Women

This is an unblinded, randomized control trial of obese women to evaluate the impact of the Traxi Panniculus Retractor (TPR) on the cesarean operative time and surgical blood loss when compared to silk tape.

The purpose of the study is to assess whether using the Traxi Panniculus Retractor during cesarean section, in obese (BMI greater than or equal to 30kg/m2 at time of delivery) women, can decrease the cesarean operative time compared to using silk tape to retract the panniculus. Operative time is defined as the time from when the patient lies on the operating room table (at completion of the epidural/spinal anesthesia) until fascial closure.

Eligibility Criteria:
Inclusion Criteria:

* Current BMI equal to or greater than 30 kg/m2 at last prenatal visit or on day of admission to L\&D
* Requires panniculus retractor for cesarean delivery, as determined by the surgeon
* Non-emergent cesarean delivery
* Spinal or epidural anesthesia
* Low transverse skin incision
* Gestational age equal to or more than 32 weeks 0 days
* Singleton pregnancy
* Three or less previous cesarean deliveries.
* English speaking

Exclusion Criteria:

* Use of Alexis or any other retractor
* General anesthesia
* Fetal demise
* Placenta previa
* History of bariatric surgery
* Adhesive allergy
Bioequivalence Study Between Two Oral Formulations of Gemfibrozil Tablets

The purpose of this study is to determine whether two oral formulations of Gemfibrozil Tablets are bioequivalent.


Eligibility Criteria:
Inclusion Criteria:

* healthy men or women 18 years of age or older
* weight within +/- 20% for height and body frame
* willing to participate and sign a copy of the informed consent form

Exclusion Criteria:

* recent history of drug or alcohol addiction or abuse
* pregnant or lactating women
* history of allergic response to gemfibrozil
* use of tobacco products
* evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
* receipt of any drugs as part of a research study within 28 days prior to study dosing
Extension Study of the Efficacy and Safety of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma

The main objective of this study is to assess the long-term effectiveness of SCIO-469 as monotherapy, or in combination with bortezomib in relapsed, refractory patients with multiple myeloma (MM) who have previously demonstrated clinical benefit in the Scios B003 study.

The main objective of this study is to assess the long-term efficacy of SCIO-469 as monotherapy, or in combination with bortezomib in relapsed, refractory patients with multiple myeloma (MM) who have previously demonstrated clinical benefit in the Scios B003 study. Patients took by mouth two capsules (60 mg) three times a day alone or in combination with bortezomib, for 168 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients who did not have disease progression on Day 73 of Study B003
* patients fully understand all elements of, and have signed and dated, the written Informed Consent Form (ICF) before initiation of protocol-specified procedures

Exclusion Criteria:

* Patients who have an active uncontrolled infection
* any condition, including laboratory abnormalities, that in the opinion of the investigator places the patient at unacceptable risk to participate in the study
* pregnant or lactating women, or who are not using adequate contraception
* sexually active women of childbearing potential (WCBP) who do not agree to use at least two forms of medically accepted birth control, including one barrier method, for the duration of the study
* men who do not agree to use an acceptable method for contraception throughout the study
Comparison of Propofol-fentanyl and Midazolam-fentanyl for Conscious Sedation

Sixty patients who refer to the emergency ward and need any painful procedure in the ward are randomized into 2 groups. One group is sedated before the procedure using propofol-fentanyl and the other with midazolam-fentanyl, with the same depth of sedation. The two groups will be compared regarding recovery time and other parameters described below.


Eligibility Criteria:
Inclusion Criteria:

* age more than 18
* candidate for a painful procedure
* negative past history of a serious medical condition
* ASA score 0 and 1

Exclusion Criteria:

* deep sedation making the patient unable to answer the questions
* pregnancy
* allergy to drugs
* hemodynamic instability
* failure to consent
Evaluating Within-Person and Between-Person Effects Of A Personalized Normative Feedback Intervention On Drinking As They Are Moderated By Self-Determination

This study evaluates within-person and between-person effects of a personalized normative feedback intervention and injunctive norms as they are altered by self-determination in heavy drinkers. Half of participants will receive personalized normative feedback and the other half will receive control feedback about media use habits.


Eligibility Criteria:
Inclusion Criteria:

* Student at the University of Houston
* Above 18 years of age
* Heavy drinker (more than 4 drinks \[women\] or 5 drinks \[men\] on a single occasion in the last 2.5 weeks and drinks, on average, at least once per week.
Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients

Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.

Helicobacter pylori (H. Pylori) infection is a wide spread disease and is endemic in many countries including Egypt with a wide range of morbidity; that requires appropriate antimicrobial therapy . However, worldwide the eradication rate following the standard triple therapy is declining and this may necessitates introduction of new antimicrobial agents . On the sight of bearing in vivo and in vitro activity against H. Pylori, the use of different strains of probiotics in treatment of H. Pylori may be thus justifiable, Lactobacillus reuteri (L. reuteri) which through different mechanisms including production of reuterin have anti H.pylori activity have been tried in improving the eradication rates of H.pylori with contradictory results . This study is conducted to test the assumption that addition of L. reuteri to the standard triple therapy in treatment of H. Pylori improves the eradication rates and clinical aspects in H. Pylori infection.

Eligibility Criteria:
Inclusion Criteria:

Inclusion of patients with these criteria

1. Age: 18-60 years
2. Any sex
3. Confirmed H. Pylori infection defined by pathological lesions and either histopathological confirmation of the organism, rapid urease test or H. Pylori antigen in stool
4. Good mentality to understand aim, benefits and steps of the study
5. Assumed availability during the study period
6. Written informed consent

Exclusion Criteria:

* Exclusion of

  1. Patients with chronic diseases e.g. diabetes, renal failure, cirrhosis...etc.
  2. Patients with malignancy.
  3. Patients with gall bladder disorders.
  4. Patients with peptic ulcer.
  5. Patients with prior upper GIT surgery.
  6. Patients with probiotics therapy in the last one month.
  7. Patients with triple therapy, antibiotics, proton pump inhibitors and H2 receptor blockers therapy within one month.
  8. Patients with known allergy to the used medications

     -
Influenza Vaccination at a Reduced Dose Using Mesotherapy in HIV/AIDS Patients at the Hadassah AIDS Center, Jerusalem

Influenza vaccination has proved it's effectiveness over many years of usage including HIV/AIDS patients who are immunocompromised. In those patients, however, a noted rise in HIV viral load which follows intramuscular injection of the vaccine is of unknown significance over the long run. Mesotherapy is a procedure developed and practiced in france by which a reduced and diluted amounts of antigens is being introduced by multiple intradermal injections over the torso and upper back. Mesotherapy is mainly used as a vehicle for introducing pain medicine and cosmetics.

We will test the effectiveness of mesotherapy as a vehicle for influenza vaccination.We will use 1:10th of the amount of seasonal trivalent influenza vaccine in approx.50 HIV/AIDS patients.A control group of approx.50 matched patients for age ,treatment schedule and immune status will receive the regular injection of trivalent vaccine. We will follow patients clinically for symptoms compatible with seasonal influenza and for direct side effects of the vaccine.In addition we will measure anti influenza antibody in the two groups .Follow up will be for 6 months following vaccination.Anti influenza antibody will be measured at 1,3,6months using hemagglutination inhibition (HAI) test.

Eligibility Criteria:
Inclusion Criteria:

* Virologic diagnosis of HIV/AIDS.
* Any immune derangement is acceptable

Exclusion Criteria:

* Allergy to eggs
Ultra-high Resolution CT: the End of Stapes Prosthesis Measurement Misestimation

Actual CT scanners overestimate stapes piston size, and do not represent a valuable technique for their follow-up, especially in case of complication. Ultra-high resolution has not yet been evaluated in this setting.

Modern temporal bone imaging systems, using 0.5 mm slice thickness, are reputed not yet able to depict the stapes piston position with a sufficient degree of accuracy, as high-resolution CT measurements consistently overestimated intravestibular piston dimensions (width by 44%, length by 6.25%) and vestibular intrusion (by 39%) because of metallic artifacts. . The exact limits of intravestibular depth are also unclear. The "safe" intravestibular prosthesis depth varies widely between studies and has been reported to range from 0.2 to 2.5 mm, so 39% may represent up to 0.9 mm of misestimation. Ultra-high resolution CT (UHR-CT) has improved spatial resolution to 0.12 mm by using ultra-small detector elements (0.25 x 0.25 mm), allowing better visualization of temporal bone structures compared to high-resolution temporal bone CT (HR-CT). However, this technique has not been described for stapes prosthesis measurement.

Eligibility Criteria:
Inclusion Criteria:

- stapes prosthesis Ultra-high resolution CT available

Exclusion Criteria:

no materiovigilance report available
3DV+TPS Software Outlines the Radiotherapy of Nasopharyngeal Carcinoma

Comparing the accuracy and speed of 3DV+TPS software with imported TPS and domestic TPS to outline the contours of crisis organs, it is proved that 3DV+TPS has superiority compared with domestic TPS, and it has non-inferiority compared with imported TPS, indicating that the software can improve contour sketching accuracy. And speed, reduce the burden on doctors, improve medical efficiency.

Comparing the accuracy and speed difference between 3DV+TPS software and imported TPS and domestic TPS to outline the contours of crisis organs, the selected organs are: bilateral eyeballs, bilateral crystals, bilateral optic nerves, bilateral parotid glands, oral cavity, spinal cord, brainstem, The brain has a total of 12 organs; verify that 3DV+TPS is superior to domestic TPS, and has non-inferiority compared with imported TPS, Ming software can improve the accuracy and speed of contour sketching, reduce the burden on doctors, and improve medical efficiency.

Eligibility Criteria:
Inclusion Criteria:

1. It is diagnosed as nasopharyngeal carcinoma by histopathological examination, and there is no tumor invasion in the organs that need to be assessed;
2. Age 18-70 years old;
3. There is nasopharynx localization enhanced CT, nasopharynx enhanced MRI.

Exclusion Criteria:

1. Patient information is incomplete; no age, gender, MRI, height, radiotherapy location CT;
2. The organs at risk that need to be assessed are invaded by the tumor;
3. Any reason cannot be combined with the research or the researcher believes that it is not suitable for inclusion in this test.
A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)

To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.

This trial is designed to assess the efficacy, safety and tolerability of flexible dose brexpiprazole as monotherapy or as combination therapy with Zoloft (Sertraline) in adult participants with PTSD.

This study will consist of a continuous 12-week, double-blind treatment period with a 14-day follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants between the years of 18-65 with a diagnosis of PTSD (diagnosis can be made at screening)

Exclusion Criteria:

* Index trauma event \>15 years before screening
* Index trauma event at age \<16
* Any traumatic event within 3 months of screening
Comparison Study of Non-invasive Measurement of Blood Pressure and Cardiac Output During Stress Echocardiography

The objectives of the clinical trial is to validate hemodynamic parameters (Blood pressure and Cardiac Output) generated by an application coupled with an off-the-shelf pulse oximeter. The validation will be done by comparing the generated information to data gathered while performing Stress Echocardiography. The first phase of the study will be done on 10 patients undergoing a Stress Echocardiography test at the cardiology department at Meir Hospital

The HeartBeat system combines an FDA/CE approved watch-like Pulse Oximeter for acquiring the data and an android software application that serves as the Hemodynamic calculator. The application performs POST-PROCESSING of the PhotoPlethismoGraphic (PPG) signal (Normally the PPG signal in Pulse Oximeters is used only to compute heart rate and SpO2). The raw data is transferred from the watch oximeter to the smartphone using a standard Bluetooth protocol.

The Post-processing uses wavelet signal processing to estimate and display certain Hemodynamic parameters like Blood Pressure (BP) and Cardiac Output (CO) in a continuous and graphical way on a standard Android device. In addition to the standard heart rate and SpO2, the application displays the measured PPG signal and estimated continues BP and CO.

HeartBeat is the only device that can non-invasively estimate Continuous BP and its Cardiac Output component and the resistance component in a mobile wearable device. Differentiating between these 2 components can play a major role in helping the doctor to understand the effect of cardiovascular medications and Lifestyle interventions.

The trial will compare blood pressure and cardiac output parameters measured during Stress Echocardiography using an echo cardiograph and standard sphygmomanometer to the parameters generated by the application.

Trial goals

* Feasibility tests for the HeartBeat application as a tool for monitoring BP and CO changes over time
* Compare BP and CO parameters generated by the applications to the ones measured by standard non-invasive equipment during a Stress Echocardiography
* Calculate additional parameters such as stroke volume, systematic vascular resistance and cardiac index

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to an Stress Echocardiography test for cardiac diagnostics
* Male and Female
* Between 18 to 90 years old

Exclusion Criteria:

* Under the age of 18 or over 90 years old
* Patients in Shock
* Patients with Moderate or Severe valvular disease
* Patients with severe sepsis
* Inadequate jurisprudence patients
* Patients supported by Amines
Efficacy Study of Acupuncture to Treat the Upper Abdominal Pain of Cancer Patients

This study is to investigate the effectiveness of acupuncture for alleviating the upper abdominal pain of cancer patients

Neurolytic celiac plexus block (NCPB) is a commonly performed procedure in patients with intractable pain due to malignancies involving the upper and mid abdomen. Recently, acupuncture is used as one of alternative interventions to treat cancer-related pains. This pilot study aims to investigate the effectiveness of pain-relief of acupuncture via comparing acupuncture plus NCPB with NCPB alone. Total 14 cancer patients with NCPB will be randomized into two groups of acupuncture and control.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Upper abdominal pain VAS ≥ 5
* Unresectable abdominal malignancy, moderate or severe abdominal pain poorly controlled with pharmacotherapy.
* All patients had advanced cancer diagnosed by histological/cytological examination
* Follow-up possible during the clinical trial
* Written informed consent voluntarily

Exclusion Criteria:

* Patient with uncorrectable coagulopathy
* Patient with allergy to local anesthesics or alcohol..
* Previous NCPB or had implanted epidural or intrathecal analgesic therapy
* Inability to lie prone
* Disease encasing the celiac plexus on computed Tomography scan
* Patients with psychiatric diseases that could have affected the study assessments
* Significant renal or hepatic disease
* Inability to comprehend or express oneself in the Korean language
* Refusal to participate in the trial or to provide informed consent
Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain

To investigate the effectiveness of BI 1026706 powder for reconstitution of an oral solution compared to placebo and the relative effectiveness compared to Celecoxib.


Eligibility Criteria:
Inclusion criteria:

1. Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure,Pulse Rate), 12-lead electrocardiogram, and clinical laboratory tests
2. Age 18 to 55 years (incl.)
3. Body Mass Index 18.5 to 29.9 kg/m2 (incl.)
4. Patients scheduled for removal of one mandibular third molar with partial or complete bony impaction. If medically indicated, the ipsilateral third molar in the upper jaw could also be removed;
5. Surgery will be conducted under local anaesthesia using 12% lidocaine (with epinephrine). Intravenous sedations and general anaesthetics are not permitted.
6. Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form
7. Examined by the attending oral surgeon or physician and medically cleared to participate in the study
8. Scheduled to undergo a qualifying surgical procedure
9. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

1. Any finding in the medical examination (including Blod Pressure, Pulse Rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease judged clinically relevant by the investigator
5. Acute local infection at the time of surgery that could confound the post-surgical evaluation
6. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
7. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
The Effect of Acupuncture on Pregnancy Rates in Women Undergoing Embryo Transfer

The present study is designed to test the hypothesis that acupuncture, before and after embryo transfer, significantly improves pregnancy rates, compared to embryo transfer with sham acupuncture and no acupuncture at all.


Eligibility Criteria:
Inclusion Criteria:

* patient is undergoing embryo transfer after IVF or ICSI
* patient has given informed consent to participate

Exclusion Criteria:

* frozen embryo transfer
* previous enrollment in study