cyrilzakka/clinical-trials huggingface dataset:
Effect of Traditional Chinese Medicine on In Vitro Fertilization (IVF) Success Rates

The purpose of this study is to determine the value of combining Traditional Chinese Medicine (TCM) Protocols including acupuncture with In Vitro Fertilization (IVF).


Eligibility Criteria:
Inclusion Criteria:

1. Subject is able to understand and provide consent
2. Subject is female, 21-42 years of age at time of screening and has at least one l ovary
3. Subject BMI is \> 18 and \< 32
4. Subject is experiencing primary or secondary infertility
5. Subject may receive sperm from donated source
6. Subject's partner has sperm in the ejaculate
7. Subject's serum basal FSH is \< 11 IU/L
8. Subject's serum basal estradiol level is between 20-80 pg/mL
9. Subject's TSH level is \< 3.0 mv/mL
10. Subject's prolactin level is \< 24 ng/mL
11. Subject will agree to limit caffeine intake to one cup (76.5 mL/day) by the time of randomization
12. Subject agrees not to make alterations in diet and lifestyle practices other than those that their Medical Practitioner deems necessary in the best interest of the subject
13. Subject agrees not to participate in any other research opportunities for the duration of the study

Exclusion Criteria:

1. Subject is pursuing sex selection
2. Subject is undergoing treatment with an egg donor
3. Subject experienced more than 2 previous failed cycles
4. Subject is undergoing a heparin or lovenox-based protocol
5. Subject is currently taking herbal therapy (1 week wash-out)
6. Subject is currently taking co-interventions of moxibustion and cupping
7. Subject is exhibiting uterine anomalies (i.e.,bicornuate, unicornuate uterus,)
8. Subject is diagnosed with severe endometriosis defined as endometriomas \> 4cm
9. Subject is currently receiving acupuncture therapy (Subject must agree to a 30 day washout period prior to randomization)
10. Subject has history of recurrent spontaneous abortions defined as \> 3
11. Subjects with a Beck Depression Inventory (BDI-II) of 29 or higher at screening, indicative of severe depression, will be excluded from the study and referred for further psychological evaluation by our in-house licensed mental health professional.
Evaluating the Relative Effectiveness of Two Feeding Interventions for the Treatment of Moderate Acute Malnutrition

Supplementary feeding programs for children with moderate acute malnutrition have been implemented in developing countries using treatment foods with minimal or no evidence of their effectiveness. Fortified peanut paste is a popular new treatment food for children with severe and moderate malnutrition.

Objectives: To investigate the relative effectiveness of two non-identical therapeutic foods in children with moderate malnutrition by comparing differences in performance indicators (i.e. recovery rates), recovery times, and change in weight-for-height z-scores in each group.

This proposed research project will evaluate the relative effectiveness of two non-identical treatment foods for the treatment of moderate acute malnutrition in children

This research protocol will be embedded as a component of the UN World Food Programme (WFP) -supported Supplementary Feeding programmes in Ethiopia. The proposed study is a prospective cluster-randomized equivalence trial that will compare the relative effectiveness of two feeding interventions in four woredas (districts). Research will be implemented in two comparable woredas (one with CSB and one with RUSF), in two different areas in Sidama zone that represent different livelihood zones, main source of crop income, and level of food insecurity

Eligibility Criteria:
Inclusion Criteria:

* All children 6 to 60 months of age who are identified as malnourished based on MUAC measurements with WFH ≥70 to \<80%.

Exclusion Criteria:

* Children with WFH \< 70% or presenting with bilateral pitting oedema (they will be referred to therapeutic feeding programme).
* Children with any illness or clinical condition that prevents them from safely ingesting either supplementary foods. A child is medically assessed upon admission for any complicated clinical condition (oedema, malaria, vomiting, chronic diarrhea, infections, appetite, etc) that would require medical care and those children will be referred to the therapeutic feeding programme.
* All children transferred from the therapeutic feeding programme directly into the supplementary feeding programme - however they will not be included in the research study.
* Children with WFH \> 80% but MUAC 110 to 120 mm- they will be admitted to SFP however will not be included in the research study.
Estrogen Patch for COVID-19 Symptoms

The purpose of this study is to find out if estrogen, a female sex hormone, given as a patch placed on skin of COVID19 positive or presumptive positive patients for 7 days can reduce the severity of COVID19 symptoms compared to regular care.

This study has two study groups. One group will receive the study drug, a single-use Climara 25cm2 estrogen patch. The other group will receive standard of care.

Participants will be asked questions about their symptoms for up 6 times in up to 45 days.

As the COVID19 pandemic has spread, it has been observed that adult men of all ages and older women are at higher risk of developing serious complications from infection with the virus. Animal model studies of SARS suggest that the age and sex difference in COVID19 symptom severity may be due to protective and acute actions of the female sex hormone estrogen. Animal and human studies support immune modulating effects of estrogen that are acute acting in viral infections and wound repair processes that may reduce the damaging effects of the virus on the lung and symptom severity.

Our hypothesis is that a short 7 day course of estradiol delivered in a transdermal patch applied to the upper buttock in COVID19+ or presumptive positive patients will be safe and will reduce symptom severity in adult men and older women when given prior to intubation. COVID19+ and presumptive positive patients not requiring intubation will be enrolled to the study and randomized to receive an estrogen patch or standard of care. Patients will be followed up at day 1, 7, 14 and 28 for clinical symptoms and disease outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Male ≥ 18 years of age or female ≥ 55 years of age
* Documentation of COVID19 positivity or the presence of one or more of the following new onset (\<7 days) clinical features defining presumptive COVID19

  1. fever of \>100.5°F or 38°C
  2. shortness of breath
  3. cough
  4. radiologic evidence of pneumonia
* Able to provide informed consent
* Able to be contacted by telephone for follow-up

Exclusion Criteria:

* Currently receiving estrogen based hormonal therapy
* Abnormal genital bleeding
* Protein C or Protein S deficiency
* Pre-existing liver impairment (e.g. Hepatitis C, cirrhosis)
* History of anaphylactic reaction or angioedema with Climara
* Receiving lamotrigine therapy
* Subjects with known past diagnosis of estrogen receptor positive breast cancer or endometrial cancer
* Subjects with severe hypoxia at risk for acute intubation in ED
* History of stroke
* Any history of thromboembolic event including deep vein thrombosis or pulmonary emboli
* Current use of St. John's Wort
* Males on testosterone
* History of myocardial infarction, cardiac stents, or active angina
Noninvasive Brain Stimulation in Adult Amblyopia

The goal of this randomized controlled trial is to investigate the effectiveness of non-invasive brain stimulation in treating adults with amblyopia. The main questions it aims to answer are:

1. What are the effects of non-invasive brain stimulation on neuronal plasticity in the visual cortex of adults with amblyopia, and does it produce lasting changes?
2. Do cumulative sessions of non-invasive brain stimulation influence neural plasticity and higher-order visual functions in adults with amblyopia?

The investigators hypothesize that non-invasive brain stimulation will show a positive cumulative effect after five (5) consecutive days of stimulation on visual perception and function in adults with amblyopia.

Participants will be randomized into one of two treatment groups:

1. High-frequency transcranial random noise stimulation (hf-tRNS).
2. Sham stimulation.

Researchers will compare baseline measurements of crowded visual acuity, contrast sensitivity, stereoacuity, phosphene thresholds, global motion perception, form pattern recognition and pattern-reversal visual evoked potentials (VEPs) to post-treatment measurements for each group.


Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 and 55 years of age
* Formal diagnosis of amblyopia in one or both eyes of any etiology

Exclusion Criteria:

* History of optic nerve disease, including glaucoma and optic neuritis
* History of neurological conditions, including demyelinating disease or stroke
* Presence of metal or electronic implants in or on the body, including pacemakers
* Taking medications that can affect normal neurological function, including antipsychotics, antiepileptics, and opioids
PACT (Platelet Activity After Clopidogrel Termination)

Clopidogrel is a medication that is used to decrease the ability of platelets to form blood clots.

The theory has been proposed that, in patients with coronary artery disease or stroke, increased platelet function after discontinuation of clopidogrel therapy is associated with an increased clotting risk. However, this theory has never been rigorously tested.

The goal of this research is to determine whether discontinuation of clopidogrel results in increased platelet function.

In this study, we will address the question: does discontinuation of clopidogrel result in platelet hyperreactivity? We will perform a double-blind, placebo-controlled, crossover study in normal subjects, in whom platelet reactivity will be measured before clopidogrel or placebo, during clopidogrel or placebo, and at various time points after discontinuation of clopidogrel or placebo. The dose of clopidogrel will be the standard, FDA-approved dose: 75 mg daily. All subjects will be treated with aspirin 81 mg daily throughout the 57 days of study assessment in both the clopidogrel arm and the placebo arm, because the clinically relevant question is: in patients who remain on aspirin, does discontinuation of clopidogrel result in platelet hyperreactivity?

Eligibility Criteria:
Inclusion Criteria:

* Must be a normal healthy subject
* Must be between 21-70 years old
* Must be able to take aspirin and clopidogrel.
* Must be able to have blood drawn 16 times over approximately 3 months.

Exclusion Criteria:

* Subject who is currently taking aspirin or another anti-platelet drug such as clopidogrel. Subject must be free of these medications for 10 days before enrolling in this study.
* Subject who is currently taking a non-steroidal anti-inflammatory drug such as ibuprofen or naproxen. Subject must be free of these medications for 3 days before enrolling in this study.
* Subject who is currently taking medications for depression or medications that lower blood pressure or lower blood sugar.
* Subject who are pregnant or may become pregnant during the study or who is breast feeding.
* Subject with a known allergy to aspirin or clopidogrel.
* Cigarette smoking or use of other nicotine product.
* Subject with a history of any of the following: coronary artery disease; stroke; bleeding disorder; ongoing bleeding; previous life-threatening hemorrhage; stomach ulcers; gastrointestinal bleeding within the past 1 month; major surgery within the past 1 month; minor surgery within the past 2 weeks; or platelet transfusion within the past 7 days.
* Subject with a blood count, measured on the pre-study drug blood sample, that is not in the normal range.
* Subject who is enrolled in another clinical trial of an investigational drug.
Retrospective-prospective Study to Evaluate Treatment Management and Outcomes of Patients With Waldenström's Macroglobulinemia (WM) Treated in Italy According to the Zanubrutinib (Brukinsa®) Compassionate Use Program (CUP) and in Common Practice Following Commercial Approval.

This is a non-interventional, observational, retrospective and prospective multicenter Italian study, to describe treatment management and outcomes of Waldenström's Macroglobulinemia (WM) patients treated according to the Italian Compassionate Use Program (CUP) and receiving zanubrutinib following its commercial approval.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent form
* Waldenström's macroglobulinemia diagnosis in need of treatment according to ESMO (European Society for Medical Oncology) guideline 2018
* Patients who received Zanubrutinib according to the Italian CUP or in common practice following Zanubrutinib commercial approval
* Treatment with zanubrutinib according to current SmPC (Summary of Product Characteristics)
* Treatment decision before inclusion into this non-interventional study
* Age ≥18 years

Exclusion Criteria:

* Contraindications according to SmPC for patients with WM
* Participation in an interventional clinical trial during zanubrutinib treatment
* Patients with disease progression during a BTKi treatment (if pre-treated with BTK, only those intolerants are considered eligible)
Could Bulk Fill Glass Hybrid Restorative Materials Replace Composite Resins in Treating Permanent Teeth?

The aim of this study is to compare the clinical and radiographic efficacy of Equia system bulk fill glass hybrid material with composite resins in the permanent restoration of pediatric patients' permanent teeth.

The study included 44 pediatric patients aged 8 to 16 years who applied to the Pedodontics Department of the Necmettin Erbakan University Faculty of Dentistry. The groups were formed as symmetrical teeth in the same patient using the split-mouth design. The study included class I caries lesions of 144 permanent teeth, 72 of which were restored with the Equia system bulk fill glass hybrid material \[Equia Forte HT+Equia Forte Coat (GC, Co, Tokyo, Japan)\] and 72 with the Charisma Smart universal composite resin (Kulzer, Gmbh, Hanau, Germany) + Clearfil SE Bond (Kuraray, Noritake, Sakazu, Okayama). Evaluations were performed clinically and radiographically by 2 physicians in the 2nd week, 3rd month, 6th month, and 12th month and the results were recorded. Clinical evaluation was carried out using modified USPHS criteria. Obtained data were statistically analyzed using Kendall's W test and Cochran's Q test for the comparison within the group, and the Chi-Square test for the comparison between the groups.

Eligibility Criteria:
Inclusion Criteria:

* The patient has no systemic disease
* The patient should have good periodontal status
* Teeth to be restored should be symptomless and vital
* Teeth to be restored should have proximal contacts on both mesial and distal surfaces and be in occlusion with the antagonist teeth
* Teeth that have class II caries lesions in external and middle 1/3 of dentine thickness radiographically

Exclusion Criteria:

* Xerostomia and bruxism;
* Absence of adjacent and antagonist teeth;
* Extremely poor oral hygiene, severe or chronic periodontitis;
* Teeth that have any restoration, endodontic treatment, periodontal and periapical pathology.
* The patients who are undergoing orthodontic treatment
Altered Chemotherapy Sequencing During Neoadjuvant Therapy for Patients With Stage II or III Rectal Adenocarcinoma

The primary objective of the pilot portion of this study is to establish the safety and tolerability of an extended treatment break period in patients who have undergone neoadjuvant chemoradiotherapy as well as use of systemic therapy during this break.

The proposed protocol aims to continue tumor-directed therapy during the typical "break period" in an effort to improve on both local tumor response as well as distant disease control. First, the duration from completion of chemoradiotherapy would increase from 6-8 weeks to 9-11 weeks. As noted above, this may allow for further cell death with resultant pathologic downstaging. Secondly, the protocol calls for continued systemic therapy during the 9-11 week period, thus allowing continuation of therapies directed towards both the primary as well as distant sites of disease. The primary aim of this pilot study would be to establish the feasibility of this intensified neoadjuvant approach, especially with respect to tolerability of the subsequent pelvic surgery. A subsequent phase II portion will evaluate the efficacy of this treatment approach.

Eligibility Criteria:
Inclusion Criteria:

1. Signed study-specific informed consent form
2. Age \> 18 years old
3. Zubrod performance status 0-1
4. Biopsy proven primary malignancy
5. AJCC Stage II or III disease (T3-4 and/or N1-2 disease) as determined by endoscopic ultrasound and/or MRI staging
6. Pretreatment rectal endoscopic ultrasound and pelvic MRI, colonoscopy, CT of chest, abdomen, and pelvis, and laboratory values as discussed below

Exclusion Criteria:

1. History of inflammatory bowel disease
2. Previous pelvic radiotherapy
3. A major psychiatric illness which would limit understanding of the proposed protocol treatment and consent process.
4. Men and women of reproductive potential must agree to use an effective contraception method
5. Pregnant or lactating women
6. Severe, active co-morbidity, defined as

   * Unstable angina and/or CHF requiring hospitalization within the last six months
   * Transmural myocardial infarction within the last 6 months
   * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
7. Presence of metastatic disease, including liver metastases
8. Laboratory values out of range
Prospective, Explorative, Research Study with Women to Investigate Menstruation Leakage At Night

The aim of this study is to investigate why and when menstruation leakages occur during sleep while using protective pads at night. Participants will be asked to use a specially designed pad during menstruation and to answer questions.


Eligibility Criteria:
Inclusion Criteria:

1. Women ≥ 18 years
2. Participant is mentally and physically able to participate in this study
3. Written informed consent to participate in this study
4. Participant with currently heavy menstruations regularly experiencing nocturnal leakages
5. Participant is a regular user of nocturnal menstruation pads
6. Participant is willing to use the prototype pad according to the protocol
7. Willingness to take picture of used pads and transfer to study sponsor anonymously during study duration
8. Available internet connection and device for taking pictures and data transfer (photo upload)
9. Underwear size M or L

Exclusion Criteria:

1. Known allergies or intolerances to one or several components of the study prototype
2. Participants without regular menstruation, pregnant or perimenopausal subjects
3. Participants not experiencing nocturnal leakages
4. Participants with pacemakers and/or implant defibrillator or having persons in the household that have a pacemaker and/or implant defibrillator
King Vision Video Laryngoscope Versus Glidescope Video Laryngoscope

The investigators plan to conduct a randomized trial comparing the intubation success rate and time of the King Vision Video Laryngoscope to the Glidescope video laryngoscope in order to demonstrate the comparability of the devices.

Both the King Vision and Glidescope video laryngoscopes are advanced airway devices that are relatively low cost and are designed to improve the efficiency of both routine and difficult intubation. Both systems use disposable blades, which eliminates the need for blade sterilization and may minimize the risk of infectious exposure to patients and improve cost and efficiency associated with the sterilization processing of non-disposable laryngoscopes. The Glidescope has been commercially available longer than the King Vision, and has been more frequently studied.

Although similar in many respects, the King Vision and Glidescope systems have differing designs which may result in differences in speed and success in the management of routine and/or difficult airways.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for elective, ambulatory surgery requiring general anesthesia and endotracheal intubation

Exclusion Criteria:

* Patients who require rapid sequence induction and intubation or fiberoptic intubation.
* Pregnancy
G-CREDIT (Gangnam-Cohort for Risk Evaluation of Diabetes and Impaired Glucose Tolerance)

The prevalence of type 2 diabetes has consistently increased and type 2 diabetes can cause many types of vascular complications. Diabetes develops due to glucose intolerance. Early detection and intervention in the stage of glucose intolerance makes it afford to prevent overt diabetes and its complications. This study was designed to make a cohort of korean patients with glucose intolerance to construct a long term database about clinical characteristics of these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 20 years old who has visited Gangnam severance hospital since January 2007.
2. Patients with either diabetes or impaired glucose tolerance
3. Patients with at least 6 months of follow-up period

Exclusion Criteria:

1. Patients with gestational diabetes, any active stage of cancer and severe disability