cyrilzakka/clinical-trials huggingface dataset:
Great Occipital Nerve Block Using Different Approach

Great occipital nerve (GON) block is commonly applied for the pain management of occipital neuralgia, migraine, and cervicogenic headache. The GON orginates from the medial branch of the dorsal ramus of the C2 spinal nerve with variable contribution from the C3 dorsal ramus. After emerging from the suboccipital triangle, the nerve courses cephalad in an oblique trajectory between the semispinalis capitis (SC) and obliqus capitis inferior (OCI) muscles. This area was recognized as a potential location for GON injury. The nerve then passes through the trapezius muscle and courses medial to the occipital artery as it ascends to innervate the posterior scalp.

Many practitioners perform GON injections using a conventional approach, relying solely on superficial bone-based anatomic landmarks to infiltrate local anesthetic and corticosteroid around the nerve at the level of the superior nuchal line.

Some clinicians also use fluoroscopy to confirm the location of bony landmarks. The ambiguity of these injections poses a risk of anesthetizing adjacent structures or injecting into vessels, such as the occipital artery. Very limited research has been done to quantify the risk of these injections, but a complication rate of 5% to 10% has been reported, including headache, dizziness, blurred vision, and syncope.

Ultrasound guidance is increasingly used to mitigate these risks and improve the efficacy of GON injections. Multiple studies have demonstrated successful ultrasound-guided GON blockade at the superior nuchal line and improvement in pain scores compared with nonguided injections.

C2 level GON block using ultrasound targets interfascial plane between OCI and SC muscles. However, a pain physician who begins ultrasound guided injections migth feel very difficult targeting interfascial plane exactly.

Since GON orginiates from deep space of suboccipital triangle, it is expected that injection within OCI muscle might have similar effect with the effect of injection into interfascial plane.

We assume that if the local anesthetics is injected within OCI muscle, the effect of GON block will be generated by the diffusion of injected local anesthetics.


Eligibility Criteria:
Inclusion Criteria:

* Cervicogenic headache
* Migraine
* Occipital neuralgia

Exclusion Criteria:

* bilateral headache
* cervical spine surgery within 1 year before
* loss of sensory sensation at the dermatome of GON innervation
* anatomical defect at the region of procedure
* coagulopathy
* pregnancy or breast feeding
* allergy to local anesthetics
Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment

This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or emtricitabine/rilpivirine/tenofovir alafenamide (F/R/TAF) from the current antiretroviral (ARV) therapy and in virologically-suppressed, HIV-1/HCV co-infected participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Chronic genotype (GT) 1, HCV infected, male and non-pregnant/ non-lactating female individuals, without cirrhosis, treatment-naive or treatment-experienced with interferon (IFN) +/- ribavirin (RBV) +/- HCV protease inhibitor (PI).
* Compensated cirrhotic individuals must be HCV treatment-naive.
* No prior treatments with NS5A and NS5B or any HCV direct acting antivirals, except boceprevir, telaprevir and simeprevir, in combination with IFN and RBV
* Currently on an ARV regimen (2 NRTI + a third agent) without change for 6 months prior to screening.
* Documented plasma HIV-1 RNA levels \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) for ≥ 6 months preceding the screening visit. After reaching HIV-1 RNA \< 50 copies/mL, single values ("blips") of HIV-1 RNA ≥ 50 copies/mL followed by resuppression is allowed.
* For individuals with 3 or more prior ARV regimens, a regimen history should be provided for approval by the Sponsor.

  * Note: Individuals that changed from TDF to TAF less than 6 months ago will be eligible as long as the TDF/ TAF change was the only change to the regimen.
* Plasma HIV-1 RNA level \< 50 copies/mL at the screening visit
* Have no documented resistance to any of the HIV study agents at time in the past, including but not limited to the reverse transcriptase resistance mutations K65R, K70E, K101E/P, E138A/G/K/R/Q, V179L, Y181C/I/V, M184V/I, Y188L, H221Y, F227C, M230I/L, the combination of K103N+L100I, or 3 or more thymidine analog associated mutations (TAMs) that include M41L or L210W (TAMs are M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R). If a historical genotype prior to first ARV is not available or individual had 3 or more prior ARV regimens, individual will have proviral genotype analysis for archived resistance prior to Day 1.
* No history of HIV virologic failure
* No evidence of Hepatitis B infection
* Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min as estimated by Cockcroft-Gault formula

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
The Association Between Serum E2 and P on the Day of FET and the Pregnancy Outcome

The outcomes of frozen embryo transfer (FET) have substantially improved over the last decade, due to the improvements in the cryopreservation process, Artificial endometrial preparation is typically accomplished by the administration of estradiol (E2) supplementation and exogenous progesterone (P) in order to transform the endometrium into a secretory one, mimicking a natural cycle , The current study aims to determine the association, if any, between serum E2 and P levels, measured same day of FET, and pregnancy outcome

Study design a retrospective cohort study for 402 FET cycles which will be conducted in Al- Baraka Fertility Hospital, Manama, Bahrain, between April 2018 and May 2019. The trial registration number for the study is (NCT04114500), and it was approved by our ethical committee Study population

* Inclusion criteria were women who underwent FET, were age below 40 yrs., body mass index (BMI) below 30 kg/m2, patients who underwent FET treatment using the endometrial preparation was initiated with oral estradiol valerate, the endometrial thickness was no less than 8 mm on the day when P was administrated; with normal endometrial ultrasound imaging and euploid pre-genetically tested embryos;
* Exclusion criteria were chromosomal and genetic disorders, age\> 40 years, BMI \> 35 , abnormal ultrasonogram of uterine cavity (acquired or congenital) and abnormal embryos not suitable for transfer.

Study protocol Endometrial preparation in frozen embryo transfer (FET) briefly, patients received treatment with 2 mg/8h E2 (Estrofem, Novo Nordisk) for 12-14 days, Endometrial thickness was evaluated with transvaginal sonography. When endometrial thickness reached 8 mm or greater and was trilaminar in appearance, patients were initiated on both vaginal micronized P (Crinone gel, Merck) and oral P (Duphastone, Abott) treatment at 200 mg/8h. P4 was given as supplementation because normal ovarian steroid production and the ovarian follicular-to-luteal transition were suppressed with estradiol. A depot GnRH agonist was administered in the midluteal phase of the preceding cycle at clinician's discretion. On the early morning of day 5 of P treatment, the same day of FET, a blood sample was obtained and immediately analyzed. Hormone determinations of E2 and P were performed. Then, embryo transfer of the pre-genetically tested euploid embryos was performed under ultrasound guidance. 12 days later pregnancy test was assessed, 4 weeks after FET date ultrasound will be scheduled to check the viability and clinical pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent frozen-thawed embryos transfer treatment
* the endometrial preparation was initiated with oral estradiol valerate
* the endometrial thickness was no less than 8 mm on the day when P was administrated;
* normal endometrial ultrasound imaging
* euploid pre-genetically tested embryos

Exclusion Criteria:

* age\> 40 years
* BMI \> 35
* abnormal ultrasonogram of uterine cavity
* abnormal embryos not suitable for transfer
The Combined Use of PRP with Lipoaspirate And/or Bone Marrow Aspirate in Osteoarthritis

To demonstrate the efficacy of the combined use of platelet-rich plasma (PRP) with lipoaspirate and/or bone marrow aspirate in osteoarthritis of major joints, and to compare the outcomes achieved using three combinations: PRP plus lipoaspirate, PRP plus bone marrow aspirate, and PRP plus both lipoaspirate and bone marrow aspirate.

The purpose of this study is to demonstrate the efficacy of the combined use of platelet-rich plasma (PRP) with lipoaspirate and/or bone marrow aspirate in osteoarthritis of major joints, and to compare the outcomes achieved using three combinations: PRP plus lipoaspirate, PRP plus bone marrow aspirate, and PRP plus both lipoaspirate and bone marrow aspirate.

A total of 240 participants will be randomly assigned to one of three treatment groups: Group A will receive PRP plus lipoaspirate, Group B will receive PRP plus bone marrow aspirate, and Group C will receive tri-partite therapy of PRP + lipoaspirate + bone marrow aspirate which allows for 80 in each group. The combination of biologic materials will be injected in to an arthritic joint.

Eligibility Criteria:
Inclusion Criteria:

1. Capable of providing written informed consent and willing and able to adhere to all protocol requirements.
2. Male or female at least 19 years of age at the time of providing written informed consent.
3. Evidence of OsteoArthritis in a major joint requires recent (within one year) imaging, either by x-ray or MRI. Kellgren \& Lawrence Grades 1-3 are accepted for participation.

Exclusion Criteria:

1. BMI \> 35
2. Arthroscopic surgery to the treatment joint within 12 months
3. Cortisone or HA injection within the last 3 months prior to stem cell injection
4. Inability to hold antiplatelet therapy according to treating provider prior to procedure
5. Kellgren \& Lawrence Grade 4 Osteoarthritis
6. Participants with a platelet count less than 100 x 109
7. Participants with a Hemoglobin less than 100 g/L
8. Participants who have an active Infection with fever and/or elevated white blood cell (WBC) count
9. Participants with an active Cancer diagnosis.
10. Participants with autoimmune disorders including rheumatoid arthritis and lupus.
11. Women who are pregnant will be excluded due to the possibility of fetal harm associated with x-rays. Should a participant become pregnant during the study, she will be withdrawn from further treatment and imaging, but can participate in symptom follow-up. Female participants of childbearing potential will be counseled at screening about contraception and encouraged to use birth control for the duration of the study.
12. Participants with allergies to lidocaine, heparin, or epinephrine.
Copy Number Variations, Inflammatory Cytokines and the Risk of Dementia

Assess the association of copy number variation (CNV) and inflammatory cytokine with the risk of dementia.

This is a hospital-based case-control study. We plan to assess the association of CNV and inflammatory cytokine with the risk of dementia. Hopefully to find some genetic biomarkers to identify the risk of dementia at an early stage.

Eligibility Criteria:
Inclusion Criteria:

* hospital recruited dementia patients and controls
Evaluation of the Effect of Chicory Inulin-type Fructans in Constipated Adults

Constipation is common in the general population, especially in women and in the elderly, which can significantly affect quality of life of the individual. There is a general consumer trend to seek natural food options, also when addressing health issues such as constipation. Consumers seek tasty options and there is a paucity of tasty functional foods to address constipation. Adding natural fiber to food, like inulin-type fructans from chicory root fiber, can increase fiber intake and potentially prevent or resolve constipation issues. This study aimed to increase the body of scientific data on inulin-type fructans by way of a randomized, placebo-controlled, cross-over study. Maltodextrin was used as the placebo in this study.


Eligibility Criteria:
Inclusion Criteria:

* Able to give written informed consent
* Between 18 and 75 years of age
* Have functional constipation according to the Rome III Diagnostic Criteria
* Subjects were to continue on their normal diet and agreed to not take probiotic or prebiotic products/supplements and supplemental dietary fibres for the duration of the study
* The subject agrees to complete the Patient Diary for two weeks prior to study entry and for the duration of the study
* Subject is in general good health as determined by the investigator.

Exclusion Criteria:

* Subjects less than 18 and greater than 75 years of age
* Females who are pregnant, lactating or wish to become pregnant during the study.
* Subjects who are hypersensitive to any of the components of the test product,
* Subjects who have an obstructive or metabolic aetiology for constipation,
* Subjects who have a history of laxative abuse (greater than the daily dosage recommended on the label for any laxative),
* Subjects currently taking supplemental dietary fibres or have taken them within two weeks of the screening visit,
* Subjects who are taking a probiotic or prebiotic product/supplement or had taken them within two weeks of the screening visit
Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer

The purpose of this study is to determine if a program of physical activity, nutritional supplements and relaxation techniques is effective at decreasing post operative complications in frail colorectal cancer patients undergoing resection.


Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer patient undergoing resection
* Frail or intermediately frail patients (Fried score 2 and above)

Exclusion Criteria:

* Unable to communicate in French or English
* Premorbid conditions contraindicating physical exercise (dementia, Parkinson Disease, previous stroke with paresis, taking carbidopa/levodopa, donepezil or antidepressants)
Body Fat Distribution and Its Associated Factors in Chinese Women With Polycystic Ovary Syndrome

To investigate the body fat distribution in chinese women with polycystic ovary syndrome (PCOS) and the association of those distribution with metabolic parameters, microeconomics, hormone profiles and psychological state.

The polycystic ovary syndrome (PCOS) is one of the most common endocrine and metabolic disorders in women of reproductive age. It is also one of the leading causes of anovulatory infertility and secondary amenorrhea, which represent major stress factors in the female life. In the previous studies, the investigators found that PCOS patients showed decreased quality-of-life and increased psychological disturbances compared with healthy controls. Body mass index (BMI) was associated with emotional disorders and physical aspects of quality-of-life and negative emotions were negatively correlated with BMI in PCOS patients.These results prompted that PCOS could be separated into at least two subtypes by the fat content. So the investigators expand the epidemiological investigation for comparing the body composition between the PCOS and the normal women, and finding specific biological indicators in different subtypes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 45 years
* For the PCOS group, PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL

Exclusion Criteria:

* Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone \< 3nmol/L) thyroid dysfunction and hyperprolactinemia.
* Type I diabetes or not well controlled type II diabetes
* Stage 2 hypertension (resting blood pressure ≥160/100mmHg)
* Psychiatric diagnoses or using psychiatric medications including antidepressants
* Pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months.

The control group are non- PCOS normal women (age 18-45) and meet the same exclusion criteria.
Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease

The purpose of this trial is to evaluate the effects of a single dose of denufosol versus placebo on mucociliary clearance in patients with mild to moderate CF lung disease


Eligibility Criteria:
Inclusion Criteria:

* have confirmed diagnosis of cystic fibrosis
* have FEV1 of greater than or equal to 60% of predicted normal for age, gender, and height
* be able to reproducibly perform spirometry maneuvers
* be clinically stable for at least 4 weeks prior to screening

Exclusion Criteria:

* have abnormal renal or liver function
* have chest x-ray at screening with abnormalities suggesting clinically significant active pulmonary disease
* have had a lung transplant
Epidural Dexamethasone for Labor Analgesia: the Effects on Ropivacaine Consumption and Labour Outcome

To assess the efficacy of epidural dexamethasone administration, compared to placebo, in reducing local anesthetics consumption during labor epidural analgesia in parturient women

It is hypothesized that reducing the consumption of local anesthetics during labor epidural analgesia could lower their side effects (rate of motor block, nausea and emesis during labor, maternal hypotension, maternal fever) and improve the duration of the second part of the labor, and the new-born adaptation to child-birth and during the first 24 hours. The use of instruments for assisted vaginal delivery and the needs to perform emergency cesarean could also be impacted.

The efficacy of the dexamethasone will be assessed by the hourly Ropivacaine consumption (milligrams/hour) measured from randomization time to the end of epidural analgesia.

Eligibility Criteria:
Inclusion Criteria:

* First and single pregnancy, Full term (\> 37 wks amenorrhea), Cephalic presentation, Spontaneous labor, Epidural analgesia requested by the parturient

Exclusion Criteria:

* Minor patient, Planned cesarean section, Gestational hypertension and preeclampsia, Gestational diabetes, opioids or ocytocin administration before epidural analgesia preparation, Allergy to dexamethasone, Untreated gastroduodenal ulcer, epidural analgesia contraindications
Variation in the Impact of Coffee on the Metabolic Rate

The purpose of this study is to explore variation in the impact of coffee on metabolic rate. The investigators plan to recruit healthy participants, half male and half female.

The investigators will study the variation in the impact of coffee on metabolic rate and investigate the impacts of age, sex, body composition and regularity of habitual coffee consumption on this effect. The investigators will recruit healthy participants, half male and half female. Participants will be required to perform no strenuous exercise for 14 hours and no moderate of vigorous exercise for 2 hours before the measurements. When the participants arrive at the lab on the day of the experiment, they will sign an informed consent form, a health history questionnaire and a daily coffee consumption questionnaire. Participants will be randomly allocated into 3 groups and given 180mls of coffee to consume containing 100, 200 or 300 mg of caffeine. A fourth group will be dosed with 100 mg of caffeine containing 13C uniform labelled caffeine to trace the pattern of caffeine degradation via the appearance of 13CO2 in the breath and labelled compounds in the urine. The primary outcome is the change in resting metabolic rate from before and after coffee drinking. Secondary outcome measures are heart rate, electrocardiogram, blood pressure, body temperature which will be measured before and after the coffee consumption. Professional nurses will take 8ml of venous blood from all participants as genotyping blood samples. Genomic DNA will be extracted from whole blood samples and analysed for single nucleotide polymorphisms (SNPS).

Eligibility Criteria:
Inclusion Criteria:

Healthy adults 18-40 years old

Exclusion Criteria:

Those who have undergone surgery in the past 6 months. People are requiring long-term medication. People have metabolic diseases, like diabetes, hypoglycemia, gout, osteoporosis, etc.

People have digestive diseases, like gastric ulcer, pancreatitis, intestinal obstruction, etc.

Those who have recently lost weight for various medical reasons ( like cancer, etc.).

People are suffering from infectious diseases ( like HIV, etc.). People have blood phobia, pathological hypo or hyper tension. People with impaired glucose tolerance. Those who are afflicted with claustrophobia.