cyrilzakka/clinical-trials huggingface dataset:
Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer

Docetaxel and sunitinib will be compared to docetaxel for their effect on CEC/CEP spikes induced by docetaxel in HRPC patients

Docetaxel (75mg/m2 q21d) is standard of care for patients with hormone refractory prostate cancer (HRPC). Recent data indicate, that chemotherapeutics given at MTD induce, besides their cytotoxic effects, mobilization of circulating endothelial cells (CEC) and - progenitors (CEP) in drug-free breaks of each cycle. In preclinical models, mobilized CEC/CEP result in tumor vasculogenesis and progression of disease.

We hypothesize that treatment with sunitinib, an anti-angiogenic tyrosine kinase inhibitor, in between 3 weekly docetaxel disrupts CEC/CEP spikes following docetaxel leading to chemosensitization and reduced tumor re-growth in HRPC patients responding to docetaxel.

Eligibility Criteria:
Inclusion Criteria:

* WHO performance status of 0-2.
* Histologically proven prostate adenocarcinoma.
* All patients must have prostate adenocarcinoma that is unresponsive or refractory to androgen ablation with biochemical progression
* Measurable and/or evaluable progressive disease, which is defined by one of the following three criteria:

  * 25% increase in bidimensionally measurable soft tissue metastases
  * Appearance of new metastatic lesions (proven by CT scan, X-ray or bone scan)
  * PSA level of at least 10ng/mL, with increases on at least 2 successive occasions at least 2 weeks apart
* If the patient has been treated with antiandrogens, treatment must have been stopped at least 6 weeks prior to study randomization

Exclusion Criteria:

- prior chemotherapy for prostate cancer
Photoacoustic Imaging of the Breast in Patients With Breast Cancer and Healthy Subjects

This trial studies photoacoustic imaging of the breast in patients with breast cancer and healthy subjects. Dense breasts typically reduce the sensitivity of a mammography and also is associated with a higher risk of breast cancer. Photoacoustic tomography combines light and sound to provide more information about breast tissue.

PRIMARY OBJECTIVES:

I. To identify photoacoustic features of breast malignancy and treatment response

OUTLINE:

Participants undergo photoacoustic imaging of the breast over 30 minutes. At subject's discretion, imaging may repeat for a total of 10 studies, each in a separate day.

Eligibility Criteria:
Inclusion Criteria:

* Women with clinically suspicious or confirmed breast cancer masses (that have not been surgically removed) and will/have already undergo/undergone breast magnetic resonance imaging (MRI).

Exclusion Criteria:

* Pregnant women (there are no known risks to these procedures, but any unforeseen risks are as yet undetermined, so pregnant women will be excluded by means of a verbal confirmation at time of screening).
* Women who have had breast implants in the previous 6 months.
* Women who have had lumpectomy
* Adults unable to consent.
* Individuals who are not yet adults (infants, children, teenagers).
* Pregnant women.
* Prisoners.
* There is no direct benefit of the study to any subject either non-English or English speaker. To facilitate the consent process, we will exclude non-English speaking subjects.
Intra-myometrial Vasopressin During Cesarean Section in Placenta Previa

Placenta previa can have serious adverse consequences for the mother, including an increased risk of maternal mobility, antenatal and intrapartum hemorrhage, and the mother may, therefore, require a blood transfusion or even an emergency hysterectomy. Although it is a relatively rare condition with an overall incidence of 0.28-2.0% of all deliveries, it has been suggested that the incidence of placenta previa is increasing. Many gynecological surgeons use a local injection of vasopressin, which is a known peripheral vasoconstrictor, at the time of laparoscopic myomectomy to decrease blood loss. In addition, the useful role for local infiltration of vasopressin to arrest hemorrhage from the placental bed has been demonstrated in several obstetrical case reports. The vasopressin V1α receptor has been demonstrated to be present in the myometrium of both non-pregnant and pregnant women and contributes to myometrial contraction. Therefore, the investigators evaluated the effect of local injection of vasopressin on the blood loss and secondary impact on complications during cesarean section in cases of placenta previa.

The study drug was administered immediately after delivery, as soon as the umbilical cord was clamped. The experimental group received a bolus injection of vasopressin (4 IU) diluted to 2 mL with saline into the myometrium of the placental bed during slow (30-seeconds) Conversely, the placebo group received a 10-mL bolus injection of saline into the myometrium during slow (30-seconds).

Eligibility Criteria:
Inclusion Criteria:

* all pregnant women with a single term fetus scheduled for an elective cesarean section for complete placenta previa and invited them to participate in the study. The placenta previa was defined as a placenta completely covering the cervical os in ultrasound examination

Exclusion Criteria:

* Patients with a cardiac, hepatic, renal or thromboembolic disease.
* patients with the high possibility of the morbid adherent placenta.
* known coagulopathy
* those presented with severe antepartum hemorrhage will be excluded
* hypersensitivity or contraindications of use of vasopressin
* patient refuses to consent
Utility of Renal Biomarkers in Cirrhosis

Evaluation of kidney function is critical in cirrhotic patients as there is a clear relationship between renal failure and prognosis. The investigators hypothesized that in this population new biomarkers of renal function could help in early detection of acute renal failure and in discrimination between renal and pre-renal causes. Finally the investigators hypothesized that such biomarkers could predict short-term outcome in this population.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Known or suspected cirrhosis
* Suspected ascitis
* Informed consent signed

Exclusion Criteria:

* Proven multifocal hepatocellular carcinoma
* Acute gastric hemorrhage (active or \< 2 weeks)
* Known end-stage renal disease or on dialysis before admission
* Recipients of kidney or liver transplants
* Transferred from another institution
Oral Vitamin D2 for Prevention of COVID-19

A total of 218 participants will be included in this study, and will be randomly assigned 1:1 to the group taking vitamin D2 and the group not taking vitamin D2. Participants in the group taking vitamin D2 orally will receive 200,000 IU of vitamin D2 on the first day of the trial, and again two weeks later (200,000 IU) . The group that will not receive vitamin D2 will not receive any intervention. The whole trial will laste four weeks.

This study is a randomized controlled multicenter clinical trial. Participants who meet the inclusion criteria can be included in this trial after signing informed consent. A total of 218 participants will be included in this study, and will be randomly assigned 1:1 to the group taking vitamin D2 and the group not taking vitamin D2. Participants in the group taking vitamin D2 orally will receive 200,000 IU of vitamin D2 on the first day of the trial, and again two weeks later (200,000 IU) . The group that will not receive vitamin D2 will not receive any intervention. The whole trial will laste four weeks. Throughout the trial, participants' nucleic acid or antigen results, 25(OH)D concentrations, etc., need to be tested.

Eligibility Criteria:
Inclusion Criteria:

1. Willing to participate in the clinical study and sign the informed consent;
2. Staff members of Peking University Third Hospital, including the hospital headquarters, Capital International Airport Hospital, North Hospital, Beijing Haidian Hospital, Peking University Third Hospital Yanqing Hospital and Peking University Third Hospital Chongli Hospital;
3. Test negative for COVID-19 antigen and have no symptoms related to COVID-19.

Exclusion Criteria:

1. Hospital staff with serious underlying diseases;
2. Pregnant and lactating women;
3. Long-term vegetarians;
4. Long-term chronic diarrhea, history of subtotal gastrectomy, biliary obstructive disease and pancreatic disease.
Symptomatic Trigeminal Neuralgia Attributed to Multiple Sclerosis - a Prospective Study in 60 Patients

Clinical characteristics, neuroanatomical findings and efficacy of medical and surgical treatment of symptomatic trigeminal neuralgia - a systematic prospective study of 60 consecutive patients

Background Among patients with TN, approximately 15% has secondary TN caused by another underlying condition such as multiple sclerosis or a tumor. Studies of classical TN patients have shown a strong association between a severe NVC of the trigeminal nerve and the painful side. This association has been less investigated in STN.

There are no previous systemic and prospective studies of the underlying causes, characteristics and treatment response of patients with STN. Most existing studies on STN have various methodological drawbacks as inclusion was not prospective, diagnosis was not consistent with international guidelines, imaging techniques were not adequately advanced at the time of publication and evaluation of treatment efficacy was not performed by evaluators independent of the neurosurgeon.

Aims

1) To describe the clinical characteristics, the neuroanatomical findings using 3.0 Tesla MRI, and the efficacy of medical and surgical treatment in STN

Hypotheses

1. In STN, there is a correlation between demylinating brainstem plaques and presence and degree of neurovascular contact of the trigeminal nerve ipsilateral to the painful side
2. The efficacy of medical and surgical treatment of STN is comparable to the efficacy in patients with classical trigeminal neuralgia

Power calculations Sample size depends on the number of patients in the inclusion period. The estimated number of included patients is at least 60 patients.

Methods Data have been collected prospectively since 2012 based on semi-structured interview forms completed at out-patient visits at the Danish Headache Center. The efficacy of medical and surgical treatment was also documented prospectively by structured interviews. Efficacy of surgical treatment was evaluated by independent assessors.

All patients had a 3.0 Tesla MRI with a special protocol adapted for the trigeminal nerve and the brainstem.

Ethical considerations The treatment of patients with STN will not differ from the usual treatment and decision-taking.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of secondary trigeminal neuralgia attributed to multiple sclerosis
Bowel Preparation Quality for Screening Colonoscopy

The study will consist of a prospective observational period performed in the GI Endoscopy Lab. The objective is to document the quality of bowel preps in patients undergoing a screening colonoscopy with and without an educational intervention.

The educational intervention will consist of a 2-3 minute video demonstrating video images of adequate and inadequate bowel preps, and reviewing instructions for split dose prep administration. This video will be posted on YouTube. Group 1 will consist of 30 subjects who will be instructed to view this video prior to beginning their colonoscopy preparation. Information to access the YouTube video will be provided to the patients by endoscopy nurse assessment staff when contacting the patients as per standard practice to review appointment scheduling and procedure-day logistics. Group 2 will consist of 30 subjects who will not receive instructions to view the video.

Nursing staff will be asked to grade bowel preps according to the Boston Bowel Preparation Scale (BBPS), a validated and reliable instrument for assessing quality of bowel preparation \[6\]. Using the BBPS, a four point scoring system is applied to each of the three broad regions of the colon: the right side of the colon (including the cecum and ascending colon), the transverse section of the colon (including the hepatic and splenic flexures), and the left side of the colon (including the descending colon, sigmoid colon, and rectum). The points are assigned as follows: (0), unprepared colon segment, (1), portion of the mucosa of the colon segment seen, (2), minor amount of residual staining, (3), entire mucosa of colon segment seen well. The three segment scores are then summed for a total BBPS score, which ranges from 0 to 9. The maximum BBPS score for a perfectly clean colon without any residual liquid is 9, and the minimum BBPS score for an unprepared colon is 0. The endoscopy nurse who is in the procedure room will be scoring the bowel preparation. This protocol has been employed previously in the VUMC Endoscopy Lab and the endoscopy nurses at Vanderbilt have completed a detailed in-service training session on using the BBPS scoring system. Prior to initiation of this current study protocol, the endoscopy nurses will have a BBPS scoring system review session to ensure continued reliable and valid BBPS scores. The endoscopy nurses will be blinded to whether the patient viewed the video or not.

Eligibility Criteria:
Inclusion Criteria:

* Elective outpatient procedures performed for diagnostic purposes:

  * screening colonoscopy
  * surveillance colonoscopy

Exclusion Criteria:

* Colonoscopy for diagnosis/therapy of acute gastrointestinal hemorrhage or for planned therapeutic intervention
* Colonoscopy performed on hospital inpatients
CLBR Per Initial Cycle With Different Starting Dose in Aged Patients With Poor Ovarian Reservation: 300IU Versus 150IU

Among aged patients with poor ovarian reservation(defined as age 35 to 42 years; antral follicle count（AFC）≤ 5 or anti-mullerian hormone（AMH）≤ 1.2 ng/ml), cumulative live birth rate(CLBR) and time to live birth(TTLB) of the first stimulation cycle were compared between a starting dose of 300IU or 150IU rFSH in controlled ovarian stimulation with gonadotropin-releasing hormone（GnRH）antagonist protocol. This study is a prospective randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

1. Age Limits≥35 and≤42；
2. AFC≤5 or AMH≤1.2ng/ml；
3. BMI≤30kg/m2；
4. The first IVF/intracytoplasmic sperm injection （ICSI） cycle；

Exclusion Criteria:

1. Any other underlying disease or condition considered IVF is contraindicated.
2. Ovarian hyperstimulation syndrome（PCOS）, moderate or severe intrauterine adhesion，untreated hydrosalpinx, adenomyosis， any myoma in cases that endometrium was affected, intramural larger than 4cm.
3. Autoimmune antibody positive, untreated.
4. History of recurrent miscarriages.
5. Patients seeking for Preimplantation Genetic Testing(PGT) treatment.
6. Simultaneous participation in another clinical study.
7. According to the judgment of the investigator, any reason or condition that precludes subject for participating in the study.
Effects of Urban Afforestation Activity on Mental Health

This single-group pretest-posttest clinical trial aims to evaluate the effects of a single-session afforestation activity on affect and vitality levels in a sample of young adults.

The participants will perform an afforestation activity for a single session of 90 minutes. The therapists will direct the participants' attention to the visual, auditory, olfactory, and tactile features of the surrounding environment.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 and 65 years.
* Any sex and gender.

Exclusion Criteria:

* Intake of any psychotropic medication.
* Other severe or medically unstable diseases that may interfere with participation.
* Severe cognitive impairment (Mini-Mental State Examination score \< 17 out of 30 points).
* Severe mental disorders in the acute phase or symptomatic phase.
* Severe intellectual disability.
* Behavioural alterations as this may interfere with their participation.
Dose-finding Study: Popliteal Sciatic Nerve Block in Patients Undergoing Diabetic Foot Surgery

The purpose of this study was to determine the minimum effective dose of a local anesthetic for proper anesthesia for popliteal sciatic nerve block under ultrasound guidance in patients undergoing surgery for diabetic foot disease.

Unlike general patients, patients with diabetic foot disease often have diabetic neuropathy and thus have increased sensitivity to local anesthetics. Therefore, when performing sciatic nerve block, it is essential to properly adjust the dose to prevent neurotoxicity and delay in recovery due to local anesthetics.

If the appropriate effective dose of local anesthetic for sciatic nerve block is found in patients with diabetic foot through this study, it is expected that it will be a useful basis for establishing a safe anesthetic method in the case of diabetic foot surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who can be operated under popliteal sciatic nerve block among patients undergoing surgery for diabetic foot disease

Exclusion Criteria:

1. Infection of the popliteal region
2. Severe coagulation abnormality
3. Allergic reaction or hypersensitivity to local anesthetics
4. Neurological abnormalities other than diabetic neuropathy in the lower extremity of the operation site
5. When it is impossible to evaluate sensory blockage and motor blockage
6. When the patient refuses
The Effect of Hot Application on Post Laparoscopic Shoulder Pain and Analgesic Use

The aim of this study; To evaluate the effect of hot application on postlaparoscopic shoulder pain and analgesic use in patients undergoing upper laparoscopic surgery in general surgery.

Among the advantages of laparoscopic surgery; smaller incisions, less postoperative pain, less need for analgesia, shorter hospital stay, earlier return to normal activities and lower morbidity. However, laparoscopic surgery is associated with postoperative shoulder pain, which is rarely seen in open surgeries. The precise mechanism of postlaparoscopic shoulder pain (PLOA) is unclear, but it is believed that the carbon dioxide remaining after laparoscopic surgery causes shoulder pain by causing irritation of the phrenic nerve. In some cases, PLOA may cause more discomfort to the patient than incisional pain.

Hot application is an effective method used to relieve pain. Hot application activates the gate control mechanism, stimulating tactile receptors, reducing ischemic pain with vasodilation, removing metabolic wastes, increasing the release of endorphins, eliminating muscle spasm, reducing effects such as pressure, stretching and hypoxia on nerve endings as a result of changes in the viscoelastic properties of tissues, raising the pain threshold, It reduces or relieves pain by sedating and creating relief in the patient.

Hot application is easy to use, inexpensive, requires no prior application, and has minimal adverse side effects when used correctly. Heat sources include a hot water heater, an electric heating pad, a warm blanket, and a warm bath or shower. In addition to being used as a pain reliever, heat is used to relieve chills or shivering, reduce joint stiffness, reduce muscle spasm, and increase connective tissue extensibility.

In the study of Mohamed et al., in which they examined the effect of hot application and early mobilization on shoulder pain, in the experimental group patients who received hot application; Postoperative shoulder pain was found to be significantly less than the control group at different evaluation times at 4 hours after surgery and at 6, 12 and 24 hours (p\<0.001).

Eligibility Criteria:
Inclusion Criteria:

1. Agreeing to participate in the research,
2. Having undergone laparoscopic abdominal surgery
3. Those who have no previous history of surgery

Exclusion Criteria:

1. Those who did not agree to participate in the research
2. Those who have had previous abdominal surgery
Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia

To evaluate the safety and efficacy profile of different treatment regimens of Ruxolitinib (INCB018424) administered to two groups of patients; those with polycythemia vera (PV) and those with essential thrombocythemia (ET). Patients in each group were refractory to hydroxyurea or for whom hydroxyurea is contraindicated.

The study consisted of a 2-stage design, which included a dose-ranging phase (during which patients received treatment at their randomized dose) and an expansion phase (after adjustment of dose/regimen to achieve an optimal balance of efficacy and safety). During the dose-ranging phase, patients in each disease group (PV or ET) were randomly assigned in a 1:1:1 ratio independent of each other to receive 1 of 3 treatment regimens with Ruxolitinib, 10 mg twice daily (bid), 25 mg bid, or 50 mg once daily (qd). After patients completed 2 cycles of treatment with Ruxolitinib at the randomized dose, Investigators were permitted to adjust the dose/regimen on an individual basis using their discretion in order to achieve an optimal balance of efficacy and safety. During the expansion phase (ie, after optimization of dose), additional patients with PV or ET were enrolled to receive Ruxolitinib at the dose that was selected upon review of data from the dose-ranging phase. Treatment continued until a patient met a withdrawal criterion, had intolerable toxicity, progression of disease, or withdrew consent.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of polycythemia vera or essential thrombocythemia as determined by treating physician
* Disease refractory to hydroxyurea or for whom treatment with hydroxyurea is contraindicated or have refused further treatment with hydroxyurea due to side effects.
* Patient meets baseline clinical lab parameters

Exclusion Criteria:

* Treatment with interferon alpha or anagrelide within 7 days and hydroxyurea within 1 day of starting INCB018424.
* Patients diagnosed with another malignancy unless the malignancy was cervical intraepithelial neoplasia or basal or squamous cell skin cancer and the patient has been disease free for \> 3 years
* Patients receiving therapy with intermediate or high dose steroids greater than the equivalent of 10 mg prednisone per day
* Clinically significant cardiac disease (New York Heart Association (NYHA) Class III or IV)
Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)

The aim of the study is to compare the effects of oral roflumilast with placebo on lung function in patients with asthma.


Eligibility Criteria:
Main Inclusion Criteria:

* Persistent bronchial asthma
* No change in asthma treatment within 4 weeks prior to visit 1
* Non-smoker or ex-smoker (for 12 months or longer)

Main Exclusion Criteria:

* Poorly controlled asthma or seasonal asthma
* History of lower airway infection four weeks prior to visit 1
* Chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease
* Patients using \> 8-puffs/day-short-acting bronchodilator (beta-agonists) (more than 3 days per week on average) prior to visit 1
* Clinically relevant abnormal laboratory values suggesting an undiagnosed disease, severe renal insufficiency, active hepatitis or an HIV infection
* Diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
* Patients with chronic heart failure
* Suspected hypersensitivity and/or contraindication to roflumilast or albuterol/salbutamol
* Female patients of childbearing potential not using adequate means of birth control or pregnant or breast-feeding females
* Patients who have received any investigational medication or device in the month prior to visit 1 or who plan to use another investigational medication during the study