cyrilzakka/clinical-trials huggingface dataset:
The Clinical Study of SHR-9839 for Injection in Patients With Advanced Solid Tumors

This study is an open-label, phase I clinical trial of SHR-9839 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
2. Have at least one measurable tumor lesion per RECIST v1.1;
3. ECOG performance status of 0-1;
4. Life expectancy ≥ 12 weeks;
5. Adequate bone marrow and organ function;
6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Exclusion Criteria:

1. Patients with active central nervous system metastases or meningeal metastases;
2. Received anti-tumor treatment such as chemotherapy, biotherapy, targeted therapy, immunotherapy, radical radiotherapy, or other unlisted clinical research drugs or treatments within 4 weeks prior to the first use of the study drug;
3. History of serious cardiovascular and cerebrovascular diseases;
4. Subjects who received\>30Gy of radiation therapy within 4 weeks before the first medication, and those who received ≤ 30Gy of palliative radiation therapy within 7 days before the first medication;
5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
Obstructive Sleep Apnea in Scleroderma and Pulmonary Involvement

Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. Obstructive sleep apnea (OSA) may also be seen in scleroderma. Less is known regarding the prevalence of OSA in scleroderma and its association with pulmonary involvement.

Scleroderma is an autoimmune disease with skin manifestations and may have pulmonary involvement. OSA may also be seen in scleroderma. Less is known regarding the prevalence of obstructive sleep apnea in scleroderma and its association with pulmonary involvement.

The investigators would like to address the prevalence of OSA in patients with Scleroderma, using overnight cardiorespiratory polygraphy. Other comorbidities and pulmonary findings on computer tomography (CT) as well as lung function tests will be evaluated.

The investigators plan to include 60 patients.

Eligibility Criteria:
Inclusion Criteria:

* Known scleroderma diagnosis
* Must be able to give informed consent

Exclusion Criteria:

* Serious neurological and/or psychiatric disease
First Trimester Screening for Trisomy 21, 18, 13 and 22q11.2 Deletion Syndrome

Combined first-trimester screening represents the gold standard of risk assessment for the presence of trisomy 21, 18, and 13. The concept is based on the age risk, the measurement of fetal nuchal translucency (NT), and the determination of serum markers free beta-hCG and PAPP-A in maternal blood.

In recent years it has been shown that the risk assessment can be improved by combining in-depth ultrasound and cell-free DNA analysis from maternal blood. In their latest study, the investigators were able to detect all fetuses with trisomy 21, 18, and 13 through this procedure. No normal fetus displayed an increased risk. In contrast, the detection rate in classic, combined first-trimester screening is about 95% and the false-positive rate is 3-5%. In this study the investigator examine the test quality - especially the false positives - of cell-free DNA analysis on trisomy 21, 18 and 13 as well as on the microdeletion 22q in 1000 pregnancies.


Eligibility Criteria:
Inclusion Criteria:

* Maternal age of 18 years and more
* Crown rump length 45 - 84mm
* Referral for first trimester risk assessment
* Singleton pregnancy
* Written consent

Exclusion Criteria:

* No consent
* Known parental microdeletion 22q11.2
* Crown rump length \<45mm or \>84mm
* Multiple pregnancies including vanishing twins
Use of Ultrasound in Lower Extremity Blocks.

Nerve "freezing" injections of the leg are very useful in providing anesthesia and pain relief for knee and ankle surgery. However, current nerve "freezing" techniques are "blind". As a result, they are not always successful and may cause complications, albeit infrequent.

The objective of the current study is to determine any advantage in performing these "freezing" injections under direct ultrasound guidance, to "visualize" the nerves. We feel that by developing this technique, it will allow us to perform these procedures with greater success and fewer complications.

This study is a randomised controlled trial. Its objective is to compare results and complications between two techniques of nerve localisation for nerve blocks of the lower limb. We have developed a real-time, image guided approach to nerve blocks of the lower extremities in three locations: the femoral nerve in the groin and the sciatic nerve in the buttock and/or popliteal fossa. We have used ultrasound imaging to locate and asess the nerves of the lower extremities and to use it as a real-time guidance for performance of lower extremity blocks in patients undergoing orthopaedic procedures. The results of our previous study will be presented as a case series reporting anatomical appearance of the nerves studied, time for block performance and success rates. In this study we aim to compare these parambeters between standard and ultrasound techniques of lower extremity block, to show any advantage.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* ASA physical status I-III
* 18-85 years of age, inclusive
* 50-110 kg, inclusive
* 150 cm of height or grater
* Scheduled for elective foot or ankle surgery

Exclusion Criteria:

* Contraindications to sciatic nerve block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the popliteal area)
* Significant peripheral neuropathy or neurologic disorder affecting the lower extremity
* Pregnancy
* Contraindications to, allergies to, and/or past adverse reactions to local anesthetics
* History of alcohol or drug dependency/abuse
Airway Morphology After En-masse Retraction in Bimaxillary Protrusion Patients

This study aims to three-dimensionally assess the changes in the airway morphology after anterior segment retraction using maximum anchorage.

Participants were recruited from the Faculty of Dentistry, Beni-Suef University. All subjects were informed of the treatment procedures and signed a consent form.

Methodology:

The patients were treated by using fixed appliance and extraction of four first premolars. Maximum anchorage was obtained by using miniscrews that were inserted between the maxillary first molars and second premolars. En masse retraction of the upper and lower anterior segments was carried out by using NiTi closed coil springs.

Cone beam computed tomography (CBCT) will be obtained before (T0) and after en masse retraction (T1). CBCT will be used for three-dimensional evaluation of the changes of the airway morphology after en masse retraction of the upper and lower anterior segments with maximum anchorage.

The results will be obtained and statistically evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Class I bimaxillary protrusion requiring extraction of four first premolars and en masse retraction of the anterior segments.
2. Age: 18 - 35 years old.
3. Fair oral hygiene.

Exclusion Criteria:

1. Active periodontal disease.
2. Systemic diseases or medications that alter bone metabolism.
Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

This study will determine whether characteristics of women with Premenstrual Syndrome influence response to treatment with serotonin reuptake inhibitors and whether SRIs can alleviate premenstrual symptoms.

Moderate to severe premenstrual disturbances afflict up to 20 percent of women. Studies have shown the use of serotonin reuptake inhibitors (SRIs) during the luteal phase of the menstrual cycle to be effective in improving symptoms in women with premenstrual dysphoric disorder (PMDD). Unfortunately, SRI treatment has only been evaluated in controlled clinical trials, and evidence suggests that patients in these clinical trials are not representative of women commonly seen in clinical practice. Thus, the real-world feasibility of intermittent dosing is questionable.

Patients in this study receive sertraline (Zoloft) during the luteal phase of their menstrual cycle every month for 6 months. The dose may be modified based on structured interviews with the patients. Assessments include questionnaires and interviews which take place at study start, at midpoint, and at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for Premenstrual syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD)
* For a diagnosis of PMS but not PMDD, patients must have 3 to 4 symptoms, complain of functional impairment as a result of their symptoms, and identify symptoms as problematic enough to warrant treatment
* Symptoms of PMS/PMDD in at least 9 of 12 menstrual cycles during the year prior to screening
* Symptom-free during the follicular phase and impairment during the luteal phase
* Regular menstrual cycles
* Adequate methods of birth control

Exclusion Criteria:

* Major depression, bipolar disorder, or psychotic disorders
* Hepatitis or hepatic failure
* Amenorrhea, oligomenorrhea, blood dyscrasias, or illnesses for which monoamine oxidase inhibitors must be prescribed
* Follicular phase symptoms consistent with a diagnosis of major depression, bipolar disorder, or psychotic disorders
* Co-existing condition that renders the patient unsuitable for the study
* Risk of suicide
* Antidepressants or other psychotropic medication
* Hypersensitivity or adverse reaction to sertraline
* Pregnancy, breast-feeding, or plans to become pregnant during the course of the study
* Depot hormonal preparation or any other medication that would lead to lack of menses or markedly irregular menses
SPECT Study With SB-773812 In Schizophrenic Patients

This study is being conducted in 2 groups of schizophrenic patients: in group 1 the relationship between the dopaminergic D2 receptor occupancy (D2 RO ) and serotoninergic 5HT2A receptor occupancy at stable plasma concentration (Cp) of SB-773812 will be investigated using SPECT scan in up to 15 chronic schizophrenic patients in an open- label design. In group 2 up to 80 patients will receive SB-773812 or Risperidone for 6 weeks to obtain at least 10 patients showing clinical improvement with SB-773812. The relationship of D2 RO, measured at steady state after chronic dosing at Cmax (6+/-2 h) and Ctrough (24+/-4 h), and PK at steady state after repeated doses, to efficacy readouts will be investigated. The SB-773812 dose administered will be selected as the highest dose proven to be safe and well tolerated from a previous study.


Eligibility Criteria:
Inclusion criteria:

* schizophrenic patients as diagnosed by DSM IV criteria.
* In group 2, subject has schizophrenia or schizophreniform disorder and show moderate disease exacerbation, a PANSS score \> 65 and a score in the PANSS positive scale (PANSS-P) =25.
* Women of childbearing potential must agree to acceptable method of birth control.

Exclusion criteria:

* Subject shows severe exacerbation, extreme instability, high risk for suicide or serious violent behaviour.
* Any clinically or laboratory significant abnormality.
* Subjects receiving a radiation dose from other activities of more than 10 mSv over any 3 year period.
* Subjects with organic brain disease and history of severe head trauma.
* Heart pacemaker, metallic prosthesis or other metallic body implants.
* Significant head deformity.
* Smokers with associated COPD.
* History or presence of clinically significant gastro-intestinal, hepatic or renal disease.
* History of cholecystectomy or biliary tract disease.
* Positive for HBV, HCV or HIV.
* Pregnant or lactating women.
Ocular Findings of Polycystic Ovary Syndrome

Purpose: This study aimed to compare the ocular surface disease test results, anterior segment parameters, and ocular response analyzer (ORA) findings of polycystic ovary syndrome (PCOS) patients with those of healthy reproductive age female controls.


Eligibility Criteria:
Inclusion Criteria:

* premenopausal with PCOS

Exclusion Criteria:

* patients with external ocular disease other than dry eye complaints,
* use of topical drops that can affect the tear film layer,
* contact lens use histories,
* those who received hormone therapy for 6 months,
* those who have systemic medication or systemic disease that may affect the tear film layer and reproductive physiology,
* previous eye surgeries,
* smokers and alcohol users,
* those having diseases (Cushing's syndrome or androgen-secreting tumors) causing similar clinical findings.
Opioid Use and Criminal Justice: Intervening to Improve the Outcomes of Women

Opioid-related overdose deaths and incarceration rates have skyrocketed and have disproportionately affected women. Despite having a higher burden of substance use disorders and HIV/AIDS than criminal justice-involved (CJI) men, CJI women are less likely to have access to substance use and HIV treatment. The planned research aims to improve how women in the criminal justice system connect to and stay in drug treatment. This will be done by creating and putting into practice a well-researched program specifically designed for women, considering their experiences with trauma. The program incorporates several best practices in substance use treatment such as the use of Certified Peer Recovery Specialists (CRS) as needed social support, assisting women who do not have stable housing in finding housing, overdose response training, and reducing known barriers to women by assisting with transportation and childcare. In addition, half of the women will be randomly selected to participate in a 12-session trauma support group led by CRS which uses the evidence-based curriculum, Beyond Trauma, which was specifically designed for women who use drugs. The aforementioned components are rarely offered in tandem with substance use treatment, and as such, this research is assessing if having this comprehensive program is linked with better substance use and social outcomes. The overall goal is to reduce the problem of opioid addiction and overdoses among women who have recently been involved in the criminal justice system and to reduce the barriers to opioid addiction treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. 18+ years of age
3. Pennsylvania resident and intends to remain in or near Harrisburg, Carlisle, York or Lancaster areas for the duration of the study
4. Use opioids illicitly
5. Interested in starting drug treatment that uses medication to stop opioid use OR are currently in a drug treatment program for opioid use that uses medication but feel that without additional support they won't be able to continue with the program
6. Not currently pregnant, planning to become pregnant, or breastfeeding during the study period
7. Released from a jail or prison within the past 12 months or have other criminal justice involvement (arrests, probation, or parole) within the past 12 months.

Exclusion Criteria:

1. Not female
2. Under 18 years of age
3. Not a Pennsylvania resident or no intention to remain in or near Harrisburg/Carlisle/York or Lancaster areas for the duration of the study
4. Do not use opioids illicitly
5. Not interested in MOUD to stop opioid use
6. No arrests, probation or parole, nor released from a jail or prison within the past 12 months
7. Pregnant, planning to become pregnant, or breastfeeding during the study period
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.

SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required continued intubation and received surfactants for the prevention or treatment of respiratory distress syndrome (RDS).

Determine the safety and tolerability of SURFAXIN administration in the first weeks of life as a therapeutic approach for prevention of BPD. Determine whether treatment with SURFAXIN during the first two to three weeks of life can decrease the proportion of infants on mechanical ventilation or oxygen or the incidence of death or BPD in VLBW infants when assessed at 28 days of life and 36 weeks post-menstrual age (as determined by the need for supplemental oxygen).

Eligibility Criteria:
Inclusion Criteria:

* Premature infants between 600 and 900 grams birth weight
* Intubated and on mechanical ventilation
* Sustained (\>= 30 minutes) fraction of inspired oxygen (FiO₂) \>= 0.30 within 8 hours prior to randomization

Exclusion Criteria:

* Mother has prolonged rupture of membranes ≥ 2 weeks
* Culture-proven sepsis
* High grade intraventricular hemorrhage (IVH)
* Congenital heart disease
* Congential anomalies inconsistent with life or likely to confound efficacy or safety endpoints
* FiO₂≥ 0.80 and mean airway pressure (MAP) ≥ 12 cmH2O at day of life (DOL) 3
* FiO₂\< 0.25 at any time between meeting the entry criteria to immediately prior to randomization
* Concomitant use of any other surfactant within the first 48 hours of life
* Prior use of nitric oxide
* Prior use of steroids
* Current participation in any other clinical trial or has received an experimental drug or used an experimental device
The Effects of Antecedent Hypoglycemia or Exercise on the Response of the Brain to Subsequent Hypoglycemia

The studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain.

The studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain.

During the past decade many studies have shown that appropriate magnetic resonance imaging (MRI) methods may be used to assess alterations in brain regional activation in response to external stimuli or tasks. Thus, this non-invasive technique will enhance our ability to learn more about brain function, during hypoglycemia and may delineate information about the role of the brain in hypoglycemia associated autonomic dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects aged 18-45
* Type 1 diabetes mellitus patients aged 18-45
* Body Mass Index 21-38 kg/m2
* Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities and an EKG stress test.
* Female volunteers of childbearing potential will undergo HCG pregnancy test. Only women who are not pregnant will participate in the study.

Diabetic Subjects:

* HBA1C= 5.5-11.0%
* Duration of Type 1 Diabetes \> 3 yr
* Normal bedside autonomic function

Exclusion Criteria:

All Subjects

* Prior or current history of poor health
* Abnormal results following screening tests
* Pregnancy
* Subjects unable to give voluntary informed consent
* Subjects with a recent medical illness
* Subjects with a history of hypertension, heart disease or cerebrovascular disease
* Subjects with known liver or kidney disease
* Subjects with recent weight loss or consuming a low carbohydrate diet
* Subjects taking steroids
* Subjects taking beta-blockers
* Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
* Evidence of diabetic neuropathy, autonomic neuropathy, proteinuria, extensive background or proliferative retinopathy, hypertension, or cardiovascular disease
The Effect of Ultrasound on Orthodontic Tooth Movement

To study whether or not the Aevo System™ medical device enhances the rate of tooth movement in human subjects who use orthodontic braces.

The study will involve comparing the effects of tooth movement with and without ultrasound treatment in a split mouth design. Treatment will consist of using the Aevo System™ device for one 20 minute period per day for the duration of the trial (up to 24 weeks). Tooth position measurements will be taken from eligible patients prior to commencing usage of the study device. Follow-up visits will be scheduled for intra-oral clinical measurements and to take full-arch impressions. The Aevo System™ consists of an ultrasound emitting mouthpiece which is wire connected to an external handheld device. The mouthpiece is placed over the teeth and over the braces every day for 20 minutes in order to deliver the therapy.

Eligibility Criteria:
Inclusion Criteria:

Subjects who meet all of the following criteria will qualify for entry into the study:

1. Scheduled to receive orthodontic treatment or in early stage of orthodontic treatment
2. Minimum of 3 mm of extraction space (on both sides of a dental arch) to be closed either by distal movement of all 6 anterior teeth from canine to canine or by distal movement of the canines.
3. Available for follow-up visits.
4. Willing and able to sign written informed consent.
5. Healthy.
6. Has permanent dentition and between the ages of 12 and 40.
7. Good oral hygiene and compliance

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from the study:

1. Any compromised medical or dental condition that prevents the subject from participating in the trial or using the medical device.
2. Any implanted assistive devices.
3. Currently involved in any other study.
4. Lives significantly outside the clinical trial site.
5. Use of bisphosphonates.
6. Pregnant females .