cyrilzakka/clinical-trials huggingface dataset:
To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference

To investigate the efficacy and safety of a single injection of GenSci094 to induce multi-follicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of GenSci094 is non-inferior to daily treatment with recFSH in initiating multi-follicular growth.


Eligibility Criteria:
Inclusion Criteria:

* Females of couples with an indication for Controlled Ovarian Stimulation (COS) and in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI);
* \>=20 and \<40 years of age at the time of signing informed consent;
* Body weight \>=50 kg and body mass index (BMI) \>=18 and \<=28 kg/m\^2;
* AMH\<4.0 and\>=1.1μg/L FSH\<10 IU/L
* Willing and able to sign informed consent.

Exclusion Criteria:

* History of ovarian hyper-response or ovarian hyperstimulation syndrome (OHSS);
* History of/or current polycystic ovary syndrome (PCOS);
* More than 20 basal antral follicles \<11 mm (both ovaries combined) as measured on ultrasound scan (USS) in the early follicular phase (menstrual cycle day 2-4);
* Presence of unilateral or bilateral hydrosalphinx (visible on USS);
* Presence of any clinically relevant pathology affecting the uterine cavity or fibroids \>4 cm;
* More than three unsuccessful IVF cycles since the last established ongoing pregnancy (if applicable);
* History of non- or low ovarian response to FSH/ human menopausal gonadotropin (hMG) treatment;
* History of recurrent miscarriage (3 or more, even when unexplained);
* Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase;
* Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
* Recent history of/or current epilepsy, human immunodeficiency virus (HIV) infection, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease;
* Use of hormonal preparations within 1 month prior to randomization;
* Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol;
* Administration of investigational drugs within three months prior to signing informed consent.
Progestin-induced Endometrial Shedding in PCOS (The PIES in PCOS Study)

Progestin-induced endometrial shedding (PIES) followed by clomiphene citrate is fertility treatment of choice in anovulatory women with polycystic ovary syndrome (PCOS). However, some preliminary data suggest that skipping PIES could result in a higher live birth rate. The investigators are performing the first randomized controlled trial to find out if skipping the use of progestin during fertility treatment of anovulatory PCOS women is associated with improved pregnancy and live birth rates compared to the traditional approach of using progestin prior to use of clomiphene citrate.

This is a prospective randomized trial of clomiphene citrate (CC) preceded by progestin-induced endometrial shedding (PIES) vs CC without PIES in the treatment of infertility in patients with PCOS, for up to 5 treatment cycles.

Participants will be randomized to receive either progestin followed by CC starting on day 3 of the induced menses, or CC without induced menses. Study participants will be monitored at regular 2 to 4 wks intervals for response to medication using ultrasound and hormonal parameters. The maximum dose of CC will not exceed 750 mg/cycle. Treatment will not exceed 5 ovulatory cycles. Participants who are resistant to 150 mg of CC will exit the study.

170 anovulatory PCOS women actively seeking pregnancy, aged 18 through 40 years will be enrolled and randomized in a 1:1 treatment ratio into the two study arms. Anovulation will be the only infertility factor in all patients.

Eligibility Criteria:
Inclusion

* Women aged 18 - 40, desiring pregnancy
* Established diagnosis of PCOS confirmed by the Rotterdam criteria
* Oligo or anovulatory, with menstrual cycles \> 35 days apart or less than 9 menstrual cycles per year
* Normal vaginal ultrasound with endometrial stripe \< 12 mm
* Normal thyroid stimulating hormone (TSH) within past one year
* Normal prolactin (PRL) within past one year
* For women with previous successful Clomid treatment, a washout period of at least 2 months is required

Exclusion

* Regular menstrual cycles occurring less than 35 days apart
* Evidence of other infertility factors such as endometriosis, tubal factor or male infertility
* Prior unsuccessful Clomiphene citrate ovulation cycles
* Abnormal vaginal ultrasound findings such as endometrial polyps, submucous myomas, synechiae
* Uterine anomaly such as unicornuate or bicornuate uterus
* Presence of hydrosalpinx
* Evidence of active endocrinopathy, such as thyroid disorder or hyperprolactinemia
* Partner with abnormal semen analysis (count \< 15 million sperm /ml)
Androgen Effects in HIV-infected Women

Androgen deficiency in HIV-infected women is associated with sarcopenia and may cause critical reductions in physical functioning and reduced bone density. The effects of long-term androgen therapy on lean body mass, bone density and other clinical endpoints including quality of life, functional status and neurocognitive function in HIV-infected women are not known.

We will perform an 18-month randomized, double-blinded, placebo-controlled study among relatively androgen deficient women with HIV, to determine the effects of testosterone administration on lean body mass. The administered dose will be 300 micrograms twice a week vs. identical placebo in the form of a transdermal preparation. Secondary endpoints include effects on bone density, quality of life, neurocognitive function and menstrual function. Open label administration at 300 micrograms twice a week will be initiated for 12 months in all subjects following the randomized portion of the study. Assuming a 15% dropout rate and 25 randomized patients, the probability is 80 percent that the study will detect a treatment difference at a two sided 5.000 percent significance level, if the true difference between the treatments is 2.7 kg. This is based on the assumption that the standard deviation of the response variable, lean body mass by DEXA, is 2.3 kg, as was shown by Choi et al1 over 12 weeks in HIV-infected women at the same dose of 300 ug 2x/week.

Eligibility Criteria:
Inclusion Criteria:

* Female 18 - 55
* BMI less than or equal to 26
* HIV-infected
* Androgen deficient, with free testosterone \< 3 pg/mL
* Stable antiretroviral regimen for 3 months prior to study
* Tubal ligation, hysterectomy, or verbalized understanding of appropriate barrier contraception methods. Subjects will be counseled in appropriate barrier contraception methods and the counseling will be documented.

Exclusion Criteria:

* Use of anabolic agent, including testosterone, GH or other preparations within 3 months of the study.
* Use of megestrol acetate within 3 months of the study
* Use of estrogen or any preparation known to affect bone density or bone turnover.This includes oral contraceptives, depo provera or combined progesterone-estrogen injections, and transdermal contraceptive patches.
* Pregnant or breast-feeding
* Hgb \< 9.0 mg/dL
* Current participation in another research study conducted by this investigator or past participation in the DHEA study funded by the same grant as this protocol.
* Creatinine \> 1.5 mg/dL
Immune and Endocrine Function in Post-Traumatic Stress Disorder

This is a study investigating immune function and relationships to the hypothalamic-pituitary-adrenal (HPA) axis in Post-traumatic stress disorder (PTSD) compared to controls without PTSD. The study involves 99 adult veterans and civilian subjects over a 3 year period. The study involves measuring immune and neuroendocrine parameters from blood samples obtained before and after a dexamethasone suppression test. The aim of the study is to determine whether immune alterations exist in PTSD and whether the immune-HPA axis interactions in this disorder are different from non-PTSD subjects with the future aim of studying whether immune dysregulation in PTSD may be linked to the increased risk for medical and psychiatric comorbidity in this population.

The subjects undergo a thorough medical (physical and blood/urine tests) and psychiatric evaluation to determine eligibility after signed informed consent is obtained. If eligible, the subject will complete questionnaires and undergo structured clinical interviews with a study psychiatrist. The subject will then undergo a 2-day testing period during which time, blood is drawn each morning at 8 am, with the subject taking 0.5 mg of dexamethasone (a synthetic steroid) at 11 pm prior to the second day of blood testing. About 80 ml of blood will be drawn on each morning. The blood collected will then be assayed for cortisol dexamethasone, lymphocyte glucocorticoid receptor levels; cytokine levels in plasma and lipopolysaccharide stimulated and unstimulated whole blood (IL-2, sIL-2R, IL-6, sIL-6R, and IL-10); lymphocyte subsets (T helper and suppressor, B, and Natural Killer cell numbers), and antigen stimulation responses to tetanus and candida. In addition, blood from the first day of testing will undergo ex vivo challenge with dexamethasone at varying concentrations to determine differential cytokine sensitivities to steroid exposure in subjects.

Eligibility Criteria:
* Subjects with DSM-IV criteria of PTSD and control subjects without any Axis I diagnosis, both groups of subjects are not on any psychotropic medications or medications that could interfere with the biological results, and do not have unstabilized medical conditions or neuroendocrine or immune disorders;
* Do not have comorbid psychosis, bipolar disorder, or substance use disorders;
* Have the capacity to give written informed consent;
* Do not have abnormalities on medical evaluation/physical examination;
* Are not a danger to self or others;
* Women subjects are not pregnant or lactacting, and use a safe form of contraception with a negative pregnancy test.
Comparison Between Return and Wastage of Your Own Blood, Collected During Spinal Surgery, for Verification of Safety When Returning Blood

The study is an open, randomized, controlled, single-centre study including a total of 42 evaluable subjects scheduled for spinal surgery with an approximate expected bleeding of 800-1500 ml. The Sangvia® Blood Salvage System will be set up for all subjects to collect blood intra-operatively. When the transfusion bag is filled, i.e. when around 500 ml of blood has been collected, the subject will be randomized to either be retransfused with the blood collected (investigational group) or not (control group). The primary objective for this study is to investigate the blood quality and isolate the systemic effects in intra-operatively collected blood. The systemic p-Hb concentration has been chosen as the primary outcome variable based on previous experience and literature and is considered as the major safety concern for the study subjects.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent.
* Male and female subjects aged 18 years and over subjected to spinal surgery with an approximate expected bleeding of 800-1500 ml.
* Subjects classified as ASA Physical Status Classification System class P1, P2 or P3 according to the American Society of Anaesthesiology.

Exclusion Criteria:

* Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site).
* Previous enrolment or randomisation of treatment in the present study.
* Participation in another clinical study, that may interfere with the present study.
* Severe non-compliance to protocol as judged by the investigator and/or Astra Tech.
* Haemophilia.
* Hyperkalemia (i.e. values above the normal reference values at study site).
* Symptoms of impaired renal function including creatinine clearance levels (using the Cockcroft-Gault formula) \<30 ml/min.
* Malignancy in the area of the operative site.
* Current or expected use of cytotoxic drugs.
* Symptoms of systemic infection or local infection in the operation field.
* Pregnancy.
* Sickle cell anaemia and/or pre-operative Hb concentration \<11 g/dl (6,8 mmol/l).
* Use of recombinant erythropoietin (EPO) or fibrin sealant.
* Use of other autologous blood transfusion than with the Sangvia® system (e.g. CellSaver and pre-donation) or other blood saving techniques (e.g. normovolemic hemodilution).
* Hypotensive anesthesia.
* Use of antithrombotic medication within 5 days of surgery (NSAID, Clopidogrel).
Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial

The object of this study is to evaluate the superiority of aprepitant therapy with a 5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a 5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first course chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥20 years old
* Sex: Not specified
* Patients with colon/rectal cancer who first underwent FOLFOX, XELOX or SOX regimen including oxaliplatin at ≥85 mg/m2 (naive patient), or those who had already started chemotherapy and had nausea of Grade 2 or higher in the last course or an earlier course (non-naive patient).
* Stage: not specified (neoadjuvant/adjuvant chemotherapy, advanced or recurrent type are allowed)
* Combination of molecular targeted therapy: allowable
* Written informed consent for participation in the study.

Exclusion Criteria:

* Severe liver or kidney disease
* Nausea/vomiting within 24 hr prior to chemotherapy.
* Treatment with antiemetics within 24 hr prior to chemotherapy.
* Presence of factors causing nausea/vomiting other than chemotherapy (e.g. brain tumor, gastrointestinal obstruction, active peptic ulcer disease, brain metastasis)
* Presence of a disease precluding 3-day administration of dexamethasone (e.g. uncontrollable diabetes)
* Pregnant or lactating women, women who plan to become pregnant.
* Current treatment with pimozide.
* Any patient judged to be inappropriate for the study by the investigator.
Trial of a Video Game Intervention to Recalibrate Physician Heuristics: A Followup Study

The objective of this study is to measure the duration of two different types of interventions to change physician decision making in trauma triage: a video game and an educational program.

Treatment at trauma centers improves outcomes for patients with moderate-to-severe injuries. Accordingly, professional organizations, state authorities, and the federal government have endorsed the systematic triage and transfer of these patients to trauma centers either directly from the field or after evaluation at a non-trauma center. Nonetheless, between 30 to 40% of patients with moderate-to-severe injuries still only receive treatment at non-trauma centers, so-called under-triage. Most of this under-triage occurs because of physician decisions (rather than first-responder decisions). Existing efforts to change physician decision making focus primarily on knowledge of clinical practice guidelines and attitudes towards the guidelines. These strategies ignores the growing consensus that decision making reflects both knowledge as well as intuitive judgments (heuristics). Heuristics, mental short cuts based on pattern recognition, drive the majority of decision making. The investigators developed an adventure video game (Night Shift) to serve as a novel method of recalibrating physician heuristics in trauma triage and compared its efficacy with a standard educational program. This study is designed to measure the degradation of the treatment effect.

Eligibility Criteria:
Inclusion Criteria:

* Physicians who care for adult patients in the Emergency Department.
* Physicians who work at a non-trauma center.
* Physicians who work at a Level III/IV trauma center.

Exclusion Criteria:

* Physicians who work only at a Level I/II trauma center.
* Physicians who do not practice in the US.
A Clinical Study of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

This is a phase 1/2 multicenter, open-label, first-in-human study of IBI130. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI130, plan to enroll 20\~182 subjects,and a phase 2 to explore efficacy, safety and tolerability of IBI130 at RP2D in specified types of solid tumor.Approximately 150 evaluable subjects will be enrolled for phase 2.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
2. Male or female subjects ≥ 18 years old;
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
4. Anticipated life expectancy of ≥ 12 weeks;
5. Adequate bone marrow and organ function

Exclusion Criteria:

1. Enrolled in any other interventional clinical research except unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study;
2. Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter;
3. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study;
4. Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study;
Triphasic Osteochondral Scaffold for the Treatment of the OCD of the Knee: Observational Study

The objective of the present study is to evaluate the clinical results of reconstructive treatment of knee OCD defects treated with osteochondral scaffolds implanted with specific instrumentation.The evaluation will be performed through clinical, subjective and objective assessments.

30 patients affected by OCD of the knee will be included in observational, perspective, monocentric trial. Patients will undergo clinical follow-up visits and administration of questionnaires before surgery and at 6, 12, 24 and 60 months after surgery. A CRF (Case Report Form) related to the patient's specific evaluation will be completed for each visit. Patients will also have imaging (MRI) examinations before surgery and at 12, 24 and 60 months after surgery as per normal clinical practice. Evaluation of the quality of cartilage repair will be assessed by specific MRI radiographic scores.

Eligibility Criteria:
Inclusion Criteria

* Male or female patients, aged 15-40 years;
* Single symptomatic osteochondral injury from OCD classified as ICRS OCD III or IV at the level of the femoral condyles;
* Failure of conservative treatment
* Lesion size between 1 and 10 cm2;
* BMI ≤ 30;
* Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up.

Exclusion Criteria:

* -Additional grade III or IV cartilage injury on the knee being treated;
* Advanced osteoarthritis
* Systemic or localized infection
* Systemic (e.g. rheumatoid arthritis) or local (e.g. synovitis) inflammatory diseases and cardiovascular diseases
* Immune system disorders
* Degenerative or vascular bone pathology (e.g. osteonecrosis)
* Coagulation disorders
* Systemic conditions that alter wound healing
* Established allergy to equine collagen and calcium phosphate salts
* Presence of ligamentous/patellofemoral instability/malignment, varus or valgus malalignment ≤ 3° that cannot be treated/corrected simultaneously;
* Previous tendon repair, ligamentous reconstruction, or realignment procedures within the past 12 months;
* Presence of any known human immunodeficiency virus, hepatitis, syphilis, malignant neoplasms and ongoing anti-neoplastic chemotherapy and radiation treatment; Uncontrolled diabetes; Uncontrolled thyroid function changes; Uncontrolled metabolic disorders; Renal disease and hypercalcemia
* Uncooperative patients, including those with a history of alcohol and drug abuse; Participation in another clinical trial or medical device trial that clinically interferes with the present pilot study;
* Incapacitated patients;
* Pregnant or lactating women. In particular, in the case of a suspected pregnancy in a patient of childbearing age, this will be excluded by serological testing (hCG).
the Research of Analgesia and Sedation Effect of Remifentanil on ICU Short Operation

Remifentanil is one kind of opiates with strong analgesic effect,which has the rapid onset and short lasting duration. Remifentanil usually is used to help reducing the pain of patients with mechanical ventilation in ICU. Maybe it can also be used to ease the pain in ICU small short time operation.The purpose of this study is to determine (1) whether remifentanil is effective in small short time operations in ICU or not, (2) the save range of remifentanil in small short time operations in ICU, (3) and the adverse reaction that happens in these operations.


Eligibility Criteria:
Inclusion Criteria:

* critically ill patients need endotracheal intubation
* tracheotomy
* central venous puncture
* pleural puncture
* abdominal puncture
* lumbar puncture
* bone marrow puncture
* fiber bronchoscopic examination
* other small short-time operations

Exclusion Criteria:

* patients allergic to opioids
* in pregnancy or in feeding
* with myasthenia gravis
* with hypovolemia,
* take monoamine oxidase inhibitor(MAOI) in 14days
* in coma and GCS\<8
* with bradycardia or hypotension
Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer

A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC) cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences based on histologic type. The investigators want to research some biomarkers that can predict clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Chemotherapy-naive patients with histologically or cytologically confirmed adenocarcinoma and large-cell carcinoma, classified as stage IIIB not amenable to curative treatment or stage IV
2. With at least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors;
3. with an Eastern CooperativeOncology Group performance status of 0 or 1,
4. At least 18 years of age
5. adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula.
6. Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment
7. patients had fully recovered from its acute effects.

Exclusion Criteria:

1. peripheral neuropathy \> National Cancer Institute Common Toxicity Criteria grade 1
2. progressive brain metastases,
3. uncontrolled third-space fluid retention before study entry.
4. Patients unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids.