cyrilzakka/clinical-trials huggingface dataset:
Cryotherapy in Treating Patients With Primary Stage I Non-Small Cell Lung Cancer or Lung Metastasis

RATIONALE: Cryotherapy kills tumor cells by freezing them. Giving cryotherapy before surgery may kill more tumor cells.

PURPOSE: This phase I trial is studying how well cryotherapy works in treating patients with primary stage I non-small cell lung cancer or lung metastasis.

OBJECTIVES:

Primary

* Evaluate the histologic result of treating patients with primary stage I non-small cell lung cancer or lung metastasis after neoadjuvant percutaneous cryotherapy (PTC).

Secondary

* Provide a qualitative assessment of the histology from the ablation and tumor margins, comparing histologic observations with imaging-enhancement patterns by CT or PET scan before and after PTC.

OUTLINE: Patients undergo CT-guided percutaneous cryotherapy (PTC) over 2 hours. Approximately 3 weeks after completion of PTC, patients undergo thoracotomy consisting of lobectomy of the primary lung cancer or wedge resection with adequate margin for the metastatic lesion, and mediastinal lymph node dissection.

Tissue samples from ablation and tumor margins are collected during thoracotomy and compared with imaging-enhanced patterns of CT or PET scans taken at baseline and after PTC.

After completion of study therapy, patients are followed periodically for 6 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed (by percutaneous transthoracic needle biopsy or transbronchial biopsy) diagnosis of 1 the following:

  * Non-small cell lung carcinoma

    * Stage I disease
    * Primary disease
    * No primary lung metastatic disease, satellite lesions of the chest, mediastinal lymph nodes \> 1.5 cm, hepatic or adrenal masses by the PET scan or the CT scan
  * Metastatic cancer to the lung

    * Must have a definitive cancer diagnosis with the primary tumor under local control and no metastatic disease other than to the lung
    * Solitary or multiple (≤ 3) peripheral lung lesions
    * No chemotherapy since the new metastatic lesion appeared
* Measurable disease, defined as 1 lesion unidimensionally measured ≤ 3.0 cm by conventional CT scan techniques
* Must be registered with the Clinical Trials office at the Karmanos Cancer Center/Wayne State University
* Must be a candidate for a thoracotomy
* No evidence of cerebral disease or metastatic disease of the brain

PATIENT CHARACTERISTICS:

* Neutrophil count \> 1,500/mm\^3
* Platelet count \> 75,000/mm\^3
* PT and PTT normal
* FEV_1 \> 1.0 L/sec
* Diffusing capacity ≥ 30%
* Not pregnant or nursing
* No other uncontrolled or concurrent illnesses including, but not limited to, any of the following conditions:

  * Active infection
  * Heart failure
  * Unstable angina
  * Cardiac dysrhythmia
  * Psychiatric illness or a social situation that would limit compliance with the study requirements

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior radiation therapy or chemotherapy for these particular tumors
* No concurrent aspirin or other platelet-inhibiting drugs (e.g., coumadin or heparin)
* No other concurrent experimental studies
Evaluation of the Alife Hera System as an Adjunctive Tool for the Prioritization of Embryos Deemed Suitable for Transfer

To evaluate the clinical pregnancy rate (pregnancy defined as fetal heartbeat at 6-8 weeks) with the adjunctive use of the Hera System (Hera System used with traditional morphological grading) with embryos already deemed suitable for transfer compared to trained embryologists using standard morphology criteria alone.

To evaluate the clinical pregnancy rate (pregnancy defined as fetal heartbeat at 6-8 weeks) with the adjunctive use of the Hera System (Hera System used with traditional morphological grading) with embryos already deemed suitable for transfer compared to trained embryologists using standard morphology criteria alone.

To evaluate the performance and utilization of the Hera System as an adjunctive embryo grading and prioritization tool in an embryology lab setting with trained embryologists.

Eligibility Criteria:
Inclusion Criteria:

1. \>21 and \< 43 years of age
2. Women undergoing in vitro fertilization treatment using their own eggs
3. At least 8 eggs retrieved
4. Fertilization using only ejaculated sperm including donor sperm (fresh or frozen)
5. Single embryo transfer (SET)
6. Willing to comply with study protocol and procedures and be able to speak English
7. Willing to provide written informed consent

Exclusion Criteria:

1. Gestational carriers
2. Use of re-inseminated eggs
3. Use of donor eggs
4. History of cancer
5. Fertilization using surgically removed sperm
6. Transfer of multiple (more than one) embryos at once
7. Participants undergoing IVF with intent to bank embryos (i.e. no intention of embryo transfer for at least 6 months following egg retrieval)
8. Concurrent participation in another clinical study that might interfere with the study results in either study
Perioperative Hemodynamic Optimization Using the NICOM Device

In the last years, there is a growing interest in the improvement of prognosis and shortening of hospital length of stay in high-risk surgical patients. Several evidence-based protocols ("fast-track" surgery) have been developed and implemented in some hospitals for this purpose. Cardiovascular optimization through the so-called "goal-directed therapy" (GDT) is a key element in these protocols. Previous studies in the literature use invasive monitors to assess hemodynamics. The NICOM ™ is a non-invasive monitor validated in several clinical scenarios. The aim of the present randomized, international, multi-center, open-label clinical trial is to use a GDT protocol (including colloid boluses and vasoactive drug infusion) based on data obtained from the NICOM™ device (cardiac index and mean arterial pressure) to test the hypothesis that GDT is superior to standard practice in terms of reduction in the incidence of perioperative complications and length of hospital stay in high-risk major abdominal surgery patients (requiring ICU surveillance for, at least, 24 hours). As secondary objectives, time to first flatus, wound infection, anastomotic leaks and mortality will be analysed. All patients will be followed from the day of surgery up to hospital discharge (determined by a specialist surgeon not involved in the study) or death.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for:
* Open colorectal surgery: hemicolectomy, pancolectomy, abdomino-perineal resection.
* Gastrectomy.
* Small bowel resection.
* Signed written informed consent.

Exclusion Criteria:

* Less than 18 years old.
* Laparoscopic procedure.
* Emergency surgery.
* Intra-abdominal infection.
* Patients not requiring ICU admission (patients should stay for at least the first day at the ICU).
* Life expectancy lower than 60 days.
* Disseminated malignancy.
Human Factors Usability Study of Ib2C Conception System

The purpose of this study is to obtain subjective feedback in a home use environment regarding usability and ease of use of the applicator and conception cap and the instructions for use. Data will be collected and evaluation to determine if the usability requirements of the conception system as determined by the usability specification have been met. The study will not involve sexual intercourse or delivery of any fluids to the cervix. The study will only involve use of the applicator to insert the cervical cap into the vagina, track it to the cervix and prepare and release the cervical cap (with removal string attached) onto the cervix. The conception cap will remain in place for no more than 6 hours.

The purpose of this study is to obtain subjective feedback in a home use environment regarding usability and ease of use of the applicator and conception cap and the instructions for use. Data will be collected and evaluation to determine if the usability requirements of the conception system as determined by the usability specification have been met. The study will not involve sexual intercourse or delivery of any fluids to the cervix. The study will only involve use of the applicator to insert the cervical cap into the vagina, track it to the cervix and prepare and release the cervical cap (with removal string attached) onto the cervix. The conception cap will remain in place for no more than 6 hours.

Eligibility Criteria:
Inclusion Criteria:

* Female, any ethnicity
* 20 - 45 years of age
* Sexually active
* Signed Informed Consent

Exclusion Criteria:

* Prior surgery to the cervix or vaginal tract
* Vaginal prolapse
* Cervical cancer
* Hysterectomy
* History of Toxic Shock Syndrome (TSS)
Early Infant Micronutrition and Development

Globally, vitamin B12 deficiency is one of the most common micronutrient deficiencies. Poor status is also seen in affluent countries such as in Norway. Vitamin B12 is crucial for normal cell division and differentiation and necessary for the development and myelination of the central nervous system. Deficiency is also associated with impaired fetal and infant growth. In the proposed study we will measure the effect of daily oral vitamin B12 supplementation infants on neurodevelopment. We also aim to measure the impact of B12 supplementation on several other outcomes.

Study design: Individually randomized double-blind placebo-controlled trial breastfed infants who will be assigned to a screening group (in which measurements will be obtained immediately) or a control group (in which serum will be stored and measurements done after one year).

Pregnant women will be informed about the study during their first antenatal visit at the clinic and that we will re-approach them on their 6-week visit to their public health nurse. Infants who are deficient will be treated with peroral or intramuscular injections with 400 µg cyano-cobalamin.

Infants in the control group will not be offered any intervention their blood sample will be stored for one year and then analyzed for the same nutrients as the intervention group.

Outcomes: Primary: (i) neurodevelopment in children measured at 12 months of age (ii) growth in children measured by attained weight and length at 12 months. Secondary: (i) neurodevelopment and cognitive functioning in children later in life


Eligibility Criteria:
Inclusion Criteria:

1. Availability of informed verbal consent
2. Plan to reside in the defined study area for the next 12 months
3. Mothers intend to breastfeed their children for at least 8 months, and exclusively for 4 months

Exclusion Criteria:

1. Severe systemic illness requiring hospitalization
2. Growth retardation
3. Severe congenital malformations
4. Plasma cobalamin concentration \<148 pmol/L (These children will be treated for vitamin B12 deficiency and not included in the RCT, but will be included in the cohort design)
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation

Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies). Patients who experience AKI after liver transplantation have higher mortality, increased graft loss, longer hospital and intensive care unit stays, and more progression to chronic kidney disease compared with those who do not. In this study, half of the participants will have their body temperature cooled to slightly lower than normal (mild hypothermia) for a portion of the liver transplant operation, while the other half will have their body temperature maintained at normal. The study will evaluate if mild hypothermia protects from AKI during liver transplantation.

This study is a randomized controlled trial of mild hypothermia during liver transplantation to provide protection from AKI. Participants will be randomized to normothermia (36.5-37.5 °C) versus mild hypothermia (34-35 °C) during a portion of the liver transplant operation. The protocol is based on preliminary data from rodent models showing that hypothermia protects the kidneys from ischemia-reperfusion injury, as well as studies in deceased organ donors showing that cooling improves post-transplant organ function. Temperature will be maintained with standard techniques plus a minimally-invasive esophageal cooling device that is approved by the U.S. Food and Drug Administration. The investigators hypothesize that mild hypothermia will reduce the incidence and severity of AKI after liver transplantation(LTx). Standard surrogates (e.g., change in serum creatinine, need for initiation of dialysis) and biomarkers will be used to assess the severity of kidney injury.

Eligibility Criteria:
Inclusion Criteria:

* Liver transplantation from a donor after neurologic determination of death

Exclusion Criteria:

* Liver transplantation from a donor after cardiac death
* Acute liver failure
* Living-donor liver transplantation
* Simultaneous liver-kidney transplantation
* Preoperative renal replacement therapy
* Preoperative intubation
* Portopulmonary hypertension
* Machine perfusion of liver graft
Pain Assessment Following Placement of a Percutaneous Radiologic Gastrostomy and Predictive Factors

A 12 months mono-center, descriptive study, to evaluate pain and predictive factors Following placement of percutaneous Radiologic gastrostomy (PRG).

The primary objective is to evaluate the abdominal pain associated with percutaneous radiologic gastrostomy (PRG) placement.

PRG is a pathway first of all enteral nutrition that has several advantages: local anesthesia, possible in case of esophageal stenosis, Rates of successful tube placement higher for radiologic gastrostomy than for percutaneous endoscopic Gastrostomy (PEG).

Abdominal pain following percutaneous radiologic gastrostomy (PRG) placement is a recognized complication. However, the prevalence and degree of severity of pain are poorly characterized. This pain often requires antalgic treatment.

The primary objective is to evaluate the abdominal pain from Baseline until 7 days after radiologic gastrostomy (PRG) placement.

The secondary objective is to evaluate predictive factors

Eligibility Criteria:
Inclusion Criteria:

* Needing a radiologic gastrostomy under local anesthesia
* Age ≥ 18 years old
* Read, write and understand the French language

Exclusion Criteria:

* Patient under guardianship, deprived of liberty, safeguard of justice
* Patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the questionnaires (at the discretion of the investigator)
* Refusal to participate in research
Endometrial Sampling (Pipelle)in IVF Patients

A prospective cross-over randomized study aimed to test the hypothesis that local injury of the endometrium increases the implantation rate in the successive cycle. Seventy IVF patients will be randomly selected to undergo either endometrial biopsies or minimal cervical scratch on days 8-10 and 21-23 of their cycle, preceding the IVF treatment. If not pregnant, the women will continue for another IVF cycle, preceded by endometrial or cervical scratch complimentary to their procedure in the first cycle. The main major outcomes will include pregnancy rate, implantation rate, endometrial thickness, abortion rate, live births and embryo quality.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing IVF treatment
* Repeated Implantation failure

Exclusion Criteria:

* PID or suspected PID
* Undiagnosed Irregular Bleeding
Safety Study of an Oral Vitamin D Analog in Postmenopausal Women

Determine the safety of 2MD, a vitamin D analog, when administered orally once daily for 28 days in healthy normal postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

1. Normal healthy postmenopausal women, ≥ 60 but ≤ 80 years of age, or between 45 and 60 years of age who have been amenorrheic for at least 2 years plus have a serum FSH level of \> 30 IU/L, or women with a documented bilateral oophorectomy at least 2 years prior to study start.
2. Within ±30% of their ideal body weight for height and body frame.
3. Demonstrated ability to understand and willingness to sign an Informed Consent Form.
4. 24-hour urinary Ca ≤250 mg/day and a urinary Ca:Cr ≤0.35.
5. Negative urine test for selected drugs of abuse.
6. Willing to maintain a total calcium intake between 700 and 1000 mg/day.

Exclusion Criteria:

1. Any acute or chronic condition that would limit the subject's ability to complete the study.
2. Active clinical manifestations of significant metabolic, hematological, pulmonary, hepatic, cardiovascular, gastrointestinal (including malabsorption), neurological, renal, urological or psychiatric disorders.
3. History or presence of any diseases known or believed to influence calcium absorption or metabolism.
4. History of renal calculi.
5. History of an eating disorder.
6. History of stomach or intestinal surgery.
7. History of hypersensitivity or allergies to any vitamin D derivative.
8. History or presence of an abnormal ECG.
9. Use of any medications or products affecting vitamin D metabolism within 6 months prior to study entry.
10. Use of any medications or products affecting calcium balance or bone turnover within 6 months prior to study entry.
11. Participation in any other investigational study drug trial in which receipt of investigational study drug occurred within 60 days prior to study entry.
12. Use of vitamin and/or mineral supplements \>1X RDI within 4 weeks prior to study entry, unless deemed acceptable by Investigator.
13. Poor peripheral venous access.
14. Receipt of blood products within 2 months prior to study entry.

    -
Repetitive Transcranial Magnetic Stimulation for Freezing of Gait

Freezing of gait (FOG) means that patients cannot walk without any known causes, other than parkinsonism, which is very disabling symptom. Patients descirbe their feeling of the feet suddenly being glued to the floor. Transcranial magnetic stiumation is a noninvasive procedure using electromagnetic induction to stimulate brain. Transcranial magnetic stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim of this study is to the therapeutic effect of rTMS for the FOG.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease or Primary progressive freezing of gait
* age 18 and older
* Freezing of gait

Exclusion Criteria:

* pregnant or any, other medical, surgical, neurological or psychiatric conditions
* other restrictions which prevent you from undergoing TMS recording, such as; surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), and/ or heart/cardiac lines
* any past or current history of seizure disorder or epilepsy
* unable to give informed consent
A Multicenter Cohort Study Assessing the Efficacy and Adverse Effects of HPV Vaccination in Chinese Women

Human papillomavirus (HPV) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, research has confirmed that carcinogenic HPV type continuous infection leads to a higher incidence of condyloma acuminatum and cervical cancer, while increasing the oropharyngeal cancer, vaginal cancer and other related cancer risk. HPV vaccines have been widely introduced worldwide to prevent cancers of the lower genital tract such as cervical, anal and vulvar cancers. For different types of HPV vaccine, divided into domestic bivalent, imported bivalent (GlaxoSmithKline), quadrivalent (Merck) and nine-valent (Merck) HPV vaccine, four vaccines all prevent HPV 16/18 high-risk type infection disease, and the four and nine-valent HPV vaccine prevention genotypes are different, and different price number of protection rates, vaccination objects and immunization procedures are slightly different. At the same time, studies have shown that women after HPV vaccine, arm redness, swelling, heat and pain have a high incidence of adverse reactions, often accompanied by menstrual disorders, sleep problems, emotional irritability, fever, dizziness, headache and other adverse reactions risk, so we plan to design a multicenter cohort study to evaluate the effectiveness of HPV vaccine with different prices. At the same time, the adverse reaction symptoms of HPV vaccine in the female population of appropriate age were monitored.

This study was led by the Fujian Provincial Maternal and Child Health Hospital, with the following research centers: Xiangya Hospital of Central South University, Fujian Provincial Center for Disease Control and Prevention, Shenzhen Maternal and Child Health Hospital, Hubei Provincial Maternal and Child Health Hospital, Shandong Province and Shaanxi Province. Recruitment was conducted in 6 provinces in different regions of China, and 2000 subjects were recruited in each province. A total of 12,000 subjects were recruited. Each subject was evaluated within 3 to 12 months after the last dose of HPV vaccine, and adverse reaction symptoms were queried by telephone follow-up and face-to-face. Peripheral blood 1 tube (3ml) was collected to detect the concentration of comprehensive antibodies to HPV vaccine. A multicenter cohort study was conducted to evaluate the effectiveness of HPV vaccine and to monitor the symptoms of adverse reactions to HPV vaccine in the female population of appropriate age.

Eligibility Criteria:
Inclusion Criteria:

- Female, aged 9-45; Get the last dose of HPV vaccine within 12 months.

Exclusion Criteria:

- Pregnancy or lactation during HPV vaccination; Those who refuse follow-up and informed consent.
Study to Assess Safety, Tolerability and PK of AZD1480 in Patients With Solid Tumours

This study is being conducted to assess the safety, tolerability and PK of AZD1480 in patients with advanced solid malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced solid cancer without available therapy in the escalation phase and mutation positive NSCLC or non-smokers with other primary tumors lung metastasis in the expansion phase
* ECOG Performance Status 0-1
* Evidence of post-menopausal status in females or males willing to use barrier contraception

Exclusion Criteria:

* Prior therapy with any JAK2 medications
* Significant lung disorder or lung disease. Previous radiation therapy to chest wall or chest infection requiring antibiotic treatment within 21 days before study screening. Evidence of significant pulmonary hypertension or COPD
* Eye disease of the cornea