cyrilzakka/clinical-trials huggingface dataset:
Nocturnal Hypoxia in Geriatric Patients After Hip Fracture

Delirium is a common complication following hip fracture surgery (HFS) in older people. Postoperative hypoxia has also been associated with delirium, but not specifically in geriatric patients. The aim of the study is to demonstrate that post-operative hypoxia is associated with in-hospital complications in patients with HFS.

Patients hospitalized in orthogeriatric unit after HFS will be monitored for nocturnal SpO2 with a pulse oximeter continuously during 3 nights. In-hospital complications will be recorded prospectively in all patients, especially the occurrence of delirium with the CAM scale. The hypoxia vs non-hypoxia (more than 20% of the time spent with SpO2\<90%) groups will be analyzed for clinical characteristics, comorbidities and medication use.

The statistical association between severe post-operative nocturnal hypoxemia and occurrence of delirium will be assessed. The dependance between this association and daytime SpO2 will also be assessed. The potential confirmation of an association between post-operative nocturnal hypoxemia in patients with HFS and the occurrence of delirium will lead the reflection on a clinical trial testing the benefit of oxygen therapy in the prevention of post-operative delirium, to improve the medical care of orthogeriatric patients.

Eligibility Criteria:
Inclusion Criteria:

* age over 70 years old,
* hospitalized in orthogeriatrics for hip fracture surgery
* information about the study and expression of non opposition
* Expected hospital stay of 5 nights or more

Exclusion Criteria:

* patient under guardianship,
* any other type of fracture associated,
* oxymetry recording not possible (behavioral disorders, night stirring,...)
The Effect of Dexmedetomidine of the Immune System

The goal of this research study is to learn about how dexmedetomidine (a standard of care sedative) affects your immune system (your defenses against cancer) by measuring your white blood cell levels before and after surgery.

Dexmedetomidine is a type of sedative used as part of anesthetic care. It is sometimes used to help lower the amount of pain killers and other anesthetics that are given to a patient during surgery. Researchers want to study how this drug works in cancer patients and review the patient's chart for pain levels and medication use after surgery. Part of this research involves studying the immune system of surgery patients.

If you agree to take part in this study, blood (about 1 tablespoon) will be drawn before you have surgery and the morning after surgery while you are still in the hospital. This blood will be used to learn more about how your immune system works.

After your second blood draw, your participation in this study will be over.

This is an investigational study.

Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

3.1.1 - Women undergoing unilateral mastectomy for malignancy at MD Anderson Cancer Center.

3.1.2 - Patients 18 years of age and older. There will be no upper age restriction.

3.1.3 - Patients must sign a study-specific consent form.

Exclusion Criteria:

3.2.1 - ASA 4

3.2.2 - Contraindication to the use of dexmedetomidine.

3.2.2.1. Decompensated congestive heart failure.

3.2.2.2. Second and third degree heart block.

3.2.2.2. Known allergy to dexmedetomidine or any of the medications used in the study

3.2.3 - Patients taking clonidine for treatment of arterial hypertension.

3.2.4 - Patients that are pregnant.

3.2.5 - Patients taking opioids at the time of surgery.

3.2.6 - Patients having plastic surgical reconstruction.

3.2.7 - Recent chemotherapy (\< 4 weeks).

3.2.8 - Active autoimmune or immunological disease including but not limited to systemic lupus erythematous, rheumatoid arthritis and Sjogren's disease

3.2.9 - Patient refusal to participate in the study.
The Role of Pelvic Peritonization in Laparoscopic or Robotic Low Anterior Resection

A randomized controlled clinical trial to compare the short and long outcomes of low anterior resection for middle-low rectal cancer with or without pelvic peritonization.


Eligibility Criteria:
Inclusion Criteria:

* Matching the diagnostic criteria of rectal adenocarcinoma
* Laparoscopic or robotic radical surgery for rectal cancer
* Preoperative TNM staging T1-3N0-2M0
* No history of malignant tumors by preoperative examination
* Middle and low rectal cancer
* Tumor size of 4 cm or less
* ASA 1-3 scores
* Written informed consent by the patient
* The patient is willing to randomize to any group

Exclusion Criteria:

* Previous abdominal surgery
* Past malignant tumor history
* Preoperative examination suggests distant metastasis
* Be participating or have participated in other clinical studies related to rectal cancer surgery within 6 months
* Emergency operation

Elimination criteria

* The tumor is confirmed to be T4b during the operation or other tumors are found to be combined with other tumors during the operation
* The anastomosis is located above the peritoneum reflex
* Intraoperative conversion to laparotomy
* Change the surgical method to perform Miles or Hartmann surgery
* Postoperative pathologically confirmed non-adenocarcinoma
* The patient asked to withdraw
Pupillometry Guided Remifentanil Administration and Total Opioid Consumption During Propofol - Remifentanil TCI

The aim of this prospective randomized study was to evaluate the impact of peroperative pupillometry monitoring on per and post-operative opioid consumption in major gynecological surgery. All patients were anesthetized with TCI of propofol and remifentanil. In the intervention group, peroperative remifentanil target was guided by pupillometry. In the other group, remifentanil was administered according to standard practice.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Elective gynecological surgery
* No ophtalmologic or neurologic disease
* No chronic analgesic medication
* Expected length of surgery 60 minutes minimum

Exclusion Criteria:

* ophtalmologic or neurologic disease
* chronic analgesic medication
Pharmacogenetic Study of Tacrolimus in Hepatic Transplant (CYPTAC'H)

The choice of an immunosuppressant after hepatic transplant is now more difficult than before because of the increasing number of drugs available.

Pharmacokinetic, pharmacodynamic and pharmacogenetic information can help to choose the best treatment and the best dose for each patient. The genetic polymorphism of enzymes metabolizing treatments can affect their efficacy and safety. Concerning tacrolimus, CYP3A5 activity is a major determinant of the dose needed to reach target concentrations. This study is aimed at evaluating the impact of both donor and recipient CYP3A5 genetic polymorphisms on tacrolimus exposure in patients with hepatic transplant.

Pharmacogenetics is a recent tool which could help to choose the best immunosuppressive therapy in patients with hepatic transplant. Indeed, the CYP3A5 gene has many polymorphisms and one of them, g.6986 A\>G, is the major determinant of the variability of expression of this protein. The allele \*1 (g6986A) leads to normal protein expression while the allele \*3 (g.6986G) causes lack of protein expression, and their different combinations induce a great variability in tacrolimus concentrations. As cytochromes are present in the liver and intestine, in hepatic transplant, tacrolimus exposure results from both recipient (enterocytes) and donor (liver) enzymes. Recent studies demonstrated a significant role of the genotype recipient on the dose/concentration relationship and on the dose needed to reach target concentrations. However, these studies were insufficient to analyze more precisely all impacts of this polymorphism because they did not include enough patients. The purpose of the investigators study is to evaluate the impact of donor and recipient CYP3A5 genetic polymorphism on tacrolimus exposure in patients with hepatic transplant after the first administration of tacrolimus and at 7 days post transplantation, when the dose has been adapted to avoid too high blood levels and to limit serious adverse reactions.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years) of Caucasian origin,
* with hepatic transplant,
* who are going to be treated by tacrolimus, and
* who gave free, well-informed and written consent.

Non-inclusion Criteria:

* Participation to another protocol incompatible with the study,
* HIV patients with antiretroviral treatment,
* Patients with legal guardianship or deprived of freedom.
Clomiphene Citrate in Combination With Gonadotropins for Ovarian Stimulation in Women With Poor Ovarian Response.

Coadministration of various drugs used for ovarian stimulation can increase the efficiency of IVF especially in poor responders. The investigators hypothesize that ovarian response of those patients could improve by using combination of clomiphene citrate with gonadotropins in infertile women with poor response to gonadotrophin administration only.

Patients diagnosed with poor ovarian response will be included in the study. The definition of poor response was based on the presence of at least one of the following criteria: Age \> 40 years old, day 2 FSH \>9.5 mIU/ml, AMH \< 2ng/ml ,at least one previous COH with less than 3 oocytes retrieved, at least one cancelled attempt due to poor response, estradiol less than 500 pg/ml on the day of HCG. All patients will be counseled regarding their prognosis and other treatment options including oocyte donation as well as adoption were also presented and discussed in detail. Early follicular phase FSH, estradiol (E2) and Anti-Mullerian Hormone (AMH) will be measured prior to the initiation of treatment. Women in the Clomiphene group will receive 100-150 mg of Clomiphene citrate once per day for 5 days in combination with gonadotropins according to short GnRH-antagonist protocol: all women will have measurements of serum FSH and estradiol and a pelvic sonogram on the second day of their cycle. Providing that serum FSH is \< 17 mIU/ml and estradiol is \< 70 pg/ml on day 2 , ovarian stimulation will be initiated with 100-150 mg of Clomiphene citrate in combination with 450 IU of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH. All patients will be re-evaluated on day 5 of the stimulation, and dosage adjustments will be made and the antagonists (Cetrorelix or ganirelix 0.25 mg/day) will be initiated. When at least 2 follicles reach an average diameter of 17 mm, final oocyte maturation will be triggered with 10,000IU of hCG ( Pregnyl, Organon, Greece Inc.). Oocyte retrieval will be performed 34 to 36 hours later. All patients will undergo ICSI. Patients with successful fertilization will have embryo transfer under sonographic guidance on day 3 after retrieval. Women in the Gonadotropin group will receive only gonadotropins according to short GnRH-antagonist protocol as it was mentioned above.

Eligibility Criteria:
Inclusion Criteria:

* Women with poor response to ovarian stimulation. The definition of poor response was based on the presence of at least one of the following criteria: Age \> 40 years old, day 2 FSH \>9.5 mIU/ml, AMH \< 2ng/ml ,at least one previous COH with less than 3 oocytes retrieved, at least one cancelled attempt due to poor response, estradiol less than 500 pg/ml on the day of HCG.

Exclusion Criteria:

* All other women that do not fulfill the above mentioned criteria
MOTIV8 - Treatment Motivation in Forensic Youth Treatment

This project entails to gain a deeper understanding of the development of treatment motivation over the course of intramural and outpatient forensic youth care. Research questions are 1) How does treatment motivation of youth and parents develop over the course of forensic systemic therapy, and following the transition from inpatient to outpatient therapy?; 2) Which client factors, interpersonal factors, and contextual characteristics moderate the development of treatment motivation?; 3) Which mechanisms play a role in the development of treatment motivation?; and 4) How does treatment motivation affect treatment retention and the achievement of primary therapy goals?

Multidimensional Family Therapy (MDFT) has been shown to motivate youth and parents in forensic care for treatment. The current study will investigate the development of treatment motivation of youth and parents over the course of MDFT, offered in a juvenile justice center. Furthermore, mechanisms and moderators will be examined, in addition to the impact of treatment motivation on treatment retention and goal achievement. Two studies with a Multiple Case Experimental Design (MCED), one with an ABC design (A = baseline, B = residential MDFT, and C = outpatient MDFT) and one with an AB design, will be conducted. Juveniles who enter residential MDFT, during a short detention period (study 1; 10 cases) or during a longer detention period (study 2; 6 cases) will be recruited, as will their parents.

Eligibility Criteria:
Inclusion Criteria:

- entering residential MDFT

Exclusion Criteria:

- (only for short term residents) residing more than an hours' drive from the juvenile justice center after detention
Abdominal Breathing Training on Reducing Anxiety

The research purpose is to investigate the effectiveness of abdominal breathing training on reducing anxiety. This study is an experimental research design. Using a randomized controlled trial approach. The patients receiving the intervention of abdominal breathing training were in the experimental group, while those who did not receive it were in the control group.

The aim of the study is to investigate the effectiveness of the abdominal breathing training on reducing anxiety. Using an experimental randomized controlled trial approach. The experimental group receiving abdominal breathing training, and control group without training. The effectiveness assessment used the Beck anxiety inventory, required to be completed by both the experimental group and control group. This study performed the pre-and-post assessments. This study performed the pre-test before the implementation of abdominal breathing training, and performed the post-test at Week 4 and Week 8 the end of abdominal breathing training. During this period, they received the abdominal breathing training at the outpatient clinic (every day 30 minutes, can include every time during the day). When the subjects were at home, they received self-training using the abdominal breathing training video (once every day and 30 minutes every time).

Eligibility Criteria:
Inclusion Criteria:

1. Who are over 20 years old.
2. The score of Beck anxiety inventory at lease of 8.
3. Agree to participate in the study and have filled out a written consent form.

Exclusion Criteria:

1. Inpatients.
2. COPD patients.
A First-in-Human Study of BG-C137, an Anti-FGFR2b Antibody Drug Conjugate, in Participants With Advanced Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 in participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed advanced or metastatic solid tumors.
2. Life expectancy of ≥ 3 months.
3. Prior standard systemic therapy in the advanced or metastatic setting. Dose Escalation: Participants for whom further standard treatment is not available, not tolerated or determined not appropriate based on the investigator's judgment. Safety Expansion and Dose Expansion: Participants who have received 1 or 2 prior lines of systemic therapy in the advanced or metastatic setting.
4. Participants must provide agreement for collection of archival tissue or recently obtained fresh tumor biopsy for central evaluation of FGFR2b expression levels and other biomarker assessments.
5. ≥ 1 measurable lesion per RECIST v1.1.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
7. Adequate organ function as determined per protocol.

Exclusion Criteria:

1. Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies.
2. Active or chronic corneal disorder, history of corneal transplantation, corneal keratitis, keratoconjuntivitis, keratopathy, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.
3. Spinal cord compression, or active leptomeningeal disease or uncontrolled, untreated brain metastasis.
4. Systemic antitumor therapy (including targeted therapy and immunotherapy ≤ 14 days, ≤ 28 days for immuno- oncological antibody, ≤ 14 days or 5 half-lives \[whichever is shorter\] for chemotherapy, ADCs, or investigational therapy) before first dose of study drug(s).
5. Toxicities due to prior therapy that have not recovered.
6. Any malignancy ≤ 2 years before first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively.
7. History of interstitial lung disease (ILD), noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen at baseline.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Remotely Monitoring Patients With Chronic Conditions in Their Home

Study will collect data from the home using the CoVa Monitoring System. Data will be captured and retrospectively analysis to determine if the data provided can alert clinician about a patient's declining health.

Study will collect data from the home using the CoVa Monitoring System. Data will be captured and retrospectively analysis to determine if the data provided can alert clinician about a patient's declining health. Data from the CoVa Monitoring System will be compared against electronic health records to determine if the data captured will provide insight into a patient's overall health. Additionally, user compliance will be monitored

Eligibility Criteria:
Inclusion Criteria:

* Chronic Disease including CHF
* Currently receiving home health care
* Recent discharge for a CHF event

Exclusion Criteria:

* Skin reaction to electrodes
* Inability to take measurements due to low BMI
Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia.

Anorexia and cachexia are devastating complications in late-stage cancer patients and is strongly associated with mortality in these patients. Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with anorexia and cachexia.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling patients ≥ 18 years of age with incurable,histologically diagnosed cancer.
* Involuntary loss of body weight of ≥ 5 % within the past 6 months

Exclusion Criteria:

* Presently hospitalized or in a nursing care facility.
* Inability to increase food intake from secondary causes.
* Liver disease
* If female-pregnant, breast-feeding or of childbearing potential.
SensAwake™ Sleep Quality Trial

The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. Upon sensing that the patient is awake the device is able to reduce positive airway pressure PAP aiming to improve patient comfort which should result in more consolidated sleep. This study will investigate Obstructive Sleep Apnea (OSA) and a automatically Adjusting Positive Airway Pressure (APAP) device with new technology called SensAwake™. This requires experimental confirmation in a randomised controlled trial. Double-blind randomised crossover trial comparing WASO on standard APAP with WASO using APAP modified by the addition of the SensAwake™ modification on consecutive nights in participants with moderate-to-severe OSA.

A total number of 45 participants will be recruited from an OSA population, aged 18-65. Participants will consist of male and female patients diagnosed with moderate-severe OSA (Apnea Hypopnea Index (AHI) greater than or equal to 15 per hour. Eligible participants, according to the protocol approved by the HREC, providing written informed consent will be enrolled into the study. Patients will be enrolled sequentially according to the randomisation list. Patients will be randomised to APAP or APAP with the addition of the SensAwake™ modification. The investigator and study staff will be blinded to the treatment of any participant.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years with moderate-to-severe OSA (Apnea Hypopnea index equal to or greater than 15 per hour).
* Epworth Sleepiness Scale (ESS) scores 0-15 inclusive (normal to moderately severe daytime sleepiness).
* Fluency in both written and spoken English.
* Do not have unstable psychiatric disease.
* No other significant sleep disorder.

Exclusion Criteria:

* Participants prescribed and fitted with any PAP device in the past 2 years.
* Unstable cardiovascular disease (untreated or resistant hypertension acceptable).
* Inability to tolerate CPAP due to nasal obstruction or claustrophobia as determined by the study investigator.
* Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease, history of non compliance to medical regimens, or unwillingness to comply with study requirements.
* Participation in another clinical trial in the previous month.
Effectiveness of Educational Intervention on Sustainable Breastfeeding: The GREEN MOTHER Project

Breastfeeding is the healthiest form of nutrition for the baby and is recommended to use exclusive breastfeeding (EB) until 6 months. The environmental footprint of artificial lactation (AL) has been studied, but that of EB is unknown.

Objectives:

The main objective of the first phase of the study is to identify the environmental impact in terms of the carbon footprint of breastfeeding and artificial breastfeeding, taking into account the accessories necessary for breastfeeding and of the diet and the factors associated with the diet of postpartum women in first month of life of the babies.

The main objective of the second phase is to evaluate the impact of a standardized intervention of educational programme on sustainable breastfeeding, diet and environment protection, providing inputs obtained from the first phase on the carbon footprint in the first month of life of the child and the prevalence of breastfeeding at the first month of the baby's life.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women over 16 years of age, between 24 and 32 weeks of gestation

Exclusion Criteria:

* women with a language barrier, under 16 years of age and those who do not want to participate or who do not give birth in the study associated centers