cyrilzakka/clinical-trials huggingface dataset:
Effect of Topical Glaucoma Therapy on Tear Film Stability in Healthy Subjects

Long term treatment with anti-glaucomatous drugs has been shown to increase the incidence of dry eye syndrome with all known consequences such as ocular discomfort and epithelial keratitis. Given that thinning of the tear film appears to be a risk factor for the development or the aggravation of dry eye syndrome, the current study seeks to investigate whether tear film thickness is changed after topical treatment with anti-glaucomatous drugs in healthy subjects.

For this purpose, tear film thickness will be measured at baseline and after single instillation of one of 5 study drugs in one randomly chosen eye. In addition, one group of 20 subjects will receive no drug and will serve as a second control. Drug effects on tear film thickness will be compared to the fellow, non-treated eye. In addition, effects on tear film thickness of timolol with preservatives (Timoptic 0.5%) will be compared to timolol without preservatives (Timophtal sine 0.5%) and three lubricants with different viscosity (Genteal HA, Hylo-Comod, Thealoz).


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 years
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 6 Dpt.

Exclusion Criteria:

* Regular use of medication (except contraceptives), abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Patients with known hypersensitivity to the study drug or any ingredients
* History or current COPD or asthma
* AV-block grade II or more
* Ametropy ≥ 6 Dpt
* Pregnancy
Self-expandable Metal Stent (SEMS) Endoscopic Placement for Malignant Colonic Obstruction Therapy

Compare the effectiveness of Self-expandable metal stent (SEMS) and diverting stoma formation for the bowel preparation as a bridge to surgical treatment of patients with MCO.

Surgical treatment of MCO is associated with high mortality and frequent development of postoperative complications. Stoma formation is the traditional method of urgent treatment of MCO. Currently there are more than 150 methods of colorectal stomas formation, but all of themare associated with a high risk of complications (10-20%), inclusively both early and late postoperative period. It results in longerhospital stay and requires additional financial expenses, also reoperations can be fatal for patients.

Analysis of recent publications devoted to the treatment of MCO shows increasing implemented of new strategies of patents management, such as "fast track surgery", or "fast track recovery strategy" in clinical practice. Minimally invasive endoscopic procedures as a first stage of MCO treatment leads to transformation of previously performed multi-stage surgical interventions into one - stage.

Development of up-to-date endoscopic science and technology provides a wide usage ofself-expandable metal stent (SEMS) in clinical practice. This strategy helps to avoid stoma formation or emergency surgery, becoming a "bridge" to a radical surgery.

There are currently no studies directly comparing discharge stoma with endoscopic self-expandable metal stenting in preparation for colorectal cancer radical surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients are 18 years old or older
2. Stage I-IV according to TNM classification
3. Patients with malignant colonic obstruction
4. Overall health status according to ASA classification: I-III
5. Overall health status according to Charlson comorbidity index ≤ 8 points
6. Signed informed consent with agreement to attend all study visits
7. The patient is not pregnant

Exclusion Criteria:

1. Inflammatory bowel disease
2. Acute purulent process in the abdominal cavity
3. The patient wants to withdraw from the clinical trial
4. Loss to follow-up
"Monoclonal Antibodies for Treatment of Multiple Myeloma. Emphasis on the CD38 Antibody Daratumumab "

Daratumumab is a new treatment for patients with myeloma. While many patients benefit from this treatment some do not and the mechanism(s) of failure are poorly understood. This study aims to clarify aspects of resistance to treatment with daratumumab in order to improve patient outcomes in the future.

The effector mechanisms of daratumumab have been extensively studied in vitro, but the in vivo correlates and key determinants of success or failure when daratumumab is used alone or in combination with lenalidomide for treatment of patients with myeloma have not been clarified.

There is potentially a wide spectrum of factors that may influence the quality and duration of response following treatment with daratumumab. The integrity of the patient's immune system may be important. Prior lines of chemotherapy or the myeloma disease itself may impair humural (i.e. complement) or cellular (i.e. ADCC) effector mechanisms that are of importance for the response to daratumumab. Also intrinsic properties of the tumor cells or interactions between myeloma cells and the bone marrow microenvironment could make the myeloma cells refractory to daratumumab.

A better understanding of these variables may enable us to improve the quality and duration of daratumumab-induced responses and make daratumumab-based therapies more effective in the near future.

Eligibility Criteria:
Inclusion Criteria:

* Accepted for a clinical trial with Daratumumab for myeloma

Exclusion Criteria:

* None
Beyond Race: Objectively Assessed Skin Color and Its Association With Pulse Oximeter Bias in Critically Ill Infants

The overall objective of this proposal is to quantify the bias in pulse oximeter reported oxygen saturation (SpO2) by evaluating its measures compared to the gold standard blood gas measured arterial oxygen saturation (SaO2) across race and skin pigmentation. The main question that the investigators intend to answer is whether

1. There is greater pulse oximeter bias and subclinical hypoxemia in (1a) Black compared to White infants, and (1b) dark versus light-pigmented infants
2. This bias increases with gestational and postnatal maturation
3. This bias is associated with adverse patient outcomes

The study investigators will conduct a prospective observational study involving 200 infants (0-3 months age) and compare simultaneously obtained pulse oximeter readings (SpO2) and co-oximeter measured blood gas arterial oxygen saturation (SaO2), among infants identified as Non-Hispanic Black and Non-Hispanic White. The investigators will also obtain an objective assessment of skin pigmentation using a non-invasive device, SkinColorCatch® (by Delfin Technologies Ltd, Finland) that provides (1) a melanin index and (2) an objective six-point categorization of skin color based on Individual Typology Angle (ITA). Therefore, the investigators will measure the pulse oximeter bias (SpO2-SaO2) across infants identified as Non-Hispanic Black and Non-Hispanic White, as well as among infants of various skin pigmentation. For infants that have an arterial line for more than one week, the researchers will measure pulse oximeter bias (SpO2-SaO2) on a weekly basis over time with skin maturation and pigmentation changes.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Postnatal age less than 3 months corrected age
* Presence of an in-dwelling umbilical or peripheral arterial line
* Gestational age \>= 25 weeks

Exclusion Criteria:

* Known skin pigmentary disorders
* Significantly impaired skin integrity
* Systemic bruising due to birth trauma
* Circulatory shock within last 48 hours
* Infants of peri-viable gestation (22-24 weeks)
A Study of 1 8F-FDHT PET/MRIScans in Women With Breast Cancer

The purpose of this study is to see whether 18F-FDHT PET/MRI scans are an effective way of identifying AR-positive breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* ECOG performance score of 0-2
* Signed informed consent
* Histologically confirmed AR+ breast cancer

  * All participants under consideration for enrollment will have their tumor specimen tested centrally at MSK; nuclear AR staining ≥ 1% will be considered positive.
* Progressive metastatic breast cancer manifested as increase in evaluable disease OR the appearance of new sites of disease since the date of the last imaging study performed and under consideration for AR-targeted therapy
* Planning to undergo treatment with agents targeting the antiandrogen signaling pathway on a clinical trial

Exclusion Criteria:

* Life expectancy \< 3 months
* Pregnancy or lactation
* Participants who cannot undergo scanning because of

  * weight limits
  * devices or implants that are not MRI safe
  * allergies to contrast materials
* CNS only disease on recent imaging
Sleep and Depression in Induction of Labour

Randomised trial comparing double balloon catheter for induction of labor between inpatient and outpatient groups. The investigators assess how sleep disturbances and depression of the mother affect to the pain during balloon catheter induction of labour.

Participants included to this randomised study are women with uncomplicated singleton pregnancy with ≥ 37- ≤ 41+5 weeks of gestation. Participants are randomised to two groups: one hundred are randomised to the inpatient and one hundred to the outpatient group.

The main outcome measure is the pain evaluated by VAS at one, five , nine and 13 hours after the placement of double balloon induction catheter. The investigators assess also the effect of the sleep disturbance and depression of the mother to the pain during balloon catheter induction of the labour.

The total hospital stay and induction to delivery interval time is measured. Also the mode of birth as well as maternal and neonatal morbidity and patient satisfaction are recorded.

Eligibility Criteria:
Inclusion Criteria:

* uncomplicated pregnancy
* singleton pregnancy
* pregnancy weeks ≥ 37 - ≤ 41+5
* the patient is living in1/2 hour away from hospital

Exclusion Criteria:

* patient has a disease that is effecting to the pregnancy e.g. pre-eclampsia, gestational hepatosis
* the patient has medical treatment of diabetes
* baby is not growing normally
* multiple pregnancy
* preterm rupture of membranes
* earlier caesarean section
* the patient is living more than 1/2 hour away from hospital
Use of an Osteoconductive Scaffold in ACL-Reconstruction

Primary objective of the study is to evaluate efficacy of the surgical technique for ACL reconstruction using an osteoconductive scaffold, enlaced into the hamstring tendon autograft, compared to the traditional technique.

Reconstruction of the anterior cruciate ligament (ACL) using autograft tissue is currently recommended as the standard of care following an ACL tear or rupture, with the bone-tendon-bone (BTB) graft and hamstring tendon graft the most common. Although a BTB autograft is widely recognized to offer high mechanical performance and rapid graft healing, these advantages come at the cost of a longer surgery time and higher risk of severe patient discomfort at the graft harvest site. Use of a hamstring tendon autograft is less painful, but is generally slower to heal with higher risk of mechanical graft failure due to poor bone ingrowth. The aim of the current study is to augment graft-to-bone incorporation by use of an osteoconductive scaffold enlaced into the hamstring tendon autograft. This bovine derived composite bone substitute is inserted into the articular aperture of the femoral bone tunnel and should provide an osteoconductive / osteoinductive environment at a biomimetic attachment site leading to improved secondary graft-fixation and a reduced incidence of tunnel widening.

Primary objective of the study is to evaluate efficacy of the surgical technique for ACL reconstruction using an osteoconductive scaffold, enlaced into the hamstring tendon autograft, compared to the traditional technique.

Secondary objectives aim to assess the clinical outcome of the interventional treatment including patient subjective knee function and objective measures of knee stability.

Eligibility Criteria:
Inclusion

* Acute unilateral complete tear of the ACL that occurred within 18 weeks before planned surgery and requires reconstruction of the
* Informed consent as documented by signature

Exclusion Criteria:

* Prior ACL reconstruction or other surgical procedure on the affected knee.
* Prior fracture of the affected leg.
* Multi-ligament reconstruction.
* Previous or current ACL injury on contra-lateral leg.
* Medical condition or comorbidity that would interfere with study participation.
* The patient is mentally compromised.
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
* Other clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, etc.).
Precise Robotically IMplanted Brain-Computer InterfacE

The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 Robot device designs in participants with tetraparesis or tetraplegia. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.


Eligibility Criteria:
Inclusion Criteria:

* Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below
* Life expectancy ≥ 12 months.
* Ability to communicate in English
* Presence of a stable caregiver

Exclusion Criteria

* Moderate to high risk for serious perioperative adverse events
* Active implanted devices
* Morbid obesity (Body Mass Index \> 40)
* History of poorly controlled seizures or epilepsy
* History of poorly controlled diabetes
* Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
* Acquired or hereditary immunosuppression
* Use of smoking tobacco or other tobacco products
* Psychiatric or psychological disorder
* Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy.
* Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure
Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers

The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices. The study uses administrative claims data of the Medicare population implanted with single-chamber ventricular pacemakers. Patients are enrolled through submission of claims or encounter data to CMS.

Micra CED study is a study of the Medicare beneficiary population implanted with single-chamber ventricular pacemakers, and will be executed by analyzing administrative claims data. The study consists of two primary objectives: estimate the: (1) acute overall complication rate and (2) the 2-year survival rate of patients implanted with a Micra leadless pacemaker. As part of the secondary objectives of the study, a comparative analysis of Micra leadless pacemakers to single-chamber ventricular transvenous pacemakers will be conducted.

The analysis will be in CMS claims data and is subject to a central IRB. However, individual hospitals are not engaged in research and local IRB oversight is not necessary.

Eligibility Criteria:
Inclusion Criteria:

• Medicare beneficiaries implanted with a leadless pacemaker (CPT 0387T or 33274 or ICD-10 PCS 02HK3NZ) on or after the study start date will be included in the study.

or

• Medicare beneficiaries with implanted with a full system single-chamber ventricular transvenous pacemaker (CPT 33207 or ICD-10 PCS 0JH605Z or 0JH604Z and 02HK3JZ) on or after the study start date.

Exclusion Criteria:

• None
An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant

The main purpose of this study is to continue to see how vonsetamig works in the body and to monitor the outcomes after kidney transplant for participants previously treated in the R5459-RT-1944 study (NCT05092347).

No study drug will be given during this study.


Eligibility Criteria:
Inclusion Criteria:

1. Received at least 1 dose of treatment with vonsetamig in study R5459-RT-1944 \[NCT05092347\].
2. Received after acceptable crossmatching, a kidney transplant while enrolled in study R5459-RT-1944
3. Willing and able to comply with clinic visits and study-related procedures
4. Provide informed consent signed by study patient or legally acceptable representative

Exclusion Criteria:

1.There are no exclusion criteria for this study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply
A First-in-human Study of GENA-104A16 in Patients With Advanced Solid Tumors

This is a first in human phase I , open label study to evaluate the safety and tolerability of GENA 104A16 administered as a single agent by intravenous (IV) once every 2 weeks ( q2w (1 cycle = 2 weeks) in patients with advanced solid tumors, for who no standard therapy exists, or standard therapy has failed.


Eligibility Criteria:
Inclusion Criteria:

* Patient with histologically/cytologically confirmed unresectable, recurrent, or metastatic advanced solid tumors
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1
* Adequate organ function including hematological, hepatic, and renal functions.
* Negative childbearing potential
* Measurable disease as per RECIST v1.1 defined as at least 1 lesion
* Patients who are willing and able to comply with scheduled cycles, treatment plans, laboratory tests, and other procedures

Exclusion Criteria:

* A WOCBP who has a positive urine pregnancy test prior to treatment
* Received prior systemic anti-cancer therapy within 4 weeks or 5 half-life periods (whichever is shorter) prior to the first dose of treatment
* Received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis
* Received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention
* Currently participating and receiving study treatments or has participated in a study of an investigational agent and received the study therapy or has used an investigational device within 4 weeks prior to the first dose of study treatment
* Had an allogeneic tissue/solid organ transplant
* A diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
* A known additional malignancy that is progressing or has required active treatment within the past 3 years
* A known active CNS metastases and/or carcinomatous meningitis
* A known prior severe hypersensitivity reactions to monoclonal antibodies or any component in their formulation (Grade ≥3)
* An active autoimmune disease that has required systemic treatment in past 2 years
* A history of (non infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* An active infection requiring systemic therapy, or has received a course of antibiotics within 4 weeks prior to the first dose of treatment
* A known history of human Immunodeficiency Virus (HIV) infection
* A known history of Hepatitis B or known active Hepatitis C virus (HCV) infection
* Diagnosed with Gliosis through a brain MRI and has experienced neurological conditions within 6 months before the first administration
* Has any one or more clinically significant cardiovascular disease
* A history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the patients participation for the full duration of the study
GEBT Lot-to-Lot and Biological Variability

The purpose of this study is to collect information regarding lot-to-lot variability in 13C-Spirulina test meal lets and within-subject biological variability.

In this study participants will participate in one or two arms of the study. In one arm the participants will be administered GEBT tests that contain different 13C-Spirulina/Egg mix drug lots. In the second arm, the participants will be administered GEBT tests from the same 13C-Spirulina/Egg mix drug lot. All GEBT kit lots will be administered according to the FDA-approved labeling.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18-85 years old at time of signing the informed consent form
* Ability to eat test meal and provide breath samples

Exclusion Criteria:

* History or physical exam suggestive of systemic disease such as diabetes mellitus or pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease, or malabsorption.
* History of abdominal surgery except appendectomy
* Use of any medications that may alter gastric motility within two days of the study
* Use of narcotics or anticholinergics within two days of the study
* Females on hormone replacement therapy other than birth control medications
* Pregnancy
* Intolerance or allergy to any component of GEBT test meal
* History of neurologic or psychiatric disorders
Fluoroglutamine PET/CT in Imaging Patients With Malignant Tumor

This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-(2S,4R)4-fluoroglutamine, a glutamic acid derivative, to image patients with malignant tumor. \[18F\]Fluoroglutamine PET may provide additional information that help diagnose and stage cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-79;
* The patient must be able to give informed consent;
* Patients can finish PET/CT scan without tranquilizers;
* Patients with pathology-proven cancer or a tumor highly suspected to be malignant ;
* Lesions can be measured and assessed at the RECIST 1.1 standard;
* No chemotherapy, radiotherapy or immune/biologic therapy,or biopsy were allowed between the 18F-FDG and the 4-\[18F\]Fluoroglutamine PET/CT.

Exclusion Criteria:

* Pregnant or lactating patients;
* Inability or refusal to have at least one peripheral intravenous line for intravenous access;
* From assays obtained \<2 weeks prior to study enrollment（ULN：the upper limit of normal value ）:Bilirubin\>1.5\*ULN,AST/ALT \>2.5 \* ULN, Albumin\< 3 g/dl, GGT \> 2.5 x ULN if ALP\> 2.5 x ULN, Creatinine\>1.5\*ULN or creatinine clearance \<60ml/min；
* Patients with a history of allergic reaction to this drugs or its analogues；
* patients with poor compliance;
* Acute major illness
Respiratory Motion Correction of Cardiac Combined Positron Emission Tomography and Magnetic Resonance Imaging (PET/MRI)

This study evaluates the possibility of Magnetic Resonance Imaging (MRI) based respiratory motion correction of simultaneously acquired cardiac Positron Emission Tomography (PET) images.


Eligibility Criteria:
Inclusion Criteria:

* 18F-FDG injection for clinical diagnostic PET/MRI or PET/CT

Exclusion Criteria:

* Diet-suppressed myocardial uptake of 18F-FDG
* General exclusion criteria for MRI (i.e. metallic implants, claustrophobia, pregnancy, etc.)
* Not willing to be informed about incidental findings