cyrilzakka/clinical-trials huggingface dataset:
Study of NM8074 in Adult C3 Glomerulopathy Patients

This is a Phase Ib, open-label, dose-escalation study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 administered intravenously to patients with C3 Glomerulopathy.

The proposed study, NM8074-C3G-101, will enroll a planned number of 18 patients, with the potential to enroll more patients. There will be 3 cohorts with 6 patients each dosed at 5, 10, or 20 mg/kg depending on which cohort they are assigned to. Enrollment in the subsequent higher dose level cohort will occur after the previous cohort has been evaluated for safety.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 and ≤ 65 years at the time of consent
* Diagnosis of C3 Glomerulopathy as confirmed by C3 nephropathy in biopsy within 12 months prior to enrollment
* Reduced serum C3 levels (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening
* Patients with confirmed proteinuria
* Willing and able to understand and complete informed consent procedures, including signing and dating the informed consent form (ICF), and comply with the study visit schedule
* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative pregnancy test at screening and must agree to use highly effective methods of contraception during dosing and for 1 week after stopping of investigational drug
* Males must agree to use contraceptives and refrain from donating sperm for the duration of the study
* Patients must have documentation of previous vaccination or be willing to be vaccinated prior to dosing with NM8074. All patients will be vaccinated against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae according to the most current Advisory Committee on Immunization Practices (ACIP) recommendations.
* Estimated glomerular filtration (eGFR) rate of ≤ 60 ml/min but ≥ 20 ml/min

Exclusion Criteria:

* Use of other investigational drugs at the time of enrollment
* Patients with other renal diseases that would interfere with interpretation of the study
* Estimated glomerular filtration rate of ≤ 20 mL/min/1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) at Screening
* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal (xULN)
* Has a known history of meningococcal disease or N. meningitidis
* Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection that requires antibiotic, antifungal, antiparasitic, or antiviral mediations
* Temperature \> 38°C for more than two weeks prior to screening
* History of renal organ transplantation
* Pregnant, planning to become pregnant, or nursing female subjects
* C3G patients currently under complement blocker treatments
* Participation in any experimental small molecule or non-antibody therapy within 60 days prior to dosing on Day 1 (participation in observational studies and/or registry studies is permitted)
Efficacy of PD-1 Inhibitor Combination Therapy in Non-small Cell Lung Cancer Patients Who Have Not Achieved Major Pathologic Response After Neoadjuvant Immunotherapy: a Multicenter, Phase II Clinical Trial

Exploring the efficacy of PD-1 inhibitor combination therapy strategies for adjuvant therapy in a population that has not achieved major pathological regression after neoadjuvant immunotherapy for non-small cell lung cancer: a multicenter, phase II clinical study

This study explores the potential resistance problem in patients with low response rates after neoadjuvant ICIs treatment by addressing their potential resistance problems through an adjuvant immune combination regimen of ICIs, with the aim of providing a personalized choice of perioperative regimens for patients with early stage II-III resectable NSCLC, and to reduce the risk of postoperative recurrence and death in patients.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥ 18 years of age on the day of signed informed consent, male or female, and willing to follow study procedures;
2. ECOG score of 0 \~ 1;
3. Patients with resectable clinical stage II-IIIB (N2 only) NSCLC prior to neoadjuvant as assessed by the investigator (AJCC 8th ed.) and who are receiving 3 to 4 courses of standard PD-1 monoclonal antibody in combination with chemotherapy (platinum-containing two-agent chemotherapy) as neoadjuvant therapy during the neoadjuvant phase
4. Pathological evaluation of tumor for MPR (less than 10% residual tumor cells from the primary tumor) and specific remission rate (1 - residual tumor/primary tumor)
5. Subjects must have had complete resection of the NSCLC (no residual tumor and all surgical margins negative)
6. Histologically or cytologically confirmed squamous or non-squamous NSCLC.

Exclusion Criteria:

1. Subjects who have undergone segmental lung resection or wedge resection only, and subjects who have not undergone systemic or lobe-specific lymph node dissection;
2. Postoperative treatment with off-protocol antitumor therapy (e.g., radiotherapy, chemotherapy, targeted therapy, other immunotherapies, etc.; antitumor herbal therapies require a 2-week washout period);
3. Severe grade 3 or higher irAE or severe organ damage during neoadjuvant immunotherapy;
4. Previous history of allogeneic bone marrow or organ transplantation;
5. Previous or current interstitial pneumonitis/lung disease requiring systemic hormone therapy;
6. Uncontrolled hypertension (blood pressure ≥150/90 mmHg at rest), with antihypertensive medications maintained at a stable dose for 7 days prior to the first dose of study drug;
7. Combination of other malignant tumors within 5 years prior to the first dose of study drug that require active treatment, except for tumors cured in the opinion of the investigator;
The Impact of ESWT on Healing of Fractured Mandible

studying if using extracorporeal radial shockwave therapy as an adjuvant therapy help in accelerating the bone healing and regeneration in mandibular fractures by comparing it with the standard protocol for fractures fixation by plates and screws.

Firstly the patient heads to the operating room being placed in a supine position, generally anesthetized by the anesthesiologist.

Sterilization of intraoral and extraoral sites and draping has been installed. Intermaxillary fixation (IMF) screws has been inserted in case of there is no arch bar is used.

If the arch bar has been used it was inserted before the operation and being cut at the fracture line between the two segments.

The transoral or extra-oral approach is utilized to expose the fracture line separating the two segments.

Fixation of the bony segments with two plates one Compression 2.3 plate at the inferior border and Tension 2.0 plate five millimeter superiorly to the compression plate.

or even one 2.0 plate(champy) Then suturing the incision layers with vicryl 3/0. Postoperative evaluation with cone beam computed tomography (CBCT). These procedures will be done for both groups. The control group with no adjuvant intervention will stop at this point. The other intervention group will be subjected to shockwave by the usage of extracorporeal shockwave device at the third day postoperative.

Then follow up at the first and fourth month with another CBCT to compare the bone healing at the fracture site.

Eligibility Criteria:
Inclusion Criteria:

1 - Patients with age ranges from 18-75 years old. 2- Patients with fresh mandibular fractures (from zero hour till four or five days).

3- Patients free of systemic conditions that might affect or interfere with the healing process of bone segments or rather interfere with carrying out the surgical procedure (thyroid condition, rheumatoid arthritis, uncontrolled diabetes and osteoporosis).

Exclusion Criteria:

1 - Patients out of the specified range group 2- Patients who went previous operations with infection or malunion. 3- Patients with thyroid condition which affects the serum calcium level. 4- Patients with systemic conditions that might affect the bone health (osteoarthritis, rheumatoid arthritis, uncontrolled diabetes). 5- Patients with heart peacemakers.
Effectiveness of an Intervention Bundle on Thirst Intensity and Dry Mouth Among Patients in ICUs

The study evaluates the effectiveness of an Intervention Bundle on Thirst Intensity and Dry Mouth among Patients admitted in ICUs. Patients were randomized into two groups - Experimental and Control group. Experimental group received intervention Bundle whereas control group didn't receive any intervention. Usual care was continued in both the groups.

The Convenience sampling technique was used to select Maharishi Markandeshwar institution of Medical Science and Researches Hospital, Mullana, Ambala. Intensive Care Units and a total of 60 patients in those units were also selected conveniently. The selected patients were randomly assigned to experimental and control group using lottery method. The total sample size for the study was 60 patients i.e. - 30 in experimental group and 30 in control group.

Experimental Group -patients were explained regarding administration of intervention bundle.Assessment of patients' mouth and lips was determined firstly. Intervention bundle consisted of sterile cold wet oral swab wipes and sterile ice cold water sprays administered for in two sessions of 15 minutes each. First session was given in 15 minutes, patients received cold wet oral swab wipes in oral cavity 2 to 3 times and mouth spray with 5 to 6 sprays. A maximum of 9 wipes and 18 sprays of sterile water. After administration of intervention bundle, Post test 1 was taken after 15 minutes observation with the same tools. Then researcher waited for 15 minutes after post test1 and session two was administered in 15 minutes with a maximum of 9 wipes and 18 sprays of sterile water. Post test 2 was taken after 15 minutes of session two.

Control group: control group was not given any intervention. Sample characteristics and clinical data (variables) were recorded in record sheet and thirst intensity and dry mouth scores were assessed only. After 30 minutes of pre test scores, post test 1 was taken and data were recorded. Then after, 30 minutes of post test 1, post test 2 was taken and data were recorded.

(Intervention to the control group was given after accomplishment of Post test for ethical consideration).

Eligibility Criteria:
Inclusion Criteria:

1. 18 or above 18 years of age.
2. Having thirst score ≥ 5 and dry mouth score ≥ 1
3. Willing to participate in the study.
4. Able to report verbally or non verbally about thirst intensity.
5. Admitted in ICCU,Respiratory ICU, Neurosurgical ICU and step Up ICU

Exclusion Criteria:

1. On mechanical ventilation.
2. Not able to follow the commands.
3. Having any oral surgery
4. Having open sores or desquamation of mouth and lips
Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins

This study aimed to compare the efficacy of punctured electrocoagulation and sclerotherapy in the treatment of incompetent perforator veins.

Background: Incompetent perforating vein (IPV) is one of the important causes of persistent venous ulcers of lower extremities and recurrence after operation of varices which is a hot button issue worth discussing in clinical practice. Minimally invasive surgery has become the trend of IPVs' treatment. Currently, sclerotherapy can be performed to treat incompetent perforating veins, which showed a 90% occlusion rate after three or fewer sessions, the recurrence was present nearly 1/3 of cases. While electrocoagulation has a reliable effect on the closure of incompetent perforating veins and simplify treatment. No comparative studies of different PAPS modalities are currently available. Therefore, this study aimed to compare the efficacy of punctured electrocoagulation and sclerotherapy in the treatment of incompetent perforating veins. Methods:This study is a multicenter, randomized controlled trial. We will recruit 84 patients with IPVs from five hospitals. Moreover, these patients will be randomized to either the experimental group (electrocoagulation) or the control group (sclerotherapy). The primary outcome is incompetent perforating veins occlusion rate in the 12th month. Secondary outcomes are quality of life scale survey results (CEAP classification, VCSS score, CIVIQ-14 score), skin ulcer recurrence rate, deep venous Thrombosis, hemorrhage, all-cause mortality, and other vascular events and serious complications.Discussion:This study will provide reliable, evidence-based clinical evidence for the efficacy of electrocoagulation therapy for incompetent perforating veins.

Eligibility Criteria:
Inclusion Criteria:

(1) outward flow of less than 500 ms duration, with a diameter of \>3.5 mm; (2) According to the CEAP classification method specified by the International Venous Federation, patients with C4b\~C6 grades are included.

Exclusion Criteria:

(1)age \< 18 years or age \> 80 years; (2)with malignant tumors and life expectancy \< 1 year; (3)with past or current history of deep vein thrombosis and/or pulmonary embolism in the lower extremities; (4)with congenital venous malformations (K-T syndrome, arteriovenous fistula and etc.; (5)inability to walk, long-term braking, restrictive bed rest; severe ischemia of lower extremities or diagnosed severity of peripheral artery occlusive disease; (6)according to the researcher's judgment, it is not suitable for foam hardener and puncture coagulation treatment; (7)allergic to the drugs and equipment materials involved in the research; (8)with inferior vena cava and/or iliac vein stenosis or occlusion; (9)with autoimmune disease, receiving chemotherapy, hormone therapy or immunomodulatory treatment; (10)other underlying severe diseases; women who are pregnant, breastfeeding or have pregnancy plans during the study period; (11)the patient cannot cooperate to complete the inspection and follow-up required by the study.
MRI Guided HIFU for Palliation of Painful Skeletal Metastases in Children

The Philips Sonalleve MR-HIFU system is expected to be effective in reducing pain intensity and/or reducing analgesic use in patients with painful uncomplicated bone metastases. No serious adverse effects are expected to result from this treatment.

The objective of this study is to determine if MR-guided high intensity focused ultrasound (MR-HIFU) is an effective technique for alleviating the pain associated with bone metastases in paediatric cancer patients. This technique meant to be an adjunct therapy to the standard-of-care, which includes radiation therapy and chemotherapy. Safety of the technique will be assessed through evaluating non-targeted heating using MRI-based temperature mapping, and inspecting patients post-treatment for skin burns. or other signs of serious adverse events. Efficacy of the technique will be assessed by evaluating/recording patients observed pain, quality of life, and pain medication usage both before and up to 3 months following treatment.

Eligibility Criteria:
Inclusion Criteria:

* able to give informed consent
* weight \<140 kg (requirement to fit safely on top of the HIFU table and inside MRI
* any radiologic evidence of bone metastases from any solid tumor (neuroblastoma, osteosarcoma, soft tissue sarcoma, or any other solid tumor metastases).
* pain specifically at the site of interest (target lesion)
* pain score for target lesion \>/ = 4 (indicating at least moderate pain) on an age-appropriate 0-10 point scale
* Target lesion in uncomplicated (ie no fracture / spinal cord compression /cauda equine syndrome/ soft tissue component)
* Available 3D MRI image of the target lesion (or be able to obtain one in a clinically feasible amount of time as part of the baseline investigational stage.)
* Proposed MR-HIFU treatment date \>/= 2 weeks from most recent treatment of target tumour or systems chemotherapy
* Proposed MR-HIFU treatment date \>/= 1 week after administration of steroids for pain flare

Exclusion Criteria:

* Unable to characterize pain specifically at the site of interest (target lesion).
* Pregnant / nursing females
* Target lesion is complicated (ie pressure of one fracture /spinal cord compression/cauda equine syndrome/soft tissue component)
* Target lesion \< 1cm from nerve bundles/ bladder/bowel
* Target lesion in contact with hollow viscera
* Target lesion located in skull, spine (excluding sacrum which is allowed) or sternum.
* scar along proposed HIFU beam path.
* Orthopaedic implant along proposed HIIFU beam path or at site of target lesion.
* Active infection.
* Contradiction to general anesthesia or or gadolinium MRI contrast agent.
* Requirement for general anaesthesia for non -HIFU related MRI scans.
Xalacom And Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension

to compare efficacy and safety of Xalacom with the combination of unfixed Latanoprost and Timolol in subjects with open-angel glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* patients with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* closed/barely open anterior chamber angle or a history of acute angel closure glaucoma
* Ocular surgery within 3 months
Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis

The purpose of this study is to compare treatment with both teriparatide and raloxifene with teriparatide alone. The study will evaluate any side effects that may be associated with the two drugs and may help to determine whether teriparatide and raloxifene together can help patients with osteoporosis more than teriparatide alone.


Eligibility Criteria:
Inclusion Criteria

* Must be diagnosed with osteoporosis.
* Must be female, age 45 through 85.
* Must be at least 5 years postmenopausal.
* Must be free of other severe or chronically disabling conditions.
* Must be able to properly use injection device.

Exclusion Criteria

* Must not have bone diseases other than osteoporosis.
* Must not have history of certain cancers.
* Must not have certain medical diseases (inflammatory bowel disease, malabsorption syndrome, kidney or bladder stones, venous thrombi or emboli, recent vaginal bleeding due to unknown causes).
* Must not have taken or are currently taking certain types of medicines.
* Must not have known allergy to the study agent or SERM.
Postoperative Pain Therapy With Hydromorphone TCI-PCA vs. Morphine PCA

Treatment of postoperative pain with hydromorphone (a strong analgesic) using patient-controlled analgesia with target-controlled infusion compared to conventional patient-controlled analgesia with morphine after elective cardiac surgery


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Scheduled for elective cardiac surgery involving thoracotomy and subsequent ICU stay

Exclusion Criteria:

* Administration of other analgesics or sedatives, if not administered in stable dosages for at least 14 days or if not used for premedication and surgery
* Administration of hydromorphone or morphine in the period between screening and surgery
* Severe hepatic or renal impairment in medical history
* BMI\>= 35 ASA\>= 4
Aquatic Therapy for ASD

This is an aquatic occupational therapy group for children between the ages of 3-12 that have an autism diagnosis. Intervention will focus on increasing the child's safety swim skills.

Information will be collected from participants' guardians during an intake visit regarding a child's sensory processing deficits, movement abilities and exposure to swim skill instruction prior to the group. The group will provide swim instruction using the Halliwick approach to learning swim skills as well as other occupational therapy techniques such as shaping, therapeutic relationship and behavior management. Groups will have a minimum ratio of 1 staff to every 2 children, with the possibility of 1:1 ratio most days. There will be a certified lifeguard present at all times. Qualitative interviews and a follow up survey will be conducted with parents (ages 18+) to determine impact on families and individual participants. Swim skills will be tracked at each session via goal attainment scaling and daily documentation. Descriptive and correlational statistics will be completed as well as coding of interview and survey data. Participants can participate for one, 10 week session, or will have the option to participate in additional 10 week sessions until child participants top out on the WOTA or plateau in progress of swim skills.

Eligibility Criteria:
Inclusion Criteria:

* pre-existing diagnosis of autism spectrum disorder from a medical professional
* family interest in swimming

Exclusion Criteria:

* ventilation system for breathing such as trachea not capped
Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults

This study aims to evaluate the accuracy of automated sleep analysis by the Dreem dry-EEG headband and deep learning algorithm in comparison to the consensus of 5 sleep technologists' manual scoring of a gold-standard clinical polysomnogram (PSG) record in healthy adult volunteers during an overnight clinic-based sleep study.

The study will enroll 25 adult volunteers who will undergo a one-night in-lab sleep study. All volunteers are first prescreened over the phone. Upon arrival at the research center, volunteers provide informed consent, are interviewed to confirm eligibility, and complete a detailed demographic, medical, health, sleep, and lifestyle survey. After the survey, participants are fitted with the PSG and the Dreem headband by the sleep technologist. During the PSG sleep study, the Dreem headband records EEG, pulse, oxygen saturation (SO2), movement, and respiratory rate.

Dreem's algorithms will be used to automatically stage the Dreem sleep data, and the results will then be compared to the consensus of 5 sleep technologists' manual scoring of the respective PSG records for the same individuals to determine the accuracy of Dreem's sleep staging algorithms.

Eligibility Criteria:
Inclusion Criteria:

* Capable of providing informed consent

Exclusion Criteria:

* Pregnant or nursing females
* History of any severe comorbidities such as cardiac, neurologic, or psychiatric diseases/disorders in the last 12 months
* Morbid obesity (BMI \>= 40)
* Use of benzodiazepines, nonbenzodiazepine (Z-drugs), or Gammahydroxybutyrate (GHB) the day/night of the study
Expression of Fas Protein in Skin Biopsies of Participants With Scarring Alopecia

The purpose of this research study is to see if a specific protein that we are interested in is involved in scarring hair loss. If these proteins are involved, further genetic work may also better define the disease as well as future treatment options.

This is a single-center study, designed to evaluate the expression of Fas protein in skin biopsies of patients with scarring alopecia including fourteen patients with central centrifugal scarring alopecia (CCSA), three patients with lichen planopilaris (LP) and three patients with discoid lupus erythematosus (DLE). Skin biopsies of five healthy participants will be used as controls.

Eligibility Criteria:
Inclusion Criteria:

* Participants ages 30 years or older with a biopsy- proven diagnosis of CCSA.
* Undergone standard of care treatment for CCSA by a WFUSM Dermatologist
* Women of child bearing age will be required to have a negative pregnancy test in order to participate in the study
* Participants ages 30 years or older with a biopsy- proven diagnosis of LP.
* Participants ages 30 years or older with a biopsy- proven diagnosis of DLE.
* Healthy participants must be ages 30 years or older.

Exclusion Criteria:

* Age less than 30 years of age.
* Clinically evident bacterial or viral infection of the scalp.
* Pregnant or nursing woman of child-bearing potential.
* Participation in any other investigative research study involving study medication.
* Inability to return for the biopsy visit.