cyrilzakka/clinical-trials huggingface dataset:
Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease

The purpose of this study is to investigate the safety of a single dose of Lu AF82422, how well it is tolerated, how the drug effects the body and what the body does to the drug in healthy non-Japanese and Japanese subjects and in patients with Parkinson's disease


Eligibility Criteria:
Inclusion criteria:

Healthy subjects:

- Men and women ≥18 and ≤55 years of age with a body mass index (BMI) ≥18 and ≤32 kg/m2 (non-Japanese subjects) and ≥18 and ≤28 kg/m2 (Japanese subjects)

Patients with Parkinson's disease:

* Men and women with a clinical diagnosis of idiopathic Parkinson's disease, Hoehn and Yahn (H\&Y, stage 1-3)
* For a minimum of three months prior to enrolment, Parkinson's disease symptoms have been stable and is anticipated to be stable during the study duration as judged by the PI
* If on Parkinson's disease treatment the dose must be stable for a minimum of three months prior to enrolment and is anticipated to be stable during the study duration as judged by the PI
* ≥40 and ≤80 years of age
* BMI ≥18 and ≤35 kg/m2

Exclusion criteria:

* Atypical Parkinsonism
* Clinically relevant structural brain abnormality, as assessed using MRI
* Mild cognitive impairment, measured as a Montreal cognitive assessment (MoCA) score =\<21
* Any past or current treatment with an active vaccine targeting alpha-synuclein
* Any past or current treatment with a monoclonal antibody within the last 12 months

Other in- and exclusion criteria may apply.
Effects of Sleep Restrictions on Maximal Strength, Muscle Power, and Strength Endurance in Resistance-trained Women.

The study aims to see how acute sleep restriction will affect women resistance trainers. Above all, the investigators will be interested in observing the relationship between shorter sleep and athletic performance, as well as other important aspects, such as their level of motivation to exercise, how much pain participants felt during exercise and how demanding they found exercise. The investigators assume that differences in subjective measures (such as pain levels, motivation and mood) will be most apparent.

Participants would take part in two identical experimental sessions under two sleep conditions:

with sleep restrictions (SR), where will experience acute sleep restriction the night before the test session (i.e., 3 h of early sleep restriction versus normal sleep); with the control condition (CON), where participants will follow their habitual sleep-wake routines.

Every session would separated by a 1-week interval. The average sleep duration (CON) is going to be estimated by using actigraphy Motionwatch 8 for 5 days (from Monday to Friday).

Female athletes will receive accelerometers one day before experimental sessions. Participants will be asked to wear them on their non-dominant wrists from 8 p.m. to the next morning (experimental sessions day).

The participants would complete the morning session with a battery of physical tests, measuring several components of specific physical performance capacity and cognitive function.

During the experimental sessions, participants would be at the luteal or follicular phases excluding the period of bleeding (4-5 days) and the time immediately before planned bleeding (3 days before), because this can have a bad influence on sleep.

Eligibility Criteria:
Inclusion Criteria:

* a minimum of 3 years of training experience;
* practicing physical activity for the last 6 months at least 3 times per week for 2h
* current medical qualification for competitive sport

Exclusion Criteria:

* diseases that can have a bad influence on the menstrual cycle (e.g. polycystic ovarian syndrome, endometriosis);
* using hormonal contraception;
* regularity of the menstrual cycle.
* diagnosed cardiovascular, metabolic, gastrointestinal, or neurological diseases;
* movement, neuromuscular or musculoskeletal disorders;
* taking medications and supplements that may affect fitness test results;
* taking supplements that may affect biochemical test results
* sleep disorders
* PSQI \>5
Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus and Heart Failure With Preserved Left Ventricular Ejection Fraction

The purpose of this study is to evaluate the results of 99mTc maraciclatide scintigraphy in diabetic subjects with HFPEF. A maximum of 20 subjects with Diabetes Mellitus (DM) and Heart Failure With Preserved Left Ventricular Ejection Fraction (HFPEF) will be enrolled and imaged with 99mTc maraciclatide. In addition, a maximum of 10 subjects with DM and diastolic dysfunction but no diagnosis of heart failure (HF) will be enrolled and imaged with 99mTc-maraciclatide.


Eligibility Criteria:
Inclusion Criteria:

* The subject is between 18 and 80 years of age.
* The subject was diagnosed with DM type 2 based upon accepted clinical criteria and currently takes at least one diabetes medication.
* For HF subjects: The subject was diagnosed with HF with preserved EF within the previous 1 year, at which time LVEF was determined to be ≥45%.
* For comparison subjects: The subject was determined to have diastolic dysfunction on EKG within the previous year and currently has no signs or symptoms of HF.
* The subject has been clinically stable for at least 7 days prior to the study imaging procedures (e.g., not experiencing continuing chest pain, hemodynamic instability, worsening HF symptoms, or clinically significant arrhythmia).

Exclusion Criteria:

* The subject had an acute myocardial infarction within the past 30 days.
* The subject had a cardiac revascularization (e.g., percutaneous transluminal coronary angiography \[PTCA\], percutaneous coronary intervention (PCI), or coronary artery bypass graft \[CABG\]) within the past 30 days.
* The subject has severe renal dysfunction.
* The subject is claustrophobic or has a movement disorder that prevents him/her from lying still in a supine position for up to 20 minutes at a time.
* The subject has participated in a research study using ionizing radiation in the previous 12 months.
Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)

The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and abutments.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Patient indicated for an ear level bone anchored sound processor.
* Healthy bone quality to allow for 4mm implant insertion.

Exclusion Criteria:

* Intraoperative switch to an alternative surgical technique
* Patients undergoing re-implantation (on the side being included in the study)
* Previous participation in the C47 study.
* Inability to participate in follow-up.
* Psychiatric disease in the medical history.
* Mental disability.
* Presumed doubt, for any reason, that the patient will be able to show up on all follow-ups.
* Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
* Patients with natural skin height of \>12mm (as there will be additional skin reduction needed)
Packing Versus no Packing for Cutaneous Abscess

The goal of this study is to examine patients undergoing incision and drainage of cutaneous abscesses to determine if routine packing of the abscess cavity affects the need for further interventions such as repeat incision and drainage, antibiotic administration or hospital admission.

Study protocol:

1. Identification of a patient with a cutaneous abscess requiring incision and drainage
2. Written consent obtained from the patient
3. Study materials will be obtained

   * Enrolling physician fills out pre-procedure information (see data sheet)
   * Enrollment data sheet has instructions indicating whether patient is to receive packing or not

     * Use of random number generator to randomize all packets
   * Provider does abscess incision and drainage with or without packing according to the instructions
   * Enrolling physician fills out post-procedure information (see data sheet)
   * Patient returns within 48 hours for wound check with removal of packing if performed
   * Research coordinator or study physician calls the patient within 14 and 30 days after the procedure for follow-up

     * Information from a return visit and/or the telephone follow-up

Eligibility Criteria:
Inclusion Criteria:

1. All patients 18 years of age and above
2. Patients that require a cutaneous abscess incision and drainage
3. English-speaking subjects only

Exclusion Criteria:

1. Unable to return for 48-hour follow-up.
2. Patients being admitted to the hospital or going to the operating room for incision and drainage
3. Pregnant patients
4. Patients less than 18 years of age
5. Prisoners or persons in police custody
6. Patients with infected bursa
7. Non-English speaking subjects
Study on the Enhancement of Intestinal and Immune Functions Through Probiotic Intervention

Evaluate the effectiveness and safety of Bifidobacterium longum subsp. infantis BI45 as a food supplement compared to a placebo in improving intestinal and immune functions in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Willing to undergo 3 follow-up visits during the intervention period Be willing to provide blood, urine and stool samples 2 times during the intervention period
2. Willing to self-administer probiotic or placebo once a day during the intervention period
3. Good eyesight, can read and write, can wear glasses
4. Have good hearing and be able to hear and understand all instructions during the intervention

Exclusion Criteria:

1. Digestive diseases, mainly gastrointestinal diseases (celiac disease, ulcerative colitis, Crohn's disease)
2. Have a serious neurological condition (epilepsy, stroke, severe head trauma, meningitis in the last 10 years, brain surgery, brain tumor, prolonged coma - not including general anaesthesia)
3. Have received/are receiving treatment for the following mental disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder
4. Take medication for depression or low mood Internal organ failure (heart, liver or kidney failure, etc.)
5. Have received radiation or chemotherapy in the past
6. Have undergone a general anesthesia procedure/procedure within the past three years, or plan to undergo a general anesthesia procedure/procedure within the next 3 months during this trial period
7. Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past
Microfracture Combined With Suture Bridge Technique Versus Greenhouse Technique in Treating of Rotator Cuff Injuries

Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. The purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.

Arthroscopic rotator cuff repair has a high rate of successful subjective and functional results. Although the rate of tendon healing is reported to be around 80% for small tears, it can decrease to about 30% for large and massive tears. Poor tissue quality of bone, tendons, and muscles can affect healing and functional recovery of the rotator cuff and has been advocated as a major cause of tendon nonhealing and/or retear. Several biological augmentation procedures have recently been suggested to enhance tendon healing after Arthroscopic rotator cuff repair, such as marrow-stimulating technique with microfractures of the greater tuberosity. The purpose of this study was to introduce a new technique, "greenhouse technique", and to compare the clinical outcomes with microfracture combined with suture bridge technique.

Eligibility Criteria:
Inclusion Criteria:

* Medium-sized full-thickness rotator cuff tear confirmed during shoulder arthroscopy
* Between 20-65 years old

Exclusion Criteria:

* Bilateral rotator cuff tear
* Underwent ipsilateral surgery
* Large-to-massive rotator cuff tear
* Combined with Bankart, SLAP or AC lesion
* Combined with diabetes, smoking, immune disease, osteoporosis, and large nodular cystic degeneration
Monitoring of Multiple Sclerosis (MS) Participants With the Use of Digital Technology (Smartphones and Smartwatches) - A Feasibility Study

This prospective pilot study will assess the feasibility of remote participant monitoring using digital technology in participants with MS and healthy controls. At the enrollment visit, the participants as well as the healthy controls will be provided with a remote patient monitoring solution which includes preconfigured smartphone and smartwatch. The configured smartphone and smartwatch pair will contain application software that prompts the user to perform various assessments, referred to as active tests and passive monitoring. Active tests will include Hand Motor Function Test (HMFT), gait test, static balance test, electronic version of the Symbol Digit Modalities Test (eSDMT), Mood Scale Question (MSQ), MS Impact Scale (29-item scale) (MSIS-29) questionnaire, MS Symptom Tracking (MSST). Passive monitoring will be done to collect metrics on gait and mobility throughout the daily life of participants in a continuous and unobtrusive manner.


Eligibility Criteria:
Inclusion Criteria:

For MS Participants:

* Definite diagnosis of MS, confirmed as per the revised McDonald 2010 criteria
* Expanded Disability Status Scale (EDSS) of 0.0 to 5.5, inclusive

For All Participants:

* Weight: 45 to 110 kilograms (kg)

Exclusion Criteria:

For MS Participants:

* Severely ill and unstable participants as per investigator's discretion
* Change in dosing regimen or switch of Disease Modifying Therapy (DMT) in the last 12 weeks prior to enrollment

For All Participants:

* Pregnant or lactating, or intending to become pregnant during the study
A Trial of Skeletal Targeted Radiotherapy Using Holmium-166-DOTMP in Patients With Multiple Myeloma

Multiple myeloma is a disease that resides primarily in the bone and has shown to be sensitive to radiation. Administration of a radiotherapy agent that targets the bone, such as Holmium-166-DOTMP, in conjunction with melphalan and an autologous stem cell transplant, may improve the patient's chance of responding to treatment. The purpose of this study is to determine the amount of Holmium-166-DOTMP that localizes in the bone and in normal organs, and to evaluate the safety and efficacy of Holmium-166-DOTMP in the treatment of patients with multiple myeloma.

The purpose of this study is to estimate the radiation absorbed dose to the bone marrow and kidneys based on whole-body gamma camera image data for comparison with that obtained using mathematical models based on whole body counting from a small gamma detection device called a thyroid probe; to obtain pharmacokinetic data following administration of 166Ho-DOTMP; and to evaluate safety and efficacy in patients who receive 25 Gy targeted therapy of 166Ho-DOTMP and 200 mg/m2 melphalan followed by autologous peripheral blood stem cell transplant (PBSCT).

Eligibility Criteria:
Mostafa Maged Technique to Control and Prevent the Post-Partum Bleeding From the Lower Uterine Segment in Placenta Previa Cases

Post - partum haemorrhage is still a headache to all obstetricians around the whole world . Every obstetrician exerts his own full effort to control bleeding which can occur post-partum by applying all maneuvers to preserve the fertility and the uterus for the patient .

demonstration of ( Mostafa Maged ) technique is applied to control and prevent post-partum haemorrhage . It is so simple maneuver and easy to be applied within short period of time .Satisfactory hemostasis can be assessed after application .

1. pfannestiel incision .
2. dissection of the bladder downwards , and then making an incision in the lower segment of the uterus , then the uterus is evacuated from the fetus and placenta .
3. Ligation of the uterine arteries on both sides is applied before proceeding and after the extraction of fetus and placenta .

5) The lower segment was bleeding so trying to do bimanual compression of the anterior and posterior parts of lower uterine segments to test if Mostafa Maged technique is useful in these cases or not (( by observing if the bleeding is minimized or stopped or not by compression )) as if it is minimized so our technique has a high chance to be effective .

6) The whole technique depends on the anterior lower uterine segment by dividing the anterior lower uterine segment by an imaginary line in two halves , then , turning over (flipping ) the upper part of the lower uterine segment onto the lower part of the lower uterine segment from the inside of uterine cavity .

7) doing this turnover (flipping ) by the hands and holding the imaginary line by two Allis forceps and by making three knots by three needles in the lower edge of the uterine incision and entering the needles of (absorbable 70 mm rounded-bodied vicryl 1 ) simultaneously into the lower segment through the uterine cavity , at the same level of , the inside wall of lower uterine segment in order to drag the upper (half) part of the lower uterine segment on the lower part of lower uterine segment ( sandwich - like ) , and after this maneuver the bleeding is re-evaluated again .

8) Third , stitching the both sides of the flipped lower uterine segment by ( absorbable 70 mm rounded-bodied vicryl 1 ) , then doing plication of the anterior lower uterine segments to strengthen the wall of the flipped lower uterine segment and secure the tension .

9) Fourth , closing the caeserian scar by suturing the already-flipped lower uterine segment onto the upper uterine segment .

10) placing a drain in the doglus pouch

Eligibility Criteria:
Inclusion Criteria:

* pregnant primigravida patients with placenta previa
* 18 to 30 years old

Exclusion Criteria:

* patients with bleeding disorders
* smokers
* morbid obese patients
Peritoneal Irrigation at Elective Cesarean Section

All participants will be randomized at elective cesarean section to either irrigation with 500 to 1000 ml of warm normal saline after closure of visceral peritoneum or non irrigation

All participants will be randomized at elective cesarean section to either irrigation with 500 to 1000 ml of warm normal saline after closure of visceral peritoneum or non irrigation during the procedure of elective lower segment cesarean section

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Gestational age 36 - 40 weeks
* Elective Cesarean section
* Under spinal anaesthesia

Exclusion Criteria:

* Chronic diseases as Diabetes and hypertension
* Intestinal diseases as Crohn's disease
* Psychological and neurological conditions affecting pain sensation
* women with ferbrile morbidity before the operation
* The need for general anesthesia
Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma

Vessels that encapsulate tumor clusters (VETC) is an invasive metastatic factor in HCC independent of the epithelial mesenchyme transition (EMT), and VETC-positive patients have a higher rate of postoperative recurrence. How to improve the prognosis of this group of patients is an urgent issue to be addressed.

Previous studies have identified VETC as a new metastatic pattern independent of EMT that may be associated with immunosuppression as well as poor prognosis. Multiple retrospective studies find higher rates of postoperative recurrence, distant metastasis in VETC-positive patients. How to improve surgical prognosis in VETC-positive patients needs to be explored. There are no published studies on how to improve prognosis for this population. One of our unpublished retrospective studies found that VETC-positive patients receiving PD-1 monoclonal antibody was not effective in improving prognosis. However, PD-1 monoclonal antibody in combination with PD-1 monoclonal antibody effectively reduced postoperative recurrence and improved prognosis in VETC-positive patients. Based on our previous retrospective data, this multicenter prospective cohort study was designed to further validate and explore effective therapeutics.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75.
2. No previous local or systemic treatment for hepatocellular carcinoma.
3. Child-Pugh liver function score ≤ 7.
4. ECOG PS 0-1.
5. No serious organic diseases of the heart, lungs, brain, kidneys, etc.
6. Pathologic type is hepatocellular carcinoma.
7. Confirmation of the presence of VETC vascular pattern by CD34 immunohistochemical staining.

Exclusion Criteria:

1. Pregnant and lactating women.
2. Suffering from a condition that interferes with the absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, impaired absorption, etc.).
3. A history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood ++ or more, or gastroscopy if persistent fecal occult blood +) that has not been targeted, or other conditions that may have caused gastrointestinal bleeding (e.g., severe fundoplication/esophageal varices), as determined by the investigator.
4. Active infection.
5. Other significant clinical and laboratory abnormalities that affect the safety evaluation.
6. Inability to follow the study protocol for treatment or follow up as scheduled.
Preoperative Oral Supplementation With Branched-Chain Amino Acids (BCAA) Improves Postoperative Quality of Life

The aims of this study are (1) to study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery, and (2) To investigate the postoperative quality of life (QOL) in receiving peri-operatively branched-chain amino acids enriched nutrient-mixture in patients who undergone the hepatic management for hepatocellular carcinoma (HCC) with chronic liver disease.

Patients with cirrhosis of the liver complicated with HCC are often in a state of protein energy malnutrition. A limited number of studies have indicated an important role for nutritional support in the surgical management of patients who have undergone hepatic resection for HCC. In a preliminary study, we reported the clinical efficacy of supplementation with branched-chain amino acids in a small number of patients with liver cirrhosis who underwent hepatic surgery for HCC. The aims of this study are (1) to study the benefit of branched-chain amino acids enriched nutrient-mixture by analyzing a variety of clinical parameter, including laboratory data, the duration of hospitalization after the surgery, and (2) To investigate the postoperative QOL in receiving peri-operatively branched-chain amino acids enriched nutrient-mixture in patients who undergone the hepatic management for HCC with chronic liver disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent elective liver resection for the treatment of hepatocellular carcinoma or adenocarcinoma with chronic liver diseases.

Exclusion Criteria:

* Body weight loss greater than 10 per cent during the 6 months prior to surgery,
* The presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.
Day to Day Variation in Fetal Heart Rate Variability

This study evaluates the day-to-day variation in fetal heart rate variability based on non-invasive fetal-ECG (NI-FECG). Furthermore, the effect of fetal movements on fetal heart rate variability will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy singleton pregnant women with an expected healthy fetus

Exclusion Criteria:

* fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor. Low birth weight or malformation diagnosed at birth.