cyrilzakka/clinical-trials huggingface dataset:
Observation of the Clinical Efficacy of Two Surgical Procedures for Varus Knee Osteoarthritis

The purpose of this study is to conduct a prospective randomized controlled trial to compare the effects between two surgical procedures in the treatment of varus knee osteoarthritis.The hypothesis was that there would be no difference in mechanical axis correction between two surgical procedures.

This was a single-center, prospective, double-blinded, randomized controlled trial, comparing two surgical procedures in the treatment of varus knee osteoarthritis. Participants were recruited from September 2019 to September 2021. Before initiating the trial, an investigator who was not involved in the study generated a computer-generated randomization list (block length 10, ratio 1:1). Allocation concealment was achieved by using opaque, sealed, sequentially numbered envelopes containing details of group assignment. Assignment occurred after baseline information was recorded. Whereas participants and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period. Operations were performed by the same team of sports medicine surgeons under general anesthesia.For the open wedge high tibial osteotomy group, Those who were randomly assigned to the OWHTO group, OWHTO Surgical procedure will be performed. For the closing wedge high tibial osteotomy group, hose who were randomly assigned to the CWHTO group, CWHTO Surgical procedure will be performed. The sample size calculation was based on data from previous studies. Accepting an α risk of 0.05 and a β risk of 0.2 in a bilateral contrast, the minimum sample size required for each group was 35. To compensate for an estimated 15% loss to follow up, at least 82 patients would be included.

Eligibility Criteria:
Inclusion Criteria:

The eligibility criteria for HTO were spontaneous osteonecrosis of the knee of the medial femoral condyle, medial compartment OA, Ahlbäck grades 1 or 2, femorotibial angle (FTA) of ≤185, flexion contracture of ≤15° , lack of damage to the anterior cruciate ligament (ACL) and posterior cruciate ligament, and no age restrictions .

Exclusion Criteria:

Congenital deformity of knee joint, severe rheumatoid arthritis, Charkoff's joint, injury of knee joint (injury of medial and lateral collateral ligament, patella fracture, etc.) or surgical history (meniscectomy, femoral or tibial fracture after surgery), large number of free bodies or soft tissue flexion contracture in the joint \>10º, and range of motion of knee joint \<100º.
Stromal Vascular Fraction (SVF) for Treatment of Recto-vaginal Fistula

The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the treatment of recto-vaginal fistula.

SF-12 Test

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Recto-vaginal fistula
* Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
* Crohn's disease diagnosed at least 3 months before accepting the clinical criteria

Exclusion Criteria:

* Presence of severe proctitis or dominant active luminal disease requiring immediately therapy
* Patients with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start
* Patients with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion
* Patients with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or patients with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years
* Patients with cardiopulmonary disease which, in opinion of the investigator, in unstable or sufficiently serious to exclude the patient from the study.
* Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
* Patients with congenital or acquired immunodeficiencies. HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) or treponema infection, whether active or latent
* Patients who have suffering major surgery or severe trauma in the prior 6 months
* Pregnant or breastfeeding women
* Patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug.
* Crohns Disease Activity Index (CDAI) Index above 200
A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms

Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal and genital) regions. This study will evaluate how well upadacitinib compared to placebo (no medicine) works to treat hidradenitis suppurativa in adult participants with moderate to severe disease. The study will assess change in disease signs and symptoms.

Upadacitinib is an investigational drug being developed for the treatment of HS. This study is "double-blinded," which means that neither the trial participants nor the study doctors will know who will be given study drug and who will receive placebo (no medicine). Participants are randomly (by chance) put into 1 of 2 groups, called treatment arms. They are randomized in a 2 to 1 ratio meaning more participants have a chance to receive upadacitinib compared to placebo.

Participants will undergo approximately 35-days of screening followed by a 48-week treatment period and a 30-day follow-up visit after the last dose of study drug for a total study duration of up to 57 weeks. The treatment period will consist of a 12-week placebo-controlled, double-blind period (Period 1) and a 36-week blinded extension period (Period 2).

There may be a higher burden for participants in this trial compared to their standard of care. Participants will attend visits every other week, once a month, or once every 2 months during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline.
* Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline, presence of HS lesions in at least 2 distinct anatomical areas, and draining fistula count of ≤ 20 at Baseline.
* History of inadequate response or an intolerance to adequate trial of oral antibiotics for treatment of HS.
* Required to use a daily antiseptic wash on HS lesions.

Exclusion Criteria:

-History of active skin disease (other than HS) that could interfere with assessment of HS, including skin infections requiring systemic treatment within 4 weeks of the Baseline visit.
Laparoscopy Versus Clinical Follow up to Detect Diaphragm Injury

Title: A randomized prospective study comparing non operative management with laparoscopic treatment in patients with a diaphragm injury following left thoracoabdominal stab wounds.

Aim of the Study: The aim of this study is to access the clinical outcome of potential occult diaphragm injuries in a group of patients presenting at the Groote Schuur trauma centre with left sided thoracoabdominal stab wounds, if an expectant non operative management course is taken.

Objects of the Study: To obtain the above mentioned aim the study will undertake;

* to do laparoscopy on a group of randomly selected patients with left thoracoabdominal stab wounds to obtain the incidence of occult diaphragm injury.
* to assess the incidence and clinical outcome of delayed diaphragm visceral herniation in the study group.


Eligibility Criteria:
Inclusion Criteria:

* Hemodynamically stable patients
* Patients with penetrating stab wounds bounded by
* Superiorly the 4th intercostal space
* Lateral the tip of the left scapula
* Inferior by the left costal margin
* Medially by the sternum
* Signed informed consent

Exclusion Criteria:

* Hemodynamically unstable patients
* Previous penetrating injury to the area mentioned under inclusion criteria
* Patients requiring early surgical exploration for injuries other than diaphragm injuries
* If a diaphragm injury is detected on imaging
* A positive pregnancy test
Double Crossover Casein Type Tolerance Trial

The investigators will recruit 45 fluid milk avoiding adults to participate in a five-week double-blind, double-crossover study in which the physiological responses to increasing doses of lactose-free (A1-rich milk), A2 milk, and lactose-free A2 milk will be explored.

Dairy provides essential nutrients and dairy products and are among the best quality and bioavailable protein sources available to humans. Milk protein allergy is extremely rare outside of childhood, and lactose intolerance is highly variable among ethnicities. Nonetheless, many adults avoid fluid milk and dairy products unnecessarily. Recent studies suggest that dairy intolerant individuals are having gastrointestinal reactions specifically to the bioactive metabolites (specifically, beta-casomorphin-7\[BCM-7\]) of casein protein subtype A1, and consuming milk void of A1 and rich in A2 casein alleviates symptoms.

The investigators will recruit 45 fluid milk avoiding adults to participate in a five-week double-blind, double-crossover study in which physiological responses to increasing doses of lactose-free (A1-rich milk), A2 milk, and lactose-free A2 milk will be explored. Enrollment assessments will include a comprehensive metabolic panel, diet history, and medical history questionnaires. Stool samples will be collected at the beginning and end of each of the 3 test phases (6 total samples per participant). Each test phase will last 6 days long, during which participants will receive increased doses of casein every 2 days.

On Day 1, participants will receive 50mg casein/kg/bw (\~125ml milk). On Day 3, participants will receive 100mg casein/kg/bw (\~250ml milk). On Day 5, participants will received 200mg casein/kg/bw (\~500ml milk). During test phases, breath hydrogen and methane will be measured every thirty minutes for three hours, and blood glucose will be measured every thirty minutes for two hours. Gastrointestinal symptoms will be assessed with visual analog scales for the following 24 hours. There will be a 7-10 day wash out period in between test phases.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18+
* Currently avoid liquid milk
* Can read and speak English

Exclusion Criteria:

* Diagnosis of milk protein allergy
* Diagnosis of Crohn's Disease, Ulcerative Colitis, Celiac Disease, or Peptic Ulcer Disease or Gastroparesis
* Using antibiotic or antiviral medications within 30 days prior to study start
* Undergoing chemotherapy, or using any investigational drugs within 30 days prior to study start
* Pregnant or lactating
Evaluation of Egg Consumption and Its Enrichment With Annatto on Cardiovascular Risk and Satiety in Healthy Adults

Healthy adult volunteers (n= 105; 18-59 years) were randomly allocated to consume daily for 8 weeks, either two whole eggs (egg group), two whole eggs added with annatto (annatto-enriched egg group), or two egg whites (control). Volunteers were asked to continue with the habitual physical activity and diet, except for the consumption of additional eggs, egg whites or annatto.

It is hypothesized that participants consuming eggs would have a less atherogenic lipid profile, feel more satisfied and increase antioxidant levels in blood, compared to the control group. Participants in the annatto-enriched egg group would have greater antioxidant capacity than the egg group and compared to control.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-59 years
* Body Mass Index (BMI): 18,5 - 29,9 kg/m2
* Healthy volunteers
* Good disposition to consume either eggs, egg whites or eggs added with annatto
* To have signed the informed consent

Exclusion Criteria:

* Fasting blood triglycerides \> 500mg/dL, Total Cholesterol \> 240mg/dL, glucose \> 126mg/dL or diabetes.
* Blood pressure: \>140/90 mmHg.
* History or having any of the following: liver, kidney, or heart disease, cancer, endocrine or gastrointestinal disorders -especially those that limit food absorption.
* Use of medications to lower blood lipids or glucose.
* Consumption of multivitamins or nutraceuticals.
* Plan to lose body weight, pregnancy or breastfeeding.
* Any known allergy or intolerance to eggs or annatto.
Cycle and Pregnancy Monitoring With Wearable Sensor Technology (AVA)

In this study physiological data is measured using wearable sensors as well as hormonal and ultrasound measurements of growing follicles/ ovulation in a group of endocrinologically healthy women with regular cycles, who aim for a spontaneous pregnancy. These women were recruited to generate reliable data on changes of the measured physiological parameters in a healthy menstrual cycle, as well as to evaluate physiological changes associated with early pregnancy.

All pregnancies beginning during the study period are to be monitored to their natural end, in order to evaluate how the same nine physiological parameters are changing during pregnancy, how strong the variations of the parameters during pregnancy are, and whether they could be associated with early onsets of pregnancy complications such as premature birth or pre-eclampsia. This will be highly valuable to develop study protocols for the specific evaluation of the screening potential of pregnancy complications.


Eligibility Criteria:
Inclusion Criteria:

* women aged 20-40 years
* regular menstrual cycle (28 days+/-)
* no hormonal therapy
* German-speaking
* written informed consent to participate in the study

Exclusion Criteria:

* any health-related issues that may affect menstrual cycle
* any consumption of medication or other substances that may affect the menstrual cycle or any of the physiological parameters investigated
* frequent travel between time zones
* sleeping disorders
* unsuccessfully trying to conceive for \> 12 months
Pruritus and Melanoma and Cutaneous Carcinomas Treated With Immunotherapy

Immune checkpoint inhibitors (ICIs) are commonly used in the therapeutic arsenal of metastatic melanoma, Merkel cell carcinoma and cutaneous squamous cell carcinoma, thanks to their inhibiting effects on cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA4) and anti-programmed death-1 (anti-PD1) respectively. These treatments can induce numerous cutaneous and non-cutaneous adverse effects that are mainly due to their immunological action. Their most frequent adverse effects are dysthyroidism, autoimmune hepatitis, colitis and skin disorders. Among those, pruritus is frequently reported as a side effect of these treatments. Its incidence has been estimated between 11% and 47%. Pruritus can deeply affect the patient's quality of life and may lead to treatment discontinuation. Until now, ICI-related pruritus has been poorly studied and it is not understood. In the literature, data on the presence and characteristics of pruritus in patients treated by ICIs were provided, without analyzing the causes of this pruritus. Indeed, it is not known if the occurrence of pruritus is related to direct or indirect effects of ICIs. Some authors reported a correlation between the occurrence of cutaneous adverse events under ICIs and the survival. The principal aim of our study was to analyze the putative causes of pruritus occurring in patients treated with ICIs for melanomas and cutaneous carcinomas. The other objectives were to assess the association between the occurrence of pruritus and survival, and between the other adverse events and pruritus.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years and older,
* treated with ICIs (nivolumab, pembrolizumab, ipilimumab, cemiplimab) for melanoma, squamous cell carcinoma or Merkel cell carcinoma
* not having formulated any opposition

Exclusion Criteria:

* age under 18 years,
* adults not legally competent,
* presence of pruritus at the inclusion,
* participation refusal
Regulation of Amygdala Via Neurofeedback in PTSD After Childhood Sexual Abuse

Post-traumatic stress disorder (PTSD) is a common debilitating disorder that affects many individuals exposed to aversive events. The severity of PTSD symptoms is positively correlated with amygdala activation. More severe PTSD symptoms following exposure to stressful events, are associated with amygdala hyper-responsivity prior to exposure. A possible intervention for PTSD is Neurofeedback (NF) - a treatment method based on learned self-modulation of neural activity in response to feedback of neural signal. Previous work in the investigator's lab established a NF training procedure that utilizes the temporal abilities of EEG with the spatial advantages of fMRI. Further work based on this method using the amygdala BOLD signal (EEG-finger-print, EFP) has demonstrated a potential for improving the ability to self-regulate amygdala activity and to improve emotional regulation in a healthy population. The current study aims to investigate the potential of this method as a therapeutic intervention for PTSD among men with a history of childhood sexual abuse (CSA).

Pretreatment phase- All participants will undergo clinician evaluation and self-report measures in TASMC. In addition, they will receive a WatchPAT (wearable technology) for tracking sleep for 2 nights.

Participants will receive 10 sessions of NF-EFP once a week for ten weeks. NF-EFP sessions: For the duration of each NF-EFP session the participant will be seated comfortably in front of a computer screen. A staff member will explain the goal of the meeting to the participant, present the equipment to be used and describe the course of the meeting. The EEG-NF practice will consist of four-minute segments repeated for up to 30 minutes. During each practice segment the participant will be asked to modify visual media that provides feedback on the degree of successful brain training. The duration of one session is approximately 45 minutes.

Post treatment phase -All participants will undergo clinician evaluation and self-report measures in TASMC. In addition, they will receive a WatchPAT (wearable technology) for tracking sleep for 2 nights.

Eligibility Criteria:
Inclusion Criteria:

Treated at Clinic for Sexual Assault with stable symptoms. Fulfill screening criteria of DSM-V for PTSD.

-

Exclusion Criteria:

* Fulfill screening criteria of DSM-V for psychosis. Substance dependence or abuse other than nicotine. Diagnosis of a neurodegenerative disease. Acute illness that could be worsen by the treatment. -
Immune Intervention With Rituximab to Preserve Beta Cell Function in Early Onset Type 1 Diabetes

Transient elimination of B lymphocytes with anti-CD20 monoclonal antibody would decrease immune-mediated destruction of beta cells and result in preserved beta-cell function in patients with type 1 diabetes of recent onset.

Although the presence of autoantibodies is a diagnostic criterion, the immunopathogenesis of beta-cell destruction in type 1 diabetes is typically associated with T-lymphocyte autoimmunity.

Many T-lymphocyte-mediated diseases include a B-lymphocyte component. B lymphocytes can play a crucial role as antigen-presenting cells, expressing high levels of class II major-histocompatibility-complex antigens and generating cryptic peptides to which T lymphocytes are not tolerant.

B lymphocytes can be selectively depleted with the anti-CD20 monoclonal antibody. We will test the hypothesis that transient elimination of B lymphocytes with anti-CD20 monoclonal antibody would decrease immune-mediated destruction of beta cells and result in preserved beta-cell function in patients with type 1 diabetes of recent onset.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of type 1 diabetes
* The age of subjects between 8 and 70 years old
* Course of disease within 12 months
* Presence of at least one type of detectable islet autoantibody \[zinc transporter 8 antibody(ZnT8A),glutamic acid decarboxylase antibody(GADA),protein tyrosine phosphatase-2 antibody(IA-2A),insulin autoantibody(IAA)\]
* Fasting C-peptide levels of at least 0.2 pmol/mL

Exclusion Criteria:

* Confirmed diagnosis of type 2 diabetes
* Severe chronic or acute complications of diabetes
* Severe infection or damage to the immune response
* Presence of chronic latent infection in vivo
* Viral hepatitis B patients whose hepatitis B virus(HBV)DNA \> log10\^5
* Liver and kidney dysfunction, alanine aminotransferase(ALT), aspartate aminotransferase(AST), and creatinine more than 2 times the upper limit of normal
* Hypotension, systolic blood pressure(SBP) ≤ 90mmHg, diastolic blood pressure(DBP) ≤ 60mmHg
* Patients with rheumatoid arthritis
* Allergic to any component of this drug
* Pregnancy, breast-feeding women
* Use of other immunosuppressive agents 3 months before selected
An Evaluation of Hip Preservation Outcomes

The purpose of this study is to assess outcomes of hip preservation surgeries including open and arthroscopic treatment of femoroacetabular impingement (FAI).

The purpose of this study is to assess outcomes of hip preservation surgeries including open and arthroscopic treatment of femoroacetabular impingement (FAI). Data will be prospectively and retrospectively collected on about 10,000 patients undergoing hip preservation at Yale-New Haven Hospital. Patients who are candidates for surgical intervention of the hip are potential participants.

The primary objective of this study is to determine whether hip arthroscopy reduces or improves post-operative outcome measures compared to pre-operative measures (including patient reported outcomes \[PROs\], revision surgery, conversion to total hip arthroplasty, and return to sport) in patients with FAI and labral tears.

The secondary objective of this study is to be able to better gauge (by assessments of patient satisfaction and psychometric thresholds of success) the progress made by recent advancements in arthroscopic hip preservation procedures with longitudinal follow-up.

The focus of this clinical trial will be the data collected prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for surgical intervention of the hip
* Participant and/or guardian has given informed consent and assent as applicable.

Exclusion Criteria:

* Documented history of pre-existing hip conditions (SCFE, LCPD, acetabular fractures)
* Has language or cognitive barriers preventing understanding of study and consent and assent documents
* Prior revision surgeries
* Patients from the trauma/emergency department
* Individuals with Unusable x-rays
Validation of a Seizure Monitoring System

The investigators aim to determine the feasibility of using the Medtronic LINQ device for epilepsy diagnosis, monitoring and management. The feasibility will be determined by comparing EEG signals from the LINQ system to the gold standard clinical recordings. If seizures can be identified using the LINQ device with the same level of accuracy as adjacent scalp EEG recording electrodes, then the LINQ will be deemed feasible.


Eligibility Criteria:
Inclusion Criteria:

* Patients with epilepsy

Exclusion Criteria:

* Women that are pregnant
* Patients that are highly dependant on medical care
* Patients that cannot give informed consent for themselves