linjc16/ctgov huggingface dataset:
Sleep Apnea in Elderly Male Twins

Study Overview
=================
Brief Summary
-----------------
To conduct a genetic analysis of anatomic risk factors for sleep apnea in a well-characterized United States population-based registry of elderly male twins who have been successfully followed for the past 30 years.

Detailed Description
-----------------
BACKGROUND: The contribution of genetic factors to sleep disorders has been demonstrated in twin and family studies, and further understanding of the genetic underpinning of sleep disorders is considered an important area of research. Many of the suggested risk factors for sleep apnea (e.g.,craniofacial morphology, obesity) have genetic determinants. However, a formal genetic analysis of these anatomical risk factors with sleep-recorded physiological measurements has not so far been conducted. DESIGN NARRATIVE: The investigators recruited a subsample of pairs from the NAS-NRC World War II Twin Registry in which at least one of the twin brothers reported sleep apnea symptoms and a subsample of control pairs in which both twins reported no symptoms. They monitoring the subgroup of twin pairs with overnight sleep recording. They also collected anthropometric measurements of weight, height, neck circumference, and craniofacial morphology and blood samples for determination of zygosity and DNA extraction for future molecular studies. The twin design is most powerful for estimating the genetic and/or environmental overlap between physiological measurements such as sleep-recorded disordered breathing, obesity, and craniofacial morphology. The investigators chose to focus on an elderly male twin sample for which a wealth of data relevant to this study had been previously collected. Twin pair concordance or discordance for monitored sleep-disordered breathing allowed the full characterization of genetic/familial and individual environmental factors associated with the expression and severity of this condition. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Lung Diseases, Sleep Apnea Syndromes, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study of Patient Management in HIV-1 Infected Patients Found to Have the Genetic Marker HLA-B*5701

Study Overview
=================
Brief Summary
-----------------
This is a retrospective observational study which follows on from CNA106030 (a study evaluating whether prospective genetic screening for HLA-B*5701 can reduce the incidence of hypersensitivity reactions to abacavir). This study aims to collect data on approximately 35 subjects who withdrew from CNA106030 when found to be HLA-B*5701 positive. HIV disease management and adverse event data in these subjects, where the risk/benefit ratio of treatment with abacavir may alter subsequent prescribing, will be collected

Official Title
-----------------
A Retrospective, Multi-Centre Observational Study to Evaluate Disease Management and Adverse Events in Adult Subjects With HIV-1 Infection Who Were Withdrawn From CNA106030 Due to a Positive HLA-B*5701 Test Result

Conditions
-----------------
HIV Infection

Intervention / Treatment
-----------------
* Drug: No Intervention -- Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have received notification not to receive abacavir in the CNA106030 study because of a positive HLA-B*5701 screen result, and were subsequently withdrawn from protocol CNA106030. Subjects willing and able to understand and provide written informed consent prior to participation in this study. French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Exclusion criteria: Subjects who were not enrolled in the CNA106030 study Subjects who are not HLA-B*5701 positive Subjects who do not consent to being told their HLA-B*5701 status

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: No Intervention -- Observational study|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HLa-B*5701 Abacavir
Gonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome

Study Overview
=================
Brief Summary
-----------------
Efficacy of the use of GnRH antagonist in treatment of those who develop early-onset severe ovarian hyperstimulation syndrome and had cancelled embryo transfer

Official Title
-----------------
Gonadotropin Releasing Hormone Antagonist in Treatment of Early-onset Severe Ovarian Hyperstimulation Syndrome - a Randomized Controlled Trial

Conditions
-----------------
Assisted Reproduction

Intervention / Treatment
-----------------
* Drug: Cetrorelix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who develop early-onset severe ovarian hyperstimulation syndrome after controlled ovarian stimulation using long GnRH agonist protocol and hCG for triggering ovulation. Exclusion Criteria: Women on short or antagonist protocols. Women who received GnRH agonist for triggering ovulation. Women who had embryo transfer.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 42 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GnRHant<br>women who received GnRH antagonist | Drug: Cetrorelix<br> <br> |
| No Intervention: Control<br>women who did not receive GnRH antagonist | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of women who needed culdocentesis or paracentesis of the ascitic fluid |  | within 2 weeks of onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of women who needed hospitalization |  | within 2 weeks of onset of symptoms | 
| Time to regression of nausea/vomiting |  | within 2 weeks of onset of symptoms | 
| Time to regression of large ovarian size |  | within 4 weeks of onset of symptoms |
Retrospective Analysis of TEM and TEM-ESD for the Treatment of Rectal Adenomas and Early Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
We retrospectively analysed all TEM and TEM-ESD procedures that took place in Surgical Clinic of the Municipal Hospital of Karlsruhe and the Surgery Department of the University Hospital of Mannheim from 2007 to 2021. We evaluated the periopüerative and long-term outcomes of both procedures for adenomas, adenocarcinomas and other tumours seperately and we compared the results between the two techniques.

Official Title
-----------------
Retrospective Analysis of TEM and TEM-ESD for the Treatment of Rectal Adenomas and Early Rectal Cancer

Conditions
-----------------
Perioperative and Long-term Outcomes of TEM and TEM-ESD

Intervention / Treatment
-----------------
* Procedure: TEM / TEM-ESD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent TEM or TEM-ESD Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TEM-Group<br>All patients that underwent TEM | Procedure: TEM / TEM-ESD<br>* Transanal local excision of a rectal tumour as a conventional, full-thickness TEM or submucosal dissection as TEM-ESD<br>|
| TEM-ESD-Group<br>All patients that underwent TEM-ESD | Procedure: TEM / TEM-ESD<br>* Transanal local excision of a rectal tumour as a conventional, full-thickness TEM or submucosal dissection as TEM-ESD<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local recurrence |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| en bloc resection |  | 5 years | 
| complete en bloc resection |  | 5 years | 
| procedure time |  | 5 years | 
| perioperative morbidity |  | 5 years | 
| long-term adverse events |  | 5 years | 
| survival |  | 5 years |
Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to historical controls.

Detailed Description
-----------------
The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to historical controls. (Tey et al.) With this dose fractionation is used for bleeding, there is an increase in response rates from 55%(historical) to 75%for pain, there is an increase in response rates from 25% (historical) to 45% for obstruction, there is an increase in response rates from 25% (historical) to 45%

Official Title
-----------------
Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Radiation: Palliative Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proven adenocarcinoma of the stomach Treated with palliative intent At least one index symptom such as bleeding, obstruction or pain No prior abdominal radiotherapy Not on chemotherapy Exclusion Criteria: Patients treated with radical intent Previous abdominal radiotherapy Patients on chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy for gastric cancer<br>Single arm study | Radiation: Palliative Radiotherapy<br>* Palliative Radiotherapy to a total dose of 36Gy in 12 fractions<br>* Other names: palliation, radiotherapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response of bleeding to radiotherapy | Percentage of patients who do not require blood transfusion after radiotherapy | At the 12th fraction of radiotherapy and at one month post radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who develop anorexia, nausea, vomiting as per common toxicity criteria v3.0 | Toxicity | within the first 14 days from start of radiotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric Cancer, Radiotherapy, palliation, bleeding, pain, obstruction
A Study Investigating the Relationship Between the Development of Laronidase Antibody and Urinary GAG (Glycosaminoglycan) Levels in Aldurazyme® Treated Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the development of antibodies to laronidase in patients with MPS I receiving Aldurazyme® impairs the clearance of GAG substrate.

Official Title
-----------------
A Multicenter, Multinational, Open-Label Study of Anti-Laronidase Antibody Formation and Urinary GAG Levels in Patients With Mucopolysaccharidosis I (MPS I) Being Treated With Aldurazyme® (Laronidase).

Conditions
-----------------
Mucopolysaccharidosis I, Hurler's Syndrome, Hurler-Scheie Syndrome, Scheie's Syndrome

Intervention / Treatment
-----------------
* Drug: laronidase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a documented diagnosis of MPS I confirmed by measurable signs and symptoms and deficient α-L-iduronidase activity (<10% of the lower limit of normal). For a patients receiving Aldurazyme therapy prior to study entry: Have available as baseline data the results of urinary GAG levels and IgG antibody titers collected prior to the patient's first Aldurazyme infusion. Provide signed, written informed consent prior to any protocol-related procedures being performed. Consent of a legally authorized guardian(s) is (are) required for patients under 18 years. Exclusion Criteria: Have previously received Aldurazyme without the collection of baseline samples as specified. Have a suspected hypersensitivity to Aldurazyme or a know hypersensitivity to components of infusion solution. Have received a Hematopoietic Stem Cell Transplantation, injection fibroblast therapy, or major organ transplant. Are receiving chronic immunosuppressant therapy. Have a medical condition, serious intercurrent illness, or other extenuating circumstances that may interfere with study compliance including all prescribed evaluations and follow-up activities. Are pregnant or lactating Have received investigational drug within 30 days prior to study enrollment
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: laronidase|dose of 0.58mg/kg body weight IV every week|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary GAG (glycosaminoglycans) |  | Up to 4 years | 
| Immunogenicity Testing |  | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | Up to 4 years |
Mood and Cognitive Outcome After Heart Transplantation (the MOODHEART Study)

Study Overview
=================
Brief Summary
-----------------
The investigators aim at characterizing neuropsychiatric consequences of heart transplantation (HTX) and at assessing the impact of depressive symptoms after HTX on mortality and cardiac allograft vasculopathy (CAV).

Official Title
-----------------
Nevropsykiatri og Hjertetransplantasjon

Conditions
-----------------
Psychiatric Diagnosis, Cognition Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant in one of two former studies and heart transplanted at the time of inclusion into this former study Exclusion Criteria: Cognitively not capable to consent to participation and/or Insufficient fluent in the Norwegian language to complete both psychiatric and neuropsychological assessment
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants from former study 1<br>Surviving participants from a former study called 'Psykosomale faktorer hos pasienter med hjertesvikt og hos hjertetransplanterte' | |
| Participants from former study 2<br>Surviving participants, included at the Norwegian centre, from a study called 'Scandinavian Heart Transplant Everolimus De Novo Study with Early Calcineurin Inhibitor Avoidance (SCHEDULE)' (NCT01266148) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychiatric morbidity | Psychiatric diagnoses by clinician and self-rapport | At time of enrollment | 
| Cognitive function | Neuropsychological assessment | At time of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | Time since enrollment in former study; i.e. approximately 14 years (study 1) and approximately 3 years (study 2) | 14 and 3 years respectively | 
| Cardiac allograft vasculopathy | Time since enrollment in former study; i.e. approximately 14 years (study 1) and approximately 3 years (study 2) | 14 and 3 years respectively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac allograft vasculopathy, Psychiatric morbidity, Cognitive function, Heart transplantation, Mortality
Identification of Mutations Responsible for Rare Familial Skin Diseases by Next Generation Sequencing

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the protocol is to use next generation sequencing to identify pathogenic variants in genes involved in very rare skin diseases. The secondary purpose will be to study the genotype-phenotype correlation in order to re-evaluate the classification of these disorders. This work could help in the understanding of the physiopathology of very rare skin disorders.

Official Title
-----------------
Identification of Mutations Responsible for Rare Familial Skin Diseases by Next Generation Sequencing

Conditions
-----------------
Familial Lipomatosis, Very Rare Dermatologic Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients affected by familial lipomatosis patients with rare dermatologic disease without molecular diagnosis written informed consent is obtained from the patient and his/her family Exclusion Criteria: the patient does not want to participate to the protocol the patient is already included in another study using next generation sequencing technologies

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with a deleterious mutation | Validation of the exome sequencing results will be done by sanger sequencing | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exome sequencing, Skin disease, Familial lipomatosis
Tissue Donation for Myoblast Culture

Study Overview
=================
Brief Summary
-----------------
Analyze human skeletal muscle and learn more about the ability of adult muscle to produce myoblasts (young muscle cells).

Detailed Description
-----------------
Study the ability of healthy human skeletal muscle to produce myoblasts, and to determine how many cells would be needed to regenerate a certain section of injured muscle. As part of this research, we hope to gain a better understanding of the effect of age on muscle and how normal skeletal muscle can regenerate itself by producing myoblasts. The information gathered from this study will be specifically used in future research for treating Anal Incontinence.

Official Title
-----------------
Tissue Donation for Myoblast Culture

Conditions
-----------------
Observe in Vitro Characteristics of Muscle Tissue, Elective Obstetric or Gynecologic Surgery

Intervention / Treatment
-----------------
* Other: Tissue Donation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Age: 18 years of age or older Female Patients who are already electing to undergo obstetric or gynecologic surgery (either vaginal or abdominal) for a preexisting condition. Exclusion Criteria: - Active systemic or pelvic infections including HIV HBV HCV, STD, PID Patients with tumors, metastatic disease or treated with cytostatics Patients undergoing emergency surgical procedures Unconscious or mentally incapable to consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tissue Donation<br>This study will involve females over 18 who are scheduled to undergo elective surgery. These patients will be screened for participation in this study, which will only involve the collection of discarded tissue. | Other: Tissue Donation<br>* Females over 18 who are scheduled to undergo elective surgery will have discarded tissue collected.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cell expansion | The goal of this pilot study is to obtain small amounts of human skeletal muscle that would normally be discarded during gynecologic surgery and instead conserve this tissue for laboratory analysis. | weekly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elective obstetric or gynecologic surgery